SAVE THE DATE!
Inaugural SAAMnow Annual Scientific Workshop (October 18-19, 2018)
Streamlining Generic Drug Development by Matching Reference Product Composition and Performance, In Vitro and In Vivo
Embassy Suites near the Inner Harbor
222 St. Paul Place, Baltimore, MD
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.