National Biotechnology Conference 2009 Preliminary Program - (Page 16) CONFERENCE PROGRAM - WEDNESDAY Challenges and Considerations in Cryopreservation of Bulk Drug Substance Feroz Jameel, Ph.D. Amgen, Inc. 1:00 pm - 3:30 pm 1:00 pm - 3:30 pm Towards Better Justification of Specifications for Biopharmaceuticals SYMPOSIUM Antibody and Vaccine Approaches Against Small-molecule Toxins SYMPOSIUM Photostability of Monoclonal Antibodies: Effects of Light Exposure on Structure and Stability Bruce Kerwin, Ph.D. Amgen, Inc 1:00 pm - 3:30 pm Advances in Understanding Tumor Penetration/Target Tissue PK/PD of Biologics SYMPOSIUM Both tissue physiological parameters and molecule properties may impact the penetration of biologics to their target site, thus affecting the efficacy. Understanding the mechanism/process of drug penetration as well as the contributing/limiting factors is voluble to develop strategies for improving drug penetration and/or selecting biologics based on their abilities to penetrate tissue, thereby increasing the therapeutic index and overcome resistance. Progress has been made in applying some advanced technologies such as BioImaging, matrix-assisted laser desorption ionization mass spectrometry (MALDI-MS) in evaluating the penetration of biologics. This symposium will focus the discussion on our current understanding about tumor penetration/target tissue PK/PD and the application of some advanced technologies such as positron emission tomography (PET), MALDI-MS in assessment of tumor target penetration /target tissue PK/PD of biologics. Moderators Ben-Quan Shen, M.D., M.S. Genentech Leslie Khawli, Ph.D. Genentech Regulatory professionals, both in industry and across global regulatory agencies, often indicate that limited data available at the time of licensure create a unique challenge in establishing adequate justification of proposed specifications for biopharmaceutical medicinal drug products. This symposium will address how regulators expect industry to justify specifications as well as how production and quality control personnel can gather additional relevant process knowledge to support the justification. Discussion topics include using evolving technologies and processes, including QbD and risk-based approaches, to assist in tying in-process testing and overall process knowledge to the critical quality attributes (CQAs) for a medicinal drug product, how to leverage the relationship between CQAs and their respective dependent product or in-process characteristics to assist in justifying proposed CQAs and their associated specifications and tying clinical experience and manufacturing process knowledge together to define product CQAs and their associated justification of specifications. These strategies, and others, will be discussed to assist both regulators and industry in addressing the gaps created by the real world of limited resources, limited batch numbers and fast track development. Moderators Sally S. Seaver, Ph.D. Seaver Associates LLC Chana Fuchs, Ph.D. U.S. Food and Drug Administration Drugs of abuse and chemical warfare agents are examples of small-molecule toxins, which can cause severe and long-term deleterious effects after exposure. Conventional pharmco-therapies and antidotes for such substances have had limited success, and in the case of chemical warfare agents, are linked with severe side effects of their own. In addition, preventive and prophylactic treatment is not possible with conventional pharmacotherapies. Vaccination may provide a new approach to block the effects of such small-molecule toxins and provide prophylaxis for subsequent exposure. Indeed, vaccines against drugs of abuse such as nicotine, cocaine, methamphetamine and PCP are under development. Vaccines against chemical warfare agents are also under investigation. The design of anti-drug antibodies (i.e., generation of a vaccine for a small-molecule epitope) requires that the small-molecule drug (e.g., cocaine, nicotine, meth, sarin) be coupled to an antigenic protein, and antibodies are selected based on affinity. Three nicotine vaccines and a cocaine vaccine are in phase III clinical trials. Vaccines against methamphetamine and PCP are in preclinical development. This symposium will present approaches to the design of such vaccines and MAbs against small-molecule epitopes, and the current status of these pioneering approaches in mitigating the effects of these smallmolecule toxins. Moderators Nurulain T. Zaveri, Ph.D. Molecular Medicine Research Institute Chang-Guo Zhan, Ph.D. University of Kentucky Relating Specifications to Assay/Process Validation Ranges Sally S. Seaver, Ph.D. Seaver Associates LLC Impact of Antibody Modification on Tumor Penetration Gregory P. Adams, Ph.D. Fox Chase Cancer Center How to Approach Setting Specifications for Biologic Products Michelle Frazier-Jessen, Ph.D. MedImmune Vaccines and Monoclonal Antibodies as Antidotes for Smallmolecule Toxins: An Overview Nurulain T. Zaveri, Ph.D. Molecular Medicine Research Institute Extravascular Distribution of Anticancer Drugs: Does Inadequate Distribution of Anticancer Drugs within the Tumor Microenvironment Thwart their Efficacy? Andrew Minchinton, Ph.D. The BC Cancer Research Center Justification of Specifications to Meet Operational Needs John P. Hennessey, Jr., Ph.D. Merck Research Laboratories Addiction Vaccines: Overview and Nicotine Vaccines for Tobacco Dependence Paul Pentel, M.D. Hennipen County Medical Center Justification of Specifications for Biotechnology Products: A Regulator's Perspective Chana Fuchs, Ph.D. (Invited) U.S. Food and Drug Administration Molecular Imaging of Biologic's Penetration and Response in Target Tissue Shawn Chen, Ph.D. Stanford University Vaccines for Cocaine Abuse: Experimental and Clinical Evidence for Efficacy Frank M. Orson, M.D. Baylor College of Medicine 2009 AAPS NATIONAL BIOTECHNOLOGY CONFERENCE 16 PRELIMINARY PROGRAM
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