This presentation will take the audience from early discovery, the demonstration of efficacy, drug/biologic agent exposure, early candidate selection, and the preclinical safety aspects which are often missed by startups. In addition, we will discuss scale-up and impurity issue considerations for the Active Pharmaceutical Ingredient (API) during the development phases through late stage drug/biologic development, selection of a preclinical safety evaluation partner, API supply, and regulatory filings.

 
Moderator:
Dr. Stephen Frantz, Senior Director of Business Development, Pacific Northwest, MPI Research, Inc.