SAAMnow held its Spring 2019 workshop Challenging Statistical Issues with In Vitro and In Vivo Bioequivalence Studies: Extreme Variability, Special Study Designs and Novel Approaches on April 4-5, 2019, at the Hilton Washington DC hotel in Rockville, MD. This was the second workshop organized by SAAMnow; the inaugural workshop Streamlining Generic Drug Development by Matching Reference Product Composition and Performance, In Vitro and In Vivo was held October 18-19, 2018, in Baltimore, MD. The Spring 2019 workshop was initiated in memory of Sanford (Sandy) Bolton (September 11, 1931 – October 12, 2011), who was a distinguished pharmaceutical scientist and educator and leader in the field of pharmaceutical statistics.
The objective of the workshop was to address the most challenging and current issues with the design and statistical analysis of in vivo and in vitro bioequivalence studies, including industry perspectives on the challenges faced, current FDA thinking on the issues, and, where appropriate, presenting novel approaches to address these challenges.
The Scientific Steering Committee for the workshop consisted of the seven members listed below:
Pina D’Angelo (Chairperson): Executive Director, Biostatistics, Novum Pharmaceutical Research Services of Delaware, Inc.
Charles Bon: Trustee of SAAMnow Corporation; President, Biostudy Solutions, LLC.
Charlie DiLiberti: Chairperson of SAAMnow Board; President, Montclair Bioequivalence Services, LLC
Keith Gallicano: Vice Chairperson of SAAMnow Board; Chief Scientific Officer, Novum Pharmaceutical Research Services of Delaware, Inc.
Mark Liu: Senior Director, Pharmacokinetics and Drug Metabolism Department, Mylan Pharmaceuticals, Inc.
Julie Szirtes: Associate Director, Clinical R&D, Apotex, Canada
Nagesh Thudi: Senior Director, Global Clinical Gx R&D-CE/PD Studies, Teva
The following seven companies provided various levels of sponsorship for the workshop:
Sandoz Inc., A Novartis Division
BioPharma Services Inc.
Logan Instruments Corp.
Drug & Biotechnology Development LLC
Novum Pharmaceutical Research Services
Raptim Research Ltd.
About 100 attendees, including 24 from FDA, participated in the 2-day workshop. The workshop was divided into four sessions, with a panel discussion at the end of each session. The session speakers and invited panelists participated in each panel session.
For a summary of key points from each session, please click on the following link.