2nd Annual Symposium on Development of Complex Drug Products Opportunities, Challenges and Solutions
Thursday, September 17, 2015
DoubleTree Hilton, Somerset, New Jersey
Complex drug products comprise a growing pharmaceutical sector, due to the safety, efficacy, and compliance benefits they provide. As reflected in recent regulatory science initiatives by the Food and Drug Administration (FDA), there is a rising interest in enhancing access to alternate and interchangeable versions available for all CDP categories by applying a rational, science-driven approach that conceptually relies on quality by design. During this symposium, we will discuss the evolving approaches for guiding formulation development, predicting in vivo performance, establishing critical manufacturing variables, and enhancing equivalence assurance of complex drug products. As an application of biopharmaceutics in the current pharmaceutical landscape, we will also review the expanding utility of BCS based biowaivers.
This session will feature presentations by leading experts, followed by a panel discussion. Topics covered in this symposium will include:
Extended Pharmaceutical Equivalence of Complex Drug
Products: Industry and Regulatory Contexts
Extensions of BCS-Based Biowaivers: Opportunities for
New Product Classes and a Review of the 2015 FDA Guidance
Approval of Generic Ophthalmic Suspensions/Emulsions:
Current Status and Challenges
Ajaz Hussain, Ph.D.
Insight, Advice & Solutions, LLC
Barbara M. Davit, Ph.D., J.D.
Merck Research Laboratories
Uday Kompella, Ph.D.
Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado
Additional Panel Members:
Lisa J. Murray, M.S., Provenir
Lcda. Lorena Rojas, Drugs National Agency, Ministry of Health Panama Republic
Charlie DiLiberti, Montclair Bioequivalence Services