clinical research news for membersQuintiles has opened an expanded research facility at Guy's Hospital in London, increasing its Phase I capacity and extending its ability to drive progress in translational medicine. With capacity for 35 patients and healthy volunteers, the extension brings the total number of Phase I beds in London to 105 and globally to 385. “Declining productivity in research and development means that the biopharmaceutical industry is under intense pressure to increase efficiency and overcome complexity,” explains Eddie Caffrey, Senior Vice President, Global Phase I at Quintiles. “Effective early-stage development can have significant impact on speed and cost of the overall development process. Our customers need a holistic solution that combines fast and cost-efficient regulatory studies with advanced scientific expertise and techniques such as modeling and simulation, biomarkers and microdosing for more complex studies."http://www.icr-global.org/resources/news/?EntryId23=6830Thu, 11 Mar 2010 13:48:06 GMTThu, 11 Mar 2010 13:48:06 GMTThu, 11 Mar 2010 13:52:59 GMTKendle has announced it has received approval from Indian authorities to proceed with development of a new operations center in a Special Economic Zone (SEZ) in the upcoming Ahmedabad-Gandhinagar Knowledge Corridor. The new unit is expected to be operational by mid April. "Continued expansion throughout the Asia/Pacific region is crucial to the future growth of Kendle," said Stephen Cutler, PhD, Senior Vice President and Chief Operating Officer. "Our increased capacity in the region will allow us to better meet the growing demands of our customers who are seeking to capitalize on India's rapidly expanding high-quality biopharmaceutical capabilities. The new SEZ operations center will be ideally suited to deliver best-in-class services to our customers seeking high-quality, innovative and cost-effective solutions for their clinical development needs." http://www.icr-global.org/resources/news/?EntryId23=6829Thu, 11 Mar 2010 13:42:06 GMTThu, 11 Mar 2010 13:42:06 GMTThu, 11 Mar 2010 13:48:06 GMTKing’s College London has partnered with Pfizer to create an open innovation laboratory for pain research. As part of the partnership, a small team of Pfizer scientists will be based at the Wolfson Centre for Age-Related Diseases to conduct research in pain biology. This new partnership and the integration of the scientific teams will potentially lead to synergies in research strategies that deliver new ideas and innovations for healthcare and patient welfare. The initiative allows the College to pursue its commitment to translational research with partners of excellence and enables Pfizer to embed its scientists in a vibrant, academic research community.http://www.icr-global.org/resources/news/?EntryId23=6828Thu, 11 Mar 2010 13:32:51 GMTThu, 11 Mar 2010 13:32:51 GMTThu, 11 Mar 2010 13:42:05 GMTThe FDA has released new draft guidance on conducting non-inferiority clinical trials. Comments are due by May 30th. The guidance provides the FDA's interpretation of the underlying principles involved in the use of non-inferiority (NI) study designs to provide evidence of the effectiveness of a drug or biologic. The guidance gives advice on when NI studies can be interpretable, on how to choose the NI margin, and how to analyze the results.http://www.icr-global.org/resources/news/?EntryId23=6827Thu, 11 Mar 2010 13:25:21 GMTThu, 11 Mar 2010 13:25:21 GMTThu, 11 Mar 2010 13:32:51 GMTThe U.S. Food and Drug Administration and the National Institutes of Health have unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients. As part of the effort, the agencies will establish a Joint NIH-FDA Leadership Council to spearhead collaborative work on important public health issues. The Joint Leadership Council will work together to help ensure that regulatory considerations form an integral component of biomedical research planning, and that the latest science is integrated into the regulatory review process. In addition, the NIH and the FDA will jointly issue a Request for Applications, making $6.75 million dollars available over three years for work in regulatory science. The research supported through this initiative should add to the scientific knowledge base by providing new methods, models or technologies that will inform the scientific and regulatory community about better approaches to evaluating safety and efficacy in medical product development.http://www.icr-global.org/resources/news/?EntryId23=6826Thu, 11 Mar 2010 13:13:25 GMTThu, 11 Mar 2010 13:13:25 GMTThu, 11 Mar 2010 13:25:21 GMTOSI Pharmaceuticals Inc.’s status as one of the few U.S. biotechnology companies with income from an approved cancer drug likely will drive up the price Tokyo-based Astellas Pharma Inc. must pay to acquire it. Astellas launched a hostile take-over bid on March 1st, following previous negotiations during 2009. However, investors suspect that another bidder might emerge, driving up the price. http://www.icr-global.org/resources/news/?EntryId23=6825Thu, 11 Mar 2010 13:08:04 GMTThu, 11 Mar 2010 13:08:04 GMTThu, 11 Mar 2010 13:13:25 GMTAstraZeneca is to close its Charnwood with the loss of up to 1200 jobs. The site will close next year, although some of the affected staff will be offered the chance to transfer to other areas of the company. A smaller facility in Cambridge will also close. Part of the company's statement added "The proposed changes, first outlined at the end of January, include focusing research efforts on a smaller number of disease areas and consolidating activities on to a reduced global footprint through the merger of some sites." In a separate statement on its restructuring, AZ added that it will cease disease-specific research on drugs to treat thrombosis, acid reflux disease, ovarian and bladder cancers, systemic scleroderma, schizophrenia, bipolar disorder, depression, anxiety, and hepatitis C. It also said it end vaccine research other than for influenza and respiratory syncytial virus.http://www.icr-global.org/resources/news/?EntryId23=6823Thu, 11 Mar 2010 12:45:28 GMTThu, 11 Mar 2010 12:45:28 GMTThu, 11 Mar 2010 12:55:07 GMTRoche and Biogen Idec have announced their decision to suspend Ocrelizumab treatment of patients in the Rheumatoid Arthritis (RA) programme. The decision follows the recommendation of the independent Ocrelizumab RA & Lupus Data and Safety Monitoring Board (DSMB) based on their assessment of the studies in RA (SCRIPT, FEATURE, FILM and STAGE) and lupus (BELONG and BEGIN). The DSMB concluded that the safety risk outweighs the benefits observed in these specific patient populations at this time. The DSMB review detected an infection related safety signal which included serious and opportunistic infections, some of which were fatal. http://www.icr-global.org/resources/news/?EntryId23=6822Thu, 11 Mar 2010 12:42:21 GMTThu, 11 Mar 2010 12:42:21 GMTThu, 11 Mar 2010 12:45:26 GMTAbbott and Facet Biotech Corporation have announced a definitive agreement for Abbott to acquire Facet, enhancing Abbott's early- and mid-stage pharmaceutical pipeline in a deal worth $722m. The acquisition brings access to biologics in two key therapeutic areas, immunology and oncology. The compounds include daclizumab – a Phase II investigational biologic intended to treat multiple sclerosis (MS) that is expected to move into Phase III development in the second quarter 2010 – and oncology compounds in early- to mid-stage development. Daclizumab is being developed in collaboration with Biogen Idec and certain oncology compounds are being developed in collaboration with other parties.http://www.icr-global.org/resources/news/?EntryId23=6821Thu, 11 Mar 2010 12:36:36 GMTThu, 11 Mar 2010 12:36:36 GMTThu, 11 Mar 2010 12:42:20 GMTThe recently-announced Indian national budget has increased tax deductions for in-house company R&D from 150% to 200%. This has been widely welcomed by pharma, biotech and CRO companies, although some called for the incentives to go still further. However, the net effect on the Indian medicines industry is expected to be more neutral, as other tax changes and import duties on raw materials are set to increase the cost of manufacturing pharmaceuticals.http://www.icr-global.org/resources/news/?EntryId23=6820Thu, 11 Mar 2010 12:32:46 GMTThu, 11 Mar 2010 12:32:46 GMTThu, 11 Mar 2010 12:36:32 GMTAnyone needing to make a payment to the MHRA will need to direct it to a new bank account.http://www.icr-global.org/resources/news/?EntryId23=6730Thu, 25 Feb 2010 16:13:02 GMTThu, 25 Feb 2010 16:13:02 GMTThu, 25 Feb 2010 16:14:40 GMTThe MHRA has launched a section of its website specifically designed to help professionals in the pharmaceutical industry find what they need more easily. The page brings together links to the most relevant sections of the existing site, and other useful content.http://www.icr-global.org/resources/news/?EntryId23=6729Thu, 25 Feb 2010 16:08:22 GMTThu, 25 Feb 2010 16:08:22 GMTThu, 25 Feb 2010 16:13:00 GMTA group from Warwick University have published a report on the management, organisation and performance of clinical trials in the UK. The report demonstrates that there has been an overall improvement in the proportion of projects that complete within time over the last decade. However, this improvement is largely related to improvements in time to recruit patients, whilst the project set-up stage continues to be a significant challenge. There is a slight drop in the proportion of projects that reach the anticipated recruitment target expected from UK sites within agreed time frames. Projects led by pharmaceutical companies were more likely to complete on time and to patient recruitment targets, as compared to other projects led by commercial organisations and those led by non-commercial research groups.http://www.icr-global.org/resources/news/?EntryId23=6728Thu, 25 Feb 2010 16:04:24 GMTThu, 25 Feb 2010 16:04:24 GMTThu, 25 Feb 2010 16:08:19 GMTThe FDA is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor. A sponsor would be required to report this information to the appropriate FDA center promptly, but no later than 45 calendar days after the sponsor becomes aware of the information. This proposal is necessary because ambiguity in the current reporting scheme has caused confusion among sponsors. The proposed rule is intended to help ensure the validity of data that the agency receives in support of applications and petitions for FDA product approvals and authorization of certain labeling claims and to protect research subjects. Submit written or electronic comments on this proposed rule by May 20, 2010.http://www.icr-global.org/resources/news/?EntryId23=6727Thu, 25 Feb 2010 15:55:06 GMTThu, 25 Feb 2010 15:55:06 GMTThu, 25 Feb 2010 16:04:23 GMTGSK have announce the formation of a new standalone unit specialising in the development and commercialisation of medicines for rare diseases. Over 5,500 rare diseases have been identified of which less than 10% are currently being treated, presenting a significant unmet medical need. Despite the rarity of each condition, the number of diseases means that between 6-8% of the population may be affected by a rare disease. Many are genetic in origin, start in childhood and cause lifelong debility and premature death. Operating under a lean structure, Marc Dunoyer, GSK's President of Asia Pacific and Chairman of Japan, will lead this new operation, working closely with Patrick Vallance, GSK’s Senior Vice President of Drug Discovery. The new unit will seek to leverage existing capabilities and partnerships and establish further in-licensing opportunities.http://www.icr-global.org/resources/news/?EntryId23=6726Thu, 25 Feb 2010 15:52:02 GMTThu, 25 Feb 2010 15:52:02 GMTThu, 25 Feb 2010 15:55:05 GMTAbbott hass announced that it has completed its EUR 4.5 billion ($6.2 billion) acquisition of Belgium-based Solvay Pharmaceuticals, providing Abbott with a large and complementary portfolio of pharmaceutical products and expanding Abbott's presence in key global emerging markets. "The acquisition of Solvay Pharmaceuticals is a key part of Abbott's strategy to bolster our presence in key markets and deliver sustainable, industry-leading growth," said Miles D. White, chairman and chief executive officer, Abbott. "In addition to taking both Abbott and Solvay products into new and expanding markets, the acquisition enhances our R&D investment, providing Abbott with the opportunity to drive future pharmaceutical growth."http://www.icr-global.org/resources/news/?EntryId23=6725Thu, 25 Feb 2010 15:46:04 GMTThu, 25 Feb 2010 15:46:04 GMTThu, 25 Feb 2010 15:52:00 GMTThe U.S. Food and Drug Administration has issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies. “This final guidance on the use of Bayesian statistics is consistent with the FDA’s commitment to streamline clinical trials, when possible, in order to get safe and effective products to market faster,” said FDA Commissioner Margaret A. Hamburg, M.D. “This is a terrific example of regulatory science in practice at FDA.” The final guidance, titled “Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials,” describes use of Bayesian methods, design and analysis of medical device clinical trials, the benefits and difficulties with the Bayesian approach, and comparisons with standard statistical methods. The guidance also presents ideas for using Bayesian methods in post-market studies.http://www.icr-global.org/resources/news/?EntryId23=6724Thu, 25 Feb 2010 15:43:14 GMTThu, 25 Feb 2010 15:43:14 GMTThu, 25 Feb 2010 15:46:03 GMTSeveral of the biggest pharmaceutical companies are set to make major job cuts in new rounds of restructuring that have been announced in recent weeks. Merck & Co (MSD outside the US) is the latest to present their 2009 financial results and give notice of major changes to their workforce, reducing their 100,000 strong global team by 15 by 2012. This follows their merger with Schering-Plough, and consolidation of duplicate roles is expected to be the initial focus of changes. Also dealing with the aftermath of a mega-merger, Pfizer cut 4200 jobs in the final quarter of 2009 following its acquisition of Wyeth. This is part of a drive to remove $2bn of costs from the business. AstraZeneca and GSK have also announced continuing restructuring programmes expected to include the loss of thousands of jobs worldwide, as the industry as a whole tries to adapt to the post-blockbuster era. http://www.icr-global.org/resources/news/?EntryId23=6723Thu, 25 Feb 2010 15:27:19 GMTThu, 25 Feb 2010 15:27:19 GMTThu, 25 Feb 2010 15:43:12 GMTReporting their Q4 and full-year 2009 financial results, Kendle has experienced a 34% reduction in net operating income compared with 2008, mainly as a result of contract cancellations. In "an effort to balance staffing levels with customer demand and sales", the company will be reducing its staffing levels by an unspecified amount in the first quarter of 2010.http://www.icr-global.org/resources/news/?EntryId23=6722Thu, 25 Feb 2010 14:48:06 GMTThu, 25 Feb 2010 14:48:06 GMTThu, 25 Feb 2010 15:27:12 GMTMDS Inc. has signed agreements to divest its remaining MDS Pharma Services Early Stage business. Upon the close of the sale, MDS will have completed its strategy to reposition out of the clinical trials sector. The Early Stage Development operations, which consist of Phase I clinics and bioanalytical labs, and the company's development and regulatory services consultancy, will be sold to a new corporation primarily owned by Bain Capital Ventures and SV Life Sciences, two leading private investment firms with established holdings in life sciences. "We believe that the new corporation's combination of talented people, scientific excellence, and world-class facilities provides a strong foundation for future growth of the business, and we look forward to continuing to provide our clients with leading early-stage clinical development services," said Susan Thornton, Ph.D., Chief Executive Officer of the new corporation. http://www.icr-global.org/resources/news/?EntryId23=6721Thu, 25 Feb 2010 14:39:28 GMTThu, 25 Feb 2010 14:39:28 GMTThu, 25 Feb 2010 14:48:05 GMTDuring 2010, the Swedish Medical Products Agency (MPA) will be in head of a collaborative effort to improve the dissemination of knowledge about medicinal effects in clinical everyday life in Europe. The MPA will support networks within the EU as a successful working in the field of "drug effectiveness". The MPA has now taken on the task to form an Oversight Committee that will select a limited number of pilot projects in Europe, which are producing data of value for the assessment of drug effectiveness. The focus will be on the improvement of generation, collecting and sharing of data that can be useful for the care of patients as well as for research, regulatory and industry purposes. The knowledge gained from the pilot projects will be disseminated from the Oversight Committee by the internet and meetings. http://www.icr-global.org/resources/news/?EntryId23=6720Thu, 25 Feb 2010 14:36:42 GMTThu, 25 Feb 2010 14:36:42 GMTThu, 25 Feb 2010 14:39:27 GMTThe FDA has published a new draft "Guidance for Industry" document on "Adaptive Design Clinical Trials for Drugs and Biologics" for comment. The draft guidance gives advice on topics such as (1) what aspects of adaptive design trials (i.e., clinical, statistical, regulatory) call for special consideration, (2) when to interact with FDA while planning and conducting adaptive design studies, (3) what information to include in the adaptive design for FDA review, and (4) issues to consider in the evaluation of a completed adaptive design study. The consultation period on the document is for 90 days from publication.http://www.icr-global.org/resources/news/?EntryId23=6719Thu, 25 Feb 2010 14:32:04 GMTThu, 25 Feb 2010 14:32:04 GMTThu, 25 Feb 2010 14:36:39 GMTThe European Medicines Agency has launched a three-month public consultation on its Road Map to 2015, coinciding with its 15th anniversary. European and international partners, stakeholders, including patients’ and doctors’ organisations as well as pharmaceutical industry, and the public are invited to make their views known on the Agency’s future strategic vision, set out in the document ‘The European Medicines Agency Road Map to 2015: The Agency’s contribution to Science, Medicines, Health’. Comments should be sent using the Agency’s comments form by 30 April 2010 to roadmap@ema.europa.eu. Building on the achievements made by the previous Road Map initiative between 2005 to 2010, the focus of the new Road Map to 2015 is on continuous high-quality delivery of the Agency’s core business in an increasingly complex regulatory and scientific environment. In addition, the document proposes three priority areas for future actions to strengthen the Agency’s role in protecting and promoting human and animal health in the European Union.http://www.icr-global.org/resources/news/?EntryId23=6718Thu, 25 Feb 2010 14:30:32 GMTThu, 25 Feb 2010 14:30:32 GMTThu, 25 Feb 2010 14:32:00 GMTThe eventual election of the new European Commission has been completed, nearly 3 weeks after an initial vote. This new Commission sees the move of the pharmaceuticals unit (including responsibility for the European Medicines Agency) from DG Enterprise to DH Health, under the leadership of Commissioner John Dalli from Malta. It is still to be seen how much of an effect this change will have on policy on pharmaceuticals, the ongoing discussions around revising the Clinical Trials Directive etc. At present, websites are still in the process of being migrated, but the unit's website should eventually be located withing the Health section of the European Commission website (http://ec.europa.eu/health/index_en.htm).http://www.icr-global.org/resources/news/?EntryId23=6716Thu, 25 Feb 2010 14:02:57 GMTThu, 25 Feb 2010 14:02:57 GMTThu, 25 Feb 2010 14:30:31 GMTThe Netherlands' three top Institutes for life-science research (the BioMedical Materials program, the Center for Translational Molecular Medicine and Top Institute Pharma) have announced a joint investment of €28m on innovative research targeted at bringing personalized medicine closer to reality. The projects funded by the group will focus on developing new ways of delivering drugs to specific disease sites within the human body, thereby reducing the required doses, minimizing unwanted side effects and increasing the drugs' effectiveness. Together with the development of tailored drug therapies, the imaging guided and targeted drug delivery techniques that these newly funded projects aim to develop, are widely regarded as one of the keys to highly personalized medicine.http://www.icr-global.org/resources/news/?EntryId23=6715Thu, 25 Feb 2010 13:33:29 GMTThu, 25 Feb 2010 13:33:29 GMTThu, 25 Feb 2010 14:02:52 GMTAs part of their 2009 financial report, Swiss pharma company Actelion confirmed its intention to keep growing it's internal staff, counter to industry trends to jobs cuts and increased outsourcing. In the statement, which started with the announcement of an 8.6% drop in profits compared with 2008, the company said that it intends to keep growing its team in 2010, increasing global head-count by around 10% during the year. This follows a 15% increase during 2009.http://www.icr-global.org/resources/news/?EntryId23=6713Thu, 25 Feb 2010 13:25:26 GMTThu, 25 Feb 2010 13:25:26 GMTThu, 25 Feb 2010 13:33:26 GMTClinTec International has announced that it has achieved organic growth with a 45% increase in global sales revenues over the past twelve months; expanded its client base and signing new contracts with 11 of the world’s top 25 pharmaceutical firms. With a presence in some 40 countries around the world, ClinTec International manages clinical trials in all major therapeutic areas, including oncology, neurology, cardiovascular, respiratory as well as gastroenterology. It also has a wealth of experience in providing consultancy services in all aspects of quality assurance (QA), with ClinTec’s QA team having all held senior positions within quality and manufacturing operations in the pharmaceutical, biotechnology and medical devices industries. Dr Rabinder Buttar, the company’s founder, President and CEO commented: “ClinTec International is at the top of its growth metrics when compared to competitors. We have met the challenges of 2009 and indeed current projections point to the company’s growth in 2010 and 2011 being sustained to the same high levels.”http://www.icr-global.org/resources/news/?EntryId23=6532Wed, 03 Feb 2010 13:34:01 GMTWed, 03 Feb 2010 13:34:01 GMTWed, 03 Feb 2010 13:42:43 GMTAstraZeneca and Dako Denmark A/S announced today that they have entered into a collaboration agreement to develop companion diagnostic tests for multiple AstraZeneca oncology projects, including biologics and small molecules, in various stages of discovery and development. Under the agreement, the companies will work together to develop diagnostic tests to help physicians determine the most appropriate cancer treatment for patients. The financial terms of the deal were not disclosed. http://www.icr-global.org/resources/news/?EntryId23=6531Wed, 03 Feb 2010 13:20:00 GMTWed, 03 Feb 2010 13:20:00 GMTWed, 03 Feb 2010 13:34:01 GMTCaprion Proteomics Inc. has announced that it has acquired from PPD, Inc. the shares and assets of PPD Biomarker Discovery Sciences, LLC, PPD’s proteomics-based biomarker services division based in Menlo Park, Calif. The acquisition, which closed on December 31, 2009, further strengthens Caprion’s market leadership position in the area of proteomics biomarker services and will also broaden its client portfolio and revenue base. Financial terms of the acquisition were not disclosed. Caprion will perform existing contractual obligations acquired as part of this acquisition from both Caprion’s facilities in Montreal and from a new facility in Menlo Park that will operate under the name Caprion Proteomics, U.S., LLC.http://www.icr-global.org/resources/news/?EntryId23=6529Wed, 03 Feb 2010 13:05:28 GMTWed, 03 Feb 2010 13:05:28 GMTWed, 03 Feb 2010 13:20:00 GMTA charter has been launched as part of PREDICT ( Increasing the PaRticipation of the ElDerly In Clinical Trials, www.predicteu.org) project, supported by the EU, to investigate in/exclusion of older people from clinical trials. Research findings will be presented of systematic reviews of the literature, surveys with health professionals working with older people, and focus groups with patients and carers. The consortium starts from the issue that clinical trials need to take into account issues relevant to the ageing population, ie, changed metabolism, multiple chronic conditions and polypharmacy. The project is intended to promote the inclusion of the elderly in clinical trials in Europe and facilitate the improvement of the rights of older people and the quality of health care for the ageing population.http://www.icr-global.org/resources/news/?EntryId23=6527Wed, 03 Feb 2010 10:51:20 GMTWed, 03 Feb 2010 10:51:20 GMTWed, 03 Feb 2010 13:05:28 GMTSimon Jose, Senior Vice President and General Manager of GlaxoSmithKline (GSK) UK Pharmaceuticals, has been named as President Designate of the Association of the British Pharmaceutical Industry (ABPI). Simon will take over from current ABPI President, Chris Brinsmead of AstraZeneca (UK), on 28 April this year. He will serve for a one-year term, with the option for re-election for a further 12 months. “I am pleased to have the opportunity to represent our industry in the UK at such an important time for the pharmaceutical sector. The UK Government has recognised the importance of the life science industry. It is both an engine of growth to support economic recovery and a continuing source of new medicines and vaccines to help the NHS deliver improved health during a time of limited resources. Against this backdrop, the industry itself is going through a period of considerable and rapid change,” said Simon.http://www.icr-global.org/resources/news/?EntryId23=6526Wed, 03 Feb 2010 10:49:40 GMTWed, 03 Feb 2010 10:49:40 GMTWed, 03 Feb 2010 10:51:20 GMTScrip reports in detail on the political changes around health economics in Germany, and particularly the developments that have resulted in the replacement of Professor Peter Sawicki as director of Germany’s Institute for Quality and Efficiency in Health Care (IQWiG). Prof. Sawicki's sometimes-controversial views have brought him into conflict with the research-based pharmaceutical industry, which he criticised for its "pseudo-innovation". Scrip described the removal of Prof Sawicki as firing a warning shot across the bows of other healthcare institutions about the political influence and reach of pharmaceutical lobbyists, despite the current economic climate.http://www.icr-global.org/resources/news/?EntryId23=6525Wed, 03 Feb 2010 10:40:55 GMTWed, 03 Feb 2010 10:40:55 GMTWed, 03 Feb 2010 10:49:38 GMTAbraxis BioScience, Inc. has confirmed that it intends to spin-off the Abraxis Health division later this year. Abraxis Health will look to establish istelf as a next-generation, evidence-based, personalized healthcare company based on validated co-diagnostics and bioinformatics. "By spinning off Abraxis Health as an independent, stand-alone company, we believe we will enhance the intrinsic value of both companies by allowing each company to pursue its differing drug development and commercialization strategies," said Patrick Soon-Shiong, M.D., Executive Chairman of Abraxis BioScience.http://www.icr-global.org/resources/news/?EntryId23=6524Wed, 03 Feb 2010 10:35:42 GMTWed, 03 Feb 2010 10:35:42 GMTWed, 03 Feb 2010 10:40:52 GMTIn the narrative discussing AstraZenenca's full year results for 2009, CEO David Brennan reported an increase in operating profits of 24%, based on cost containment on a revenue increase of 4%. AZ expect to continue their "focus on externalisation" (ie, outsourcing) and are embarking on initiatives "designed to achieve material efficiency savings in R&D". This is expected to impact on around 3500 positions and lead to a net reduction of 1800 employees. This restructuring is expected to be completed by 2014, with more than 50% to be addressed by 2011.http://www.icr-global.org/resources/news/?EntryId23=6523Wed, 03 Feb 2010 10:07:42 GMTWed, 03 Feb 2010 10:07:42 GMTWed, 03 Feb 2010 10:35:40 GMTMedpace, a privately held, global, full-service clinical research organization is pleased to announce that it has acquired Medical Consulting Dr. Schlichtiger GmbH, a European CRO with extensive drug development expertise providing customized regulatory and pharmacovigilance services to pharmaceutical, biotechnology, and nutritional companies of all sizes based in Munich, Germany. Medical Consulting will add strategic expertise to Medpace in terms of providing centralized European hubs for regulatory submissions and approvals as well as drug safety management and reporting. "I am pleased to have Dr. Schlichtiger join the Medpace team to support our growing presence in the European drug development market as Managing Director and Senior Director of Medical and Regulatory Affairs, Europe." said Dr. August Troendle, President and CEO, Medpace. "Dr. Schlichtiger has built a reputation in Europe as a distinguished professional having founded Medical Consulting in 1989 and building the company into an organization widely recognized for their successful interaction with European governmental agencies."http://www.icr-global.org/resources/news/?EntryId23=6522Wed, 03 Feb 2010 10:03:59 GMTWed, 03 Feb 2010 10:03:59 GMTWed, 03 Feb 2010 10:07:41 GMTPPD, Inc. is celebrating 25 years as one of the world's leading contract research organizations, building upon its strong foundation and history of helping clients deliver safe, effective medicines to patients. Founded in 1985 as a one-person consulting firm by Fred Eshelman, PPD went public in early 1996. Over the past 25 years, PPD has strengthened its services, technologies and geographic reach through acquisitions and organic growth to meet growing client demand. Today, PPD employs more than 10,500 professionals with 85 offices, clinics and labs in 40 countries. "From day one, our commitment at PPD has been to deliver exceptional service, consistent quality and innovative ideas that help our clients and partners achieve their research and development goals," said Eshelman, executive chairman of PPD. "We take pride in what we have achieved in our first quarter century and salute our employees who consistently bring expertise, dedication and a passion for doing what's right for our clients, patients and sites."http://www.icr-global.org/resources/news/?EntryId23=6521Wed, 03 Feb 2010 10:01:47 GMTWed, 03 Feb 2010 10:01:47 GMTWed, 03 Feb 2010 10:03:59 GMTAs Dr. Frank Rockhold assumes the position of Chair, CDISC Board of Directors, this month, CDISC would like to formally congratulate Paula Brown-Stafford on being voted as the new Chair Elect of the CDISC Board. Paula has more than 20 years experience of working in the Pharmaceutical and CRO industry. She has worked closely with the CDISC standards and has ensured that Quintiles has devoted time and energy to their implementation within the organization. She has also served as head of the Board Financial Oversight Committee for the Board for the past two years and will continue in this role. Dr Edward Helton, who served as Chair for the past two years, is now Past-Chair and head of the Board Governance Committee. In addition, following a rigorous process of selection, CDISC is pleased to announce that two highly qualified individuals will be added to its Board of Directors for a three year term (2010-2012). Dr Steven Hirschfeld and Wayne R. Kubick will have now been welcomed to the CDISC Board.http://www.icr-global.org/resources/news/?EntryId23=6520Wed, 03 Feb 2010 09:57:35 GMTWed, 03 Feb 2010 09:57:35 GMTWed, 03 Feb 2010 10:01:47 GMTA study reveals the existence of a significant "operational gap" between long-range planning and project-level metrics – a gap that hampers informed decision-making. Fully 76% of survey respondents said they are under increasing pressure to improve portfolio management efficiency, yet 87% of those surveyed complained that they lack visibility to key project-level operational metrics for use in long-range planning and for proactively shifting portfolio direction. Further defining the challenge the industry faces in long-range planning, two years ago only 7% of respondents had to manage to a 5% acceptable variance on their portfolio budget. Today that number has climbed to 33% of respondents, with 67% now needing to stay within 10% of target. "You can’t fix what you can’t see," observed ClearTrial CEO Mike Soenen in assessing these findings. "How do companies expect to bring portfolio budgets within 5% or 10% variance if they don't have visibility to the activities that drive that variance? This inability to roll up study-level operational forecasts into the portfolio forecast means that companies are not working with current information -- and will only increase the margin of error in long-range planning."http://www.icr-global.org/resources/news/?EntryId23=6518Wed, 03 Feb 2010 09:46:06 GMTWed, 03 Feb 2010 09:46:06 GMTWed, 03 Feb 2010 09:57:34 GMTIndia will have an extensive regulatory system for clinical trials in place over the next 18 months, under which regular random on-the-spot inspections will be carried out from July 2010, according the Drug Controller General of India Surinder Singh, speaking at a conference.http://www.icr-global.org/resources/news/?EntryId23=6441Fri, 15 Jan 2010 11:26:37 GMTFri, 15 Jan 2010 11:26:37 GMTFri, 15 Jan 2010 11:34:30 GMT"The underlying theme of my work will be Patients First, Consumers First", John Dalli, Commissioner-designate for Health and consumer policy told MEPs during his hearing, prior to a vote by the European Parliament on the entire proposed Commission, to take place on January 26th. In a potentially significant change, the European Commission's Pharmaceuticals Unit will move from DG Enterprise to DG Sanco (under Mr Dalli) if the proposed new Commission is approved. Replying to a question by Marina Yannakoudakis (ECR, UK), on how to strike a balance between the needs of the patients and the industry, he said that he wanted to put patients first, but that this did "not exclude a strong commitment that the pharma industry remains competitive". He agreed with Glenis Willmott (S&D, UK), that the health perspective needs to be paramount but added that it would be possible eventually to achieve a "win-win situation". To put forward the patient's perspective he would rely on MEPs and patients' organisations, which "should be properly supported". There was a need for new ideas for funding them, he added in a reply to Peter Liese. http://www.icr-global.org/resources/news/?EntryId23=6440Fri, 15 Jan 2010 11:04:02 GMTFri, 15 Jan 2010 11:04:02 GMTFri, 15 Jan 2010 11:26:37 GMTThe FDA has issued draft guidance on "IRB Continuing Review after Clinical Investigation Approval." The guidance document is now available from FDA's website. This draft guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations. The draft guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review. When finalized, this document will supersede the Information Sheet, Continuing Review After Study Approval (September 1998, Office of Health Affairs, Food and Drug Administration). http://www.icr-global.org/resources/news/?EntryId23=6439Fri, 15 Jan 2010 11:03:15 GMTFri, 15 Jan 2010 11:03:15 GMTFri, 15 Jan 2010 11:04:02 GMTThe NIHR CRN Coordinating Centre provides quarterly performance metrics on the delivery of closed Industry studies plus a range of metrics on the current Industry portfolio. The latest set of data was compiled on 18 November 2009. 342 Industry studies have been adopted into the NIHR CRN Portfolio; 64 new industry studies have been adopted since the last quarterly report. 80% of closed NIHR CRN Industry studies achieved 100% of the planned UK target – a 30% increase over last quarter, while 0% of Industry studies adopted by the NIHR CRN failed to recruit.http://www.icr-global.org/resources/news/?EntryId23=6397Thu, 07 Jan 2010 14:45:38 GMTThu, 07 Jan 2010 14:45:38 GMTThu, 07 Jan 2010 14:50:27 GMTThe first three state of the art manufacturing research centres funded under a new £70M Government investment will be based at Southampton, Loughborough and Brunel universities, to help UK businesses develop the technology products of the future and underpin manufacturing growth, Business Secretary Lord Mandelson announced today. The EPSRC Centre for Innovative Manufacturing in Regenerative Medicine will be based at Loughborough University and will # carry out world-leading research, test and implement ideas in clinical and industrial settings, create next generation platforms for manufacturing regenerative medicines and inform business models, policy and public debate. Investment from EPSRC will total £5.3M over a five year period starting in September and 28 industrial and government partners will contribute a further £3M. Partner universities are Nottingham and Keele.http://www.icr-global.org/resources/news/?EntryId23=6396Thu, 07 Jan 2010 13:48:10 GMTThu, 07 Jan 2010 13:48:10 GMTThu, 07 Jan 2010 14:45:37 GMTBiovitrum AB has announced that AstraZeneca has acquired all of Biovitrum’s rights to its leptin modulator programme (currently in the preclinical phase) aimed at treating obesity. Biovitrum will receive from AstraZeneca an upfront payment of Euro 6M and milestone payments contingent on development progress and sales, as well as single digit percentage royalties. If a product is approved, the agreement allows up to a total of Euro 186M in upfront and milestone payments to Biovitrum.http://www.icr-global.org/resources/news/?EntryId23=6395Thu, 07 Jan 2010 13:38:23 GMTThu, 07 Jan 2010 13:38:23 GMTThu, 07 Jan 2010 13:48:10 GMTNovexel, a speciality pharmaceutical company focused on the discovery and development of novel antibiotics designed to overcome the significant global problem of microbial drug resistance, announces today that its shareholders have signed a definitive agreement whereby Novexel shall be acquired by AstraZeneca for a total cash consideration of up to $505 million, including contingent payments and the net cash position of the company at closing. The transaction is expected to close in the first quarter of 2010, subject to certain customary conditions. Under the terms of the agreement, AstraZeneca will acquire 100 percent of Novexel’s shares for $350 million in cash payable upon completion and will pay up to an additional $75 million to Novexel shareholders if specified development milestones are reached.http://www.icr-global.org/resources/news/?EntryId23=6394Thu, 07 Jan 2010 13:31:17 GMTThu, 07 Jan 2010 13:31:17 GMTThu, 07 Jan 2010 13:38:23 GMTSeveral leaders in UK healthcare have received honours including knighthoods in the New Year Honours list. Andrew Dillon CBE, Chief Executive of NICE, received a knighthood, along with cancer 'tsar' Mike Richards and NHS Chief Executive David Nicholson and other senior leaders. Other clinical research figures received CBEs, OBEs etc in the honours list.http://www.icr-global.org/resources/news/?EntryId23=6393Thu, 07 Jan 2010 13:20:11 GMTThu, 07 Jan 2010 13:20:11 GMTThu, 07 Jan 2010 13:31:17 GMTChiltern International Limited has announced a collaboration with Dr Nawab Qizilbash of OXON Epidemiology. Dr Nawab Qizilbash, MBChB BSc MRCP (UK) MSc Phil (Oxon) is the Director of OXON Epidemiology Ltd. He served as Director of Epidemiology and Evidence-based Medicine at GlaxoSmithKline. Formerly an Honorary Consultant Physician/Senior Research Fellow at Radcliffe Infirmary, Oxford University, Nawab trained under Professor Sir Richard Peto F.R.S. in epidemiology, Phase IV trials and meta-analysis. He also collaborates with Professor Stephen Evans in academic research on statistical signal detection. He founded the Cochrane Dementia Group and is chief editor of an international textbook on clinical dementia.http://www.icr-global.org/resources/news/?EntryId23=6392Thu, 07 Jan 2010 12:51:13 GMTThu, 07 Jan 2010 12:51:13 GMTThu, 07 Jan 2010 13:20:11 GMTMerck & Co. Inc., (operating in the United Kingdom as MSD) and Avecia Investments Limited have entered into a definitive agreement by which Merck will acquire the biologics business of the Avecia group through a Merck affiliate (Merck Sharp & Dohme (Holdings) Limited or "MSD"). Avecia Biologics is a contract manufacturing organization with specific expertise in microbial-derived biologics. Financial details of the transaction were not disclosed.http://www.icr-global.org/resources/news/?EntryId23=6391Thu, 07 Jan 2010 12:49:22 GMTThu, 07 Jan 2010 12:49:22 GMTThu, 07 Jan 2010 12:51:12 GMTLinkedIn, the business networking site, seems to be a tool used far more to date, by CRAs and Project Managers in clinical research, than Research Nurses. However, we want to change that and so have started a new group called "UK Research Nurses" on LinkedIn. Joining LinkedIn allows you to find past and present colleagues and network with others in the clinical research environment. We have established the UK Research Nurses group specifically for Research Nurses and Study Site Coordinators to share discussions and news in the area of clinical research and to provide access to industry experts willing to share advice. So if you are involved with clinical research in the patient homecare setting or at a research site why not join the group? For Christmas we are having a Champagne draw once the first 50 members have joined (there are just 15 members at the time of going to press).http://www.icr-global.org/resources/news/?EntryId23=6323Mon, 21 Dec 2009 12:49:01 GMTMon, 21 Dec 2009 12:49:01 GMTMon, 21 Dec 2009 12:51:18 GMTTen Clinical Trials Units are the latest to be registered by the UK Clinical Research Collaboration Clinical Trials Unit Registration Process, which is designed to help improve the quality of available expertise to carry out clinical trials in the UK. Clinical Trials Units are specialist units that bring together the expertise needed to undertake a clinical trial, including clinicians, statisticians and trial managers. Running a trial is a complex process and registered Units have the expertise to design, coordinate and analyse multi‐centre clinical trials, ensuring that they are conducted in line with appropriate standards and regulations. The newly Registered Units join a network of UK wide Clinical Trials Units who were registered following the first round of the process in 2007. The network now has a total of 49 Registered Units. To be eligible to apply, the Units had to demonstrate they were capable of centrally coordinating multi‐centre clinical trials and other well‐designed studies, taking overall responsibility for the design, conduct, data management, publicity and analysis of a trial. The registration process was coordinated by the National Institute for Health Research Clinical Research Network Coordinating Centre on behalf of the UK Clinical Research Collaboration.http://www.icr-global.org/resources/news/?EntryId23=6322Mon, 21 Dec 2009 12:45:04 GMTMon, 21 Dec 2009 12:45:04 GMTMon, 21 Dec 2009 12:47:57 GMTEngland’s Chief Medical Officer, Sir Liam Donaldson, will step down in May 2010 after 12 years of service, the longest serving Chief Medical Officer of modern times. Sir Liam is the 15th person to take up the independent role since the first Chief Medical Officer was appointed in 1855 as a response to the cholera epidemics that swept Victorian England. Since 1998, Sir Liam has been at the forefront of reforms to the NHS and major improvements to the country’s public health. His work and policy recommendations in the role have led to many reforms including: • Smokefree public places and work places; • the creation of the Health Protection Agency; • the introduction of clinical governance in the NHS; • the setting up of the National Patient Safety Agency; • new legislation for research using embryonic cells; • new legislation on consent for removal of organs and tissues; and • action plans in key areas of infectious disease control such as tuberculosis, West Nile fever and health care associated infection. In keeping with the traditions of the post, Sir Liam holds critical responsibilities across the whole field of health and healthcare. He is the United Kingdom’s chief adviser on health issues and advises the Secretary of State for Health, the Prime Minister and other Government Ministers. He represents the United Kingdom in international fora including the World Health Organization.http://www.icr-global.org/resources/news/?EntryId23=6321Mon, 21 Dec 2009 12:39:39 GMTMon, 21 Dec 2009 12:39:39 GMTMon, 21 Dec 2009 12:41:32 GMTCovance Inc has announced the opening of new clinical development offices in Seoul, South Korea and Mumbai, India and office expansions in Tokyo, Japan and Hong Kong, China to accommodate growing demand for clinical development services in Asia-Pacific. The new clinical development office in Seoul will help Covance further increase patient access in the region, while supporting its regional network of field-based CRAs throughout Asia-Pacific. The new Mumbai office will function as the main clinical trial support hub for the Indian sub-continent. Covance also expanded existing clinical development offices in Hong Kong and Tokyo, Japan to increase service capacity. The Tokyo office expansion provides additional capacity for both clinical development and central laboratory services, including sales, administration, and kit customization for the Japanese market. http://www.icr-global.org/resources/news/?EntryId23=6313Thu, 17 Dec 2009 16:11:37 GMTThu, 17 Dec 2009 16:11:37 GMTThu, 17 Dec 2009 16:13:10 GMTBritish Prime Minister Gordon Brown has announced the appointment of Chris Brinsmead and Lord Darzi as two of six new Business Ambassadors - business and academic leaders who will support the Government in promoting the UK's excellence internationally. The Business Ambassadors Network was created in October 2008, with a particular focus on helping small and medium-sized enterprises (SMEs), which sometimes face greater barriers to accessing global markets than larger businesses.http://www.icr-global.org/resources/news/?EntryId23=6312Thu, 17 Dec 2009 16:04:18 GMTThu, 17 Dec 2009 16:04:18 GMTThu, 17 Dec 2009 16:06:21 GMTA consortium comprising funds advised by Apax Partners and company management has reached agreement to acquire Marken, a company specialising in clinical trial logistics, for an undisclosed sum from Intermediate Capital Group. The transaction is subject to the relevant anti-trust clearances and is expected to complete in early 2010. Khawar Mann, Partner and Global Co-Head of the Apax Healthcare team, commented: “We are delighted to have the opportunity to back Marken and its excellent management team. Marken is a world leader in providing clinical logistics services to the biopharma industry, and its top quality offering means that it is poised for substantial growth as the industry continues the process of globalisation. Apax Partners’ considerable expertise in healthcare and our global network means we are the natural partners to assist Marken in the next phase of its growth.”http://www.icr-global.org/resources/news/?EntryId23=6311Thu, 17 Dec 2009 15:41:07 GMTThu, 17 Dec 2009 15:41:07 GMTThu, 17 Dec 2009 15:42:59 GMTSynexus has agreed to acquire Leipzig based ClinPharm and will complete the acquisition in January 2010. This deal will increase the number of Synexus' Dedicated Research Centres to 26 in nine countries, thus significantly strengthening its European reach. Commenting on the deal, Synexus Chief Executive Michael Fort said: "In order to keep pace with the market's demands it is necessary for us to increase our infrastructure and patient reach. ClinPharm provided the ideal opportunity as they have considerable presence in Western, Central and Eastern Europe and also understand the way we work."http://www.icr-global.org/resources/news/?EntryId23=6310Thu, 17 Dec 2009 15:20:17 GMTThu, 17 Dec 2009 15:20:17 GMTThu, 17 Dec 2009 15:34:37 GMTGood Publication Practice 2 (GPP2), a key guidance document for the publication of company-sponsored medical research, has been published online today by the British Medical Journal (BMJ). “The publication of GPP2 in BMJ is strong recognition of the importance of providing support and guidance for industry sponsored research and the publication of study results in the peer-reviewed medical literature,” said Chris Graf, Associate Editorial Director, Wiley-Blackwell, lead author of GPP2 and member of the International Society for Medical Publication Professionals (ISMPP) Board of Trustees. Among the most important areas addressed in GPP2 are the responsibilities of authors, reimbursement and honoraria, recommendations for use of publication steering committees and how to assemble them, the role of the professional medical writer, and different types of manuscripts beyond the primary clinical trial results paper.http://www.icr-global.org/resources/news/?EntryId23=6244Thu, 03 Dec 2009 09:41:59 GMTThu, 03 Dec 2009 09:41:59 GMTThu, 03 Dec 2009 09:44:56 GMTOur Netherlands correspondent, Edgar Smeets, tells us that the CCMO (the Dutch Central Committee on Research in Humans) has published the following news items on its website: * Since 01 November 2009, a new version of the central application form called 'ABR form' is available. The version actually is dated Sep 2009, and should be used for submitting new trials but also to submit amendments to trials approved previously. By using the web portal 'Toetsingonline', users will be taken to the right (new) form version automatically. As compared to the previous version, questions in the new ABR form have changed, disappeared or new ones have been added. The form is also bi-lingual, available in Dutch or English. * A new guideline for users of the web portal 'Toetsingonline' is available, dated November 2009. * As of 01 January 2010, it is obliged to report SAEs and SUSARs in investigator-initiated trials conducted in the Netherlands, digitally, via the web portal 'Toetsingonline'. This is for all investigator-initiated trials, irrespective of the substance tested (nutritional, medical device, pharmaceuticals), but already registered in Toetsingonline. Later in 2010, the same obligation will apply to all sponsor-initiated trials too. To enable this third party reporting, Toetsingonline will need to be adapted, to allow the submitting investigator to authorise this reporting role to the sponsor delegate. * The CCMO will host a convention on 11 December 2009, on the topic of 'Ensuring the safety of the clinical trial participant', during which all new items of Toetsingonline will be discussed. There have also been many developments in the field of pediatric clinical research. Since implementation of the Dutch Medical Research (Human Subjects) Act (abbreviated to the 'WMO') in 1999, and its modification in 2006 (to be more in line with the EU GCP Directive), much has happened in the field of medical research in children. In their Annual Report 2006, the CCMO concluded that research in children is difficult if not impossible to be conducted in the Netherlands. This was found not be compliant to the current thinking that sick children should benefit more from the new pharmacotherapeutic insights, often gained from trials in adults. The Minister took this at heart and installed a committee, headed by Prof. dr. Jaap Doek. On 26 November 2009 this committee forwarded their report to the Minister who will reply by Spring of 2010. The committee recommends adapting some WMO clausules freeing the way for well considered research in children. Edgar also informs us of the largest vaccination trial ever run in the Netherlands, coordinated by the Julius Center in Utrecht. The study group, headed by Prof. Marc Bonte and supported by drugmaker Wyeth and the Dutch Ministry of Health, Welfare and Sports, aims at enrolling 85,000 volunteers aged 65 years and above. It is a randomised, two arm trial, where a 13-valent conjugate vaccine developed to prevent pneumococcal infections, is compared to placebo. Volunteers are being selected by their GPs, and will be followed for three years after vaccination, to look at incidence of pneumonia. CAPITA is the acronym, for Community Acquired Pneumonia Immunization TriAl. 'FPI' was on 30 March 2009, and the principal investigator mentioned that the counter is at 52,000 in a TV interview on 27 Oct 2009. (www.vaccinatieonderzoek.nl, accessed 30 Nov 2009).http://www.icr-global.org/resources/news/?EntryId23=6240Tue, 01 Dec 2009 16:47:44 GMTTue, 01 Dec 2009 16:47:44 GMTThu, 03 Dec 2009 09:49:38 GMTIn July the Office for Life Sciences (OLS) published the ‘Life Sciences Blueprint’ which announced a package of measures to help maintain a competitive life science sector. One of the initiatives announced in the blueprint was the introduction of an ‘Innovation Pass’. The Innovation Pass will make selected innovative medicines available on the NHS for a time-limited period, prior to a NICE appraisal. Funding will be drawn from a new ring-fenced £25m budget, set aside exclusively for the Innovation Pass. The Pass gives earlier access to innovative drugs for patients with the greatest need, and at the same time it will facilitate the collection of further information to support a subsequent NICE appraisal. The UK Department of Health has launched a consultation, seeking views from the NHS, industry and other stakeholders on the Government’s proposals for an Innovation Pass pilot. These proposals will be revised in light of comments received as part of this consultation and will be used to inform the first set of decisions for the pilot in 2010/1.http://www.icr-global.org/resources/news/?EntryId23=6239Tue, 01 Dec 2009 16:42:03 GMTTue, 01 Dec 2009 16:42:03 GMTTue, 01 Dec 2009 16:47:44 GMTPlans for the next European Commission include the transfer of the Pharmaceutical Products Unit ENTR F.2 from DG Enterprise to DG Sanco, part of the Health and Consumer Policy brief. As the European Medicines Agency works through the F.2 unit, this will also come within the scope of DG Sanco. Also moving to DG Sanco is the Biotechnology, Technology and Health unit, which comes from DG Environment. The shake-up is dependent on a vote of the European Parliament expected to take place by the end of January. The longer-term consequences of this move for European health policy are unclear, but it is expected that industry will be less happy with the move than their academic counterparts.http://www.icr-global.org/resources/news/?EntryId23=6238Tue, 01 Dec 2009 16:07:05 GMTTue, 01 Dec 2009 16:07:05 GMTTue, 01 Dec 2009 16:42:03 GMTPfizer (China) Research and Development Co., Ltd. and Wuhan National Bioindustry Base Construction and Management Office have signed a Memorandum of Understanding to establish a new Pfizer R&D center in Wuhan. This new center, located in Biolake (Wuhan National Bioindustry Base), represents an expansion of Pfizer's existing R&D facility in Shanghai and will serve as a state-of-the-art platform for global drug development and strategic biomedical alliances. Pfizer's R&D operations in Wuhan will be initially engaged in supporting various global clinical drug development programs, including Phase I-IV clinical trials. Once the facility is built, Pfizer expects the number of employees to grow to 200 within 3 years. Pfizer R&D in Wuhan will also liaise with local research institutes and universities utilizing the rich resources of local talent and existing industry capabilities to develop research collaborations on drug innovation and development. In the mean time, Shanghai will remain the operations hub of Pfizer's R&D effort in China.http://www.icr-global.org/resources/news/?EntryId23=6237Tue, 01 Dec 2009 15:57:18 GMTTue, 01 Dec 2009 15:57:18 GMTTue, 01 Dec 2009 16:07:05 GMTThe Institute for Quality and Efficiency in Health Care (IQWiG) is calling for registration and publication of the results of all clinical trials to be made obligatory. The German Federal Government must push for a mandatory regulation to be implemented at EU level; in the USA this obligation has been in force since 2008. This has been brought to a head by the publication of the final report on three antidepressants which was greatly hindered by Pfizer. IQWiG's experience has shown that the existing countermeasures, which are primarily based on voluntary solutions in Germany and Europe, are inadequate. It is not known when and how statutory regulations aimed at solving the problem will actually take effect. IQWiG is therefore calling for an EU-wide legal obligation, bound by tight deadlines, to publish the results of clinical trials.http://www.icr-global.org/resources/news/?EntryId23=6236Tue, 01 Dec 2009 15:32:19 GMTTue, 01 Dec 2009 15:32:19 GMTTue, 01 Dec 2009 15:57:18 GMTMerck Serono has announced plans to strengthen its global R&D capabilities by establishing a global R&D center in Beijing, China. Merck Serono is planning to invest more than 150M € and create more than 200 new qualified jobs over the next four years to set up the China R&D center and conduct R&D activities in China. The China team will lead drug development for China and other Asian countries, for local clinical trials as well as for the participation in global clinical trials. The team also will ensure the management of collaborations with research institutions in China and continue to look for partnerships with local academic institutions and companies. Research activities conducted in the China R&D center will mainly focus on biomarker research including pharmacogenomics and bioanalytics activities.http://www.icr-global.org/resources/news/?EntryId23=6235Tue, 01 Dec 2009 15:29:40 GMTTue, 01 Dec 2009 15:29:40 GMTTue, 01 Dec 2009 15:32:19 GMTFrom January 2010, the Note for Guidance on Good Clinical Practice (GCP) (CPMP/ICH/135/95) issued by the European Medicines Agency (EMEA) is expected to be adopted in New Zealand as the standard for designing, conducting, recording and reporting on clinical trials. This guideline is based on the International Committee for Harmonisation (ICH) document E6 (R1) and is the internationally accepted standard. It replaces the “Interim Standard for Good Clinical Research Practice” published by Medsafe in 1998. There are a few instances where there is a conflict between the CPMP guideline and specific requirements relating to clinical trials that are set out in Section 30 of the Medicines Act 1981. Where such a conflict arises, the requirements of the Medicine Act 1981 apply. New Zealand has also recently agreed a standard indemnity for all clinical research sites.http://www.icr-global.org/resources/news/?EntryId23=6233Tue, 01 Dec 2009 15:01:59 GMTTue, 01 Dec 2009 15:01:59 GMTTue, 01 Dec 2009 15:26:01 GMTThe European Medicines Agency is announcing major changes to its identity over the coming months. Early in December it will launch a bew brand, changing from the EMEA to the EMA, with new logo, colourscheme and internet domain suffix (ema.europa.eu) for all email and web addresses. The Agency has been undergoing a reorganisation over the past months, and early December will also see the publication of the new organisation chart. Early in 2010, these developments will flow through into an entirely new website for professionals and the public.http://www.icr-global.org/resources/news/?EntryId23=6232Tue, 01 Dec 2009 14:57:11 GMTTue, 01 Dec 2009 14:57:11 GMTTue, 01 Dec 2009 15:01:59 GMTScientists in the field of dementia research will get more help to access funding thanks to a new ministerial group, which will drive forward research into the causes, cure and care of dementia. The new group, chaired by UK Care Services Minister Phil Hope, will also focus on increasing the volume, quality and impact of dementia research. It follows the Government’s Dementia Research Summit in July at which leading experts identified priority areas for dementia research. The priority areas, which ranged from basic biomedical science, to practical steps that could boost dementia research, will provide a basis for the group. They include: * Ensuring better use of existing funding opportunities; * Increasing public support for dementia research; * Giving people with dementia better access to clinical trials; * Ensuring research translates to better treatment and care; and * Strengthen collaborative work, especially with the commercial sector.http://www.icr-global.org/resources/news/?EntryId23=6156Thu, 19 Nov 2009 16:06:49 GMTThu, 19 Nov 2009 16:06:49 GMTThu, 19 Nov 2009 16:16:47 GMTA recently-published report by RAND Europe shows the NIHR Biomedical Research Centres (BRCs) scheme is already contributing to observable changes in institutional relationships between the NHS, academia, industry and other players, and helping to shape the health research system to pursue translational research and innovation with the clear goal of realising patient benefit. http://www.icr-global.org/resources/news/?EntryId23=6155Thu, 19 Nov 2009 16:03:45 GMTThu, 19 Nov 2009 16:03:45 GMTThu, 19 Nov 2009 16:06:49 GMTA new report has been launched, exploring the impact of public involvement through an in-depth review of published literature. It draws together a wealth of examples of how public involvement is conducted, and what difference it is making. But it also raises questions of the quality of the evidence for the impact of such involvement, revealing huge variation in how this is assessed and reported and highlighting difficulties in judging it or drawing general conclusions.http://www.icr-global.org/resources/news/?EntryId23=6154Thu, 19 Nov 2009 16:00:50 GMTThu, 19 Nov 2009 16:00:50 GMTThu, 19 Nov 2009 16:03:45 GMTThe MHRA have implemented a solution that will allow their customers to make payment by either credit or debit card through their website (www.mhra.gov.uk/MakeapaymenttotheMHRA).http://www.icr-global.org/resources/news/?EntryId23=6152Thu, 19 Nov 2009 15:48:21 GMTThu, 19 Nov 2009 15:48:21 GMTThu, 19 Nov 2009 16:00:50 GMTBristol-Myers Squibb Company will split off its holdings in Mead Johnson Nutrition Company. The split-off is expected to be net cash flow positive to the BioPharma business and accretive to earnings per share beginning in 2010. “This marks the latest step in our company’s transformation into a BioPharma leader,” said James M. Cornelius, chairman and chief executive officer of Bristol-Myers Squibb. “By executing our healthcare divestment strategy, we have sharpened our BioPharma focus, improved the overall financial strength of the company and supported our ability to pursue strategic business development opportunities. All of these actions help us fulfill our mission to discover, develop and deliver innovative medicines to help patients prevail over serious diseases.”http://www.icr-global.org/resources/news/?EntryId23=6151Thu, 19 Nov 2009 15:38:37 GMTThu, 19 Nov 2009 15:38:37 GMTThu, 19 Nov 2009 15:48:21 GMTi3 Pharma Resourcing has launched resourcing services in Switzerland and Belgium. Now active in over 50 countries, i3 Pharma Resourcing draws on its clinical understanding and global resources to screen and interview each candidate carefully, matching the individual’s skill set, qualifications and competencies with clients’ specific requirements.http://www.icr-global.org/resources/news/?EntryId23=6150Thu, 19 Nov 2009 15:33:47 GMTThu, 19 Nov 2009 15:33:47 GMTThu, 19 Nov 2009 15:38:37 GMTThe Council of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has approved an updated Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases. This extends the range of clinical trials that member companies should provide information on to include all clinical trials in patients, as a minimum. The scope of this new Joint Position will include early stage safety trials of medicines for life-threatening conditions, which are typically not done in healthy volunteers. The new Joint Position will enter force in 6 months time, when its provisions will supersede those of the previous one, dated 18 November 2008. The first such Joint Position was established in January 2005. When the new Joint Position enters force, member companies should post registry details of all new trials in patients on a publicly accessible website within 21 days of the start of patient enrollment. Thereafter, they should also post summary results of any trial falling with the scope of the new Joint Position within one year of the medicinal product concerned being first approved and made commercially available in any country.http://www.icr-global.org/resources/news/?EntryId23=6149Thu, 19 Nov 2009 15:31:57 GMTThu, 19 Nov 2009 15:31:57 GMTThu, 19 Nov 2009 15:33:47 GMTThe International Conference on Harmonisation (ICH) Steering Committee and its expert working groups met in St. Louis, Missouri from October 24-29, 2009. The main achievements are outlined below. This meeting was highlighted by progress made in the area of safety of pharmaceutical products. The S9 Guideline, "Non-clinical Evaluation of Anticancer Pharmaceuticals" reached Step 4. This Guideline addresses non-clinical data requirements for pharmaceutical products intended to treat cancer in patients with late stage or advanced disease. The guideline aims to accelerate development and availability of drugs for these patients with unmet medical need while safeguarding patients' safety. In addition, the S6 Guideline, "Revision of Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals" reached Step 2. This Guideline outlines a reduced duration and number of studies involving animals and could have a major impact on the use of animals in safety testing of pharmaceutical products. ICH remains committed to the "3 R's" agenda, which is reducing/refining/replacing animal testing in the drafting of new or revision of existing guidelines. In addition, ICH Safety experts participated in a one day "Safety Brainstorming Session" to discuss any current gaps in ICH safety guidelines and identified several potential new topics.http://www.icr-global.org/resources/news/?EntryId23=6083Thu, 05 Nov 2009 15:24:39 GMTThu, 05 Nov 2009 15:24:39 GMTThu, 05 Nov 2009 15:26:18 GMTAn implementation report providing a progress update on activities being conducted by the European Union and the U.S. Food and Drug Administration within the framework of the action plan to simplify the administrative burden involved in medicines regulation has been published.http://www.icr-global.org/resources/news/?EntryId23=6082Thu, 05 Nov 2009 15:23:18 GMTThu, 05 Nov 2009 15:23:18 GMTThu, 05 Nov 2009 15:23:49 GMTAmylin Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited have entered into a worldwide exclusive license, development and commercialization agreement to co-develop and commercialize pharmaceutical products for the treatment of obesity and related indications. The agreement includes products to be developed from Amylin’s pipeline, including pramlintide/metreleptin and davalintide, which are compounds currently in phase 2 development for treatment of obesity. The agreement also includes additional compounds from both companies’ obesity research programs. Amylin will receive a one-time up-front payment of $75 million from Takeda and, over the term of the agreement and in relation to the compounds under the agreement, is eligible to receive additional payments upon achieving certain development, commercialization and sales-based milestones that could exceed $1 billion. The agreement also provides for future tiered, double-digit royalty payments to Amylin based on global product sales.http://www.icr-global.org/resources/news/?EntryId23=6079Thu, 05 Nov 2009 11:18:49 GMTThu, 05 Nov 2009 11:18:49 GMTThu, 05 Nov 2009 11:20:19 GMTAs part of its strategy to discover and develop more biotechnology medicines, Eli Lilly has officially opened a new state-of-the-art biotechnology center on the West Coast. The facility, known as the "Lilly Biotechnology Center - San Diego," is opening three months after Lilly announced it is moving its ImClone research headquarters (which specializes in developing cancer biologics) into a new biopharmaceutical research cluster in New York, and just one year after Lilly completed construction of its biotechnology research and development complex at company headquarters in Indianapolis, Indiana. "We are moving full speed ahead toward building a biotechnology powerhouse," said John Lechleiter, Ph.D., Lilly chairman and chief executive officer. "The science, technology and talent at our new center in San Diego will help bring novel biotech medicines to patients faster and more efficiently, and reinforces Lilly's commitment and contributions to San Diego's burgeoning bioscience industry." http://www.icr-global.org/resources/news/?EntryId23=6078Thu, 05 Nov 2009 11:15:47 GMTThu, 05 Nov 2009 11:15:47 GMTThu, 05 Nov 2009 11:17:09 GMTThe FDA has issued guidance for industry on "Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects". The goal of the guidance is to help investigators better meet their responsibilities with respect to protecting human subjects and ensuring the integrity of the data from clinical investigations. This guidance is intended to clarify for investigators and sponsors FDA’s expectations concerning the investigator’s responsibility (1) to supervise a clinical study in which some study tasks are delegated to employees or colleagues of the investigator or other third parties and (2) to protect the rights, safety, and welfare of study subjects.http://www.icr-global.org/resources/news/?EntryId23=6077Thu, 05 Nov 2009 11:01:09 GMTThu, 05 Nov 2009 11:01:09 GMTThu, 05 Nov 2009 11:12:52 GMTPRA International announces the opening of a new office in Milan, Italy. PRA has operated in Italy since 2003 through home‐based PRA staff. During the past three years alone, PRA has participated in more than 80 studies spanning 13 therapeutic areas in Italy. “We are pleased to continue our global expansion with the opening of the Milan office,” noted Ludger Langer, PRA Vice President, Clinical Operations ‐ Europe, Asia‐Pacific, Africa.http://www.icr-global.org/resources/news/?EntryId23=6076Thu, 05 Nov 2009 10:51:35 GMTThu, 05 Nov 2009 10:51:35 GMTThu, 05 Nov 2009 11:01:03 GMTA significant step in driving innovation, improving patient care and increasing efficiency in early stage clinical research was taken today with the announcement that two of the UK’s leading institutions - Guy’s and St Thomas’ NHS Foundation Trust and King’s College London - have signed a collaborative agreement with Quintiles, the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. As part of the agreement, Quintiles has commissioned a state of the art research facility with 30 beds, for both patients and healthy volunteers involved in research, on the 14th floor of Guy’s Hospital in central London. The facility, to be completed in early 2010, will now be known as the Quintiles Drug Research Unit at Guy’s Hospital. The facility significantly increases Quintiles’ capacity to conduct proof-of-concept programmes that help biopharmaceutical companies develop better medicines faster.http://www.icr-global.org/resources/news/?EntryId23=5980Mon, 26 Oct 2009 15:01:09 GMTMon, 26 Oct 2009 15:01:09 GMTMon, 26 Oct 2009 15:05:07 GMTThe MHRA has two consultations on proposals to change the levels of regulatory fees charged for medicines (including herbal and homoeopathic medicines), medical devices, hospital blood banks and blood establishments from 1 April 2010http://www.icr-global.org/resources/news/?EntryId23=5958Thu, 22 Oct 2009 12:55:47 GMTThu, 22 Oct 2009 12:55:47 GMTThu, 22 Oct 2009 12:56:51 GMTBioKinetic Europe, an Independent Phase I Clinical Pharmacology Unit in Belfast City Centre, is delighted to announce receipt of MHRA Phase I Standard & Supplementary Accreditation in July 2009. They successfully completed MHRA GCP and GMP Inspections in April 2009 and the assessment for Phase I Standard & Supplementary Accreditation was conducted at the same time. The voluntary UK Accreditation Scheme for Phase I Clinical Trials Units is valid for a period of two years after which re-inspection is required. The remit of the inspections is GCP compliance and volunteer safety. Supplementary Accreditation assesses the stringent systems required for the conduct of trials involving compounds at all levels of risk including First in Man (FIM) and those that require review of risk factors by the MHRA’s Clinical Trials Expert Advisory Group (EAG). http://www.icr-global.org/resources/news/?EntryId23=5957Thu, 22 Oct 2009 12:41:53 GMTThu, 22 Oct 2009 12:41:53 GMTThu, 22 Oct 2009 12:43:43 GMTClinTec International, Scotland’s leading global clinical research organisation (CRO), has launched its Cairo office. The new operation not only provides ClinTec International’s global biopharmaceutical associates with access to new patient populations, but it also further consolidates the privately-owned company’s reputation as a major presence in the Middle East and North Africa (MENA) region. “The launch of the new office cements ClinTec International’s reputation as one of the few truly global providers of quality assured clinical research services,” said its founder, President and CEO, Dr Rabinder Buttar. “It also reflects the increasing importance of Egypt – and wider MENA region – to the global clinical research market too.”http://www.icr-global.org/resources/news/?EntryId23=5956Thu, 22 Oct 2009 12:39:41 GMTThu, 22 Oct 2009 12:39:41 GMTThu, 22 Oct 2009 12:41:15 GMTAzopharma Product Development Group, LLC and PharmaNet Development Group, Inc. are pleased to announce the completion of a business development and co-promotion alliance to leverage complementary services, develop business opportunities, and jointly manage projects for certain services provided by the two companies. Phil Meeks, chief executive officer, Azopharma Product Development Group commented “This agreement is an exciting opportunity for both of our organizations. Both companies will be introduced to new sets of clients and the clients will be exposed to new compelling solutions for their early phase development.”http://www.icr-global.org/resources/news/?EntryId23=5955Thu, 22 Oct 2009 12:11:01 GMTThu, 22 Oct 2009 12:11:01 GMTThu, 22 Oct 2009 12:14:01 GMTGlaxoSmithKline plc (GSK) announced today that it has entered into a unique partnership with the UK Government, The Wellcome Trust and the East of England Development Agency (EEDA) to develop an innovative new biotechnology science park located at GSK’s site at Stevenage. The project aims to create a world-leading hub for early-stage biotechnology companies. The campus will pioneer a new operating model of open-innovation that should strengthen and grow the UK bioscience sector. It is hoped that this campus, supported by Government, business and academia, will compete with those in Boston, California and North Carolina in the United States.http://www.icr-global.org/resources/news/?EntryId23=5954Thu, 22 Oct 2009 12:09:06 GMTThu, 22 Oct 2009 12:09:06 GMTThu, 22 Oct 2009 12:10:34 GMTWorld Courier is pleased to announce the opening of its newest purpose-driven investigational drug storage facilities in Melbourne (Australia) and Johannesburg (South Africa), bringing its network of GMP (Good Manufacturing Practice)-compliant clinical trial depots to a total of 11 worldwide and providing cost-effective logistical access to two continents critical to the global pharmaceutical industry. “Together these two continents undertake over 15 per cent of current global clinical trials conducted outside North America, representing an annual estimated market of almost US $3 billion and a study frequency almost double that of China and India combined,” says Wayne Heyland, President and CEO of the World Courier group of companies. “As clinical research represents the most critical, yet expensive phase of drug development, demand for more cost-effective outsourcing options has intensified in recent years, with clients actively soliciting infrastructure support in emerging and strategic nations. Given the relative isolation of both locations – as well as their inherent appeal – our local depots offer a much-needed and highly cost-efficient ‘one-stop’ logistical alternative for bio-pharmaceutical companies with demanding clinical trial storage and distribution needs.”http://www.icr-global.org/resources/news/?EntryId23=5953Thu, 22 Oct 2009 12:05:15 GMTThu, 22 Oct 2009 12:05:15 GMTThu, 22 Oct 2009 12:06:45 GMTFollowing the divestiture of its US Pharmaceutical Development Services business which included the rights to the AAIPharma name, AAIPharma Inc. has changed its name to ZeeCRO Inc. ZeeCRO Inc. continues to provide early and late stage development services to its customers worldwide. The new global headquarters for ZeeCRO is 1001 Winstead Drive, Suite 455, Cary, NC 27513 USAhttp://www.icr-global.org/resources/news/?EntryId23=5952Thu, 22 Oct 2009 11:55:36 GMTThu, 22 Oct 2009 11:55:36 GMTThu, 22 Oct 2009 11:57:31 GMTIn a statement by company President David Spaight, beleaguered CRO MDS Pharma Services has announced that its Global Central Laboratory operations will be bought by Czura Thornton, the private equity firm that also owns Chiltern International. The financial terms of the deal have not been disclosed and the proposed transaction does not include bioanalysis operations at the MDS Pharma Services facilities in Lincoln, Nebraska; Lyon, France; Montreal, Canada; and Zurich, Switzerland. In a joint statement, Czura Thornton’s founders Tony Czura and Nick Thornton said: “We are delighted to be acquiring MDS’s global central laboratory platform and the deep expertise of the people there. Combined with our focus on the consistent delivery of high quality service and the flexibility and responsiveness that private ownership allows, we look forward to seeing renewed strength and growth in the business.” They added that, “While we see excellent opportunities for collaboration with Chiltern, a leading CRO also owned by Czura Thornton, the two entities will operate independently.” The transaction is expected to close in the fourth quarter of 2009 and is subject to customary approvals and closing conditions.http://www.icr-global.org/resources/news/?EntryId23=5951Thu, 22 Oct 2009 11:32:49 GMTThu, 22 Oct 2009 11:32:49 GMTThu, 22 Oct 2009 11:48:57 GMTBiomedical Systems, a global provider of centralized diagnostic services to the pharmaceutical and healthcare industries plans to open an office in the city of Puducherry, located 300 kilometers from Bangalore on the southeast coast of India. The facility will provide pharmaceutical sponsors with an in-country resource for site training, query resolution, 24/7 technical support and logistics for clinical trial equipment and supplies. Pierre Soumenkoff, who has over 11 years of business development experience with Biomedical Systems, plus operational experience with both Covance and Quintiles Transnational Corporation, will be rejoining the company to serve as the Managing Director of the India office. “We are extremely pleased on two accounts,” said Kevin J. Klingler, President of Pharmaceutical Services for Biomedical Systems. “First we will have a local presence to assist our sponsors to obtain quality clinical trial data in India for cardiac safety and efficacy, respiratory and imaging studies. A recent Ernst and Young report shows that India’s outsourcing sector is growing at 43%. Its growth and importance in the area of drug development cannot be overlooked. Opening this office reaffirms Biomedical Systems’ continued commitment to providing industry leading customer service to our clients. Second, the return of Pierre Soumenkoff to manage the office ensures sponsors that an experienced industry veteran who understands the process and workflow for clinical trials will be available to them for trials in this region.” The Puducherry facility, which is located 300 kilometers from the pharmaceutical and biotechnology centers of Bangalore, will open in the first quarter of 2010. The process of establishing the headquarters and hiring staff for the facility has already begun.http://www.icr-global.org/resources/news/?EntryId23=5950Thu, 22 Oct 2009 11:29:32 GMTThu, 22 Oct 2009 11:29:32 GMTThu, 22 Oct 2009 11:32:42 GMTIn its Communication of 10 December 2008 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on “Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector”, the Commission announced that an assessment would be made of the application of the Clinical Trials Directive. This assessment would consider, in particular, various options for improving the functioning of the Clinical Trials Directive with a view to making legislative proposals, if appropriate, while taking the global dimension of clinical trials into account. A public consultation document along this line has been published. Interested parties are invited to comment by 8 January 2010.http://www.icr-global.org/resources/news/?EntryId23=5884Tue, 13 Oct 2009 16:24:23 GMTTue, 13 Oct 2009 16:24:23 GMTTue, 13 Oct 2009 16:25:39 GMTThe Human Fertilisation and Embryology Act 2008 has come into force, ensuring the UK remains at the forefront of developments in treatment and research. The 2008 Act responds to changes in society and ensures it is fit for purpose in the 21st Century. Government undertook a review of the 1990 Act, bringing legislation up to date with society, and to reflect technological developments, such as new ways of creating embryos. It enables scientists to investigate cures for serious illnesses such as Parkinson’s disease and regulate assisted reproductive treatments.http://www.icr-global.org/resources/news/?EntryId23=5839Thu, 08 Oct 2009 12:26:34 GMTThu, 08 Oct 2009 12:26:34 GMTThu, 08 Oct 2009 12:27:47 GMTThe NIHR has issued a new Implementation Plan for the NIHR Office for Clinical Research Infrastructure (NOCRI). The NOCRI, which will be established by December 2009, will help to facilitate collaborations between NIHR-funded infrastructure and funders of research, including industry.http://www.icr-global.org/resources/news/?EntryId23=5838Thu, 08 Oct 2009 12:23:43 GMTThu, 08 Oct 2009 12:23:43 GMTThu, 08 Oct 2009 12:24:44 GMTThe European Medicines Agency has begun implementing a series of changes to its internal organisation aimed at improving the functioning of the Agency and the way in which it delivers its core tasks. The changes will be introduced gradually from September to December 2009. In line with its increased responsibilities, the Agency has developed over the past years in terms of staff numbers and internal processes. The number of scientific committees and the complexity of procedures have also grown, and the cross-relationship between committees brings with it the need for enhanced coordination. In addition, future legislative proposals are expected to bring further responsibilities to the Agency. Following an Agency-wide process improvement exercise initiated in 2006, from May 2007 attention focused specifically on core business – examining processes within the two units dealing with medicinal products for human use and monitoring their interactions in order to assess their potential for adapting to future needs. The resulting reorganisation includes the following key changes: * The life-cycle management of medicines for human use is brought together into one Unit, Human Medicines Development and Evaluation, led by Patrick Le Courtois and responsible for the provision of advice during R&D, through to management of the review process and changes to products after they have been approved. * The creation of a Unit, Patient Health Protection, led by Noël Wathion, contributing to patient health protection from the multiple perspectives of pharmacovigilance, risk and crisis management, patient and health care professional information, inspections (for both human and veterinary products), and appropriate regulatory compliance. The Unit will also be in charge of community procedures for both centrally and non-centrally authorised productshttp://www.icr-global.org/resources/news/?EntryId23=5837Thu, 08 Oct 2009 12:19:15 GMTThu, 08 Oct 2009 12:19:15 GMTThu, 08 Oct 2009 12:21:24 GMTEURORDIS has sealed a Strategic Partnership agreement with the National Organization of Rare Disorders (NORD). This partnership will bring patient advocates from Europe and the US closer together and seek to promote rare diseases as an international public health priority. It will set the ground for key joint initiatives and increased transatlantic collaboration. The agreement spells out the common vision and objectives that the two organisations have identified in the last year. It is the culmination of a series of discussions between EURORDIS’ CEO Yann Le Cam and NORD’s President and CEO Peter Saltonstall. Both leaders and their Boards are convinced that rarity of patients, as well as the scarcity of expertise and of resources present a common public health challenge that should be tackled from a solid platform bringing together both sides of the Atlantic. http://www.icr-global.org/resources/news/?EntryId23=5835Thu, 08 Oct 2009 11:59:43 GMTThu, 08 Oct 2009 11:59:43 GMTThu, 08 Oct 2009 12:01:13 GMTSanofi-aventis has signed a binding agreement for the acquisition of Fovea Pharmaceuticals SA, a privately held French research and development biopharmaceutical company, focused on ocular diseases. Created in 2005 in Paris, Fovea has a portfolio of three clinical compounds, a unique technology platform and several discovery programs dedicated to back of the eye diseases. “The acquisition of Fovea, one of the pioneer French biopharmaceutical ophthalmology company, is a further step in our company’s goal to focus on new approaches to strengthen our R&D portfolio” , declared Christopher A. Viehbacher, Chief Executive Officer of sanofi-aventis. “Fovea and its unique technology platform represent a major opportunity for sanofi-aventis in the very promising and dynamically growing ophthalmic area, driven by unmet medical needs and aging population. I am extremely excited to welcome Fovea in the sanofi-aventis family and to work with highly motivated teams to bring innovative solutions to patients for the treatment of ocular diseases”.http://www.icr-global.org/resources/news/?EntryId23=5834Thu, 08 Oct 2009 11:56:32 GMTThu, 08 Oct 2009 11:56:32 GMTThu, 08 Oct 2009 11:58:15 GMTGlaxoSmithKline (GSK) and Jiangsu Walvax Biotech Company (Walvax) have a long-term Joint Venture (JV) to develop and manufacture paediatric vaccines for use in China. The JV will produce vaccines for measles, mumps, and rubella (MMR) (Priorix™) and potentially other paediatric vaccines. GSK will also transfer the technology to enable the JV to manufacture the vaccines locally over time. “This JV further builds on GSK's global business model which has fostered innovative partnerships to develop and deliver vaccines all over the world” said Jean Stephenne, President of GSK Biologicals. “In China, GSK is establishing local production capacity with a leading vaccine manufacturer and developer, in advance of the significant expansion in the Chinese public vaccine market. Together with Walvax, we can support China’s goals to accelerate vaccination and save children from preventable diseases.” In addition to the technology transfer, the JV will build a new manufacturing facility for GSK’s paediatric vaccine Priorix and once the facility is operational, the JV will supply the vaccines to China’s public vaccine market. http://www.icr-global.org/resources/news/?EntryId23=5833Thu, 08 Oct 2009 11:48:20 GMTThu, 08 Oct 2009 11:48:20 GMTThu, 08 Oct 2009 11:49:40 GMTJohnson & Johnson and Crucell N.V. have announced that J&J, through its subsidiary Ortho-McNeil-Janssen Pharmaceuticals, Inc., and Crucell have entered into a strategic collaboration focusing on the discovery, development and commercialization of monoclonal antibodies and vaccines for the treatment and prevention of influenza and other infectious and non-infectious diseases. The immediate focus of the collaboration will be the development and commercialization of a universal monoclonal antibody product (flu-mAb) for the treatment and prevention of influenza. The focus of the long-term innovation collaboration will be on new discovery programs leading to the development and commercialization of a universal influenza vaccine as well as the development of monoclonal antibodies and/or vaccines directed against up to three other infectious and non-infectious disease targets. Johnson & Johnson, through its affiliate JHC Nederland B.V., has also purchased 14.6 million newly issued ordinary shares of Crucell, representing approximately 18% of Crucell's outstanding ordinary shares, for an aggregate purchase price of € 301.8 million.http://www.icr-global.org/resources/news/?EntryId23=5832Thu, 08 Oct 2009 11:17:04 GMTThu, 08 Oct 2009 11:17:04 GMTThu, 08 Oct 2009 11:20:14 GMTAbbott has announced a definitive agreement with the Solvay Group for Abbott to acquire Solvay's pharmaceuticals business for EUR 4.5 billion ($6.6 billion) in cash, providing Abbott with a large and complementary portfolio of pharmaceutical products and a significant presence in key global emerging markets. Belgium-based Solvay Pharmaceuticals will add more than $3 billion in annual sales, the majority outside the US. Solvay has significant presence and infrastructure in key high-growth emerging markets, including Eastern Europe and Asia. Emerging markets are growing faster and increasing in importance due to demographics, rising incomes and expanded treatment of chronic disease. "The acquisition of Solvay Pharmaceuticals further diversifies our pharmaceutical portfolio, expands our presence in key high-growth emerging markets, enhances our investment in R&D and accelerates our long-term earnings-per-share growth outlook," said Miles D. White, chairman and chief executive officer, Abbott. Solvay's pharmaceutical portfolio complements Abbott's presence and expertise in specialty markets such as cardiovascular disease, neuroscience and gastroenterology. The acquisition also includes Solvay's vaccines business, which will provide Abbott entry into the expanding global vaccines market. Solvay has a small molecular diagnostics unit that will become part of Abbott's diagnostics organization upon the transaction close.http://www.icr-global.org/resources/news/?EntryId23=5831Thu, 08 Oct 2009 11:11:52 GMTThu, 08 Oct 2009 11:11:52 GMTThu, 08 Oct 2009 11:16:44 GMTThe Pan-African Clinical Trials Registry (PACTR) has been accepted as a primary clinical trials registry – the first World Health Organization (WHO) endorsed trials registry in Africa. This registry will feed data into the global WHO International Clinical Trials Registry Platform (ICTRP) search portal facilitating African representation in the global picture of planned, ongoing and completed clinical trials. The Registry is currently funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) and coordinated by the South African Cochrane Centre (SACC) at the Medical Research Council (MRC). “We are delighted to be able to offer access to a WHO primary register to all trialists in Africa. We hope the PACTR will become the first choice for African trial registration,” says Nandi Siegfried, co-director at the SACC. http://www.icr-global.org/resources/news/?EntryId23=5830Thu, 08 Oct 2009 11:05:31 GMTThu, 08 Oct 2009 11:05:31 GMTThu, 08 Oct 2009 11:06:29 GMTThe two leading UK biology organisations – the Institute of Biology (IoB) and the Biosciences Federation (BSF) – have united to form the Society of Biology. Sir Paul Nurse, Nobel laureate and President of Rockefeller University, said: “The establishment of the Society of Biology is a significant event for UK biosciences. The field of biology encompasses a wide diversity of disciplines. The creation of a single organisation will enable stronger, more effective representation, and will serve all with an interest in the future of the biosciences.” The creation of a single organisation to represent the biological sciences is fully supported by members of both the IoB and BSF, who voted overwhelmingly in favour of the move at Annual General Meetings held in early 2009. The Society’s diverse membership includes students, practising scientists and interested non-professionals - as individuals, or through learned societies and other organisations.http://www.icr-global.org/resources/news/?EntryId23=5828Thu, 08 Oct 2009 10:27:54 GMTThu, 08 Oct 2009 10:27:54 GMTThu, 08 Oct 2009 11:03:28 GMTTo enhance service offerings throughout Europe, Quintiles Transnational Corp. has announced the opening of an expanded regional facility near Edinburgh, Scotland. The purpose-built facility consolidates three buildings into a single state-of-the-art complex. Located within the Alba Campus, a research and development center near Edinburgh, the 115,000-square-foot (10,350 square meters) building hosts more than 500 employees and has space for Quintiles Clinical Development Services, including Project Management, Regulatory Affairs and Data Management. The facility is BREEAM (BRE Environmental Assessment Method) certified for sustainable design and low environmental impact. The focal point of the new facility is an 80,000-square-foot (7,200 square meters) Central Laboratory that more than doubles previous capacity and allows higher throughput of clinical trial materials, including the ability to process up to three times more kits per day. Strategically located to serve the entire European region, on-site lab services include chemistry, hematology, urinalysis, serology markers, coagulation, specimen management, endocrinology and biomarkers.http://www.icr-global.org/resources/news/?EntryId23=5827Thu, 08 Oct 2009 10:19:06 GMTThu, 08 Oct 2009 10:19:06 GMTThu, 08 Oct 2009 10:27:06 GMTThe FDA has issued final guidance providing information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs). The purpose of an EOP2A meeting is to facilitate interaction between FDA and sponsors who seek guidance related to clinical trial design employing clinical trial simulation and quantitative modeling of prior knowledge (e.g., drug, placebo group responses, disease), designing trials for better dose response estimation and dose selection, and other related issues. The guidance is intended to further FDA initiatives directed at identifying opportunities to facilitate the development of innovative medical products and improve the quality of drug applications through early meetings with sponsors.http://www.icr-global.org/resources/news/?EntryId23=5745Thu, 24 Sep 2009 11:39:47 GMTThu, 24 Sep 2009 11:39:47 GMTThu, 24 Sep 2009 11:44:25 GMTEuropean Commission Directive 2009/120/EC of 14 September 2009 amends Directive 2001/83/EC relating to medicinal products for human use as regards advanced therapy medicinal products. It amends the Annex to Directive 2001/83/EC by updating the definitions and detailed scientific and technical requirements for gene therapy medicinal products and somatic cell therapy medicinal products and establishing technical requirements for tissue engineered products, as well as for advanced therapy medicinal product containing devices and combined advanced therapy medicinal products. It was published in the Official Journal on 15 September 2009 and enters into force 20 days later.http://www.icr-global.org/resources/news/?EntryId23=5744Thu, 24 Sep 2009 11:36:38 GMTThu, 24 Sep 2009 11:36:38 GMTThu, 24 Sep 2009 11:39:46 GMTA report published today by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMEA) calls for greater development of antibacterial agents to combat multidrug-resistant bacteria that kill 25,000 people in the European Union every year. The report highlights the public-health threat caused by the current gap between the frequency of infections caused by such bacteria and the decline in research and development of new antibiotics to combat them, and suggests there is an urgent need for European and global strategies to address this gap. http://www.icr-global.org/resources/news/?EntryId23=5743Thu, 24 Sep 2009 11:19:05 GMTThu, 24 Sep 2009 11:19:05 GMTThu, 24 Sep 2009 11:36:37 GMTThe conduct of studies according to a Paediatric Investigation Plan (PIP) are leading to a delay in submission of 70% of marketing authorisations applications according to respondents of a new survey from The Organisation for Professionals in Regulatory Affairs (TOPRA). Conducted to provide background for a major conference on this subject, the survey also highlighted the other issues industry might face on this new area of legislation. For example, 86% of those surveyed encountered difficulties with compliance checks. To facilitate open discussion of these issues an unprecedented event was held by TOPRA, the European Medicines Agency (EMEA), The European Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE), who joined forces to discuss and work through these issues with members of the Paediatric Committee (PDCO). The workshop, held in London on 15 September 2009, was attended by over 150 senior-level regulatory personnel and sold-out very quickly, further highlighting the need for industry and regulators to discuss PIPs. http://www.icr-global.org/resources/news/?EntryId23=5742Thu, 24 Sep 2009 10:43:24 GMTThu, 24 Sep 2009 10:43:24 GMTThu, 24 Sep 2009 11:19:04 GMTThe Wellcome Trust and Merck & Co., Inc. have announcde the creation of the MSD-Wellcome Trust Hilleman Laboratories, a unique research and development joint venture with a not-for-profit mission to focus on developing affordable vaccines for diseases that commonly affect low-income countries. The joint venture marks the first time a research charity and a pharmaceutical company have partnered to form a separate entity with equally shared funding and decision-making rights. Pairing two of the world's preeminent healthcare institutions provides an opportunity to integrate the best of both to drive the investment and expertise needed to develop and deliver vaccines to low-income countries. The vision: a sustainable, not-for-profit operating model to turn innovative science into practical solutions for those in greatest need The heart of this concept is the creation of a sustainable R&D organisation that operates like a business, but with a not-for-profit operating model, to address the vaccine needs of low-income countries. As well as developing new vaccines in areas of unmet need, the Hilleman Laboratories will also work on optimising existing vaccines, an important and powerful way of increasing the impact of vaccination in resource-limited settings. By working in partnership, the Wellcome Trust and Merck seek to achieve what neither can do alone.http://www.icr-global.org/resources/news/?EntryId23=5741Thu, 24 Sep 2009 10:35:49 GMTThu, 24 Sep 2009 10:35:49 GMTThu, 24 Sep 2009 10:43:24 GMTBioClinica, a publicly traded e-clinical service provider, has acquired Tourtellotte Solutions, a Massachusetts software firm founded by Ed Tourtellotte, best known for its supply chain simulation and interactive voice (IVR)/interactive web (IWR) software. BioClinica, which was forged when Bio-Imaging Technologies acquired Phoenix Data Systems 18 months ago, offers medical image management, electronic data capture (EDC), and other services to maximize manageability. Peter Benton, executive VP and president of the eClinical division at BioClinica, says the firm was attracted to many aspects of Tourtellotte's technology. "We're looking for enhancements, anything that helps speed up and improve both the design and execution of clinical trials," Benton told eCliniqua. "Whether it's imaging, EDC, IVR... there's a huge opportunity to bring radical improvements in the drug development process and in how products are brought to market."http://www.icr-global.org/resources/news/?EntryId23=5740Thu, 24 Sep 2009 10:31:02 GMTThu, 24 Sep 2009 10:31:02 GMTThu, 24 Sep 2009 12:01:03 GMT PPD, Inc. has announced that it has opened its global central lab facility in Singapore, strengthening its ability to provide biopharmaceutical clients an extensive range of customized laboratory services in Southeast Asia, a high-growth region for clinical research. "Expanding our global central lab services into Singapore demonstrates our commitment to deliver high quality specimens and laboratory results for our clients in a growing biopharmaceutical market," said Steve Lobel, vice president, global laboratory operations, PPD. "We can expedite delivery of lab data through reduced transportation and shipping time at better logistics costs for our clients." PPD also has an office in Singapore where for more than 10 years it has provided a range of clinical development services, including clinical trial management and monitoring, patient recruitment, site identification and regulatory affairs.http://www.icr-global.org/resources/news/?EntryId23=5739Thu, 24 Sep 2009 10:24:06 GMTThu, 24 Sep 2009 10:24:06 GMTThu, 24 Sep 2009 10:31:02 GMTICON plc has announced that three of its laboratories have received industry accreditations. ICON’s bioanalytical laboratory in Manchester, UK, has received GCP and GLP accreditation from the MHRA (Medicines and Healthcare products Regulatory Agency). This laboratory accreditation covers bioanalysis of small molecules by mass spectrometry and large molecules by immunoassay techniques. In addition, ICON’s clinical pathology laboratory, also located in Manchester, has received GCP accreditation. ICON now has two GLP accredited bioanalytical laboratories, following the company’s acquisition of US-based Prevalere Life Sciences Inc., in November 2008. http://www.icr-global.org/resources/news/?EntryId23=5738Thu, 24 Sep 2009 10:07:55 GMTThu, 24 Sep 2009 10:07:55 GMTThu, 24 Sep 2009 10:24:05 GMTWoodley Equipment Company Ltd was established in 1989 by Mike Wickham. Twenty years on, Woodley have worked with the largest clinical research companies across the globe, supplying a vast range of equipment from the smallest study to global blockbusters. Over the last 20 years, Woodley have been pivotal in providing medical and laboratory equipment to the pharmaceutical industry, bringing simplicity to the world’s most complicated clinical trials. To mark their 20th anniversary, Woodley Equipment Company invite you to enter their fantastic prize draw to win one of three bottles of Chateau Pitray 1989 Bordeaux red wine. Simply visit www.woodley20years.com to register your details to be in with a chance of winning this vintage red. The winner will be drawn on Friday 30th October 2009.http://www.icr-global.org/resources/news/?EntryId23=5737Thu, 24 Sep 2009 10:05:30 GMTThu, 24 Sep 2009 10:05:30 GMTThu, 24 Sep 2009 10:07:54 GMTEli Lilly and Company has announced a major reorganisation, with seven high-ranking Lilly leaders being appointed to new senior corporate roles, to take effect on November 1st. The company will create a Developmental Center of Excellence to tackle the industry-wide problem of development timelines and efficiency, and will organise its business around five product areas: oncology, diabetes, established markets, emerging markets and animal health. As part of this, Lilly has also announced its intention to decrease staffing levels to 35,000 by the end of 2011, representing a reduction of around 5,500 jobs. It is not clear in what developmental or geographical areas these jobs will be cut.http://www.icr-global.org/resources/news/?EntryId23=5687Tue, 15 Sep 2009 14:32:32 GMTTue, 15 Sep 2009 14:32:32 GMTTue, 15 Sep 2009 14:46:18 GMTAbbott has announced a definitive agreement to acquire the outstanding equity of Evalve, Inc., the global leader in the development of devices for minimally invasive repair of cardiac mitral valves. The acquisition provides Abbott with a presence in the growing area of non-surgical treatment for structural heart disease, in which physicians use catheter-based devices to repair or replace basic structural components of the heart such as mitral and aortic valves. The agreement includes an upfront payment of $320 million in cash, plus an additional payment upon completion of certain regulatory milestones, for a total of up to $410 million.http://www.icr-global.org/resources/news/?EntryId23=5685Tue, 15 Sep 2009 10:35:36 GMTTue, 15 Sep 2009 10:35:36 GMTTue, 15 Sep 2009 10:37:46 GMTThe Drug Information Association (DIA) has announced the hiring of Paul Pomerantz, MBA, CAE, as its new worldwide executive director. Paul will transition from his current position as executive vice president of the American Society of Plastic Surgeons (ASPS) to DIA worldwide executive director effective December 1, 2009. Pomerantz replaces William Brassington, MBA, who has served as acting executive director since July 2008. Brassington will resume his role as worldwide director of finance at DIA.http://www.icr-global.org/resources/news/?EntryId23=5684Tue, 15 Sep 2009 10:17:39 GMTTue, 15 Sep 2009 10:17:39 GMTTue, 15 Sep 2009 10:35:36 GMTQED Clinical Services has recently joined forces with QED Partnership, another highly experienced UK based CRO. The coming together of the two companies under the QED Clinical Services umbrella means that the merged organization can now provide further expertise, capacity and enhanced quality in the conduct of clinical trials. The two companies were already long term partners, sharing many similarities and hence this is a highly complementary pairing. The resulting enhanced QED Clinical Services organization can now draw on the vast experience of new Senior Management team members, such as Susan Ollier, BSc, MRQA, HonFICR, CSci and David Ollier BSc, MICR. Susan was previously the chair of the Institute of Clinical Research (ICR) for 2 years and a member of the ICR Board for 6 years and David has an extensive clinical background with focus on working closely with the NHS. The QED Partnership team also bring a diverse customer base ranging from large pharmaceutical sponsors to small Biotech which complement the numerous existing QED Clinical sponsors. Furthermore the team possess a wealth of experience in Research Governance, Auditing and Training within the NHS which will allow QED Clinical to expand its non-commercial sponsor business significantly.http://www.icr-global.org/resources/news/?EntryId23=5683Tue, 15 Sep 2009 10:12:07 GMTTue, 15 Sep 2009 10:12:07 GMTTue, 15 Sep 2009 10:17:37 GMTBioClinica, Inc. has acquired the CardioNow unit of Agfa HealthCare. With this addition, BioClinica now offers streamlined electronic transport solutions to facilitate the blinding, sharing, tracking and archiving of medical images for multi-center clinical trials as part of its suite of imaging services. Imaging information will also be integrated with BioClinica Express electronic data capture to further simplify and enhance the clinical trial process for life science companies.http://www.icr-global.org/resources/news/?EntryId23=5668Thu, 10 Sep 2009 12:48:29 GMTThu, 10 Sep 2009 12:48:29 GMTThu, 10 Sep 2009 12:50:49 GMTAtlantic Research Group (ARG) has announced its membership into the Pharmaceutical Service Network (PSN), a partnership of small CROs focused on providing exceptional service with extensive local knowledge in a broad geographical footprint. Founded in 1995, the PSN offers full service CRO services with the benefits of working with a small CRO in addition to the depth of experience across an international scale. The PSN is currently made up of 8 owner-operated CROs “Joining the PSN offers our clients the advantage of having extensive expertise in each region, a more cost effective option for clinical development, and the benefits of working with smaller focused CROs for their clinical development needs” comments Paul Bishop, Managing Partner, ARG. The PSN applies a flat management structure that allows each member to be flexible and reactive to changing study requirements. All processes and infrastructure have been integrated to provide a seamless operation of each project. The PSN will utilize TrialVista as well as other operational systems to enhance development performance. “We are excited for the opportunity to further collaborate with the PSN partners to provide our clients with additional services and outside of US range while still maintaining the philosophy and identity of a smaller CRO”, says Lyle Camblos, Managing Partner.http://www.icr-global.org/resources/news/?EntryId23=5667Thu, 10 Sep 2009 12:43:43 GMTThu, 10 Sep 2009 12:43:43 GMTThu, 10 Sep 2009 12:48:29 GMTMDS has announced that it intends to sell its MDS Pharma Services business, a leading provider of innovative drug discovery and early-stage development solutions for pharmaceutical and biotechnology companies. This sale encompasses the group's early stage (I-IIa) business, following the sale of later phase operations to INC earlier this year. The decision follows a comprehensive strategic review by a Special Committee of independent Directors working with Management and financial and legal advisors. In an open letter to clients, MDS Pharma Services President, David Spaight, said "Discussions are under way with interested parties who are attracted by our position as a top-three provider in the Discovery through Phase IIa clinical proof-of-concept space, and who want to build on the strong foundation we have established to successfully serve clients."http://www.icr-global.org/resources/news/?EntryId23=5666Thu, 10 Sep 2009 12:32:29 GMTThu, 10 Sep 2009 12:32:29 GMTThu, 10 Sep 2009 12:43:43 GMTCommission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises was published in the Official Journal on 25 July 2009 and has entered into force.http://www.icr-global.org/resources/news/?EntryId23=5665Thu, 10 Sep 2009 12:21:35 GMTThu, 10 Sep 2009 12:21:35 GMTThu, 10 Sep 2009 12:32:29 GMTIn a paper published in PLoS Medicine, researchers analysing over 7500 clinical trials registered with ClinicalTrials.gov have found that reporting of optional data elements varied and publication rates were low. These findings indicate that, over the period studied, critical trial information was not included in the ClinicalTrials.gov registry. The FDA Amendments Act should remedy some of these shortcomings but only if the accuracy and completeness of the information in ClinicalTrials.gov is carefully monitored. These findings also reveal that registration in ClinicalTrials.gov does not guarantee that trial results will appear in a timely manner in the scientific literature. However, they do not address the reasons for selective publication (which may be, in part, because it is harder to publish negative results than positive results), and they are potentially limited by the methods used to discover whether trial results had been published. Nevertheless, these findings suggest that the FDA, trial sponsors, and the scientific community all need to make a firm commitment to minimize the selective publication of trial results to ensure that patients and clinicians have access to the information they need to make fully informed treatment decisions.http://www.icr-global.org/resources/news/?EntryId23=5663Thu, 10 Sep 2009 12:09:07 GMTThu, 10 Sep 2009 12:09:07 GMTThu, 10 Sep 2009 12:21:08 GMTThe U.S. Food and Drug Administration is proposing to amend postmarket safety reporting regulations for three of its centers to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format. The agency issued two proposed rules: one that applies to electronic medical device adverse event reporting and one that applies to electronic drug and biologic product adverse experience reporting. The rules would not change what types of incidents are required to be reported to the FDA; it would require that the incidents be reported in an electronic format that the FDA can process, review and archive. “Both proposed rules will improve the agency’s ability to obtain safety information more quickly, which will help lead to faster identification of potential safety problems,” said David Buckles, Ph.D., director of the Division of Postmarket Surveillance at the FDA’s Center for Devices and Radiological Health (CDRH). “Information obtained from these reports may be critical to future action that improves patient safety.”http://www.icr-global.org/resources/news/?EntryId23=5662Thu, 10 Sep 2009 12:08:04 GMTThu, 10 Sep 2009 12:08:04 GMTThu, 10 Sep 2009 12:09:07 GMTIn the final step of its phased introduction of the use of the Electronic Common Technical Document (eCTD) format for the submission of electronic-only applications for marketing-authorisation applications, the European Medicines Agency will require that the eCTD format be used from 1 January 2010 for all applications relating to medicinal products for human use.http://www.icr-global.org/resources/news/?EntryId23=5660Thu, 10 Sep 2009 11:46:16 GMTThu, 10 Sep 2009 11:46:16 GMTThu, 10 Sep 2009 11:56:05 GMTWith the establishment of five new Clinical Research Units the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) hopes to give a further boost to clinical research in Germany and drive progress in the scientific investigation and possibilities for the treatment of disease. Just like the existing Clinical Research Units, the newly established units also tightly link the fields of clinical research, applied research and basic research, in so doing making a significant contribution to developing and raising the scientific profile of the medical schools involved. "Over and above that, this funding instrument also helps to improve the training of young researchers", said Dr. Petra Hintze from the DFG's Life Sciences Division, who is responsible for the Clinical Research Units. The research of the five new Clinical Research Units focuses on highly topical medical issues, such as improving the treatment of metastases in bowel cancer patients, or how to treat hormone-related obesity more effectively. Another topic studied will be the effects of transport abnormalities in the liver and how to improve the treatment of bone marrow cancer or inflammation of the renal corpuscles. The five new Clinical Research Units, which are the first to have been approved since the programme was reformed in 2008, bring the total number of Clinical Research Units established by the DFG since 2001 to 46.http://www.icr-global.org/resources/news/?EntryId23=5658Thu, 10 Sep 2009 11:26:29 GMTThu, 10 Sep 2009 11:26:29 GMTThu, 10 Sep 2009 11:46:16 GMTCovance Inc. has opened new clinical development offices in Sao Paolo, Brazil and Mexico City, Mexico. These offices further expand Covance's global footprint with a comprehensive range of services across Latin America. Earlier this year, Covance announced new offices in Santiago, Chile and Lima, Peru. These new sites will support staff in these countries, Central America, and the Caribbean, as well as the regional network of field-based clinical research associates in the region. Covance has been providing clinical trial support in Latin America since 1997 with the company's first office in Buenos Aires, Argentina. Operations in the region expanded quickly through a network of regional clinical trial monitors trained and supervised under guidelines meeting both local and international regulatory requirements as well as global Covance quality standards. "Our continued expansion in Latin America highlights the region's growing significance in Covance's clinical development service offerings. These new offices increase our access to patients who are currently not receiving medical therapies and will enable us to shorten clinical trial cycle times for our pharmaceutical and biotech clients," said Wayne Langlois, vice president and general manager of global clinical development services at Covance.http://www.icr-global.org/resources/news/?EntryId23=5657Thu, 10 Sep 2009 11:12:49 GMTThu, 10 Sep 2009 11:12:49 GMTThu, 10 Sep 2009 11:26:28 GMTPhlexglobal has signed a contract with global biopharmaceutical company UCB to implement a complete trial master file management solution. The new contract will see Phlexglobal employ up to 30 new staff to provide electronic and paper trial master file (TMF) management services for UCB global operations. This will include centralising UCB's historical and ongoing global clinical study files from Phase I through to Phase IV. This will include use of PhlexEview, an end-to-end TMF solution which allows logical electronic searching and viewing of TMF documentation, once it has been prepared, scanned and indexed into the system. Preparing for archive, TMF QC checking and archive storage completes the management cycle. "Perhaps the most interesting part of the solution is the management insight that will be provided to UCB," comments Nicola Murgatroyd, CEO of Phlexglobal. "PhlexEview allows key users to gain a complete overview of their study documents at any one point in time, this in turn, will provide UCB with business critical information on the status and activity at all study sites. This facility would just not be possible when using paper TMFs." Mark Hill, global head of global trial master file management for UCB added: "We are really excited about working with Phlexglobal. Online document viewing is a new concept for many of our staff but we believe it is going to make our processes so much quicker and smoother."http://www.icr-global.org/resources/news/?EntryId23=5646Tue, 08 Sep 2009 15:13:18 GMTTue, 08 Sep 2009 15:13:18 GMTTue, 08 Sep 2009 15:18:40 GMTThe 8th edition of the UK Human Fertilisation and Embryology Authority (HFEA) Code of Practice, updated consent forms and HFEA Directions have now been published. They come into force on 1 October 2009. The 8th Code has been updated to reflect changes in the Human Fertilisation and Embryology Act 2008 and in HFEA policy. The consent forms and Directions have also been updated in line with the amended Act. The Code, consent forms, and Directions come into force on 1 October 2009. Until then, the 7th edition of the Code, the existing consent forms and Directions must continue to be used. http://www.icr-global.org/resources/news/?EntryId23=5577Wed, 19 Aug 2009 16:20:22 GMTWed, 19 Aug 2009 16:20:22 GMTWed, 19 Aug 2009 16:22:58 GMTUKRIO's Code of Practice for Research, revised following a public consultation on a draft version earlier this year, is now available in PDF form. The Code has been produced as part of UKRIO's continuing work to support researchers and research organisations in the promotion of good practice in research and the conduct of research of the highest quality. The Code has been revised following the valuable feedback given during the consultation. Particular attention has been paid to those areas of the Code which were considered by some to be unclear or excessively prescriptive. The Code is applicable to all subject areas and does not attempt to micro-manage research. It covers areas of good practice typically included in organisational policies for the conduct of research, drawing upon existing good practice and the experiences of UKRIO in addressing good conduct and misconduct in research. Additional consideration has been given to areas where UKRIO has most often been approached for guidance, in the hope of passing on lessons learned to the research community.http://www.icr-global.org/resources/news/?EntryId23=5576Wed, 19 Aug 2009 16:19:08 GMTWed, 19 Aug 2009 16:19:08 GMTWed, 19 Aug 2009 16:20:22 GMTGeron Corporation has announced that its IND for GRNOPC1, a cell therapy for neurologically complete, subacute spinal cord injury, has been placed on clinical hold by the FDA pending the agency's review of new nonclinical animal study data submitted by the company. A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing trial. Since filing the IND, Geron has been undertaking studies to enable dose escalation of its spinal cord injury product, and has been investigating application of the product to other neurodegenerative diseases. The company has also been performing additional product characterization and conducting further animal studies. Data from this work has been submitted to the FDA. Geron will work closely with the FDA to facilitate their review of the new data and to release the clinical hold. No patients have yet been treated in this study.http://www.icr-global.org/resources/news/?EntryId23=5571Wed, 19 Aug 2009 13:45:38 GMTWed, 19 Aug 2009 13:45:38 GMTWed, 19 Aug 2009 13:51:38 GMTPAREXEL International Corporation have reported financial results for the fourth quarter and Fiscal Year ended June 30, 2009. The Company has determined the need to correct certain accounting errors in the recently acquired ClinPhone business, as described in greater detail below. These changes relate to (1) the ClinPhone Interactive Voice Response (IVR) component of the Perceptive Informatics business segment, and (2) purchase accounting for ClinPhone, which the Company acquired in August 2008. The changes do not have an impact on the Company’s fundamental business or on its economics in terms of cash or cash flow.http://www.icr-global.org/resources/news/?EntryId23=5570Wed, 19 Aug 2009 13:31:42 GMTWed, 19 Aug 2009 13:31:42 GMTWed, 19 Aug 2009 13:45:38 GMTThe U.S. Food and Drug Administration today announced it has stepped up its efforts to prevent non-compliant investigators and others from participating in new product development. The FDA's procedures for debarment and disqualification have been enhanced to better protect participants in clinical studies and for ensuring the safety and effectiveness of the medical products marketed to the American public. The new debarment and disqualification procedures will also help ensure that sponsors of clinical studies do not unknowingly use individuals who potentially may be debarred or disqualified by the FDA. “The FDA views any deviation from its high standards for developing or marketing drugs and devices as a potential threat to patient safety and public health,” said Norris Alderson, the FDA's associate commissioner for science. “We will take strong action against anyone who chooses to ignore or flout the legal requirements for the products we regulate.” Under current law, the FDA can ban, or debar, individuals known to have broken the law from working for companies with approved or pending drug applications at the FDA. The agency can also disqualify researchers conducting clinical testing of new drugs and devices, when the FDA determines that they have not followed the rules intended to protect study subjects. Further, the FDA can disqualify a clinical investigator who has, for example, manipulated data so as to inaccurately report study findings.http://www.icr-global.org/resources/news/?EntryId23=5569Wed, 19 Aug 2009 13:11:02 GMTWed, 19 Aug 2009 13:11:02 GMTWed, 19 Aug 2009 13:31:42 GMTOmniComm Systems, Inc. has acquired the EDC assets of UK-based clinical software provider Logos Technologies Ltd. Logos’ software is used to collect clinical trial data gathered while conducting Phase I clinical trials and complements OmniComm’s TrialMaster® software, which is primarily used in later stage clinical trials. Regular EDC solutions for later stage trials do not include a pro-active data collection system, which is imperative for the very time-controlled data collection during many early stage clinical studies. "We look forward to becoming part of OmniComm," said Simon Kemp, Logos’ Managing Director. "OmniComm’s team of industry professionals was a key factor in our decision making process. We have worked closely with OmniComm in the past with several joint clients and see this as an opportunity to enhance and fully integrate the Logos products with OmniComm’s eClinical solutions. Our clients, which include Top 10 Pharmaceutical, leading Academic and Clinical Research Organizations, will also benefit from working with a larger global company like OmniComm." http://www.icr-global.org/resources/news/?EntryId23=5568Wed, 19 Aug 2009 12:46:43 GMTWed, 19 Aug 2009 12:46:43 GMTWed, 19 Aug 2009 13:11:02 GMTA paper currently being prepared for publicatin in online journal BMC Medical Research Methodology describes the challenges a research team experienced recruiting physicians within a randomised controlled trial about leg ulcer care that seeks to foster the cooperation between the medical and nursing professions. The aim of this article is to investigate the success of different recruitment strategies employed and reasons for physicians' non-participation. Various reasons for community physicians' non-participation are presented as stated spontaneously during phone conversations that might explain low recruitment rates. The recruitment strategy utilised is discussed against the background of factors associated with high participation rates from the international literature.http://www.icr-global.org/resources/news/?EntryId23=5566Wed, 19 Aug 2009 12:32:17 GMTWed, 19 Aug 2009 12:32:17 GMTWed, 19 Aug 2009 12:46:42 GMTAs we predicted when they launched a similar initiative on GMP inspections last year, the EMEA and the FDA have agreed to launch a joint initiative to collaborate on international GCP inspection activities. The objectives of the initiative include the sharing of information on inspection planning, policy and outcomes and the conduct of collaborative inspections. This initiative is an important contribution to ensuring the protection of clinical-trial subjects in the context of the increasing globalisation of clinical research. The EMEA and the FDA will start their new initiative with an 18-month pilot phase on 1 September 2009. Announcing this pilot Thomas Lönngren, the European Medicines Agency’s Executive Director said: “This important initiative demonstrates the increasing collaboration between the EMEA and the FDA. It marks an important step to the building of a global regulatory network for supervision of clinical trials. By working together in a collaborative and synergistic manner GCP inspection resources can be used more efficiently.”http://www.icr-global.org/resources/news/?EntryId23=5565Wed, 19 Aug 2009 12:27:29 GMTWed, 19 Aug 2009 12:27:29 GMTWed, 19 Aug 2009 12:32:17 GMTThe U.S. Food and Drug Administration has published two rules that seek to clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don’t have other satisfactory treatment options. To support the effort to help these patients, the agency also is launching a new website where patients and their health care professionals can learn about options for investigational drugs. The new rule, “Expanded Access to Investigational Drugs for Treatment Use,” makes investigational drugs more widely available to patients by clarifying procedures and standards. The other rule, “Charging for Investigational Drugs Under an Investigational New Drug Application,” clarifies the specific circumstances and the types of costs for which a manufacturer can charge patients for an investigational drug when used as part of a clinical trial or when used outside the scope of a clinical trial. “With these initiatives, patients will have the information they need to help them decide whether to seek investigational products,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “For patients seeking expanded access to investigational drugs and biologics, the new rules make the process easier to understand.”http://www.icr-global.org/resources/news/?EntryId23=5564Wed, 19 Aug 2009 12:25:39 GMTWed, 19 Aug 2009 12:25:39 GMTWed, 19 Aug 2009 12:27:28 GMTMDS Pharma Services is pleased to announce that its Phase 0, I and IIa early clinical research facility in Belfast, Northern Ireland, has received both Standard and Supplementary Accreditation from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The voluntary accreditations, which are valid for two years and renewable after a satisfactory re-inspection, address human research subject safety and set stringent standards for facilities that perform early-stage clinical trials, including high-risk first-in-human (FIH) studies involving biologics. The MHRA program was introduced in April 2008.http://www.icr-global.org/resources/news/?EntryId23=5473Thu, 30 Jul 2009 13:46:19 GMTThu, 30 Jul 2009 13:46:19 GMTThu, 30 Jul 2009 13:48:17 GMTGlobal life sciences executive search specialists RSA have launched the UK's first register of Non-Executive Directors dedicated wholly to the life sciences. Identifying independent, experienced and authoritative Non-Executive Directors can be a major challenge to even the most well-established pharmaceutical and life sciences companies. RSA's new register brings together the small, but powerful, niche community of Non-Executive Directors. The register will facilitate networking, produce research into the challenges and opportunities of Non-Executive Directorship, and place qualified individuals into Board vacancies with life sciences companies (within both the public and private sector).http://www.icr-global.org/resources/news/?EntryId23=5471Thu, 30 Jul 2009 12:49:18 GMTThu, 30 Jul 2009 12:49:18 GMTThu, 30 Jul 2009 12:58:24 GMTThe European Medicines Agency has started to receive data on H1N1 pandemic vaccines and the review began in July, with the commitment from the Committee for Medicinal Products for Human Use, to fast-track the review of data as vaccine manufacturers make them available. Given the public health threat posed by the current pandemic, the Agency’s goal is to ensure data submitted to support marketing authorisations for vaccines are reviewed as early as possible, before the beginning of the Northern hemisphere flu season, expected in September. At present the Committee (or CHMP) is reviewing data relating to manufacture of vaccines. Additional clinical trials in adults and children are currently being initiated by the vaccine manufacturers and the results will be reviewed in the coming months as they become available. Four ‘mock-up’ vaccines developed by Baxter, GlaxoSmithKline and Novartis have already been approved in the European Union based on earlier data generated with the H5N1 virus strain, which is similar to H1N1. These vaccines were developed in the knowledge that the virus strain would be changed in the event of a declared pandemic, to include the strain causing the pandemic. Altogether, they have been tested in more than 8,000 subjects. Decades of experience with seasonal influenza vaccines indicate that insertion of a new strain in a vaccine, as will apply with the change from H5N1 to H1N1 in the mock-up vaccines, should not substantially affect the safety or level of protection offered.http://www.icr-global.org/resources/news/?EntryId23=5470Thu, 30 Jul 2009 12:48:25 GMTThu, 30 Jul 2009 12:48:25 GMTThu, 30 Jul 2009 12:49:18 GMTSanofi-aventis and Mérieux Alliance have signed a strategic agreement for the acquisition by Sanofi Pasteur of Mérieux Alliance’s French subsidiary ShanH, which owns a majority stake in vaccine company Shantha Biotechnics based in Hyderabad, India. Alain Mérieux will chair the Board of ShanH and a new joint committee will be created to be chaired by Alain Mérieux on vaccine strategy for the Emerging Markets. Under the terms of the agreement, Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, will support Shantha’s ongoing development as a platform to address the need for high quality affordable vaccination in international markets. Commenting on the agreement, Christopher A. Viehbacher, Chief Executive Officer of sanofi-aventis said: “Shantha provides Sanofi Pasteur with a portfolio of new vaccines in development which complement Sanofi Pasteur’s current vaccines, positioning the company to accelerate its growth in strategically important emerging markets.”http://www.icr-global.org/resources/news/?EntryId23=5468Thu, 30 Jul 2009 12:08:31 GMTThu, 30 Jul 2009 12:08:31 GMTThu, 30 Jul 2009 12:31:01 GMTThe Australian regulator, the TGA, has proposed three more EU guidelines for adoption, continuing an ongoing process of considering all EU guidelines on medicinal products and medical devices. These include the "Guideline on Human Cell-Based Medicinal Products" (EMEA/CHMP/410869/2006). These proposals are open for comments for a short period.http://www.icr-global.org/resources/news/?EntryId23=5467Thu, 30 Jul 2009 12:03:46 GMTThu, 30 Jul 2009 12:03:46 GMTThu, 30 Jul 2009 12:08:31 GMTThe National Institute for Health and Clinical Excellence (NICE) welcomes the referral of four clinical areas by the Department of Health following advice from the National Quality Board and will now begin work on setting NICE quality standards for the NHS using a pilot process. The Darzi report, High Quality Care For All (June 2008), expanded NICE’s role to include setting and approving more independent quality standards for the NHS. The report highlighted the difficulties clinicians faced in keeping up with the best evidence. It stated that standards should clarify what high quality care looks like with regard to: * clinical effectiveness * patient safety * patient experience. This work is a key part of making quality the organising principle of the NHS and supporting the drive to improve standards of care.http://www.icr-global.org/resources/news/?EntryId23=5466Thu, 30 Jul 2009 11:52:12 GMTThu, 30 Jul 2009 11:52:12 GMTThu, 30 Jul 2009 12:03:46 GMTThe Medicines and Healthcare products Regulatory Agency (MHRA) and the Appointments Commission are pleased to announce the re-appointment of the chairs to both the Commission on Human Medicines (CHM), and the Herbal Medicines Advisory Committee (HMAC). Sir Gordon Duff has been re-appointed as chair of the CHM and has served on the committee for the past 16 years. He received a knighthood for services to public health in 2006. Professor Philip Routledge OBE has been re-appointed as chair of the HMAC. He is currently head of the department of pharmacology, radiology and oncology at the Wales College of Medicine at Cardiff University and is chair of the All Wales Medicines Strategy Group (AWMSG), a public appointment in Wales.http://www.icr-global.org/resources/news/?EntryId23=5464Thu, 30 Jul 2009 11:33:58 GMTThu, 30 Jul 2009 11:33:58 GMTThu, 30 Jul 2009 11:41:38 GMTThe US FDA has published a Q&A document on its program of registration of Institutional Review Boards (IRBs, comparable to RECs elsewhere), which came into effect on July 14th.http://www.icr-global.org/resources/news/?EntryId23=5463Thu, 30 Jul 2009 11:26:54 GMTThu, 30 Jul 2009 11:26:54 GMTThu, 30 Jul 2009 11:33:58 GMTThe European Medicines Agency has published its annual report for 2008, a highly productive year in which the Agency consolidated its work in core activity areas and made good progress with many of the initiatives it is involved in. Both a full version (158 pages) and a summary version (17 pages) are available.http://www.icr-global.org/resources/news/?EntryId23=5462Thu, 30 Jul 2009 11:04:45 GMTThu, 30 Jul 2009 11:04:45 GMTThu, 30 Jul 2009 11:26:54 GMTThe "Questions and Answers document" in the EudraLex volume 10 on clinical trials has been revised. This new document supersedes the version published last month, adding two new questions ("Is an authorised medicinal product used as comparator in a clinical trial an investigational medicinal product?" and "What can be considered a “non-interventional trial?") and revising the answers to two others ("Can the sponsor delegate tasks or responsibilities?" and "Can the dates of the annual safety reports be aligned with other periodic reporting requirements?").http://www.icr-global.org/resources/news/?EntryId23=5461Thu, 30 Jul 2009 11:00:04 GMTThu, 30 Jul 2009 11:00:04 GMTThu, 30 Jul 2009 11:04:45 GMTAn investigator in Gujarat, India, Dr Amul Bhattacharya, has been suspended following investigations into his work as an investigator in a clinical trial conducted at Guru Govind Singh Hospital in Jamnagar. This follows the site and Dr Bhattacharya being reported to the Drugs Controller General of India (DCGI) by study sponsor Glenmark Pharmaceuticals and CRO Omnicare, following initial suspicions of misconduct in April 2009 and after detailed investigations two months later. As a result, Dr Bhattacharya and three other suspects face criminal charges. Glenmark commented that: “It is important to confirm that no patients have been put at risk, and no further patients have been or will be recruited in the clinical study at Jamnagar.” http://www.icr-global.org/resources/news/?EntryId23=5451Tue, 28 Jul 2009 15:48:21 GMTTue, 28 Jul 2009 15:48:21 GMTTue, 28 Jul 2009 17:32:04 GMTPhase Forward has acquired privately held Maaguzi LLC, an innovative provider of Web-based, electronic patient reported outcomes (ePRO) and late phase solutions, for $11 million in cash. Maaguzi has operations in Indianapolis, Ind. and Morrisville, N.C. The acquisition of Maaguzi extends Phase Forward’s integrated clinical research suite (ICRS) and marks the company’s entry into the increasingly important ePRO and observational studies markets. “The acquisition of Maaguzi is another step in our strategy of providing customers with an end-to-end, integrated clinical research suite for efficiently managing all of their trials,” said Bob Weiler, chairman and CEO, Phase Forward. “Our customers tell us that improving the involvement of patients and other parties in the clinical research and post-marketing areas is of critical importance, and Maaguzi’s technology leadership in this area will help us meet that need. We welcome Maaguzi to the Phase Forward team.” http://www.icr-global.org/resources/news/?EntryId23=5450Tue, 28 Jul 2009 15:46:13 GMTTue, 28 Jul 2009 15:46:13 GMTTue, 28 Jul 2009 15:48:21 GMTIn February 2009, NICE asked Professor Sir Ian Kennedy to undertake an independent study in response to the views expressed by Sir David Cooksey in his Review and Refresh of Bioscience 2015. Sir Ian Kennedy was asked to carry out a short study on how NICE establishes the value of innovation, and in particular to make recommendations about what approach should be adopted by NICE to ensure that innovation is properly taken into account when establishing the value of new health technologies. Sir Ian presented his report at the public NICE Board meeting on the 22 July 2009. The report and further information about the study is available on the NICE website at: http://www.nice.org.uk/aboutnice/howwework/researchanddevelopment/KennedyStudyOfValuingInnovation.jsp Although taking the view that that NICE appraisals should continue to be based on the QALY approach, the report makes 25 recommendations including: * Social benefits should not currently be taken into account, but should be the subject of further research * NICE should consider developing and piloting a transparent process to offer incentives (such as a higher threshold) for innovation * NICE should establish a mechanism to 'claw back' costs incurred if a product subsequently proves not to meet initial expectations * NICE should work with the Office of Life Sciences with regard to the "Innovation Pass" * NICE should play an increasingly active role in encouraging research to be carried out in the UK NICE’s Board will set out a formal response at its next public Board meeting in September, which will then be the subject of a three-month consultation.”http://www.icr-global.org/resources/news/?EntryId23=5421Thu, 23 Jul 2009 10:41:03 GMTThu, 23 Jul 2009 10:41:03 GMTThu, 23 Jul 2009 11:03:25 GMTBristol-Myers Squibb and Medarex have signed a definitive agreement providing for the acquisition of Medarex by BMS in a deal worth approximately $2.1 billion. "Medarex's technology platform, people and pipeline provide a strong complement to our company's biologics strategy, specifically in immuno-oncology," said James M. Cornelius, chairman and chief executive officer, Bristol-Myers Squibb. "With its productive and proven antibody discovery capabilities, ability to generate interesting therapeutic programs and unique set of pre-clinical and clinical assets in development, Medarex represents what we're looking for in terms of our String of Pearls strategy. This acquisition is another important step in our BioPharma transformation." "We believe that this combination with Bristol-Myers Squibb, a global leader in oncology, provides an excellent opportunity to realize the full potential of Medarex's development portfolio and our UltiMAb(R) technology platform through a transaction which also provides an attractive valuation for our shareholders," said Howard H. Pien, chairman and chief executive officer, Medarex. "Medarex has evolved significantly over the past two decades from a research platform to a development company. We believe that this transaction represents a great opportunity to place our clinical programs and technology assets in the hands of one of the world's premier biopharmaceutical companies with the expertise, resources, motivation and dedication to bring innovative cancer treatment options to patients in need."http://www.icr-global.org/resources/news/?EntryId23=5419Thu, 23 Jul 2009 10:35:04 GMTThu, 23 Jul 2009 10:35:04 GMTThu, 23 Jul 2009 10:40:55 GMTA report by the Association of Clinical Research Organizations (ACRO) has concluded that clinical trials in the developing world meeting the same safety, ethical and quality standards as those conducted in the developed world. Two factors are fueling the growth in developing world trials: because fewer Americans are enrolling in trials, and because global trials enable pharmaceutical companies to bring drugs to market more quickly and cost-effectively. The report found that trials in emerging countries, such as China and India, are subject to the same standards as those conducted in the U.S. and Western Europe. CROs train research staff around the world in good clinical practice (GCP) principles and proof of compliance is required by drug regulators in every major pharmaceutical market. “On a flattened earth with waning U.S. participation in clinical trials, global trials are helping speed important drugs to market,” said Doug Peddicord, executive director of ACRO. ACRO makes several recommendations to make sure the quality and ethical standards match the international spread of the trials. Among them, ACRO recommends that: * The U.S Food and Drug Administration be provided sufficient resources to conduct inspections on a global basis in order to ensure that research quality is protected and improved around the world. * All governments take measures to foster the development of a clinical research infrastructure and encourage clinical research participation. * Overseas regulatory bodies recognize drug development as a global enterprise and that globalization leads to faster cures. * All participants in clinical research – no matter where they live or the environment in which research takes place – be protected by the same level of safety and ethical considerations, and that they be afforded the same standard of care, including adherence to the GCP principles promulgated by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).http://www.icr-global.org/resources/news/?EntryId23=5414Wed, 22 Jul 2009 16:04:09 GMTWed, 22 Jul 2009 16:04:09 GMTWed, 22 Jul 2009 16:10:49 GMTMoher et al have published the PRISMA Statement on Preferred Reporting Items for Systematic reviews and Meta-Analyses. Summarising the introduction to the paper: Systematic reviews and meta-analyses have become increasingly important in health care. Clinicians read them to keep up to date with their field and they are often used as a starting point for developing clinical practice guidelines. As with all research, the value of a systematic review depends on what was done, what was found, and the clarity of reporting. As with other publications, the reporting quality of systematic reviews varies, limiting readers' ability to assess the strengths and weaknesses of those reviews. In 1996, to address the suboptimal reporting of meta-analyses, an international group developed a guidance called the QUOROM Statement (QUality Of Reporting Of Meta-analyses), which focused on the reporting of meta-analyses of randomized controlled trials. This article summarizes a revision of these guidelines, renamed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses), which have been updated to address several conceptual and practical advances in the science of systematic reviews.http://www.icr-global.org/resources/news/?EntryId23=5412Wed, 22 Jul 2009 12:14:51 GMTWed, 22 Jul 2009 12:14:51 GMTWed, 22 Jul 2009 12:20:32 GMTThe EMEA has formally adopted a guideline on the investigation on medicinal products in term and preterm neonates (up to 27 days). Whilst they account for a low percentage of the total use of medicines in childhood, up to 90% of medicinal products are used unauthorised or off-label in this population, especially if treated on Neonatal Intensive Care Units (NICUs). There are several reasons as to why few clinical trials of medicinal products have been performed in neonates (e.g. feasibility difficulties linked to: age, small patient group and uniqueness of their diseases.) The Regulation on Medicinal Products for Paediatric Use (Regulation (EC) 1901/2006) creates obligations with regards to conducting clinical trials in paediatric patients including neonates in order to meet the recognised need for authorised medicinal products and the information on the use of medicinal products in children. Therefore clinical trials to investigate medicinal products in the neonatal population have to address the needs of this population. Neonatal studies encompass multiple difficulties, such as ethical (high vulnerability) and technical issues (immaturity, prematurity, lack of self assessment, need for specific formulations, high variability, etc). Notwithstanding the difficulties, the standards of the trials should remain the same.http://www.icr-global.org/resources/news/?EntryId23=5411Wed, 22 Jul 2009 12:11:34 GMTWed, 22 Jul 2009 12:11:34 GMTWed, 22 Jul 2009 12:14:51 GMTThe MHRA has issued draft guidance on the proposed UK exemption scheme for advanced therapy medicinal products (ATMPs) under Article 28 (2) of Regulation EC No 1394/2007 (“the ATMP Regulation”). The question and answer document does not replace the existing material that is published on the website about the Regulation but aims to clarify the specific areas where advice can be provided. In addition, a draft advice form has been developed which will replace existing arrangements for companies who wish to seek advice on the regulatory classification of a product. This form should only be used where advice is sought on product classification. The MHRA would welcome comments on the draft documents by 18 September 2009. Information about the launch of the exemption scheme arrangements will be posted n due course.http://www.icr-global.org/resources/news/?EntryId23=5397Mon, 20 Jul 2009 15:20:47 GMTMon, 20 Jul 2009 15:20:47 GMTMon, 20 Jul 2009 16:02:57 GMTA new Blueprint to put innovation at the heart of healthcare delivery has been launched. The Office for Life Sciences (OLS) Blueprint sets out to transform the UK environment for life sciences companies and ensure faster patient access to cutting-edge medicines and technologies. The OLS forms part of the Government’s active industrial policy. Agreed across Government, and with industry, academia and the NHS, key actions include: * The Government, with the National Institute for Health and Clinical Excellence (NICE), will introduce an "Innovation Pass", a 3-year initiative that will make selected innovative medicines available on the NHS for a time-limited period. The Pass will be piloted in 2010/2011, with a budget of £25 million; (cf 2.5) * The NHS Chief Executive will review system levers and incentives, including Payment by Results, to accelerate the uptake of medical technologies; (cf 2.9) * The Government will reinforce the need for greater emphasis on research and clinical trials in the next NHS Operating Framework; (cf 2.10) * The Technology Strategy Board (TSB) will launch an £18 million “RegenMed” programme of investment to support commercial R&D with additional funding from the Medical Research Council, the Engineering and Physical Sciences Research Council, and the Biotechnology and Biological Sciences Research Council. The TSB has also committed to improve its expertise in the life sciences. (cf 4.8) Lord Drayson, Minister for Science & Innovation, said, “The UK life sciences have everything going for them: world-class facilities, talented scientists and entrepreneurial flair. By championing innovation, the NHS can support the life sciences industry in developing ways to improve people’s health. And we are changing how industry, academia, Government and the NHS work together to create jobs and ensure a bright future for this country." Lord Darzi, Health Minister for Quality and Innovation, said: “By placing innovation at the heart of healthcare delivery we will help create a pioneering NHS, one that responds to patients expectations, and one where the adoption of new ideas and the diffusion of innovation is encouraged and supported. Establishing a culture of innovation is also essential for the NHS to meet any current economic challenges, and the Life Sciences Blueprint will help us continue to support this country's knowledge industries and ensure that we benefit from the competitive edge which they provide.” Andrew Dillon, Chief Executive of NICE, said: "Securing a successful future for the life sciences industries is important for patients and the UK economy. NICE is committed to engaging constructively with companies and we are extending the access that companies have to us, as we appraise their products. The Innovation Pass is an opportunity for data to be gathered on potentially important new treatments. NICE has been involved in discussions about the Innovation Pass, and we are looking forward to continuing to play a key role in developing the Pass.”http://www.icr-global.org/resources/news/?EntryId23=5395Mon, 20 Jul 2009 14:56:12 GMTMon, 20 Jul 2009 14:56:12 GMTMon, 20 Jul 2009 15:15:05 GMTPhase Forward has signed an agreement to purchase the Interactive Voice & Web Response Services (IVRS/IWRS) business of Covance Inc. for $10 million in cash. As part of this transaction, Phase Forward and Covance have also agreed to enter into a multi-year marketing agreement to provide Phase Forward’s EDC and IVRS solutions to Covance clients. Phase Forward expects the purchase, which is subject to customary closing conditions, to be completed by the end of August. “Covance and Phase Forward are committed to working together to deliver best-of-class solutions to our clinical trial customers,” said Bob Weiler, chairman and CEO of Phase Forward. “Covance has been a pioneering leader in the IVRS/ IWRS market and we look forward to building upon their success. We are also pleased to solidify our long-term strategic relationship with one of the world’s leading and most successful CROs.”http://www.icr-global.org/resources/news/?EntryId23=5394Mon, 20 Jul 2009 14:44:24 GMTMon, 20 Jul 2009 14:44:24 GMTMon, 20 Jul 2009 14:56:11 GMTWriting in the Wall Street Journal, Jared Favole reports that the US House of Representatives voted to approve a $2.99b budget for the FDA in 2010, up a record £393m on 2009. Despite some tough exchanges in the debate, the measure was overwhelmingly approved. The Senate has yet to vote on the bill.http://www.icr-global.org/resources/news/?EntryId23=5393Mon, 20 Jul 2009 14:37:58 GMTMon, 20 Jul 2009 14:37:58 GMTMon, 20 Jul 2009 14:44:23 GMTWater Street Healthcare Partners, a leading private equity firm focused exclusively on the health care industry, has acquired the Pharmaceutical Development division from AAIPharma Inc. Water Street has committed up to $75 million in equity financing to expand the business’ capabilities with the goal of building it into the leading provider of pharmaceutical development services. The new company is named AAIPharma Services Corp. The company, which will retain its headquarters in Wilmington, North Carolina, serves more than 300 large pharmaceutical and biotechnology companies throughout North America. Its team of 450 scientists and professionals specialize in services that encompass the entire process of pharmaceutical drug development from discovery through commercialization. “We are thrilled to partner with Water Street to establish ourselves as an independent company,” said L. Lee Karras, who has led the business for the past 3 years and has been appointed the company’s CEO. “In addition to providing significant capital resources, Water Street offers extensive pharmaceutical expertise that will benefit our company, employees and customers as we embark on a new strategic course. Together with Water Street, we will build on our core strengths to provide our customers with unparalleled knowledge and capabilities that will enable them to successfully navigate the complex drug development process.”http://www.icr-global.org/resources/news/?EntryId23=5392Mon, 20 Jul 2009 14:35:12 GMTMon, 20 Jul 2009 14:35:12 GMTMon, 20 Jul 2009 14:37:55 GMTThe FDA IRB Registration Rule is effective Tuesday, July 14, 2009. All IRBs reviewing FDA-regulated research must register between July 14 and September 14, 2009. IRBs that review FDA-regulated studies and that are not already in the OHRP IRB registration system must submit an initial registration. If your IRB is already registered in the OHRP system, the registration information must be updated to include all of the information required by the FDA IRB Registration Rule. Please see the guidance referenced below for more information. This registration will be accomplished through a modified version of the database used by the Office for Human Research Protections (OHRP). Please note: the database for electronic submission of IRB registrations will not be available until July 14, 2009.http://www.icr-global.org/resources/news/?EntryId23=5363Fri, 10 Jul 2009 11:31:13 GMTFri, 10 Jul 2009 11:31:13 GMTFri, 10 Jul 2009 11:43:26 GMTQuotient Clinical has been awarded Supplementary Accreditation from the Medicines and Healthcare products Regulatory Agency (MHRA). This is one of the highest levels of accreditation in Europe and confirms that Quotient Clinical is qualified to perform the full range of Phase I trials, including First-in-Human (FIH) studies for low molecular weight chemical entities and biologics. The MHRA voluntary accreditation scheme was introduced in April 2008 in line with recommendations from the MHRA clinical trial expert advisory group, to maximise subject safety, and provides formal guidance on the standards expected in a clinical unit conducting FIH studies. Mark Egerton, Managing Director of Quotient Clinical comments, “Our MHRA Supplementary Accreditation provides volunteers and sponsors with additional reassurance of the high standards we apply in performing clinical studies. This award acknowledges our continued commitment to quality and safety and underpins our status as one of the leading clinical units in Europe.”http://www.icr-global.org/resources/news/?EntryId23=5360Fri, 10 Jul 2009 10:52:44 GMTFri, 10 Jul 2009 10:52:44 GMTFri, 10 Jul 2009 11:31:12 GMTICON plc has acquired Veeda Laboratories Ltd., a wholly-owned subsidiary of Veeda Clinical Research Group. Veeda Laboratories is a specialist provider of biomarker laboratory services to global pharmaceutical and biotechnology industries. The acquisition adds to ICON Development Solutions’ existing bioanalytical and immunoassay capabilities, which are delivered through its laboratory in Manchester, UK, and Prevalere Life Sciences LLC., the US-based bioanalytical and immunoassay laboratory which ICON acquired in November 2008. “Biomarkers of disease are assuming an ever increasing role in the discovery and development of drugs,” commented Dr. Thomas Frey, President, ICON Development Solutions. “In Veeda Laboratories, we have acquired a company that has a very strong reputation for biomarker development and has well-established relationships with top-tier pharmaceutical and biotechnology companies. Veeda’s team of scientists will also greatly enhance ICON’s existing team of biomarker experts.” “We are excited to be joining ICON,” commented Dr. John Allinson, Head of Veeda Laboratories, Oxford. “This deal will enable us to enhance and expand our biomarker, pharmacokinetic and immunogenicity services and to offer our clients a broader suite of drug development services. We look forward to working closely with ICON’s global network of laboratories to develop innovative biomarker solutions that improve clients’ drug development and therapeutic decision making.” http://www.icr-global.org/resources/news/?EntryId23=5359Fri, 10 Jul 2009 10:49:06 GMTFri, 10 Jul 2009 10:49:06 GMTFri, 10 Jul 2009 10:52:41 GMTThe European Medicines Agency has recommended the first marketing authorisation for an advanced therapy medicinal product, following a positive opinion from the Agency’s Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP). ChondroCelect, from TiGenix NV, is a cell-based medicine that is used to repair defects in the cartilage of the femoral condyle (the end of the thighbone) in the knee. It consists of chondrocytes (cartilage-forming cells) that are taken from a healthy region of the patient’s cartilage, grown outside the body, and then re-implanted during surgery. ChondroCelect is the first product to benefit from the new legal and regulatory framework for advanced therapy medicinal products (Regulation (EC) No 1394/2007). This framework is designed to ensure the free movement of advanced medicines within the European Union (EU), to facilitate their access to the EU market, and to foster the competitiveness of European pharmaceutical companies in the field, while guaranteeing the highest level of health protection for patients.http://www.icr-global.org/resources/news/?EntryId23=5340Tue, 07 Jul 2009 13:34:00 GMTTue, 07 Jul 2009 13:34:00 GMTTue, 07 Jul 2009 13:36:05 GMTA new UK national genome centre has been officially opened by Nobel Laureate and genome pioneer Prof Sir John Sulston and the Lord-Lieutenant of Norfolk. The Genome Analysis Centre (TGAC), on the Norwich Research Park, will further the UK’s capacity in genomics. TGAC has been established in Norwich by the Biotechnology and Biological Sciences Research Council (BBSRC) in partnership with regional economic development partners. Dr Jane Rogers, Director of TGAC, said: “The Genome Analysis Centre will give the UK a lead in the sequencing of the genomes of plants, animals and microbes. By concentrating on specific organisms and problems we will develop an understanding of the genetic makeup of economically important crops and livestock animals. In addition, the genomic analysis of microbes will be a major focus, not only because they infect both animals and plants, but because they are already a source of drugs for the treatment of bacterial and fungal infections and therefore they have the potential to provide new, superbug beating antibiotics.”http://www.icr-global.org/resources/news/?EntryId23=5339Tue, 07 Jul 2009 13:26:21 GMTTue, 07 Jul 2009 13:26:21 GMTTue, 07 Jul 2009 13:33:59 GMTThe Science and Technology Select Committee of the UK House of Lords has published its report on genomic medicine. The report commends the strategic approach of OSCHR to this area of translational research and recommends that it continue to take a leading role in this area.. Among many recommendations, the report also calls for the EU Clinical Trials Directive and its UK implementation to be reviewed in order to be less burdensome to researchers, and that the Government continue to work with the pharmaceutical industry to extend value-based pricing for the stratified use of medicines and the increasing use of genetic tests to accompany such treatments. The report will be considered by government, and a response issued (probably in the latter part of 2009) before any of these recommendations progress towards implementation.http://www.icr-global.org/resources/news/?EntryId23=5338Tue, 07 Jul 2009 13:17:53 GMTTue, 07 Jul 2009 13:17:53 GMTTue, 07 Jul 2009 13:26:20 GMTThe European Commission has published a draft of its proposed third revision of its "Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial" This draft is to supersede the revision published in October 2005 and aims to incorporate changes of the legislative framework (eg, paediatrics, advanced therapies) and clarify and further harmonise the requirements of format and content of the request for authorisation, substantial amendment, and declaration of end of the clinical trial. This draft is released for public consultation. Contributions should be sent by email to entr-pharmaceuticals@ec.europa.eu by September 8th 2009.http://www.icr-global.org/resources/news/?EntryId23=5331Mon, 06 Jul 2009 13:01:47 GMTMon, 06 Jul 2009 13:01:47 GMTMon, 06 Jul 2009 13:06:12 GMTUtah-based molecular diagnostics company, Myriad Genetics, has spun off its pharmaceutical operations into a wholly separate company, Myriad Pharmaceuticals. Headed by CEO Adrian Hobden, Myriad Pharmaceuticals aims to discover, develop and commercialise first-in-class/best-in-class products for the treatment of diseases with high unmet need such as cancer and HIV, with three products currently in clinical development: * Azixa™ (MPC-6827) for metastatic melanoma and glioblastoma multiforme (GBM) * MPC-3100 for cancer * MPC-4326 for HIV-1 infection At present, both companies are still headquartered at Myriad Genetics' premises in Salt Lake City.http://www.icr-global.org/resources/news/?EntryId23=5323Fri, 03 Jul 2009 14:46:00 GMTFri, 03 Jul 2009 14:46:00 GMTFri, 03 Jul 2009 14:52:55 GMTThe UK Medicines and Healthcare products Regulatory Agency (MHRA) has made four appointments to its Board of Directors. Ms Lisa Arnold and Mr Michael Fox, who have both served on the Board since 2003, have been re-appointed for a further 3 years. Sir John Lilleyman and Mr John Williams CBE are both newly appointed for 4 year terms. The Agency Board is chaired by the MHRA Chairman, Alasdair Breckenridge, and consists of seven non-executive directors and the chief executive officer. The Board is responsible for monitoring the implementation of ministers’ objectives for the strategic direction of the Agency, taking into account the perspectives of its stakeholders and advising ministers and the Agency accordingly.http://www.icr-global.org/resources/news/?EntryId23=5321Fri, 03 Jul 2009 13:15:37 GMTFri, 03 Jul 2009 13:15:37 GMTFri, 03 Jul 2009 13:19:24 GMTJohnson & Johnson has moved firmly into the Alzheimer's sector in a massive deal with Irish drugmaker Elan Pharma. J&J will acquire substantially all of the assets and rights of Elan related to its Alzheimer's Immunotherapy Program, through a newly formed company. This will continue the programme of collaborative research and development with Wyeth, with an initial commitment of up to $500m to continue the development and launch activities of late-stage candidate bapineuzumab. In addition, Johnson & Johnson, through its affiliate, will invest $1 billion in Elan to take a stake of just over 18% of the company's ordinary shares.http://www.icr-global.org/resources/news/?EntryId23=5319Fri, 03 Jul 2009 12:49:04 GMTFri, 03 Jul 2009 12:49:04 GMTFri, 03 Jul 2009 13:07:44 GMTThe US Institute of Medicine has published its "Initial National Priorities for Comparative Effectiveness Research (CER)", which establishes a working definition of CER, develops a priority list of research topics to be undertaken with funding from the current US stimulus package, and identifies the necessary requirements to support a robust and sustainable CER enterprise. The highest-priority quartile of topics for research includes "comparing the effectiveness of different strategies of introducing biologics into the treatment algorithm for inflammatory diseases, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and psoriatic arthritis" and "comparing the effectiveness of pharmacologic and non-pharmacologic treatments in managing behavioral disorders in people with Alzheimer’s disease and other dementias in home and institutional settings". The report can be read online free of charge, the list of priorities can be downloaded as a PDF, or a hard copy of the report can be purchased.http://www.icr-global.org/resources/news/?EntryId23=5318Fri, 03 Jul 2009 12:42:01 GMTFri, 03 Jul 2009 12:42:01 GMTFri, 03 Jul 2009 12:49:03 GMTIn an article in today's Washington Post, CEO of Johnson & Johnson, William C Weldon applauded the $1.1bn dollar funding for comparative effectiveness research in the current US stimulus package. However, he called for the US government to go further and make this funding permanently sustainable. Acknowledging that "patient groups, physicians and developers of treatments fear that comparative effectiveness research will be used to restrict access to a broad range of treatments", he called for "a public-private entity focused on improving the evidence for treating individual patients." He also said that "life-science companies should be encouraged to be part of the effort" and that "we must reduce costs, but in a way that does not harm the care of individual patients."http://www.icr-global.org/resources/news/?EntryId23=5311Thu, 02 Jul 2009 17:03:06 GMTThu, 02 Jul 2009 17:03:06 GMTThu, 02 Jul 2009 17:08:48 GMTBusiness media sources are discussing the decision of Roche, announced earlier this week, to leave worldwide trade associations for the pharmaceutical industry (eg, the ABPI in the UK and PhRMA in the USA). There could be a number of reasons behind this move. Roche's recent prolonged battle to acquire biotech firm Genentech suggests that the firm sees itself at least as much a part of a new wave of "big biotech" as its "big pharma" background. This view is also borne out by the announcement that it intends to join the BIO, the largest biotech trade association. However, Roche could also be questioning the value that pharma trade associations are able to deliver. Perhaps still smarting from a 6-month suspension from membership of the ABPI, Roche has stated that it intends to continue working within the ABPI Code of Conduct. Indeed, due to the timing of announcements, the company is still technically a member of the ABPI, but has stated that it "will not rejoin for the time being.", possibly leaving the door open for future negotiations (perhaps to treat revenues from small molecules and biologicals differently).http://www.icr-global.org/resources/news/?EntryId23=5302Thu, 02 Jul 2009 14:58:31 GMTThu, 02 Jul 2009 14:58:31 GMTThu, 02 Jul 2009 15:14:35 GMTThe Contract Research Organisations (CRO) version of the model Clinical Investigation Agreement for medical technology research conducted in NHS hospitals was published on Friday June 26th. It can be found through the following links: http://www.nihr.ac.uk/Pages/default.aspx www.abhi.org.uk/technical_regulatory/groups/clin_invest.aspx http://www.ukcrc.org/regulationgovernance/modelagreements/cromcia.aspx The Agreement is intended to be used in unmodified format to enable the faster set up of commercial Clinical Investigations which are outsourced to CROs, as one of a number of bureaucracy-busting measures to improve the NHS clinical research environment for industry. Versions for use in the Devolved Administrations have been produced.http://www.icr-global.org/resources/news/?EntryId23=5260Mon, 29 Jun 2009 12:35:33 GMTMon, 29 Jun 2009 12:35:33 GMTMon, 29 Jun 2009 12:37:39 GMTPharmaLinkFHI have announced that they have officially changed their name to Novella Clinical. Global growth through the 2008 acquisition of Matrix Clinical in the U.K. made the name change necessary. The announcement was made simultaneously at their global headquarters in Research Triangle Park, as well as at their European office in Stevenage U.K. and at the Drug Information Association’s (DIA) annual conference. “The combination of PharmaLink and Matrix was an important event in the history of the company. It has allowed us to support our biopharmaceutical and medical device clients globally in their efforts to bring promising products to market. Our focus on leveraging clinical and therapeutic expertise with industry leading eClinical processes and technologies allows us to manage our business more effectively and provide superior clinical trial execution for our sponsors, now on a global scale” said Richard Staub, President and Chief Executive Officer. Nigel Trim, Managing Director, European Operations, added, “As Novella Clinical we are poised to continue our growth globally – both within our current geographic footprint as well as expanding into new regions of the world. We are excited to reintroduce ourselves to the market as Novella Clinical.”http://www.icr-global.org/resources/news/?EntryId23=5242Thu, 25 Jun 2009 15:36:55 GMTThu, 25 Jun 2009 15:36:55 GMTThu, 25 Jun 2009 15:38:28 GMTEli Lilly and ICON plc have signed a strategic partnership to manage the Lilly’s clinical trial site set-up and monitoring in Europe for Lilly-managed studies. The agreement, which is subject to the relevant employee consultation processes, is a continuation of Lilly’s ongoing transformation of its research and development organisation. “We are constantly evaluating how we can do things better to increase our flexibility and focus our internal efforts on our core capabilities,” commented Jeff Kasher, Lilly Vice President and Chief Operating Officer of Global Clinical Development. “This strategic agreement enables us to leverage ICON’s significant expertise in clinical trial monitoring and site management in Europe and will increase our ability to speed innovative medicines to patients.”http://www.icr-global.org/resources/news/?EntryId23=5241Thu, 25 Jun 2009 15:10:51 GMTThu, 25 Jun 2009 15:10:51 GMTThu, 25 Jun 2009 15:11:14 GMTA month after reporting a 75% drop in quarterly net income, Kendle has opened new offices in Kuala Lumpur, Malaysia; Bangkok, Thailand; and Manila, Philippines. Kendle has been active in the Asia/Pacific region since 1998. “With more than half of the world's population, Asia offers an abundance of patients in nearly every therapeutic area,” added Dr. Ross Horsburgh, Vice President, Global Clinical Development - Asia/Pacific. “Furthermore, governments have highlighted biopharmaceutical development as a key pillar to their economies, resulting in much more favourable environments for global clinical development work.”http://www.icr-global.org/resources/news/?EntryId23=5240Thu, 25 Jun 2009 15:10:27 GMTThu, 25 Jun 2009 15:10:27 GMTThu, 25 Jun 2009 15:10:51 GMTICON has signed a collaborative agreement with the Central Manchester University Hospitals Foundation (CMFT) to develop a purpose-built translational medicine facility. The new facility will form part of an ambitious expansion plan being undertaken by CMFT to develop the existing Manchester Royal Infirmary campus, due for completion by April 2012. In the interim period ICON will transfer its current clinical pharmacology services into dedicated clinical research facilities on the Manchester Royal Infirmary site. Mike Deegan, Chief Executive of the CMFT added: “Our aim is to build upon our investments in facilities and high calibre clinical academic staff to consolidate our reputation as a leading international research hospital. This exciting new collaboration with ICON is a major step for the Trust and will accelerate the translation of research discoveries into new medicines. We look forward to working with the highly regarded ICON team.”http://www.icr-global.org/resources/news/?EntryId23=5239Thu, 25 Jun 2009 15:10:05 GMTThu, 25 Jun 2009 15:10:05 GMTThu, 25 Jun 2009 15:10:27 GMTShortly after announcing its intentions to sell its Phase II-IV business and refocus on early phase research services, MDS posted a $17m operating loss for the quarter, with a globally-adjusted net revenue drop of 10%. The company has also announced a renovation and expansion of its discovery pharmacology operation in Taiwan to serve the growing global demand for work performed in Asia, to be completed in 2010. The Taiwan facility supports both molecular screening and profiling, as well as in vivo safety and efficacy testing, and the renovation plan calls for significant expansions and upgrades in each area.http://www.icr-global.org/resources/news/?EntryId23=5238Thu, 25 Jun 2009 15:09:42 GMTThu, 25 Jun 2009 15:09:42 GMTThu, 25 Jun 2009 15:10:05 GMTTo improve efficiency and expand capacity to monitor the growing number of clinical studies being conducted in Western Sub-Saharan Africa, Quintiles has opened a new office in Accra, Ghana. The office is based at the grounds of the University of Ghana at the Noguchi Memorial Institute for Medical Research. In opening this new facility, Quintiles has worked with Professor Alex Nyarko PhD, Director of the Institute. As part of the agreement with the institute, Quintiles will provide training for new investigators across a range of therapeutic areas, as well as training for CRAs. “This expansion offers huge potential to reach patients in Sub-Saharan Africa, which has an estimated population of 760 million people,” said Gillian Corken, Chief Executive Officer, Quintiles Africa. “Initially the focus will be on diseases such as malaria, TB and HIV. However, we anticipate that as the infrastructure and economies in Africa develop, like many other non-traditional regions before, it will play an increasingly important role in recruiting patients for many other therapeutic areas, such as oncology and cardiovascular.” For more information see www.quintiles.com/news-events/news/2009-6-16/quintiles-announces-new-ghana-office/.http://www.icr-global.org/resources/news/?EntryId23=5237Thu, 25 Jun 2009 15:09:09 GMTThu, 25 Jun 2009 15:09:09 GMTThu, 25 Jun 2009 15:09:42 GMTThe European Medicines Agency (EMEA) has released for public consultation a draft transparency policy that sets out how the Agency intends to provide for greater clarity and openness in all areas of its operations. The objectives of the transparency policy are: * To apply a more proactive approach to transparency in the daily operations of the Agency * To further strengthen interaction with the Agency’s stakeholders * To promote cooperation on transparency issues within the European medicines network Consultation on the transparency policy is open until 25 September 2009. To read and comment on the draft policy, visit www.emea.europa.eu/htms/human/transparency/transparency.htm. http://www.icr-global.org/resources/news/?EntryId23=5236Thu, 25 Jun 2009 15:08:30 GMTThu, 25 Jun 2009 15:08:30 GMTThu, 25 Jun 2009 15:09:09 GMTThe final report of the ICREL project has been published. ICREL was a one-year project, financed by the European 7th Framework Programme, to measure and analyse the direct and indirect impact of the Clinical Trials Directive2001/20/EC and related legislations in the EU on all categories of clinical research and on the different stakeholders: commercial and non-commercial sponsors, ethics committees and competent authorities. The first results of this survey were presented and discussed during a conference in Brussels on 2 December 2008 (as reported in CRfocus). The conclusions of the meeting are presented in the final report to the European Commission. For more information, and to read the full report and complete appendices, visit www.efgcp.be/ICREL.http://www.icr-global.org/resources/news/?EntryId23=5235Thu, 25 Jun 2009 15:07:52 GMTThu, 25 Jun 2009 15:07:52 GMTThu, 25 Jun 2009 15:08:29 GMTThe Medical Research Council (MRC) has issued a £2m call for proposals in methodology research in collaboration with the National Institute for Health and Clinical Excellence (NICE). The need for methodological research to underpin decision-making by NICE was highlighted in a House of Commons Health Select Committee Report in 2008. Since then MRC has been working with NICE to identify its methodological research priorities and the new call for proposals has been developed in response to the needs identified. Professor Peter Littlejohns, NICE Clinical and Public Health Director, said: “This research will address some of the key issues in our process and methodology. Of particular importance are the issues around how we measure health-related quality of life.” Scientists interested in submitting a proposal should visit www.mrc.ac.uk/Fundingopportunities/Initiatives/MRP/index.htm. The deadline for submissions is July 22nd 2009.http://www.icr-global.org/resources/news/?EntryId23=5234Thu, 25 Jun 2009 15:07:22 GMTThu, 25 Jun 2009 15:07:22 GMTThu, 25 Jun 2009 15:07:52 GMTThe FDA has issued revised guidance on the harmonised Q8(R1) topic on pharmaceutical development. The guidance has been expanded by the addition of an Annex, which provides further clarification of key concepts outlined in the original guidance and also describes the principles of quality by design (QbD). The annex is not intended to establish new standards or to introduce new regulatory requirements; however, it shows how concepts and tools (eg, design space) outlined in the Q8 parent guidance could be put into practice by the applicant for all dosage forms. For more information, see www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073507.pdf.http://www.icr-global.org/resources/news/?EntryId23=5233Thu, 25 Jun 2009 15:06:43 GMTThu, 25 Jun 2009 15:06:43 GMTThu, 25 Jun 2009 15:07:21 GMTThe International Conference on Harmonisation (ICH) Steering Committee and its expert working groups met in Yokohama on June 6-11. Highlights of the meeting with relevance to clinical trials include: * The ICH Guideline E16 “Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions” reached Step 2. The guideline provides recommendations on the context, structure and format of regulatory submissions for genomic biomarker qualification in order to facilitate submission and review of biomarker qualification data among regions. * Public comments on the ICH Guideline E2F “Developmental Safety Update Reports” have been taken into account and made good progress toward Step 4. The guideline will harmonise the requirements for annual clinical trial reporting to the regulators in the three regions and will provide an additional level of protection for patients in clinical trials. * Progress was made on the harmonization of pharmacopoeial texts, which will reduce testing requirements for the industry. Two annexes to the Q4B Guideline reached Step 4 and another two reached Step 2. * The Quality Implementation Working Group delivered a set of Q&As to answer questions arising from the Q8, Q9, and Q10 Guidelines. The next ICH meeting will be held in St. Louis, MO, USA on October 24-29, 2009.http://www.icr-global.org/resources/news/?EntryId23=5230Thu, 25 Jun 2009 14:53:16 GMTThu, 25 Jun 2009 14:53:16 GMTThu, 25 Jun 2009 14:54:36 GMTA UK Statutory Instrument, “The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009” (SI No. 1164) came into force on May 8th. Although it was brought into effect the day after being laid before Parliament, it is principally an enabling measure, with key provisions only to be brought into full operation “if a pandemic is declared, or Ministers judge that the pressure on the health service is such that emergency measures are required”. The declaration by the WHO of a level 6 pandemic (as eventually happened on June 11th) did not automatically trigger these provisions. Other SIs coming into force at the same time made provisions for amendments to prescribing processes and charging policies relating to a future pandemic. The intention of the amendment is to facilitate prescribing of antivirals such as oseltamivir (eg, Tamiflu) in children despite no product being licensed in the UK. The Statutory Instrument amends Regulation 30 of the UK Clinical Trial Regulations relating to urgent safety measures. In CRAdvisor, Prof. David Hutchinson highlights that a new paragraph has been added, to allow urgent safety measures to be made where a disease is pandemic and is (or is potentially) a serious risk to human health. In this event, the sponsor has to notify the licensing authority and ethics committee, “as soon as possible” rather than the usual 3 days. SI 2009/1164 is among the first of a number of SIs setting out specific contingency provisions for use in the case of a flu pandemic. In the event of a pandemic it is likely that a vastly increased number of people will contact NHS services for advice, diagnosis, treatment and medicines, in particular antivirals. These measures set out to streamline regimes so that access to both antivirals and other medicines can be maintained at a time when access to health professionals may be limited. http://www.icr-global.org/resources/news/?EntryId23=5183Mon, 15 Jun 2009 10:45:55 GMTMon, 15 Jun 2009 10:45:55 GMTMon, 15 Jun 2009 15:41:55 GMTThe MedDRA Board endorsed the recommendations of the 6th Blue Ribbon Panel on the extent of MedDRA versioning and the feasibility of an annual MedDRA release. Specifically, the Board tasked the M1P Points to Consider (PTC) Working Group to incorporate into the "MedDRA Term Selection: Points to Consider" document recommendations that categorize the extent to which users perfom a version update. The Board agreed with the Panel that the current biannual release should be reviewed in 2011.http://www.icr-global.org/resources/news/?EntryId23=5181Mon, 15 Jun 2009 10:43:24 GMTMon, 15 Jun 2009 10:43:24 GMTMon, 15 Jun 2009 10:45:55 GMTThe UKCRC Clinical Trials Unit (CTU) Registration Process is designed to register units with relevant high quality trials expertise that are committed to working with the UKCRC to support clinical research. The UKCRC has announced its second call for applications from CTUs in the UK that centrally coordinate multi-centre clinical trials and other well-designed studies (ie, have the overall responsibility for the design, recruitment, data management, publicity and analysis of the trial). The deadline for applications is August 7th. Full Registration will be given to CTUs possessing all essential competencies. Provisional Registration will be given to newer or smaller CTUs that are working towards possessing the expertise to enable Full Registration status. CTUs with current provisional registration will also be able to apply for Full Registration at this time, further information is available in the information pack and guidance notes. These units should contact Lyndsey Tuck (email lyndsey.a.tuck@nihr.ac.uk Tel 0113 3430412) to discuss the process for this.http://www.icr-global.org/resources/news/?EntryId23=5180Mon, 15 Jun 2009 10:42:42 GMTMon, 15 Jun 2009 10:42:42 GMTMon, 15 Jun 2009 10:43:24 GMTThe UK Medicines and Healthcare products Regulatory Agency (MHRA) has now moved over to a Risk Based Inspection Process. The process will use a combination of information provided to the MHRA including a GCP Compliance Report, which should be submitted to the MHRA by June 30 via email to: gcpriskbasedinspections@mhra.gsi.gov.uk. For more information and to download a template for the GCP Compliance Report, see http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodClinicalPractice/Riskbasedinspections/index.htm.http://www.icr-global.org/resources/news/?EntryId23=5179Mon, 15 Jun 2009 10:41:55 GMTMon, 15 Jun 2009 10:41:55 GMTMon, 15 Jun 2009 10:42:39 GMTMerge Healthcare and etrials Worldwide, Inc. have reached a definitive agreement for the acquisition of etrials by Merge. The combined organization will provide clinical trial sponsors and contract research organizations comprehensive and configurable solutions that include both critical imaging technologies and proven eClinical capabilities. The Merge tender offer, which consists of a mix of $0.80 in cash and 0.3448 shares of Merge common stock for each share of etrials common stock, represents an aggregate value of $1.70 per share, calculated using the $2.610, 20-day volume-weighted average price of Merge common stock as of the close of market on May 26, 2009, which was the last trading day before Merge made this offer to etrials. The Merge offer was formally recognized as a Superior Proposal by etrials' Board of Directors pursuant to the terms of etrials' previously announced definitive agreement with Bio-Imaging Technologies, Inc. dated as of May 4, 2009, and as amended on May 15 and May 19, 2009. "etrials welcomes this opportunity to become part of Merge Healthcare," adds M. Denis Connaghan, CEO of etrials. "It continues with our strategy to take the industry in a new direction that is increasingly in demand by bringing our customers access to additional capabilities that we believe increases the value of the important clinical trial development they perform. It also gives the etrials organization a broader base of financial, product and development resources, and international relationships to continue the improvements that have been made and enable an expansion of the business."http://www.icr-global.org/resources/news/?EntryId23=5114Tue, 02 Jun 2009 16:40:54 GMTTue, 02 Jun 2009 16:40:54 GMTTue, 02 Jun 2009 16:43:49 GMTINC Research Inc.has entered into an agreement to acquire the Phase II-IV operations (Global Clinical Development) of MDS Pharma Services. The acquisition is subject to customary approvals and closing conditions. The acquisition of MDS Pharma Services' Phase II-IV operation is expected to deepen INC Research’s therapeutic expertise with its leadership in vaccine, respiratory, cardiovascular and endocrinology clinical research, and extend its global presence in emerging markets including South America, Asia Pacific and Africa. The combination of such complementary businesses and integration of operations through INC Research’s Trusted Process® will enable INC Research to enhance its global services to deliver cost-effective results with reduced variability. With nearly 800 clinical research staff globally, MDS Pharma Services Phase II-IV operation has conducted more than 700 Phase II-IV clinical projects involving more than 42,000 sites and nearly 300,000 patients in a wide range of therapeutic areas from 2000 to 2008. The MDS Pharma Services Phase II-IV operation has been consistently ranked as one of the Top 5 CROs in the CenterWatchSM survey of investigators from 2001-2008 in various service attributes; its therapeutic expertise complements INC Research’s reputation in managing clinical research on the central nervous system (CNS), infectious diseases and oncology. This acquisition is expected to create a broader spectrum of service offerings and capabilities for INC Research to meet customer demands across the globe. The acquisition will expand INC Research’s global footprint to nearly 2,000 employees and operations in 40 countries. “MDS Pharma Services Phase II-IV operations have been significantly strengthened in recent years through global expansion and investments in process improvements that have made it an attractive acquisition target,” said David Spaight, president of MDS Pharma Services. “The sale of our Phase II-IV operations to INC Research will build on and extend those strengths, and will allow MDS Pharma Services to focus on core competencies in drug discovery through Phase IIa.” http://www.icr-global.org/resources/news/?EntryId23=5088Mon, 01 Jun 2009 14:45:16 GMTMon, 01 Jun 2009 14:45:16 GMTMon, 01 Jun 2009 14:49:42 GMTOxford BioTherapeutics (OBT) and GlaxoSmithKline have announced a strategic alliance to discover, develop and commercialise novel, therapeutic antibodies for the treatment of primary, metastatic and recurring forms of cancer. GSK will develop novel antibody therapies against selected OBT targets. In parallel, OBT will develop one of its own monoclonal antibodies through to clinical proof of concept, at which point GSK will have an exclusive option to in-license this monoclonal antibody and will thereafter assume responsibility for further clinical development and commercialisation on a worldwide basis.http://www.icr-global.org/resources/news/?EntryId23=5087Mon, 01 Jun 2009 14:43:29 GMTMon, 01 Jun 2009 14:43:29 GMTMon, 01 Jun 2009 14:45:16 GMTFollowing a rigorous review of its development portfolio that saw 14 compounds in phases I-III being discontinued, Sanofi-Aventis has signed agreements that could be worth up to $1b with US biotech company Exelixis. The agreements cover global licensing of two development compounds and exclusive collaboration on the discovery and development of PI3K inhibitors for the management of solid malignancies.http://www.icr-global.org/resources/news/?EntryId23=5086Mon, 01 Jun 2009 14:42:35 GMTMon, 01 Jun 2009 14:42:35 GMTMon, 01 Jun 2009 14:43:29 GMTItalian CRO, Pierrel SpA looks set to acquire the US operation of Encorium, which posted a 14.5% drop in revenues for 2008. Pending due diligence, Pierrel will acquire the CRO’s US business, including backlog and part of working capital assets, by mid-2009 for an investment of around $1.8m. Encorium is also in the process of selling its Finnish subsidiary, Encorium Oy, to an as-yet-undisclosed US CRO.http://www.icr-global.org/resources/news/?EntryId23=5085Mon, 01 Jun 2009 14:41:00 GMTMon, 01 Jun 2009 14:41:00 GMTMon, 01 Jun 2009 14:42:35 GMTJohnson & Johnson and Cougar Biotechnology have announced a definitive agreement whereby Cougar Biotechnology will be acquired for approximately $1.0 billion in cash. Cougar, which has compounds in development for the treatment of prostate cancer, as well as breast cancer and multiple myeloma, will work with Ortho Biotech Oncology Research & Development, a unit of Centocor Research & Development, Inc., a Johnson & Johnson company. “The acquisition of Cougar Biotechnology with its talented team will strengthen our growing capabilities toward a leadership position in the global oncology market," said William Hait MD, Global Therapeutic Head, Oncology, Ortho Biotech Oncology Research & Development.http://www.icr-global.org/resources/news/?EntryId23=5084Mon, 01 Jun 2009 14:38:51 GMTMon, 01 Jun 2009 14:38:51 GMTMon, 01 Jun 2009 14:41:00 GMTTen healthcare scientists from across England have been awarded research fellowships worth a total of over £1million for projects that will lead to improvements in patient care, announced by Professor Sue Hill, Chief Scientific Officer (CSO). The awards were the results of the first round of the new CSO Research Fellowship competition launched in September 2008 to support the development of research capacity in healthcare science in the NHS. The scheme is funded by the Department of Health and managed by the National Institute of Health Research (NIHR). The ten new research fellows are: * Lisa Ayers * Bashir Mnene Matata * Nigel Davies * Owen Driskell * Rachel Marrington * Gareth Price * Tom Ford * Jonathan Reeves * Arlene Frater * Philip Morganhttp://www.icr-global.org/resources/news/?EntryId23=5083Mon, 01 Jun 2009 14:37:47 GMTMon, 01 Jun 2009 14:37:47 GMTMon, 01 Jun 2009 14:38:51 GMTIn a judgment published in April 2009, the European Court of Justice ruled that Directive 2001/83/EC is to be interpreted as meaning that dissemination by a third party of information about a medicinal product may be regarded as advertising within the meaning of that directive, even though the third party in question is acting on his own initiative and completely independently, de jure and de facto, of the manufacturer and the seller of such a medicinal product. In that regard, the Court stated that even where the activity is carried out by an independent third party outside any commercial or industrial activity, advertising of medicinal products is liable to harm public health, the safeguarding of which is the essential aim of Directive 2001/83/EC. To read the full judgement, see http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2009/2009_05/case-421-07.pdf.http://www.icr-global.org/resources/news/?EntryId23=5082Mon, 01 Jun 2009 14:36:56 GMTMon, 01 Jun 2009 14:36:56 GMTMon, 01 Jun 2009 14:37:47 GMTThe UK Health Departments are inviting comments on a proposed harmonised edition of Governance Arrangements for Research Ethics Committees. The new edition is intended to replace versions previously issued separately in England and Scotland in 2001. It will also apply in Wales and Northern Ireland. The revision takes account of legal, policy and operational developments since the previous version was published. The revisions are open for consultation until June 26th. To read the proposed document, or take part in the consultation, visit www.nres.npsa.nhs.uk/news-and-publications/news/harmonised-gafrec-consultation.http://www.icr-global.org/resources/news/?EntryId23=5081Mon, 01 Jun 2009 14:35:41 GMTMon, 01 Jun 2009 14:35:41 GMTMon, 01 Jun 2009 14:36:56 GMTIt was confirmed at a meeting at the EMEA at the end of April that the EudraCT database of clinical trial applications will be upgraded to version 7 shortly. The upgrade is expected to clear internal testing on June 1st, and to go into full use on June 18th. The database is designed for use by the Competent Authorities (CAs) throughout the EEA, with sponsor companies able to prepare study applications via a secure site, before making submissions to individual CAs by paper/CD-ROM. This basic purpose will not change in v7. Among the functions of the new version are the validation of the XML data file produced by the system, the preparation of an application package (collating the raw XML, the completed application document and the validation report) and the compare two data files (eg, versions of the same application, during the preparation process). This will be discussed further in next month’s issue, but is previewed on the CRfocus blog (http://crfocus.wordpress.com).http://www.icr-global.org/resources/news/?EntryId23=5080Mon, 01 Jun 2009 14:34:52 GMTMon, 01 Jun 2009 14:34:52 GMTMon, 01 Jun 2009 14:35:40 GMTQuotient Bioresearch Limited has acquired Charles River Laboratories' Edinburgh clinical research facility. This represents the sixth acquisition in approximately three years for Quotient. The Charles River facility, formerly Inveresk Clinical Research, will combine with Pharmaceutical Profiles, acquired by Quotient in December 2008, to form a new strategic business unit within Quotient: Quotient Clinical. With a long heritage in early development services, the Charles River Edinburgh clinical unit will combine with Pharmaceutical Profiles to offer a suite of integrated services stretching from First-in-Human (FIH) through to Phase 2a patient studies. Founded almost 20 years ago, the Edinburgh clinical unit is an industry leader in FIH studies. It was awarded Supplementary Accreditation status by the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2009, demonstrating its experience and capabilities to conduct FIH trials for small molecules and biologics. Quotient Clinical will have a workforce of approximately 160 medical, scientific and clinical staff across the two facilities in Edinburgh and Nottingham. The principal focus of Quotient Clinical is to provide a unique and comprehensive range of early development services to a broad range of pharmaceutical and biotechnology customers. Paul Cowan, Chairman and CEO of Quotient comments, "The creation of Quotient Clinical represents the next step in expanding the range of specialised services we offer pharmaceutical and biotech customers worldwide. We are delighted to have completed the acquisition of the Charles River Edinburgh clinical facility. With the Inveresk heritage we are bringing a world-class facility and clinical experience to Quotient Clinical." Quotient Clinical will be headed by Mark Egerton, formerly Chief Executive Officer of Pharmaceutical Profiles. "We will continue to build on the innovative approaches we developed at Pharmaceutical Profiles to increase the effectiveness of early development processes. Combined with the Phase I/2a expertise of the Charles River Edinburgh clinical unit, our approach to integrating flexible drug product manufacture into clinical trials will enable us to deliver significant benefits to our customers."http://www.icr-global.org/resources/news/?EntryId23=5026Mon, 18 May 2009 10:58:16 GMTMon, 18 May 2009 10:58:16 GMTThu, 28 May 2009 12:32:33 GMTDianthus Medical Limited opened for business in May 1999, and so have recently celebrated their 10th birthday. Started by Adam Jacobs, initially working alone as a freelance medical writer, the company has gradually grown both in size and the range of services offered. Dianthus currently has 11 staff and offers medical writing, statistical consultancy, and clinical data management, although medical writing remains the core business. Given that over half of all new small businesses fail within their first 3 years, having a company that is not only surviving but thriving and still growing after 10 years has been a very proud achievement for Adam and the team. To celebrate this achievement, the team took the day off together to eat, drink and generally make merry. More details of what they did are on the Dianthus bloghttp://www.icr-global.org/resources/news/?EntryId23=5025Mon, 18 May 2009 10:56:16 GMTMon, 18 May 2009 10:56:16 GMTThu, 28 May 2009 12:32:25 GMTThe New York Times reports that Dr Margaret Hamburg "breezed through" the Senate hearing to confirm her as the next FDA Commissioner. The committee could vote as soon as next week to recommend her confirmation to the full US Senate. The Times speculates that "One reason for the enthusiasm for Dr. Hamburg may be the unease many conservatives have expressed about Dr. Joshua M. Sharfstein, the agency’s acting commissioner".http://www.icr-global.org/resources/news/?EntryId23=4987Fri, 08 May 2009 13:13:38 GMTFri, 08 May 2009 13:13:38 GMTThu, 28 May 2009 12:22:43 GMTBusiness Secretary Peter Mandelson announced a range of actions on bioscience aimed at ensuring Britain remains a world leader in the sector. In the Government's response to the independent report "Review and Refresh of Bioscience 2015", Peter Mandelson outlined key commitments to encourage the development of bioscience in the UK and to create supportive conditions for bioscience investment, including: * Government and industry to develop a new stratified disease strategy to support the development of drugs that are effective in niche populations * NHS to include clinical research metrics in the annual Quality Accounts produced by Trusts. Aim to double the number of patients participating in clinical studies over the next five years. * A consultation on changes to the taxation system relating to innovation activity Lord Drayson, Minister for Science and Innovation, added "The Government Response to the Review and Refresh of Bioscience 2015 is the first and key part of a broader cross government strategy on life sciences. This agenda will continue to be driven forward by the Office for Life Sciences. In July we will publish a Life Sciences Industrial Blueprint, detailing the actions the OLS has taken to improve the operating environment for the life sciences industry." However, this stops short of some of the recommendations in the Bioscience 2015 Review and Refresh report, which was published in January 2009 following work by Lord Cooksey. At a public meeting shortly after its launch, Cooksey was critical: "When you strip away the veneer of this report, you find that there is very little new in it. It is disappointing."http://www.icr-global.org/resources/news/?EntryId23=4985Fri, 08 May 2009 12:55:05 GMTFri, 08 May 2009 12:55:05 GMTThu, 28 May 2009 12:22:33 GMTVernalis plc and Servier, France’s largest privately-owned pharmaceutical company, have signed a new three-year joint oncology collaboration, focused on the discovery of drugs for a new target. Under the terms of the collaboration which uses Vernalis’ proprietary fragment and structure-based drug discovery platform on this undisclosed cancer target, Vernalis will receive fees and a share in the downstream success of the product in the form of milestones and royalties on sales, the terms of which are not disclosed. Vernalis and Servier already have an existing collaborative agreement to develop two promising oncology targets involved in protein-protein interactions. http://www.icr-global.org/resources/news/?EntryId23=4984Fri, 08 May 2009 12:34:01 GMTFri, 08 May 2009 12:34:01 GMTThu, 28 May 2009 12:22:25 GMTChiltern International Limited has announced the acquisition of Vigiun, a full service CRO located in São Paulo, Brazil. Established in 1999 by Eduardo Forleo, MD, and Elisa Halker, BSN, Vigiun has extensive experience conducting clinical trials in a variety of therapeutic areas, in particular infectious disease, oncology, and respiratory. “We warmly welcome Vigiun to the Chiltern team,” stated John Vann, Executive Vice President, Americas. “The acquisition of Vigiun enhances Chiltern’s growing presence in Latin America, which was established nearly a year ago when we began operations in Argentina under the leadership of Oscar Podestá, our General Manager for Latin America. The knowledge and experience of Eduardo Forleo and Elisa Halker, and all of the Vigiun staff, will further strengthen our ability to serve our clients and continue our strategy for growth in the region.” Dr. Forleo has been appointed Chiltern’s Country Manager for Brazil and Medical Director for Latin America. Ms.Halker will serve as Director of Clinical Operations for Brazil.http://www.icr-global.org/resources/news/?EntryId23=4983Fri, 08 May 2009 12:26:16 GMTFri, 08 May 2009 12:26:16 GMTThu, 28 May 2009 12:21:53 GMTBio-Imaging Technologies, Inc. has rebranded itself as BioClinica following its acquisition last year of Phoenix Data Systems Inc. The company has also announced that it intends to acquire troubled EDC company etrials Worldwide, Inc. Mark L. Weinstein, President and Chief Executive Officer of BioClinica said, "etrials is an excellent fit with our long-term corporate strategy. This addition instantly broadens our eClinical product offering while leveraging our global operations and brand reputation for quality client service. Together with our services-based approach, the combination enhances our existing relationships with customers from both companies and creates a new, stronger and stable partner for new pharma, biotech and medical device sponsors."http://www.icr-global.org/resources/news/?EntryId23=4982Fri, 08 May 2009 12:14:38 GMTFri, 08 May 2009 12:14:38 GMTThu, 28 May 2009 12:22:07 GMTThe U.S. Food and Drug Administration is requesting a budget of $3.2 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2010 budget – a 19 percent increase over the current FDA fiscal year budget. The FY 2010 request, which covers the period of Oct. 1, 2009, through Sept. 30, 2010, includes increases of $295.2 million in budget authority and $215.4 million in industry user fees. The FDA budget proposes two major initiatives for FY 2010: Protecting America’s Food Supply and Safer Medical Products. It also includes increases for current law user fees and for infrastructure to support critical agency operations.http://www.icr-global.org/resources/news/?EntryId23=4981Fri, 08 May 2009 11:57:19 GMTFri, 08 May 2009 11:57:19 GMTThu, 28 May 2009 12:22:17 GMTThe PROTECT project (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) has been accepted for funding by the Innovative Medicines Initiative Joint Undertaking (IMI JU). PROTECT is a collaborative European project aiming to develop innovative methods in pharmacoepidemiology and pharmacovigilance. The European Medicines Agency (EMEA) coordinates the project and manages a multi-national consortium of 29 public and private partners. PROTECT will run over five years, with a total funding of EUR 20 million. Half of the funding will be in-kind contributions from the participating EFPIA companies. The target start date of the project is September 2009.http://www.icr-global.org/resources/news/?EntryId23=4980Fri, 08 May 2009 11:53:25 GMTFri, 08 May 2009 11:53:25 GMTThu, 28 May 2009 12:32:19 GMTMajor CROs including PPD, Parexel and Kendle have announced gloomy Q1 results recently, suffering from “unprecedented levels” of cancelled projects. While the biomedical industry in general, and CROs in particular, had been seen as a relatively ‘recession-proof’ sector earlier in the current financial crisis, these results show knock-on effects of pharma companies’ strategic shifts and desire to increase cash holdings to stave off their own financial problems and provide funds for major acquisitions.http://www.icr-global.org/resources/news/?EntryId23=4979Fri, 08 May 2009 11:52:53 GMTFri, 08 May 2009 11:52:53 GMTFri, 08 May 2009 11:53:25 GMTPfizer is planning to spend up to $136m in buying back a third of its Indian subsidiary back from shareholders. This will increase the parent company’s stake to 75% of the Indian firm. The buy-back offer offers a premium of around 22% above the current trading price of the shares. Novartis took similar action to increase direct control of its Indian subsidiary after shares slumped in 2008.http://www.icr-global.org/resources/news/?EntryId23=4978Fri, 08 May 2009 11:47:34 GMTFri, 08 May 2009 11:47:34 GMTFri, 08 May 2009 11:52:53 GMTJames Thorburn MICR CSci notified us of an interview with Amy Huang, Vice President and China Director at GSK, in which she said, “GSK does not intend to cut its budget for China this year. We will on the contrary, invest more for developing new medicines.” In 2008, GSK achieved a 12% growth in sales in emerging markets. China outperformed the others with a 22% increase in sales, while the global numbers fell by 3%. Huang said the rapid China sales growth could mainly come from the vaccine sector and prescription drugs. Global drug makers have been ramping up their presence in China, partly in anticipation that the country’s massive healthcare reform could unleash big orders in coming years.http://www.icr-global.org/resources/news/?EntryId23=4977Fri, 08 May 2009 11:46:07 GMTFri, 08 May 2009 11:46:07 GMTThu, 28 May 2009 12:32:04 GMTUniversity College London (UCL) has entered into a collaboration with Pfizer to advance development of stem cell-based therapies for age-related macular degeneration (AMD), which AMD affects around a quarter of people over the age of 60. The London Project to Cure Blindness, led by Professor Pete Coffey (UCL Institute of Ophthalmology), is involved in producing a cell replacement therapy from human embryonic cells; a therapy which it aims to introduce into clinics by 2011. The goal is to replace cells essential for ‘seeing’ lost through disease at the back of the eye. Under the terms of the agreement, Pfizer Regenerative Medicine will provide funding to UCL to enable research into the development of stem cell-based therapies for AMD as well as other retinal diseases. Pfizer will also contribute expertise in the design and execution of clinical studies, interaction with global regulators, and in product manufacturing techniques. After the completion of preclinical safety studies, Pfizer will have the option to conduct clinical trials to determine efficacy of treatment and commercialise any resulting product.http://www.icr-global.org/resources/news/?EntryId23=4976Fri, 08 May 2009 11:45:17 GMTFri, 08 May 2009 11:45:17 GMTThu, 28 May 2009 12:31:53 GMTPPD has ended April with a flurry of corporate activity. It has sold its preclinical operation Piedmont Research Center LLC to Charles River Laboratories for $46m while buying biotech firm Magen Biosciences Inc for $14.5m. Magen has an exclusive agreement with Eli Lilly to develop and commercialise dermatology products. PPD has also completed its acquisition of AbCRO, a CRO with a strong presence in Central and Eastern Europe, which was announced earlier this year.http://www.icr-global.org/resources/news/?EntryId23=4975Fri, 08 May 2009 11:44:09 GMTFri, 08 May 2009 11:44:09 GMTThu, 28 May 2009 12:31:46 GMTCRF Health won the ‘DIA EuroMeeting 2009 Greenest Exhibitor’ award in March. The award is given to the company that demonstrates the highest commitment to environmental issues at the conference. At the DIA EuroMeeting, CRF Health’s exhibit booth was paper-free. Visitors to the booth completed request forms via an electronic diary device and were emailed information after the conference rather than being given printed material. Through an arrangement with CarbonFund.org, the company offset the carbon emissions of its company staff at the conference and gave attendees an opportunity to offset their own carbon emissions. Rachael King, the company’s CEO, said, “CRF Health is committed to global environmental issues and we are delighted to be chosen for this year’s Green Award. We promote paperless clinical trials. In addition to what we believe is a more efficient way of conducting clinical trials, we recognize the impact that printing and shipping have on the environment.”http://www.icr-global.org/resources/news/?EntryId23=4974Fri, 08 May 2009 11:39:31 GMTFri, 08 May 2009 11:39:31 GMTFri, 08 May 2009 11:44:09 GMTGlaxoSmithKline plc and Pfizer Inc have entered into an agreement to create a new world-leading HIV company focused solely on research, development and commercialisation of HIV medicines. The new HIV business will be more sustainable and broader in scope than either company’s individually, and will hold a 19% share of the growing market and have an industry-leading pipeline. GSK will initially hold an 85% equity interest in the new company and Pfizer will hold 15%. Andrew Witty, CEO of GSK said: “Today marks a definitive step by GSK to renew our focus and deliver more medicines, more efficiently, to people living with HIV/AIDS. HIV remains a global threat with increasing incidence and viral resistance. This new company will be better placed to meet these challenges and improve access to treatments.” Jeff Kindler, CEO of Pfizer said: “By combining Pfizer’s and GlaxoSmithKline’s complementary strengths and capabilities, we are creating a new global leader in HIV and reaffirming our ongoing commitment to the treatment of the disease.”http://www.icr-global.org/resources/news/?EntryId23=4973Fri, 08 May 2009 11:38:17 GMTFri, 08 May 2009 11:38:17 GMTThu, 28 May 2009 12:31:31 GMTSanofi-aventis is to acquire BiPar Sciences Inc., a privately held US biopharmaceutical company, developing novel tumor-selective approaches for the treatment of different types of cancers, in a deal worth up to $500m. BiPar works in the emerging field of DNA repair using PARP (Poly ADP-Ribose Polymerase) inhibitors. By preventing cancer cells from repairing their own DNA, PARP inhibitors ultimately cause cancer cell death. “We are extremely pleased to join with one of the most successful and innovative global pharmaceutical companies,” said Hoyoung Huh, MD PhD, President and CEO of BiPar. “This agreement validates BiPar’s novel scientific approach and will maximize patient access to this new class of breakthrough cancer therapy.”http://www.icr-global.org/resources/news/?EntryId23=4972Fri, 08 May 2009 11:35:45 GMTFri, 08 May 2009 11:35:45 GMTThu, 28 May 2009 12:31:23 GMTGlaxoSmithKline plc and Stiefel Laboratories Inc. have signed an agreement to create a new world-leading specialist dermatology business in a deal worth up to $3.5 billion. GSK’s existing prescription dermatological products will be combined with Stiefel’s and the new specialist global business will operate under the Stiefel identity within the GSK Group. Andrew Witty, Chief Executive Officer of GSK said, “As part of our strategy to grow and diversify GSK’s business, we are continuing to make new investments through targeted acquisitions. The addition of Stiefel’s broad portfolio will provide immediate new revenue flows to GSK with significant opportunities to enhance growth through leveraging our existing global commercial infrastructure and manufacturing capability.” Charles W. Stiefel, Chairman and CEO of Stiefel, said, “Along with adding hundreds of marketed dermatology products, this deal will increase the value of Stiefel’s unparalleled dermatology pipeline by expanding the customer base to which we will be able to offer these products.”http://www.icr-global.org/resources/news/?EntryId23=4971Fri, 08 May 2009 11:35:11 GMTFri, 08 May 2009 11:35:11 GMTThu, 28 May 2009 12:31:15 GMTA new retrospective study of 232 clinical trial investigators shows that insurance claim data can be used effectively to predict success in patient enrolment and retention. The study, conducted in the USA by i3 Pharma Informatics, used de-identified insurance claims to calculate the proportion of each investigator’s patients who qualified for a trial. The model pinpoints both the investigators with the most patients, and those geographies with the highest concentrations of appropriate patients for more successful trials. The study also showed the top 30% of investigators recruit 70% of trials’ total patients.http://www.icr-global.org/resources/news/?EntryId23=4970Fri, 08 May 2009 11:34:43 GMTFri, 08 May 2009 11:34:43 GMTFri, 08 May 2009 11:35:11 GMTThe European Medicines Agency, the European Commission and Health Canada, the Canadian regulatory authority for medicines, have agreed on an implementation plan for their confidentiality arrangement. The implementation plan details the process for both regular and ad-hoc exchanges of information, and describes the process for monitoring the progress of the implementation plan. It also foresees an exchange programme for staff to promote mutual learning and sharing of regulatory experience. The terms of the confidentiality arrangement, signed in December 2007, allow the parties to share non-public information on all human and veterinary medicines (already authorised or still under review) that fall within the scope of the agreement. It also allows the exchange of information on legislation under development or draft regulatory guidance documents. In the initial implementation phase, emphasis will be given to exchange of information on medicines used in oncology and on veterinary medicines. The implementation plan with Health Canada follows largely the plan in place for implementation of the confidentiality arrangements with the United States Food and Drug Administration (FDA). The regulatory agencies will explore potential joint implementation activities with the FDA to avoid duplication of efforts.http://www.icr-global.org/resources/news/?EntryId23=4969Fri, 08 May 2009 11:33:04 GMTFri, 08 May 2009 11:33:04 GMTThu, 28 May 2009 12:30:57 GMTThe centralised Streamlined NHS Permissions Approach to Research – Cymru (SPARC) system was launched on April 1st. The system is designed to provide a streamlined and consistent process for obtaining NHS permission for primary care research studies in Wales. It is intended that all new primary care studies requiring NHS permission shall be processed through the system. Studies that are already undergoing review by the Local Health Boards in Wales or that have already started shall continue to be processed by the Welsh Local Health Boards. The system: * Provides a single point of contact for researchers to apply for NHS permission to conduct primary care research studies in multiple Local Health Boards. * Reduces duplication in the review processes that primary care research applications currently undergo in Wales. * Minimises the administrative burdens currently placed on researchers and Local Health Boards. * Ensures research studies comply with the Research Governance Framework and other regulatory and legislative requirements for research.http://www.icr-global.org/resources/news/?EntryId23=4968Fri, 08 May 2009 11:32:17 GMTFri, 08 May 2009 11:32:17 GMTThu, 28 May 2009 12:30:37 GMTThe Member States of the European Union have approved a new Commission Directive amending, as regards advanced therapy medicinal products, Annex I to Directive 2001/83/EC. The draft Directive was put to vote at a meeting of the Standing Committee on Medicinal Products for Human Use. The text now enters a period of scrutiny by the European Parliament and Council until early June, before it can be formally adopted by the Commission and enters into force.http://www.icr-global.org/resources/news/?EntryId23=4967Fri, 08 May 2009 11:31:38 GMTFri, 08 May 2009 11:31:38 GMTThu, 28 May 2009 12:30:29 GMTVersion 1.3 of the template for costing industry-sponsored studies for sites in the NHS has been released. This update includes 2009/10 staffing rates, ‘payment by results’ factors and inclusion of more qualitative procedures. Further updates are planned during the year.http://www.icr-global.org/resources/news/?EntryId23=4966Fri, 08 May 2009 11:30:39 GMTFri, 08 May 2009 11:30:39 GMTThu, 28 May 2009 12:30:20 GMTClinical trials taking place in India will have to be registered on the Clinical Trials Registry India (CTRI) website (www.ctri.in) from June 2009. The database was launched in 2007 for voluntary use, and this was revised to “advised” in January this year. This move will increase transparency in Indian clinical research at a time when business is booming: a March 2008 report estimated that $300m of clinical trials have been conducted at Indian sites, having increased by 65% since 2006.http://www.icr-global.org/resources/news/?EntryId23=4965Fri, 08 May 2009 11:21:46 GMTFri, 08 May 2009 11:21:46 GMTThu, 28 May 2009 12:30:09 GMTThe Better Regulation Executive (BRE) has published its report of the Hampton Implementation Review (HIR) into the MHRA. The review was carried out in October 2008 and by senior officials from BRE, the National Audit Office, the Human Fertilisation and Embryology Authority, and the National Consumer Council. As part of the review key stakeholders from the pharmaceutical and device industry were interviewed, as well as a cross section of Agency staff. The findings of the HIR were supportive of the Agency and its ongoing effort to be a proportionate, transparent and risk-aware regulator. The review also makes positive comments about the MHRA and its understanding of the industry it regulates. It specifies the Agency is an effective player in Europe and provides ‘outstanding leadership’ in European negotiations. It also states it is a learning organisation, acting in a joined-up manner and is highly focused on objectives and outcomes of protecting public health. Some issues identified to ensure the Agency becomes Hampton compliant are the internal capacity for regulatory costs, formalising its risk-based approach and being more aware of the risk of ‘gold plating’ the implementation of regulations. It highlighted the need to communicate reasons for its decisions and the necessity of fine-tuning its use of IT systems.http://www.icr-global.org/resources/news/?EntryId23=4964Fri, 08 May 2009 11:21:05 GMTFri, 08 May 2009 11:21:05 GMTThu, 28 May 2009 12:30:00 GMTThe European Medicines Agency has appointed Fergus Sweeney as the new Head of its Inspections Sector. Dr Sweeney, who holds a PhD in pharmacology from University College Dublin, joined the Agency’s Inspections Sector in 1999, where he assumed responsibility for coordination of GCP and pharmacovigilance inspections. He has been closely involved in the development of procedures and guidance in these areas, and is Chair of the GCP Inspectors and Pharmacovigilance Inspectors Working Groups, and has been a regular speaker at ICR conferences. Prior to joining the Agency, Fergus worked in the pharmaceutical industry, where he was involved in phase I-IV clinical research, laboratory and pharmacovigilance activities, primarily in the field of quality-assurance audit. The Head of Inspections Sector position, which Fergus will assume from 1 May 2009, was vacated in January 2009 by the appointment of the former Head, Emer Cooke, as the Agency’s International Liaison Officer.http://www.icr-global.org/resources/news/?EntryId23=4963Fri, 08 May 2009 11:20:04 GMTFri, 08 May 2009 11:20:04 GMTThu, 28 May 2009 12:29:17 GMTThe UK National Research Ethics Service (NRES) has published its plan of activities for the coming year. Highlights ofhe plan, available from www.nres.npsa.nhs.uk/EasySiteWeb/GatewayLink.aspx?alId=28142, include the further reduction of RECs from 100 to 90, continuation of the pilot of the fast track scheme, implementation of an ISO9001:2008 Quality Management System, publication of review opinions alongside research summaries, further development of the IRAS system and a comprehensive review of REC SOPs.http://www.icr-global.org/resources/news/?EntryId23=4962Fri, 08 May 2009 11:19:09 GMTFri, 08 May 2009 11:19:09 GMTThu, 28 May 2009 12:29:10 GMTThe Department of Health has published new guidance for funding excess treatment costs and subventions to clarify the directions set out in HSG(97)32. The guidance takes into account changes made as a result of the research strategy Best Research for Best Health and the introduction of Payment by Results, and relates to non-commercial research studies eligible for entry onto the National Institute for Health Research (NIHR) Clinical Research Network Portfolio database. The principles outlined in HSG(97)32 remain unchanged.http://www.icr-global.org/resources/news/?EntryId23=4961Fri, 08 May 2009 11:18:13 GMTFri, 08 May 2009 11:18:13 GMTThu, 28 May 2009 12:25:53 GMTCoast IRB, a private Independent Review Board (IRB, performing the same function as a Research Ethics Committees), has agreed to voluntarily halt some aspects of its clinical trial oversight operations due to serious concerns about the company’s ability to protect human subjects participating in clinical trials. This actions follow a recent undercover operation by the US Government Accountability Office (GAO), who submitted for review a fictitious research study involving a purportedly FDA-cleared medical device. Although no human subjects were involved, the operation heightened FDA’s concerns about Coast IRB’s ability to protect the rights and welfare of human research subjects. In evaluating the information provided by the GAO investigators, FDA determined that Coast IRB committed several violations of the laws and regulations intended to protect the rights and welfare of human research subjects in clinical trials and that the company failed to perform the robust review needed to approve a study. Until further notice, Coast IRB has agreed to stop reviewing new FDA-regulated studies. Also, Coast IRB will direct clinical investigators in on-going FDA-regulated studies approved by Coast IRB to halt new subject enrolment. FDA has issued a Warning Letter to Coast IRB outlining its concerns and FDA will continue to actively monitor the company and take appropriate action as necessary.http://www.icr-global.org/resources/news/?EntryId23=4960Fri, 08 May 2009 11:17:08 GMTFri, 08 May 2009 11:17:08 GMTThu, 28 May 2009 12:25:41 GMTWe are a research group from the University of Warwick and Queen Mary, University of London. We have developed an on-line survey to collect information about how clinical research is organized and managed in the UK. Specifically the project aims to identify the different models of clinical research that are being used and the standards that are achieved across each in terms of patient recruitment, regulatory approval, time taken to set-up NHS recruitment sites etc. We would like to invite you to complete the survey yourself, and also forward the survey link and project flyer to colleagues within your organisation who are involved with managing and conducting clinical research. The responses from researchers who have experience of all types of clinical research, including academic, commercial & contract-organisation-led, and medicines, medical devices and complex interventions, are very important to help us to produce a detailed and representative picture of how all types of clinical research are managed across the UK. With your help, we hope that this research will provide a better understanding of the challenges of clinical research in the UK and what kinds of organisation support success. This study will provide much needed practitioner and policy advice on the challenges of trials management. From the findings, we plan to produce practically useful reports for Clinical Research Directors/Managers, focal Professional & Trade Associations such as the NIH Clinical Research Networks, ABPI, BIA, ABHI & ICR, and UK Policy Makers on the status of the UK clinical research base. We estimate that the survey takes around 20 minutes to complete, but please be aware that by using the same computer, you may come back to complete the survey at any time. Please be assured that any responses provided are anonymous and cannot be used to identify an individual, research group or company, and that the data collected is for the purpose of an academic research project based at Warwick Business School, University of Warwick. We have attached an information sheet providing the link to the online survey, together with details for participants about this project. The online survey can be accessed using the following link: If you would like any further information about our research group, or you would like to be informed about the findings of this study, please feel free to contact us. Thank you in anticipation of any help that you can provide. http://www.icr-global.org/resources/news/?EntryId23=4602Mon, 23 Mar 2009 09:04:54 GMTMon, 23 Mar 2009 09:04:54 GMTMon, 23 Mar 2009 09:06:57 GMTThe MHRA participated in the production of a regulatory route map for stem cell research and manufacture which has been developed by the Department of Health with the support of regulatory bodies and the Gene Therapy Advisory Committee. This interim UK regulatory route map is intended to be a reference tool for those who wish to develop a programme of stem cell research and manufacture ultimately leading to clinical application. A more detailed, web-based version of the map is currently being developed and will be available by the end of 2009. http://www.icr-global.org/resources/news/?EntryId23=4583Fri, 20 Mar 2009 09:33:53 GMTFri, 20 Mar 2009 09:33:53 GMTFri, 20 Mar 2009 09:34:27 GMTProvisional abstract: The motivations of clinicians to participate in clinical trials have been little studied. This project explored the potential role of payment for participation in publicly funded clinical trials in the UK. The aims were to review relevant guidelines and to collate and analyse views of clinical trialists on the role of payments and other factors that motivated clinicians to join clinical trials. Limited scope exists for paying clinicians over-and-above the cost of their time to be involved in research. Most trialists favour full payment of all expenses related to research. Payment of clinicians beyond expenses is perceived to be a less important motivating factor than researching important, salient questions, and facilitating research by reducing bureaucracy and delay.http://www.icr-global.org/resources/news/?EntryId23=4573Thu, 19 Mar 2009 15:59:25 GMTThu, 19 Mar 2009 15:59:25 GMTThu, 19 Mar 2009 15:59:25 GMTThis PLOS article proposes five way in which authors and editors can improve the published scientific record and be free from bias when publishing; publication bias, reporting bias, declaring financial/competing interests and improve access to data etc. They hope that if authors and editors address these issues prior to publishing, science will be transparent which will lead to "a more rigorous and unbiased knowledge base".http://www.icr-global.org/resources/news/?EntryId23=4572Thu, 19 Mar 2009 15:59:25 GMTThu, 19 Mar 2009 15:59:25 GMTThu, 19 Mar 2009 15:59:25 GMTThe Wellcome Trust has set up a webpage dealing with personal information and its use in research.Writing in Clinical Discovery, Nicola Perrin talks about what is needed to ensure public trust when accessing patients' personal information in research. She discusses current issues of using personal information and covers some of the discussion and recent consultations that will be published soon. She also refers to the use of personal information in other countries and new opportunities for research.http://www.icr-global.org/resources/news/?EntryId23=4571Thu, 19 Mar 2009 15:59:25 GMTThu, 19 Mar 2009 15:59:25 GMTThu, 19 Mar 2009 15:59:25 GMTUK charities involved in clinical research have called for greater public participation in the debate on the use of patients’ data, in particular electronic records. The British Heart Foundation, the Wellcome Trust, and Cancer Research UK warned that clinical trials are being delayed because of problems identifying patients suitable for research projects. Time spent recruiting patients is also eroding the money and time available to spend conducting clinical trials, they said. Mark Walport, director of the Wellcome Trust, said that patients had "a very strong altruistic view" of the use of their medical records for research. "Surveys show that most patients want their data to be used," he said. "The big challenge is in gaining public confidence about access to electronic patient records. There has to be some form of partnership to help that debate and move it forward."http://www.icr-global.org/resources/news/?EntryId23=4570Thu, 19 Mar 2009 15:59:25 GMTThu, 19 Mar 2009 15:59:25 GMTThu, 19 Mar 2009 15:59:25 GMTThe Medicines and Healthcare products Regulatory Agency (MHRA) is set to welcome a new Product Lifecycle Assessment Team (PLAT) to the Licensing Division. The dedicated assessment team will primarily focus on processing non-prescription products and will handle both new applications as well as non-safety related variations. Since the introduction of the Decentralised Procedure (DCP) for processing Marketing Authorisation Applications (MAA) in late 2005, the United Kingdom has been a major Member State contributing to the assessment of these types of applications in the European Regulatory Network (ERN). Dr Lam said the MHRA recognised this area of service required improvement and by establishing the new assessment team UK non-prescription product applications will be handled a lot more efficiently. “The creation of a new PLAT together with the expansion of assessment capacity over recent years reflects the UK’s commitment to both national medicines regulation and support to the ERN for the benefit of public health,” he said.http://www.icr-global.org/resources/news/?EntryId23=4569Thu, 19 Mar 2009 15:59:24 GMTThu, 19 Mar 2009 15:59:24 GMTThu, 19 Mar 2009 15:59:24 GMTFrom 9 March 2009 all the data that are required to make an application to the Medicines and Healthcare products Regulatory Agency (MHRA) for authorisation of a clinical trial of an Investigational Medicinal Product (IMP) can now be completed within the Integrated Research Application System (IRAS) (external link). Previously IRAS only collected information about the IMP that was also required by other review bodies. That meant that although information could be imported and exported between IRAS and EudraCT, further information also needed to be completed in EudraCT before an application to the MHRA could be made. Now through IRAS all the information about a study can be entered in one place and researchers need only to go to EudraCT to obtain their EudraCT number. IRAS contains extensive guidance to support researchers in completing their application form. Additionally, it is now possible to generate the application form to the MHRA in the appropriate formats directly from IRAS.http://www.icr-global.org/resources/news/?EntryId23=4568Thu, 19 Mar 2009 15:59:24 GMTThu, 19 Mar 2009 15:59:24 GMTThu, 19 Mar 2009 15:59:24 GMTImproved patient-oriented research in Europe will benefit European citizens and the European medical industry and facilitate the transfer of scientific discoveries from the laboratory bench to the bedside. For Europe and for the rest of the world this effort will be of great importance for the quality of life of individuals and the wellbeing of society as a whole. To achieve this important objective, the European Medical Research Councils (EMRC) at the ESF mandated the undertaking of a foresight study, a so called Forward Look, on ‘Investigator- Driven Clinical Trials’ (IDCT). “This project marks the most comprehensive examination and analysis of the issue in Europe and proposes particular steps towards better clinical research in Europe,” said Dr. Carole Moquin-Pattey, Head of EMRC and coordinator of the study. Investigator-driven clinical trials - trials instigated by academic researchers aimed at acquiring scientific knowledge and evidence to improve patient care – deal with potential diagnostic and therapeutic innovations that do not attract or could be even against commercial interest.http://www.icr-global.org/resources/news/?EntryId23=4567Thu, 19 Mar 2009 15:59:24 GMTThu, 19 Mar 2009 15:59:24 GMTThu, 19 Mar 2009 15:59:24 GMTThe BBC and the Financial Times have both covered this story on the 12th of March. The story introduces clinical trials as being bureaucratic and therefore hampering clinical research in the UK and "inadvertently killing people", despite increased funding in clinical trials. It says that the additional funding is being used to deal with paperwork, monitoring and detailed labelling of drugs, according to experts. The amount of clinical trials conducted in the UK has been reduced from 6% to 2% between 2002 and 2007. According to Professor Rory Collins, co-director of the Clinical Trial Service Unit at the University of Oxford, trials of already known medicines or treatments, such as aspirin, have to go through the same long regulatory procedure as new drugs. He thinks that people are over-interpreting regulations to cover themselves. [More in news item on BBC.]http://www.icr-global.org/resources/news/?EntryId23=4566Thu, 19 Mar 2009 15:59:24 GMTThu, 19 Mar 2009 15:59:24 GMTThu, 19 Mar 2009 15:59:24 GMT