National Biotechnology Conference 2009 Preliminary Program - (Page 12) CONFERENCE PROGRAM - TUESDAY AND WEDNESDAY 3:30 pm - 5:00 pm 5:00 pm – 6:00 pm Emerging the Role of Drug Disposition in the Early Optimization of Biotherapeutics HOT TOPIC Contributed Papers Reception 5:15 pm – 9:00 pm Wednesday, June 24 7:00 am – 5:00 pm Industry Tour Pacific Biometrics and CMC ICOS Biologics Additional Fee Required Tour two local biotechnology laboratories while in Seattle: Pacific Biometrics, Inc.’s biomarker services laboratory and CMC ICOS Biologics’ GMP production facility. The tour begins at Pacific Biometrics, Inc. One of the premier biomarker services laboratories in the clinical trials industry, Pacific Biometrics, Inc (and its wholly owned subsidiary Pacific Biomarkers, Inc), PBI has been supporting clinical trials for the pharmaceutical and biotech Industries since 1989. Through complex methods, biomarker development, and technology transfers this facility has helped to bring novel small and large molecules to the advancement of modern medicine. Hors d'oeuvres, soft drinks, beer and wine will be available upon your arrival at PBI. The tour continues to CMC ICOS’ GMP production facility located in Bothell, WA. A pre-tour presentation will orient guests to the layout of the facility. Tour participants will be able to view the purification and production areas through windows that line a common hallway. The production area contains various sized bioreactors ranging from 350L to 3000L. The purification area is typical of an efficient workspace designed to process kilogram quantities of protein. CMC ICOS Biologics, previously ICOS Corporation, has manufactured biologics for clinical testing since 1994. With the recent acquisition by CMC Biologics (Copenhagen), CMC ICOS now focuses solely on CMO activities. All aspects of developing proteins for clinical and commercial production are carried out on-site. The manufacturing facility has recently been modified to enable commercial production. The shuttle bus to the two facilities leaves the convention center at 5:15 pm. Plan to return to the Sheraton Seattle by 9:30 pm. Refreshments will be available. Register for the tour by purchasing a Laboratory Ticket on the registration form. As the biotherapeutic landscape becomes increasingly competitive, including new follow-on biologic strategies, it will no longer be sufficient to develop the first biotherapeutic agent toward a mechanism, but rather the first agent with the most optimal properties. One key area of optimization is the disposition or ADME properties of a biotherapeutic. Furthermore as the complexity and risk associated with prosecuting unprecedented mechanisms and novel biotherapeutic modalities increases, research programs with a sophisticated understanding of the disposition and PK/PD properties of their agents will speed development and enhance survival of their clinical candidates. There are a variety of under-utilized (or under-reported) opportunities for optimizing a biotherapeutic agent in early drug discovery in regards to disposition or ADME properties with some examples including improving catabolic stability through site specific mutations to remove enzymatic consensus sequences, optimization of receptor binding properties in order to modulate pharmacokinetic and pharmacokinetic/pharmacodynamic properties and targeting distribution of biotherapeutics to improve safety or efficacy. We foresee this aspect as a rapidly growing area in the development of best in class pharmaceutical biotherapeutics and therefore propose the introduction of this new hot topic “Emerging Role of Drug Disposition in the Early Optimization of Biotherapeutics” given the opportunity we would be happy to present a podium presentation at the 2009 AAPS NBC meeting. The presentation will focus on optimization of biotherapeutics and its impact on drug disposition as it relates to PK-PD and efficacy and will include case studies investigated at Pfizer. However if this Hot Topic were to be expanded to a full session, this subject matter could be expanded to include other strategies for biotherapeutic ADME property optimization. The cross discipline nature of this topic should generate a lot of interest in a larger audience spanning PK, PD, PK-PD modeling, immunogenicity, drug metabolism, safety and protein engineering. We forecast that introduction of this topic at NBC 2009, could lead to larger forum discussion (roundtables) in subsequent AAPS meetings. Speakers to be Announced Registration Wednesday Morning Sunrise Sessions Funded by a Grant From 7:30 am - 8:30 am Novel Technologies of Drug Delivery SUNRISE SESSION New and advanced technologies for drug delivery will be discussed and explored in terms of biologics, the control of biologics and the notion of advanced PK approaches (e.g., nasal delivery to the central nervous system). Moderator Brian R. Moyer, M.S. Health and Human Services Multifunctional Nanoparticles for Therapeutic and Diagnostic Applications Jeff Hrkach, .D. BIND Biosciences Novel Technologies for Drug Delivery Daniel Anderson, M.D. Massachusetts Insitute of Technology 7:30 am - 8:30 am GLP, CLIA/CAP, or ISO: Quality Systems in Use in the Bioanalysis of Macromolecules SUNRISE SESSION For the latest information visit: www.aapspharmaceutica.com/nationalbiotech Bioanalytical laboratories are often processing samples from clinical as well as from pre-clinical studies and as good laboratory practice (GLP) is mandatory for the latter this quality system is by many laboratories and auditors regarded as the most applicable system. In the small molecules field there is also a large consensus on technical and scientific demands a method has to be in agreement with since the early nineties. The basis for this consensus was laid in the first Crystal City conference in December 1990 culminating in a Bioanalytical Method Validation guidance per May 2001. Performing method validation and sample analysis in agreement with this guidance and Crystal City conference reports, and under the U.S. Food and Drug Administration (FDA) or the Organization for Economic Co-operation and Development (OECD), GLP is often referred to as GLP 2009 AAPS NATIONAL BIOTECHNOLOGY CONFERENCE 12 PRELIMINARY PROGRAM http://www.aapspharmaceutica.com/nationalbiotech
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