9am - 12pm A Reasoned Approach to Proof-of-Concept Decision Making

Instructors:

John Arrowsmith, Ph.D., Science Director, Europe, Thomson Life Sciences Consulting

Richard K. Harrison, Ph.D., Scientific Director, North America, Thomson Life Sciences Consulting

The Pharmaceutical Industry is currently faced with major issues due to decreased revenue generation and low productivity. Consequently it has been actively adopting a variety of strategies, aimed at managing costs and increasing the flow of novel compounds into their pipelines. Strategies aimed at R&D productivity include downsizing and outsourcing, increasing access to new drugs and technologies through partnering, acquisitions and mergers, R&D realignments with a more narrowly focused portfolio. New revenue generating strategies include repurposing old drugs, expanding into emerging markets, greater reliance on biologics, and expansion into vaccines, consumer health, animal health and diagnostics.

These strategies are being adopted as means to maintain revenue streams and to mitigate some risk, but fundamentally they are being driven by the low output of new medicines from the R&D divisions of Pharma.

How did we get here? Despite the huge increases in the investments made in Pharma R&D over the last few decades productivity, as measured by the NDA approval of new molecular entities, has remained fairly constant. The 20 NMEs produced yearly is not sufficient to sustain an R&D based pharmaceutical industry that relies heavily on NME’s to drive future revenue streams.

Analysis of benchmarking data reveals that Phase II survival is the Achilles Heel of R&D industry, as 1 in 5 drugs entered into a Phase II proof-of-concept study (POC) will successfully transition into Phase III. This is only marginally better than the 50% attrition from Phase III to submission. Clearly changes need to be implemented in order to ensure survival of the industry. This interactive short course will discuss the key criteria that underpin quality PoC decisions for both NMEs and repositioned drugs as well as highlight strategies to consider in achieving a PoC in a timely and cost effective manner. Retrospective analysis of the consequences of poor scientific and business decision making in Phase II will be used to highlight the impact on Phase III success.

*Separate Registration Required