John Geigert, PhD, BioPharmaceutical Quality Solutions, BioAB Chair | Mar 06, 2017
PDA’s Biotechnology Advisory Board is now officially the Biopharmaceutical Advisory Board (BioAB). This new name better represents
the scientific and technical information this advisory board provides to PDA’s board of directors and its membership regarding biopharmaceutical
manufacturing, quality and regulations.
But BioAB is more than an advising group. Its members actively participate and take leadership roles in numerous PDA events. And
2017 is proving to be an active year with BioAB members involved in three major upcoming events:
2017 PDA Annual Meeting
Michael De Felippis, PhD, Senior Research Fellow, Bioproduct R&D, Eli Lilly & Company and Vice-Chair of BioAB, and Morten
Munk, Senior Technology Partner, Global Business Development, NNE Pharmaplan, are co-chairing this signature PDA event in April,
assisted by Laurie Graham, Acting Director, OPQ, US FDA, and a number of other PDA volunteer members from across the bio/pharmaceutical
industry on the conference planning committee.
2017 PDA Cell and Gene Therapy Workshop
Due to the increasing importance of cell and gene therapy products, BioAB has designated this area of biopharma as a major initiative
for the advisory board, led by volunteers Vijay Chiruvolu, PhD, Senior Director, Product Sciences, Kite Pharma, Michael Blackton,
Vice President, QA CMC, Adaptimmune, and Karen Walker, Global Head, Quality, Cell and Gene Therapy Units, Novartis. All three
have been heavily involved in developing this workshop on these “next wave” biopharmaceutical products. It is scheduled to follow the
Annual Meeting in April.
2017 PDA Biosimilars Conference
Vince Anicetti, Executive Director, Quality, Coherus Bioscience, and Stephan Krause, PhD, Director, QA Technology, AstraZeneca
Biologics, are co-chairing this year’s biosimilars conference in June, assisted by Michael VanDerWerf, Director, Regulatory Affairs, Teva,
Laurie Graham, and Jens Schletter, PhD, Head, Regulatory CMC Group Biopharmaceuticals, Sandoz. BioAB has been heavily involved
in this area as biosimilars are already market-approved in both Europe and the United States, with many more in various stages of clinical
development or under active regulatory authority market approval review.
PDA’s BioAB members continue to work hard to cover emerging developments and technology in biopharma. The advisory board hopes
these three PDA events offer members a chance to learn more about the latest biopharmaceutical trends and challenges as well as debate
these topics with other members.