National Biotechnology Conference 2009 Preliminary Program - (Page 8) CONFERENCE PROGRAM - TUESDAY Tuesday Morning Roundtables Funded by a Grant From production and analytical technologies have contributed to increased safety and expanded therapeutic use of these drugs. This symposium provides an overview of the technologies used to create bispecific antibodies and discusses examples of potential therapeutic use. Moderator Wolfgang Glaesner, Ph.D. Eli Lilly and Company 9:00 am - 10:30 am Freezing of Biologics: Understanding the Solute Distribution and Physical Property Changes in Various Freeze/Thaw Systems Parag Kolhe, Ph.D. Pfizer Do We Need QTc Studies for Monoclonal Antibodies? ROUNDTABLE In 2005, ICH S7B and E14 guidelines were issued, which contained recommendations on how to assess QTc interval prolongation potential for non-antiarrhythmic drugs. There are many questions and unknowns on how to apply to these guidelines to therapeutic monoclonal antibodies (mAbs). Biotech companies are currently developing nonclinical and clinical strategies to evaluate the QTc prolongation potential of mAbs that adequately evaluate cardiac safety and takes into account the unique challenges of studies with biologics. An overview of the ICH S7B and E14 guidelines. To review the current state of knowledge on the potential for binding of biologics to ion channels and to prolong the QTc interval. To outline possible options for assessing the QTc prolongation potential of mAbs. The QTc is a required assay for defining the cardiac risk of drugs. The question is should this test also be within the scope of concerns for biologics? The question will be addressed from both regulatory-based and toxicology-based concerns. Moderators Wendy S. Putnam, Ph.D. Genentech Shuang Bai, Ph.D. Genentech Bite: Teaching Antibodies to Engage T Cells for Cancer Therapy Patrick Baeuerle, Ph.D. Micromet, Inc. Applying Isolator Technology to Biotech Product Fill Lines: VPHP Cycle Development and Detection Challenges Mary Houchin, Ph.D. Amylin Pharmaceuticals Title to be Announced Chengbin Wu, Ph.D. Abbott Laboratories Evaluation of Filling Technologies for Manufacturing Protein Products Fangdong Yin, Ph.D. Eli Lilly and Company Title to be Announced Zhenping Zhu, Ph.D. ImClone Powder Filling: Equipment, Process and Flow Properties Sunil Shah, Ph.D. Amylin Pharmaceuticals 9:00 am - 11:30 am New Technology Nitin Rathore, Ph.D. Amgen, Inc. Introduction into Biotechnology Drug Product Manufacturing: Current 9:00 am - 11:30 am Challenges and Strategies In Vitro In Vivo Correlations SYMPOSIUM of Antibody Therapeutics With the advent of recombinant biotechnology and the introduction of a number of biotechnology products to treat similar diseases, biotechnology companies are striving to reduce cost of goods during manufacturing with introducing new technologies for automation and increased output. In addition, the regulatory expectations are becoming more stringent. The new technologies being introduced include E-beam sterilization of syringe tubs, barrier isolation and vapor phase hydrogen peroxide sanitization, time over pressure filling and automated visual inspection. Introduction of these technologies pose challenges as the product quality and consistency needs to be maintained. In addition, these new technologies require unique process and equipment characterization studies which need to be completed early on in product development prior to the technology transfer process for commercial manufacturing. In this symposium, we would like to discuss various challenges currently faced by biotechnology industry from the perspective of process development, technology transfer and validation during the manufacture of the biotechnology product using these new technologies. We will bring together experts from industry and academia to get insight to the challenges and strategies being developed for the manufacture of biotechnology products using these new technologies. Moderator Vinay Radhakrishnan, Ph.D. Pfizer Global Biologics Pharmaceutical SYMPOSIUM Automated Visual Inspection: Challenges and Strategies Monoclonal Antibodies and QT Prolongation: What is the Risk? Andrew R. Erdman, M.D. Genentech Exposure/QTc Response Information for Monoclonal Antibodies in Early Development Megan A. Gibbs, Ph.D. Amgen, Inc. Current Thinking on QTc Assessment for Monoclonal Antibodies Hong Zhao, Ph.D. (Invited) U.S. Food and Drug Administration 9:00 am - 11:30 am Bispecific Antibodies: A New Technology that Enables Novel Therapeutic Strategies SYMPOSIUM In contrast to small molecular weight drugs (SMD), the development of in vitro in vivo correlations (IVIVC) for antibody (Ab) therapeutics is still in its infancy. High-throughput in vitro assay capabilities that exist for SMD have not yet advanced to the same extent for Ab therapeutics; however, a battery of important in vitro and in vivo methods are routinely applied to the preclinical development of IVIVCs for Abs in the field of biotechnology. For instance, in vitro binding is of particular interest considering that the in vivo Ab pharmacokinetic/pharmacodynamic (PK/PD) behavior can be influenced by cognate target antigen binding, FC receptor binding, and levels of target expression. Furthermore, in vitro potency, efficacy and metabolism data in cellular and subcellular systems also play critical roles. This symposium is intended to investigate measurable in vitro parameters, such as binding affinity, expression level, rate of internalization, antibody and target turnover, cellular metabolism to in vivo efficacy, toxicity and other PD effects. Special topics such as antibody drug conjugate will also be covered. This symposium will address correlations relating in vitro and in vivo phenomena; binding to FC receptors and target antigens in vitro potency and/or cytotoxity cellular metabolism antigen binding and/or targeting PD and/or potency PK in vivo metabolism. The use of monoclonal antibodies in clinical practice has been well established over the last decade and advances in engineering, 2009 AAPS NATIONAL BIOTECHNOLOGY CONFERENCE 8 PRELIMINARY PROGRAM
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