Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.
Adaptive Development: A leap forward in efficiency
Michael J Rosenberg, President and CEO, Health Decisions Inc., USA
Logical Considerations in the Implementation of Adaptive Trial Designs
Eva R. Miller, Director, Biostatistics, ICON Clinical Research, USA
Wednesday, March 10, 2010
09:00 Session 0106
INNOVATION IN EARLY AND LATE PHASE CLINICAL TRIALS II
Session Chair:
Michael Krams, Vice President, Adaptive Trials and Applied Program
Strategies, Wyeth Research, USA
• What impact can adaptive designs have on timelines and cost?
• Can innovative trial design reduce risk?
Adaptive Design in Confirmatory Trials: A way forward
Solange Corriol Rohou, Director, Regulatory Affairs, AstraZeneca, France
Flexible Trial Design: New techniques in interim analysis
John Whitaker, Vice President, Biostatistics and Scientific Programming, Kendle,
USA
Exploiting Scientific Intent of ICH Guidelines to Accelerate Proof of Concept
Richard Williams, Vice President, Regulatory and Strategic Drug Development,
INC Research, USA
Adaptive Trials: Too complicated for too little return?
Bill Byrom, Senior Director, Product Strategy, Perceptive Informatics, UK
11:00 Session 0107
HAVE THE BENEFITS OF TRANSLATIONAL MEDICINE BEEN REALISED?
Session Chair:
Damian O’Connell, Vice President, Clinical R&D, Global Research and
Development, Pfizer, Ltd. UK
Developments in translational medicine, triggered in response to the
pharmaceutical industry's ongoing attrition, have come to the centre of many
companies exploratory development paradigms. These translational strategies
have been highlighted by both the European Innovative Medicines' and FDA’s
Critical Path Initiatives as means to catalyse new opportunities for innovation in
early clinical R&D and help select mechanisms most likely to lead to
breakthrough therapies. This session will look at how various companies have
implemented translational medicine strategies in different therapeutic areas to
make better and more informed choices around candidates to accelerate from
research to proof of concept and the impact of translational medicine on their
success rates in achieving positive POCs.
Pre-Clinical and Clinical Development of Anticancer Pharmaceuticals
Klaus Olejniczak, Scientific Director, Department of Drug Toxicology, BfArM,
Germany
Translational Research in the Pharmaceutical Industry: From theory to reality
Damian O’Connell, Vice President Clinical R&D, Global Research and
Development, Pfizer, Ltd. UK
Experimental Models of Pain
Boris Chizh, Platform Director, Pain & Neurophysiology, GlaxoSmithKline, UK
14:00 Session 0108
INNOVATION TO REDUCE ATTRITION
Session Chair:
Jackie Hunter, Senior Vice President, Science Environment Development,
GlaxoSmithKline, UK
Theme 1 - Theme 2
• Predictive validity in animal models
• Innovations in target discovery and validation
• Updates on clinically relevant animal models
• Novel methods to identify clinically important new treatments pre-clinically
Addressing the Impact of Protocol Complexity on Clinical Trial Performance
Kenneth A. Getz, Senior Research Fellow, Center for the Study of Drug
Development, Tufts University; Chairman, CISCRP, USA
Regulatory View
Spiros Vamvakas, Head of Scientific Advice, Technical Coordinator for ICH,
European Medicines Agency, EU
Theme 2
Staying in Business: How to make sure you comply with all
rules and regulations, quality, compliance and external
challenges
Theme Leaders:
Beat Widler, Global Head, Clinical Quality Assurance, F. Hoffman-La Roche
AG, Switzerland
Gabriele Schwarz, Head, GCP Inspection Services, BfArM, Germany
In the EU, the Pharmaceutical Package and in other countries, other new rules
and regulations have created new obligations. Also, advocacy groups, the
public and the media – the scientific as well as the general press – are
becoming more active and questioning. This makes the development of new
medicines more and more demanding, not only from a clinical and scientific
perspective but also from a process and regulatory aspect. Globalisation is, for
instance, seen by some as progress as patients in developing countries are
getting access to innovative medicines through earlier involvement in clinical
trials and because of a strengthening of local economies through improved
healthcare systems. Others are fearful that there is a shift in the focus of clinical
development from industrialised countries to Asia and Latin America, thus
depriving investigators in these “traditional” regions of access to clinical trials,
and trials in developing countries are a new form of colonialism and result in the
exploitation of vulnerable populations. The counter argument to this is a not
uncommon topic in the debate about development: protection of patients in
developing countries by well-intentioned and often self-nominated advocates
from the so-called industrialised countries is nothing other than paternalism.
Two sessions will look at this conflict and give background information about
patients, the healthcare system and risks and benefits when conducting clinical
trials in India and Latin America. In this context the expectations by the public
for transparency do not come as a surprise and will be the topic of another
session. Misuse of medicines and counterfeiting are other facets of globalisation
and closely linked to the widespread use of the Internet. A session will review
the so far rather neglected topic of misuse of therapeutic agents in doping.
Doping would not be made so easy without manufacturing capacities in
countries with weaker regulatory controls and e-commerce, and this leads to
another session about counterfeiting. New regulations and mounting pressure
are also an opportunity for smarter strategies and the use of “intel-ligence” for
study management and quality oversight: progress of the Clinical Trial
Transformation Initative (CTTI), innovative approaches to quality risk
management that make extensive use of computerised processes and in the
management of partners will be the focus of three sessions.
Monday, March 08, 2010
16:30 Session 0201
TRANSPARENCY: A PANDORA’S BOX OR A PANACEA?
Session Chair:
Greg Koski, Associate Professor of Anesthesia, Massachusetts General Hospital
Partners Healthcare System, USA
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