Streamlining Generic Drug Development by Matching Reference Product Composition and Performance, In Vitro and In Vivo
Our inaugural workshop addresses the issues surrounding reverse engineering methods and strategies in the context of Q1/Q2/Q3 comparisons, with an eye toward reducing the clinical burden of generic drug development programs via BCS class 3 biowaivers, in vitro-only pathways for locally-acting and complex drug products, and, where biowaivers are not possible, streamlining complex human bioequivalence studies. The program was developed to appeal to stakeholders across a broad range of disciplines and to span a diverse group of product classes. The agenda covers cutting-edge approaches to facilitate the development of solid oral, semi-solid (locally- and systemically-acting topical and vaginal), long-acting injectable (suspension and liposomal), and oral inhalation products and brings key industry leaders, researchers, and regulators together to present the latest strategies for deformulation, process optimization, and bioequivalence study design. We believe this is the first comprehensive workshop to focus on the challenges industry faces in taking advantage of these streamlined development pathways.
Registration fees includes calendar year 2018 and 2019 membership dues ($100 value).
A block of rooms has been reserved at a rate of $139.00 plus taxes breakfast included. The rate is available for Oct. 17-18. A limited number of rooms are available at this remarkable rate until September 17, 2018. Please call the hotel directly at +1-410-727-2222 for reservations and mention “Scientists Advancing” for this special workshop rate.
Lunch is included both days with Cocktails served the first evening during the Networking Reception.
Speakers and Panelists
Robert Lionberger, PhD, FDA
Markham Luke, MD, PhD, FDA
Xiaohui (Jeff) Jiang, PhD, FDA
Sam Raney, PhD, FDA
Priyanka Ghosh, PhD, FDA
Wenlei Jiang, PhD, FDA
Kimberly Witzmann, MD, FDA
Bing Li, PhD, FDA
Siddhartha Bhoopathy, PhD, Absorption Systems
Vijendra Nalamothu, PhD, Tergus
Lakshmi Raghavan, PhD, Solaris Pharma
Izzy Kanfer, PhD, University of Toronto
Philippe Colucci, PhD, Learn and Confirm
Diane Potvin, Excelsus
Eric Uffman, PhD, Evans Analytical Group
Mansoor Khan, PhD, Texas A&M
Jag Shur, PhD, Nanopharm/U Bath
Gur Jai Pal Singh, PhD, Cipla
Yu Chung Tsang, PhD, Apotex
Nageshwar Thudi, PhD, Teva