Cambridge Healthtech Institute Course: A Reasoned Approach to Proof-of-Concept Decision Making
3 hour course to be held in Philadelphia on October 3, 2011, by John Arrowsmith, Ph.D., Science Director, Europe, Thomson Life Sciences Consulting & Richard K. Harrison, Ph.D., Scientific Director, North America, Thomson Life Sciences Consulting
Where: Crowne Plaza Hotel Philadelphia Downtown, Philadelphia, PA
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.
This course will be held prior to the start of CHI’s third annual Accelerating Proof-of-Concept:
View more details and register for the short course and/or CHI conference at http://www.healthtech.com/
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About Cambridge Healthtech Institute (www.chicorporate.com)
Cambridge Healthtech Institute (CHI) is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. CHI’s portfolio of products includes Cambridge Healthtech Institute Conferences, Insight Pharma Reports, Barnett International, Cambridge Marketing Consultants, Cambridge Meeting Planners and Cambridge Healthtech’s Media Group, which includes numerous e-newsletters as well as Bio-IT World magazine.
Founded in 1992, Cambridge Healthtech Institute strives to develop quality information sources that provide valuable new insights and competing points of view while offering balanced coverage of the latest developments. Basic research related to commercial implications is covered, with heavy emphasis placed on end-user insights into new products and technology as well as coverage on the strategy behind the business.
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