The 2010 Hoehn Lectures in Regulatory Science
The 2010 Hoehn Lectures in Regulatory Science were held May 10, 2010, featuring Prof. Charles Cooney from MIT and Dr. Steve Swanson from Amgen, Inc. Read below for descriptions of each lecture.
Professor Charles Cooney
Robert T. Haslam, Prof. of Chemical Engineering, MIT
Topic: Bioprocess Optimization: The Challenge of Manufacturing Science
Dr. Cooney is a leading expert on production of protein pharmaceuticals. He set up some of Genetech's earliest production lines, and is currently the Haslan Chair of Chemical Engineering at MIT and Faculty Director of the Deshpande Center for Technological Innovation and International Innovation. Early—even preliminary—decisions in biopharmaceutical production can have a tremendous impact on the safety, efficacy and cost of the product, but can rarely be altered after initial clinical trials. Dr Cooney spoke on considerations in balancing risk and reward in decisions from clone selection to finishing and formulation. Although many tools can provide detailed analysis, such as microreactors, transcriptional analysis and process analytical technologies, their uncertain relations to clinical and business endpoints can make all metrics "inherently imprecise, imperfect, incomplete and uncertain." Nonetheless, bioproduction must go on. Dr Cooney described the state-of-the-art in evaluating risk and consequences, through the 4 perspectives of efficacy, safety, cost and regulatory. Despite uncertainties and with appropriate caution, we will be seeing not just biosimilars, but "bio betters."
Dr. Steve Swanson
Executive Director & Head of the Clinical Immunology Dept. Amgen, Inc.
Topic: The Challenge of Immunogenicity When Developing Therapeutic Proteins 
Dr. Swanson reviewed the challenges in evaluating immunogenicity of biopharmaceuticals. Some level of immune response is detected with nearly all protein drugs, and is generally detectable only late in clinical trials. Its effects can range from being innocuous, to neutralizing (or sustaining) the drug, to rare lethal situations of autoimmunity or a cytokine storm. Human immune responses cannot be predicted from animal responses, or cellular or computer models, and may be patient-specific. The state-of-the-art is detecting antibodies against the drug; kinetic binding data from surface plasmon resonance has advantages in detecting antibodies of weak or unknown affinity, over ELISA methods. The importance of immunogenicity is especially important to consider with biosimilars, because small differences between similar proteins can show large differences in immunogenicity, and trace residuals such as sub-visible aggregates are especially problematic. So biosimilars cannot be generic - it will always be unwise to switch between products.
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