National Biotechnology Conference 2009 Preliminary Program - (Page 13) CONFERENCE PROGRAM - WEDNESDAY Bioanalysis. Though very valuable, unfortunately its focus is on instrumental assays, chromatography plus (mass spectrometric) detection and small molecules. Macromolecule analytes of bioanalytical laboratories are not as traditional as small molecules are. In fact, the techniques and applications much more have their home base in clinical chemistry laboratories (e.g., diagnostics and patient safety). This is specifically the case for endogenous molecules/biomarkers. For the more common molecules, validated/ approved commercial kits are available and can or were already set-up and validated in-house at an accredited laboratory. For the more esoteric compound that is not the case and methods may only be operational at a few research institutes. Clinical study outcome parameters, whether they are PK or PD, require validated methods run in a compliant laboratory. That is clear and what everybody would agree to. However according to which concept methods should be validated and run; GLP bioanalysis or “clinical” is not so clear and open for debate. Each of the systems has its own merits and is proven to be valuable in its own field. But they are different. Bioanalytical labs hardly ever do round robins, clinical labs usually do not issue method validation and sample analysis reports to name just a few aspects. To facilitate the discussion on this topic and get insight in most common practices the outcome of a survey conducted by the subgroup, Macromolecules of the European Bioanalytical Forum (EBF), will be presented. Moderator Margarete Brudny-Kloeppel, Ph.D. Bayer Schering Pharma Moderator Mark Peterson, Ph.D. Biogen Idec mAbs PK Behavior Mark Peterson, Ph.D. Biogen Idec Title to be Announced Donald Mager, Ph.D. University at Buffalo, SUNY 9:00 am - 10:30 am Rational Approaches to Design and Discovery of Protein Drugs ROUNDTABLE of pharmaco/toxicodynamic properties in a potentially relevant species, it undoubtedly would enhance the complexities and challenges encountered during the course of antibody development process. As successful translation of preclinical information during the course of antibody development requires particular understanding of both antibody, and antigen properties in various species, the application of surrogate approach in antibody development will necessitate comparative investigations of the relevant pharmacology, antibody affinity, the sequence and structural properties of the antigen, as well as understanding of the factors impacting the antibody exposure-response relationships. During this session, application of surrogate molecules and surrogate animal models in development of antibodies will be evaluated. Moderator Mohammad A. Tabrizi, Ph.D., R.Ph. AnaptysBio Rational design approaches to protein drug discovery are becoming more and more promising in recent years, as some exciting outcomes resulted from rational design (via computational modeling and simulation) have been reported in literature. However, rational design of protein drugs is also controversial. This roundtable will present some recent case studies and allow scientists with different opinions to discuss both the upside and downside of the rational design of protein drugs. Moderator Chang-Guo Zhan, Ph.D. University of Kentucky Application of Surrogate Antibodies in Development of Monoclonal Antibodies Mohammad A. Tabrizi, Ph.D., R.Ph. AnaptysBio Application of Surrogate Animal Models in Development of Monoclonal Antibodies: Preclinical Pharmacology, a Case Study Ronald Herbst, Ph.D. MedImmune Computational Design of Site Specific Endonucleases David Baker, Ph.D. University of Washington Risk Assessment for Biotherapeutics: Surrogate Models in Nonclinical Safety Testing Patrick Finn, Ph.D. Genzyme Corp. Implementation of a CLIA and GLP-like Hybrid Quality System in Immunogenicity Testing Mark Schwerzler, M.S. Genzyme Corp Engineering a Stable Biological Therapeutic from an Unstable Protein Roger Sunahara, Ph.D. University of Michigan 9:00 am - 10:30 am Quality Systems Used in Bioanalysis of Macromolecules: Outcomes of a Survey Held Among European and American Pharma Companies Peter H. Van Amsterdam, Ph.D. Solvay Pharmaceuticals Efficient Tech Transfer in Biologics Manufacturing ROUNDTABLE 9:00 am - 10:30 am The Surrogate Approaches in Development of Monoclonal Antibodies ROUNDTABLE 7:30 am - 8:30 am Prediction of Human PK for Monoclonal Antibodies SUNRISE SESSION The nature of monoclonal antibodies (mAbs) leads to often unpredictable PK patterns. It is the goal of this session to explore the nature of mAbs interactions, elimination mechanisms and other biologic actions that may help in the prediction of the mAb behavior. Therapeutic monoclonal antibodies exhibit exclusive specificity for the target antigen. This unique characteristic discriminates antibodies from other therapeutic modalities such as the traditional small molecule drugs. However, when cross-reactivity of the lead antibody across the species is limited, the antibody development program will require generation of surrogate antibodies or surrogate animal models that are necessary for the conduct of preclinical pharmacology and safety studies. Although the surrogate approach allows examination Outsourcing of biologics manufacturing is steadily trending up. With increasing demand of reducing cycle time in early stage and need to control resource burn in phase III/commercial manufacturing, it is ever more important to look for opportunities of efficient tech transfer, and when possible use such criteria for partner selection. This session will highlight aspects of complexities of tech transfer in biologics manufacturing, areas of improvement for efficiency and assessment of failure risk mode analysis. Moderators Tapan K. Das, Ph.D. Pfizer Satish K. Singh, Ph.D. Pfizer 2009 AAPS NATIONAL BIOTECHNOLOGY CONFERENCE 13 PRELIMINARY PROGRAM
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