ICR 30th Anniversary Conference & Exhibition

Facilitator: Martin Ince, Science Journalist

Panel members: to be confirmed

Parallel Sessions

The Heart of Cardiology

Chair - Prof Avijit Lahiri, Wellington Hospital, London

Evolving role of cardiac CT and assessment of coronary atherosclerosis

Prof Avijit Lahiri, Wellington Hospital, London

• Advances in dual source cardiac CT angiography

• Dual energy cardiac CT imaging

• Coronary artery plaque morphology

• CT coronary angiography compared to myocardial perfusion imaging

Title to be confirmed 

Dr Marcus Flather, Royal Brompton Hospital, London

MIST trail Migraines/ Devices

Dr Mike Mullen, Royal Brompton Hospital, London

Off-Shoring in Clinical Research?

Paul Wathall, HCA International Limited, Harley Street Clinic

David Jefferys, Eisai Europe Limited

Off-shoring has been around for sometime particularly in the banking and IT industries.  The cost savings are well documented but what are the other driving factors?

Topics include:

• Arguments for and against offshoring

• The market and bioethical concerns

• The impact of socioeconomic conditions

An effective offshoring strategy requires….

• Full integration of systems and processes

• Provision of support and training

• Performance indicators and monitoring

• Effective workload distribution

Evidence for Good Quality: The Hidden Costs of Inspections

This session will look at whether the increased regulatory elements of clinical research have actually improved quality or added to the burden for researchers and diverted limited resources.

Professor Richard Gray, Birmingham Clinical Trials Unit

• The practical impact of the increase in regulations/inspections

• The reality of the work involved (diverting resources) in the NHS/University for an MHRA inspection

• The effects on resource and the true cost of the inspection process

• Is this then being transferred to an increase in price of new drugs? 

Theresa Ledger

• Experience of MHRA inspections from a Clinical Research Facility viewpoint 

Joan Perou

• Recent MHRA findings

• Improving and changing standards in the last 30 years

Leadership Workshop

Ian Robson, Perception Dynamics

This session will show delegates how to:

• Develop High Performance, Cross Functional and Virtual Teams

• Eliminate Silo Mentality and Resistance to Change

• Ensure that everyone is focused on the Common Goal

• Create a collective and aligned view of the big picture

• Build a genuine commitment to the success of the organisation

Refreshments, Exhibition and Posters

Parallel Sessions

The Heart of Cardiology (Continued)

More details soon 

Fundamentals of Paediatric Investigation Plans (PIPs)

Before & Beyond the Nuts & Bolts of PIPs

Klaus Rose, F. Hoffmann-La Roche Ltd

• Off-label use of drugs in children; history of paediatric legislation in USA, EU; key elements of the US legislation; the WHO paediatric campaign 'make medicines child size'

• What a team and a company have to do before they can even start writing a PIP - paediatric homework: epidemiology of the targeted disease(s) in adults and children, assessment of therapeutic alternatives, identify key opinion leaders, identify appropriate paediatric networks, consider paediatric development strategies in the US and try to avoid duplications US / EU

• How would we like the EU paediatric legislation modified in the two review rounds in 2013 and 2017?

Paediatric Investigation Plans (PIPs)

Dr Ian Dews, Envestia Ltd

• Overview of the PIP process

• The letter of intent

• Relevant guidelines for completing the PIP

• Basic shape of the PIP documentation

• Mandatory headings for PIP sections

• Publishing the paper & electronic versions

• Details that can bring you down!

• Validation

• The PDCO summary report

• Responding to requests for modification

Inspectors: Why do they do it?

Mark Poulton, Medicines and Healthcare products Regulatory Agency (MHRA)

More details soon

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

Lunch, Exhibition and Posters

Closing Keynote Plenary Lecture & Panel Debate

Pharma 2020: Virtual R&D - Which path will you take?

Kate Moss, PricewaterhouseCoopers LLP

This lecture will provide a visionary persepctive on how companies can work to shorten their R&D process and increase productivity.  It will explore:

• Dynamics, Environment & Key Challenges for Pharma in 2020

• Innovation Essentials

• Getting to know ourselves

• Expediting Development

• Collaborating to bring treatments to the market

• Imperatives for change

Closing plenary question and panel debate

Facilitator: Martin Ince, Science Journalist

Conference Close