Introduction to Biologic and Biosimilar Product Development and Analysis

1. Principles of Recombinant DNA Technology a. Introduction b. Production methods c. Purification technology d. Characterization e. Analysis and regulation f. Summary points 2. Therapeutic Proteins a. Introduction: Protein/peptide structure and what that means for delivery b. Delivery challenges c. Potential methods of delivery d. Summary points 3. Therapeutic Antibodies a. Drug development and antibody engineering b. Pharmacokinetics of monoclonal antibodies c. Delivery methods d. Clinical applications e. Antibody-specific adverse effects f. Therapeutic areas g. Summary points 4. Analysis and Regulation of Biologics, Including Biosimilars a. Introduction b. FD&C Act Section 505(b)(2) and the products that currently may be approved via this pathway c. PHS Act / Biologics Price Competition and Innovation (BCPI) Act of 2009 d. Summary Points