ICR 30th Anniversary Conference & Exhibition

Opening plenary question & panel debate

Facilitator: Niall Dickson, CEO Kings Fund

Panel members: Professor Nick Bosanquet, Imperial College School of Medicine, Professor Karol Sikora, Imperial College School of Medicine

Parallel Sessions

Oncology Care in the Future

Chair – Prof Karol Sikora, Imperial College School of Medicine, London

Future of Cancer Care 

Prof Nicholas James, Clinical Oncology, University of Birmingham, Birmingham

• Outcomes are steadily improving with longer survival times and fewer side effects

• Long term quality of life is therefore more of an issue

• Demographic burden of cancer is increasing which increases pressure on health service

• New drug cost pressures very high in cancer

• New drugs tend to migrate from late to early disease with further cost pressures

The Challenge of Prostate Cancer

Prof Jonathan Waxman, Hammersmith Hospital, London

• Brief background on the challenges of prostate cancer

• Current therapies for prostate cancer

• Pipeline of drugs/compounds

• The future for care of patients with prostate cancer

Contracts in Global Clinical Trials

Legal Aspects of International Clinical Trial Contracts

i3 speaker (tbc)

Project Management

Tanya Gee, PAREXEL International

• Contracts used in Clinical Research

• Current environment

• Planning – understanding requirements and dependencies

• Timelines in Contracting

• Handling expectations

• Common inspection findings

• Top tips to take away

Quality and Productivity: Can you have both?

Alison Messom, Averion International (UK) Ltd

• Defining quality and productivity

• Why are they seen as conflicting objectives?

• How to have it all

Improving Quality & Productivity Using Lean Sigma

Andrew Borrisow, MDS Pharma Services

• The place of Lean Sigma in Quality Management Systems

• How Lean Sigma operates to remove waste & variability

           - Comparison with other systems

• Implementation of Lean Sigma

           - What are the short-term resource requirements and how quick is the payback?

           - Would implementation be easier for certain types of organisation?

• Case study: putting Lean Sigma into practice in a clinical research context

Medical Devices Workshop

Medical Devices Special Interest Group

• The differences between pharmaceuticals and devices

• Study design

• Regulations

Refreshments, Exhibition and Posters

Parallel Sessions

Oncology Care in the Future (Continued)

Chair – Prof Karol Sikora, Imperial College School of Medicine, London

Cancer Vaccines

Prof Angus Dalgleish, St Georges Hospital, London

• History of immunotherapy and vaccines for cancer

• Virus related cancer and vaccination

• The problem with tumour antigens and tolerance

• Why good phase 2 studies have yet to succeed in phase 3 and be registered

• The future is choosing the right disease, the right stage and the right combination of treatments

Cancer prevention

Prof Will Steward, University of Leicester, Leicester

• It has been estimated that approximately 65% of all cancers are caused by lifestyle choices – predominantly smoking and diet

• Making changes in population lifestyle with smoking reduction is effective in reducing cancer death rate

• Long term alteration of dietary behaviour in societies is extremely difficult to achieve

• Chemoprevention is the use of agents, often diet derived, to reduce or delay cancer development

• To date, chemoprevention has been shown to significantly reduce the incidence of breast and prostate cancer and current trials are focusing on reducing colorectal and head and neck cancer incidence.

Electronic Data Capture (EDC) – Issues and Practical Solutions

Paul Mason, The University of Birmingham

Vivienne Miller, i3 Research

One area that has been particularly slow in catching up with the electronic age is the capturing of information for the use in clinical trials.  Electronic data capture (EDC) is a computerised system designed for the collection of clinical data in electronic format for use mainly in human clinical trials.  No matter what type of EDC you’re referring to, the goal remains the same – to replace the paper-based process of capturing information with an electronic system to expedite the availability of accurate data for the research programme.

The aims of this session are to provide an introduction to EDC and focus on the practical issues surrounding EDC and to include: 

• What is EDC – why use it?

• What are the cons?

• Views from the NHS, Pharma and Academia

• The future and what can be done to improve EDC?

International Inspections

Gunnar Danielsson, Swedish Medical Products Agency, Sweden

The EMEA works as a network, bringing together the scientific resources of the Member States (MSs) to ensure the highest level of evaluation and supervision of medicines in the EU. The Agency co-operates closely with international partners, reinforcing the EU contribution to global harmonisation.

The current EU Regulatory System is unique in the international regulatory environment in so far that Community legislation has provided for a network between all national regulatory bodies, co-ordinated by the EMEA.

Topics include:

• How the EMEA is facilitating Inspections across the EU and the nature of collaboration with the FDA and other regulatory agencies in the future

• The experiences of an Investigator

Image in Business: It’s Personal

Ann Skidmore, Colour Me Beautiful

First Impressions

• How your appearance impacts others

• The importance of personal image
• What your image says about you
• What your image says about your company
• Confident body language
• Creating the desired impression

Professional Colour

• Wearing colour for impact
• Suitable options

Your Business Style

• Appropriate business dress
• Bodyline, proportions and scale

Grooming

• Attention to detail
• Finishing the look

Lunch, Exhibition and Posters

Parallel Sessions

Organ Transplantation: Past, Present and Future

Chair - Prof James Neuberger

Introduction

Prof James Neuberger, University Hospital Birmingham NHS Foundation Trust

30 years of organ transplantation

Mr Simon Bramhall, University Hospital Birmingham NHS Foundation Trust

The future of organ transplantation, including the controversial topic of xenotransplantation

Prof Massimo Malago, University College Hospital, London

A personalised perspective from the British Transplantation Trust

Ray Pearson

The A-Z of Adaptive Study Design

Recent advances in clinical trials have focused on more individualised novel therapeutic approaches in clinical trials.  Adaptive study designs are emerging as attractive options for study modifications in relation to accumulating data and interim data analyses.  The potential for accelerated drug development and optimised resource allocation needs to be balanced with an increased focus on rigorous planning of flexible designs and on the regulatory standards for continued trial integrity, validity and patient safety based on the scientific evidence in the regulatory decision-making process.

The aims of this session are to provide an introduction to adaptive study designs and focus on practical worked and published examples.

Dr Lucinda Billingham, Cancer Research UK Clinical Trials Unit

• What is adaptive design?  Is it just another buzz word?

• Can it save money and resources?

• Safety of patients

• Integrity of research

• Does it reach decisions quicker

• Does it interrupt patient recruitment

• Practical examples

Mark Richardson PhD FTOPRA, Richardson Associates Regulatory Affairs Ltd

• The regulatory paradigm of clinical development phase progression and trial design

• The paradigm shift of adaptive trial design as preferred by regulators

• Compressing clinical phase progression as not preferred by regulators

The Impact of the Declaration of Helsinki

The Declaration of Helsinki was developed by the World Medical Association (WMA), as a set of ethical principles for the medical community regarding human experimentation. It is widely regarded as the cornerstone document of human research ethics (WMA 2000), although it is not a legally binding instrument in international law. It draws its authority from the degree to which it has been codified in, or influenced national or regional legislation and regulations.

Dr Eva Nilsson Bågenholm, Chair of the WMA's Ethics Committee and President of the Swedish Medical Association

• Changes in the Declaration and their impact

Dr Bev Holt, GDRU, Quintiles Limited

• Historical aspects of the Declaration from its derivation and a look at the impact of the subsequent revisions.

Project Management Workshop - Growing Project Managers into Leaders

Andy Taylor, Dan Long, Dave Rowan, People Deliver Projects Ltd

The Project Management Industry tends to focus too hard on processes and methods, and often overlooks the more vital ingredient, namely people.  This is sometimes because the importance of the human side is not recognised, but more often because there is not an effective enough alternative to traditional soft skills training, which unfortunately rarely has lasting impact.  This presentation will be all about projects and people; it will provide evidence of the people challenges of project delivery, will actually demonstrate good and bad influencing skills, and will explain how to grow leaders successfully.  It is neither soft nor fluffy, and there will be lots of audience involvement in an energetic and enjoyable session. 

Topics include:

• Correcting the balance, from process back towards people - the case and the evidence

• Ownership and influence, the core qualities of project leaders

• Forum theatre - professional actors demonstrate the skills and involve the audience

• Why traditional soft skills training is not the answer

• Growing leaders - effective strategies for growing project managers into leaders

• Free coaching sessions are available on the People Deliver Projects Exhibition stand throughout the two days

Refreshments, Exhibition and Posters

Parallel Sessions

Organ Transplantation: Past, Present and Future

More details soon

Stem Cells: Current Advances and Applications

Human Stem Cell Biology and Therapeutic Applications

Prof Peter Andrews, University of Sheffield

Current Controversies with Stem Cell Research

Prof Sir Nicolas Wright, Cancer Research UK

The aim of this session is to:

• Provide delegates with the applicable current understanding of stem cell biology

• Describe technologies and applications in drug discovery and development to include experimental models for drugs targeted at stem cells

• To raise awareness of the global issues associated with stem cell derivation, commercialism and use, ethical, societal, regulatory and legal

Putting a Price on Patient Value

Speakers to be announced

This session will discuss the contentious issue of determining whether and how the costs of healthcare interventions should be reimbursed by payers (eg, the NHS, health insurers etc.). Central to this are the assessments of the balance of value and cost made by organisations such as NICE. Speakers will address these issues from a variety of perspectives. Among the questions to be discussed are:

• How is the overall value of a new intervention assessed? How does this vary between countries?
• Do prominent advocates for a new treatment (eg, patient groups, key opinion leaders, media etc.) make a purely rational decision politically impossible?
• Are decisions fair (or equally unfair) to all therapy areas or patient subgroups?
• Does enabling patients to pay for non-reimbursed treatments undermine the NICE assessment or make it easier for NICE to make difficult decisions?
• How does a country’s potential market value for a drug influence whether it is included in the drug’s clinical development?
• How might value models develop as pharma explores innovative impact-based pricing schemes?

GCP Question Time

Chair - David Talbot, LEO Pharmaceuticals, Chair of ICR's GCP Forum and member of the steering group

The interpretation of GCP issues is often difficult.  This session will take the issues and by means of discussion and consensus look to resolve and give suggestions on possible solutions. 

The session will be interactive with a number of questions being presented and making full use of the voting pad system to ensure everyone has a voice in the session.

Closing Plenary Question and Panel Debate
Facilitator: Niall Dickson, CEO, Kings Fund

Champagne Reception, ICC

Gala Dinner, ICC

Day 1 Conference Close