Ways to Accelerate Drug Development: Fast-Track, Breakthrough Designation, Accelerated Approval, Priority Review
Speaker: Michele Bronson, Ph.D. – Vice President, Program Management, Portola Pharmaceuticals
Date/Time: Friday, March. 27th, 8:00-10:00 AM, presentation begins at 8:30 sharp
Place: Genentech, 475 East Grand Ave, SSF, CA 94080, Building 42-1C
RSVP: http://NCBPPMMar2015Breakfast.eventzilla.net (Admission is free, but registration is required by 9:00 am 03/25)
Speaker Bio:
Michele is a drug development professional, who has built and led Regulatory, Quality and Project Management organizations. Michele joined Portola in November 2014, with over 15 years of experience at start-up to medium-size biotech companies. She was most recently Vice President of regulatory and quality at Labrys Biologics developing an anti-CGRP monoclonal antibody for the prevention of migraine. Labrys was acquired by Teva Pharmaceuticals for $825 million in July 2014. Prior to Labrys, Michele was Vice President of Regulatory, Quality and Project Management at Medivation, Inc., where she oversaw the development of their prostate cancer compound (enzalutamide) from pre-IND stage through FDA approval. Michele served in roles of increasing responsibility in regulatory affairs at Chiron Corporation, until its acquisition by Novartis in 2006. Michele received her Ph.D. in molecular biology from UT Southwestern Medical School.
Abstract:
Whether one is working a start-up or an established company, the sooner a product can be brought to market the better—better for patients and better for the company. Over the last few years, the FDA has created numerous pathways to accelerate drug development. In addition to the long-standing Accelerated Approval process and Priority Review status, the FDA has also created both Fast Track and Breakthrough Therapy Designation. The differences and advantages of each program will be presented, along with experience to date in the industry, as well as general considerations that impact drug development programs considering these pathways must examine.
*2 PDUs awarded for PMP re-certification
RSVP: http://NCBPPMMar2015Breakfast.eventzilla.net (Admission is free, but registration is required by 9:00 am 03/25)
Speaker Bio:
Abstract:
Whether one is working a start-up or an established company, the sooner a product can be brought to market the better—better for patients and better for the company. Over the last few years, the FDA has created numerous pathways to accelerate drug development. In addition to the long-standing Accelerated Approval process and Priority Review status, the FDA has also created both Fast Track and Breakthrough Therapy Designation. The differences and advantages of each program will be presented, along with experience to date in the industry, as well as general considerations that impact drug development programs considering these pathways must examine.*2 PDUs awarded for PMP re-certification
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