2014

Development of Complex Drug Products: Opportunities, Challenges and Solutions for ANDA & 505(b)(2)
Thursday, September 18, 2014
DoubleTree Hilton, Somerset, New Jersey

Complex drug products, including dermal, ophthalmic, and intraoral delivery systems, are increasingly prevalent due to their pharmacokinetic and commercial benefits. Correspondingly, there is
a growing demand for generic products and better or complementary versions of existing products in the complex drug space. However, the unique development issues and inherent regulatory challenges of establishing therapeutic equivalence for such products, including reliance on clinical endpoint studies, have significantly hindered progress. Recently, the focus on increased utilization of biopharmaceutics principles and in vitro tools to evaluate product performance and/or establish equivalence without needing clinical studies has facilitated development of both new and generic complex drugs and improved regulatory review outcomes.

Presentation Topics and Speakers:

An overview of the current challenges with complex drug development and the opportunities this has created
Industry Perspective
Charles DiLiberti, Montclair Bioequivalence

Advances with in vitro tools and other models for guiding formulation strategy & demonstrating product equivalence
505(b)(2) Development Perspective
Indiran Pather, D. Pharm., College of Pharmacy, California Northstate University

Insights from industry and agency interactions that may help guide improved regulatory outcomes
Improved Regulatory Outcomes
Barbara M. Davit, Ph.D., J.D., Merck Research Laboratories

Additional Panel Members:
Vijay Tammara, Ph.D., Provenir
Ismael Hidalgo, Ph.D., Absorption Systems