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Developing a Biotherapeutic: From Clone to Clinic®

Presented at: NESACS Advances in Chemical Sciences “Bench to Pilot Plant” Symposium Cambridge, MA, October 23, 2009

Developing a biologic is very different from developing a small molecule drug and the data needed to support regulatory filing of an IND reflects these differences. This presentation describes the development process for a biotherapeutic and compare it to development of a NCE. It also includes discussions of the regulatory expectations for filings, with particular focus on IND filings.