3rd Annual Symposium on Development of Generics & 505 (b)(2): Opportunities, Challenges, and Solutions
Thursday, September 29, 2016
DoubleTree Hilton, Somerset, New Jersey

Development and approval of generic versions of some of the most widely used drug products has become increasingly challenging as reflected in the GDUFA Regulatory Science Priorities which are based on industry comments received by the FDA. Due to the increasing demand for generic products, FDA has prioritized research into new BE methodologies to support the development of guidances and policies that clarify the ANDA pathway for such products.

Our previous symposiums have focused on the increased utilization of biopharmaceutics principles, advances in non-clinical tools for guiding formulation strategy and predicting in-vivo performance, and demonstrating product equivalence without the need for clinical studies along with a review of the expanding role of BCS based biowaivers.

This symposium will provide insights into; methodologies that better elucidate active ingredient availability at the site of action and correlate these to the formulation function of the product; harmonization efforts that enable the design and conduct of more efficient and multi-jurisdiction applicable BE studies and challenges with comparator drug availability for drug development.

  1. In Vitro Methodologies to Elucidate Formulation Function; Emphasis on Q3 and Building “Bio-context”
  2. Proceedings from the Global Bioequivalence Harmonization Initiative; Second International Workshop
  3. Comparator Drug Challenges

Topics and Speakers:
Emphasis on Q3 and Building “Bio-context”
Mansoor Khan, R.Ph., Ph.D.
Professor and Vice Dean
Director, Formulations and Drug Delivery Core Laboratory Texas A&M Health Science Center, Rangel College of Pharmacy, College Station, TX

Proceedings from the 2nd Global BE Workshop
Barbara M. Davit, Ph.D., J.D.
Executive Director
Translational Pharmacology, Merck Research Laboratories

Comparator Drug Challenges

Charlie DiLiberti
Montclair Bioequivalence Services

Comparator Drug Challenges
Nicholas Tantillo
Head, Policy and Regulatory Strategy
Sandoz Inc.

Absorption Systems
Amneal Pharmaceuticals