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A Must-Attend Event for CROs, Big Pharma, Executives
and Scientists
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Are you wondering what is being done to increase Phase III success? Are you ready to adapt a new strategy, learn a new technology or try a new trial design to move your drug forward? Phase III success rates for the pharmaceutical industry are low, but recent advances in simulation & modeling, clinical trial design, proof-of-concept, and pre-clinical decision making are set to reduce the attrition rate. Join the experts from pharma, biotech, academia and CROs to discuss the current state of Phase III studies and how we can improve them. Presentations, panel discussions and networking sessions that are guaranteed to have you charting a new course for Phase III success!
At this forum, you will:
- Learn how to utilize modeling & simulation technology to improve phase III design
- Meet & network with experts from the pharma industry
- Discuss the latest in regulatory recommendations for adaptive design and conditional approval
- Listen to presentations on how translational medicine is changing how pharma looks at non-approval
» 2:00 Keynote Presentation: Have We Lost the Plot in Phase III Development?
 Declan Doogan, M.D., CMO, Amarin
In 2010 twenty one NDA/NBAs were approved. The ratio of NME:NBE was 15:6. A decade earlier 29 entities were approved; NME:NBE ratio was 27:2. The rapid evolution of the science base has enabled access to new targets, but the failure rate has grown dramatically too. This can be traced back to poor decision making. The main reason is that candidates were inappropriately nominated at the end of Phase II or did not have the appropriate characterization during Phase II.
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PRESENTATIONS BY:
Abbott Laboratories
Amarin
AstraZeneca
Daiichi Sankyo Pharma Development
Johnson & Johnson
Pharmaceutical Research & Development L.L.C.
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Pfizer, Inc.
SomaLogic, Inc.
Takeda Global Research & Development, Inc.
University of Maryland
Vertex Pharmaceuticals, Inc.
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