National Biotechnology Conference 2009 Preliminary Program - (Page 17) CONFERENCE PROGRAM - WEDNESDAY Molecular Design of Monoclonal Antibodies and Active Vaccines for Treating the Medical Problems Caused by Methamphetamine and Phencyclidine Abuse Michael S. Owens, Ph.D. University of Arkansas for Medical Sciences Defining Boundaries for Predictive Stability Tapan K. Das, Ph.D. Pfizer Moderator Arthur J. Shaw, Ph.D. Pfizer Global Biologics Pharmaceutical Top-down and Bottom-up Modeling and Experimental Approaches for Predicting Protein Aggregation Christopher Roberts, Ph.D. University of Delaware The Analytical and Regulatory Challenges of Extractables and Leachables for Biologics Dennis Jenke, Ph.D. Baxter BioPharma 3:30 pm - 5:00 pm Utility of the MABEL Approach for Estimating Starting and Escalation Doses ROUNDTABLE 3:30 pm - 5:00 pm The Analytical and Regulatory Challenges of Extractables and Leachables for Biologics Ingrid Markovic, Ph.D. (Invited) U.S. Food and Drug Administration The utility of minimum anticipated biological effect level (MABEL) to aid in the prediction of the starting and escalation doses for first in man trials will be explored. Moderator Mark Peterson, Ph.D. Biogen Idec The Analytical and Regulatory Challenges of Extractables and Leachables for Biologics ROUNDTABLE 3:30 pm – 5:00 pm Monoclonal Antibodies for Drug Delivery HOT TOPIC MABEL Applications for Biologics Marilyn E. Morris, Ph.D. University at Buffalo, SUNY Appropriate Use of MABEL Dose Setting Mark Rogge, Ph.D. Biogen Idec 3:30 pm - 5:00 pm Don’t Cook your Protein: Realistic Approaches for Biologics Predictive Stability ROUNDTABLE Determining extractables and leachables in biological products can be challenging for several reasons. Regulatory guidance is still evolving, the biologics matrix often contains numerous trace impurities that can interfere with leachable methods, and trends in single use manufacturing equipment expose the drug product to large surface areas of plastic and elastomer surfaces – a good source of leachables. In addition, leachables that pose little concern for small molecules may pose serious issues for biologics. Panel members representing equipment suppliers, pharmaceutical companies, and regulators will discuss some of the challengers and working solutions being used to determine and qualify biological API’s and drug products for extractables and leachables. A great deal of interest surrounds the use of monoclonal antibodies as drug carriers for the treatment of cancer. Recently, there has been significant progress in this field based on clinical trials of Herceptin-DM1 (Genentech) for the treatment of breast cancer and from SGN-35 (Seattle Genetics), a monoclonal antibody auristatin conjugate for the treatment of Hodgkin’s lymphoma. Both drugs induce regressions and objective clinical responses in Phase I and Phase II clinical trials. Several other promising agents are now in Phase I clinical trials from companies such as Wyeth, MedImmune, Genentech, Seattle Genetics, Curagen, ImmunoGen, and Progenics. Speakers to be Announced Accelerated stability is a widely used and valuable tool in formulation development of protein-based drug candidates. Due to time crunch, quite often researchers attempt to super-accelerate the process by employing exaggerated stress on protein formulations. Such approaches tend to result in denatured states of protein that are seldom relevant to predicting pharmaceutical stability. This session will highlight disadvantages of exaggerated stress methods and discuss realistic acceleration protocols that might predict relevant stability information. Moderator Tapan K. Das, Ph.D. Pfizer 2009 AAPS NATIONAL BIOTECHNOLOGY CONFERENCE 17 PRELIMINARY PROGRAM
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