Track G

G5 Drug Discovery and Development Primer for More Effective Technology Commercialization

Track: Other

Target Audience: All Audiences

Isabelle Gorrillot, Ph.D., Areon Biosciences

Thomas Campi, DVM, MPVM, Elanco
Ines Holzbaur, Ph.D., Amorchem
Alan Naidoff, DMD, J.D., CLP, InnovationAdventure, LLC
Arundeep Pradhan, Apio Partners

Many universities and research centers are investing in "acceleration" programs, which means that technology transfer officers are increasigly going to need to truly understand the early phases of medical product development and their requirements. Such knowledge is critical to effectively interact with inventors in fine-tuning their reduction-to-practice phase so that they generate preliminary (i.e. non GMP) data that is worthy, but also to effectively structure development license agreements with reasonable expectations. Preparing a strong discovery package (pre-GMP) can substantially build confidence with a potential partner, and contribute to mitigating risk.  This is also valuable information for patent scoping and filing strategy because an increasing number of foreward-thinking investors favor companies that can bridge animal and human product development in order to mitigate development cost and corporate development risk. Join us for an overview of the road to medical product regulatory approval, with an emphasis on the preclinical development phase and the preclinical-to-clinical hinge (IND process) both for human and animal drug development, as well as the regulatory path for diagnostics and medical devices, and the orphan drug designation process in the United States and European Union.

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