Speakers: Azin Shahzamani (Genentech/Roche), Yaning Wang (FDA), Mike Eldon (Nektar), Terry Sweeney (Nektar), Ramani Raghavan (Genentech), Detlef Albrecht
Organizers:
Date: 2015-09-18
Time: 8:45-17:00 Pacific Time
Registration fee: (USD): Regular: $195; For major-sponsor rep (incl lunch): $0; For vendor-show rep: $35; For unemployed & students: $30
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2015-09-16  (it will close sooner if the seating cap is reached)

About the Topic

An End-of-Phase 2 (EOP2) meetings is a meeting between the US FDA and the sponsor of a clinical development program after the completion of the Phase 2 study and prior to the start of the Phase 3 study. It is most useful to the sponsor and should be held before major efforts and resources are committed to specific Phase 3 studies. The purpose of an EOP2 meeting is to determine sufficient safety prior to Phase 3, to evaluate the Phase 3 plan and protocols, the adequacy of current studies and plans to assess pediatric safety and effectiveness, and to identify any additional information necessary to support a marketing application for the uses under investigation.

This workshop is intended to address the important topics for an effective discussion at an EOP2 meeting and to provide an overview of a successful meeting preparation. Regulatory aspects will be provided from the FDA and the industry perspective. For clinical pharmacology the progress of PK study data and additionally needed studies will be reviewed. The preclinical safety and toxicology as it relates to dose, duration & route of administration will be discussed. In the CMC area the approach to specifications and test methods as well as the formulation to be used in clinical trials and “to be marketed” formulation will be addressed. In the clinical discussion at an EOP2 meeting, agreement  needs to be reached with FDA on pivotal study designs, dose selection, patient population and the safety and efficacy endpoints for Phase 3 studies. 

Agenda:

8:45am - 8:50am               PBSS Welcome (Peter Staehr, MD, Abbott Vascular)

8:50am - 9:50am               1. Regulatory Overview of End of Phase 2 meeting – What to consider? – Industry perspective (Azin Shahzamani , Genentech/Roche)

9:50am - 10:50am             2. FDA perspective on a successful EoP2 meeting; Phase 3 dose selection aspects (Yaning Wang, PhD, Division of Pharmacometrics, FDA)

10:50am - 11:00am          Major Sponsor Presentation (Celerion)

11:00am - 11:15am          Break   

11:15am - 12:15pm          3. Clinical pharmacology aspects and strategy (Mike Eldon, PhD, Nektar)

12:15pm - 1:15pm            Lunch   

1:15pm - 2:15pm              4. Nonclinical safety and toxicology aspects and strategy (Terry Sweeney, PhD, Nektar)

2:15pm - 2:30pm              Break   

2:30pm - 3:30pm              5. CMC aspects and strategy (Ramani Raghavan, PhD, Genentech/Roche)

3:30pm - 3:45 pm             Break   

3:45pm - 4:45 pm             6. Clinical aspects and strategy (Detlef Albrecht, MD)

4:45pm – 5:15 pm            Panel Discussion (All speakers)