The Science and Technology Law Center of Albany Law School hosted an afternoon panel program called "Follow-On Biologics: Scientific, Legal and Policy Issues" on March 26, 2007, from 3 p.m.-5 p.m.

The program addressed the scientific, legal and policy hurdles that stand in the way of producing "generic" or "follow-on" versions of off-patent biologic products. Topics included:

  • Differences between biologics and small molecule drugs
  • Hurdles to FDA approval
  • The proposed: "Access to Life-Saving Medicine Act"
  • Effects on healthcare: cost and safety considerations
  • Options for the future of follow-on biologics and implications for the biopharmaceutical industry

Panelists:
Gordon Johnston - biologics
Gordon Johnston
Vice President Regulatory Affairs
Generic Pharmaceutical Association

Bruce Manheim - biologics
Bruce Manheim, Esq
Ropes & Gray, LLP

Prof. Gregory Mandel
Associate Dean of Research and Scholarship and Professor of Law
Albany Law School

Shaker Mousa - biologics
Dr. Shaker Mousa
Executive Vice President and Chairman
Pharmaceutical Research Institute of Albany College of Pharmacy

Randall Rupp - biologics
Randy Rupp, Ph.D.
Senior Vice President of Manufacturing and Process Sciences
Regeneron Pharmaceuticals, Inc.

Recordings:

Intro. by Annette Kahler, Dean Guernsey and Prof. Greg Mandel - Click HERE to download the audio or Play It Now!

Dr. Shaker Mousa - Click HERE. Play It Now!

Randall Rupp, PhD - Click HERE. Play It Now!

Gordon Johnston- Click HERE. Play It Now!

Bruce Manheim. - Click HERE. Play It Now!