Monday, October 3
11:00-1:30pm Main Conference Registration
1:30-2:15 Keynote Address: How to Get and Learn so Much More from Data Captured in Clinical Trials of Cancer Therapeutics
Antonio Tito Fojo, M.D., Ph.D., Head, Experimental Therapeutics Section, NCI, NIH
2:15-3:00 Keynote Address: Delivery of a Robust Phase III Ready Package with First Dose in Clinic to Last Visit in Phase II in 15 Months – Example of PF-04971729 at Pfizer
Neeta Amin, Pharm D., Director, CVMED Research Unit, Pfizer
When PF-04971729 started First-in-Human (FIH), others within the same mechanism-of-action (MoA) had started Phase III with several others in Phase II as well as Phase I. Being a late entrant in a competitive landscape, Pfizer leveraged existing published data to optimally design clinical development program, accurately and adequately characterized the dose-response for efficacy, and maintained a relentless focus on quality (not only speed). The team took serial, compounded, calculated risks including finalization of tablet strengths for Phase II before initiation of FIH, as well as initiation of screening in Phase II before availability of drug supply and results from the clinical 2 week multidose, dose-escalating study.
3:00-3:30 Networking Refreshment Break with Exhibit & Poster Viewing
Chairperson: John Arrowsmith, Ph.D., Scientific Director, Thomson Reuters Consulting
3:30-4:00 The Consequences of PoC Decision Making
John Arrowsmith, Ph.D., Scientific Director, Thomson Reuters Consulting
Clinical proof-of-concept is the single biggest point of failure in drug development continuum. Examination of actual project data shows that success is achieved by building a robust body of evidence to demonstrate that modulation of a target results in clear clinical benefit to the patient. Failure can occur because the body of evidence clearly shows there is no benefit to the patient or can result from the drug being inadequately tested in man. While the first reason for failure is acceptable the latter is not and all efforts need to be made to avoid such failures.
4:00-4:30 Building a Networked Pharmaceutical Enterprise
Kenneth A. Savin, Ph.D., Advisor to Special Projects, Global External Research and Development/Due Diligence, Eli Lilly and Company
Sponsored by
4:30-5:00 The Living Document: Developing an Accelerated Proof-of-Concept
Alan Copa, Pharm.D., President, Clinical Operations, Fargo, Cetero Research
This session focuses on how-to’s for developing a robust, yet flexible protocol to accommodate up to four different studies. Topics covered include: Regulatory and ethical concerns, Inclusion/exclusion criteria, Dose flexibility, Stopping points, Timing and logistics of overlapping cohorts, Safety reviews
Sponsored by
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5:00-6:00 Evening Reception with Exhibit and Poster Viewing
6:00pm End of Day One
Day 2 | Day 3