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Bethesda North Marriott Hotel and Conference Center

Mar 18, 2014 8:30 AM - Mar 20, 2014 4:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Beginning with the End in Mind – Study Endpoints: Targeting Patient-Centered Outcomes

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Beginning with Differentiation in Mind – Easier Said than Done

Session Chair(s)

Linda S. Deal, MS

Linda S. Deal, MS

Head of Patient-Centered Outcomes Measurement

Pfizer Inc., United States

Because yesterday’s blockbuster is today’s generic, the complexity of the development process for new drugs includes raised approval, adoption and reimbursement hurdles. To be competitive and truly groundbreaking, pharmaceutical and biotech companies must be willing to begin earlier in development to evaluate an asset’s potential to differentiate. And, because developing a new endpoint/outcomes measure takes time and investment, an early understanding of the end target(s) is critical when evaluating whether an existing clinical outcomes measure will be sufficient, whether it will need to be adapted, or whether a new measure needs to be developed, for addressing the program goals. The current state of regulatory challenges for study endpoints requires early planning and must be integrated into and accounted for within the overall development strategy. Internal company infrastructure, processes and governance may also present a challenge and may need to be reengineered to meet patient-centric objectives while still adhering to competitive timelines that optimize return on research and development investment and patent terms. This session further emphasizes the case for beginning early with the intention to differentiate, and discusses some of the internal and regulatory challenges to carrying out this objective.

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