National Biotechnology Conference 2009 Preliminary Program - (Page 11) CONFERENCE PROGRAM - TUESDAY 1:00 pm - 3:30 pm Origin of Opalescence in Protein Therapeutics, Not so Clear SYMPOSIUM The appearance of protein therapeutics is routinely assessed over the shelf-life of a product. The clarity of the solution is often connected with the presence of insoluble aggregates. However, there are several other factors that can lead to turbid solutions. The focus of the symposia is to discuss potential origins of opalescence such as protein concentration, insoluble aggregates, particulates and phase separation. Moderators Theodore W. Randolph, Ph.D. University of Colorado at Boulder Jamie M. Moore, Ph.D. Genentech Spinodal Phase Separation Mary Cromwell, Ph.D. Genentech changes observed in early development to decisions on the safety and efficacy of the target and the mechanism (e.g., proof of pharmacology/mechanism/concept). There are some important questions to be addressed during this translation process are. What are the available target and mechanism biomarkers and how are they used in drug development? General issues with biomarker development and characterization; how to choose between target vs. mechanism biomarkers, choice of relevant animal models, biomarker assay issues, design of biomarker studies, interpretation of data including PK/PD modeling and simulation. Are the standard target vs mechanism biomarker decision rules any different in therapeutic areas like oncology and inflammation where biomarker development poses a stiff challenge? This roundtable will include speakers involved in translational medicine and biomarker development, and will focus on the issues highlighted above, specifically for biologic programs. A potential positive outcome would be an understanding of the role of target and mechanism biomarkers in translational research within biologics programs and the existing challenges. Moderators Lorin Roskos, Ph.D. MedImmune Balaji Agoram, Ph.D. Pfizer number of new label free technologies have been introduced into the marketplace. This roundtable session will review the some of the label free systems currently in use for biotherapeutic applications and contrast and compare data obtained from the perspective of end-users. Moderator Valerie Quarmby, Ph.D. Genentech Challenges in Generating Molecular Interaction Data to Support Drug Development Jihong Yang, Ph.D. Genentech Label Free Screening of Biomolecular Interactions Matthew Cooper, Ph.D. Cambridge University 3:30 pm - 5:00 pm Impact of Immunogenicity on PK and PD: What is the Real Issue? ROUNDTABLE Particulates in Biotech Formulations Hanns-Christian Mahler, Ph.D. F. Hoffmann-La Roche Understanding and Coping with Opalescence and Viscosity in a Monoclonal Antibody Formulation Branden A. Salinas, Ph.D. The University of Colorado Discovery and Development of Target Biomarkers for Soluble and Cell-surface Biologic Receptors Binodh S. DeSilva, Ph.D. Amgen, Inc. 3:30 pm - 5:00 pm Target vs. Mechanism Biomarkers in Translational Research of Biotherapeutics ROUNDTABLE Mechanism Biomarkers: From Pharmacology to Gene Expression Wendy White, Ph.D. MedImmune The role of biomarkers in translational research is well accepted. Target biomarkers (free target levels, receptor occupancy, imaging, etc.) are useful in many ways in biologic programs. It can help provide “proof of pharmacology” in early clinical trials, demonstrate depletion or accumulation of the target due to antibody binding and internalization or stabilization respectively and highlight potential safety concerns and provide rationale for doses in early clinical trials. Where receptor occupancy cannot be directly measured or is not clearly quantitatively related to PD effect, mechanism biomarkers may be used. These biomarkers may be measured either in the absence or presence of a “challenge”. For example, hemoglobin levels can be used as PD markers of erythropoietin receptor agonism and inflammatory marker levels after administration of an endotoxin “challenge” (e.g., lipopolysaccharide) are used as PD markers after anticytokine antibody treatments. The aim of translational research is to link these biomarker Role of Target and Mechanism Biomarkers in Translational Research Donald Mager, Ph.D. Univeristy at Buffalo, SUNY 3:30 pm - 5:00 pm Beyond ELISA: Label Free Techniques in Biotherapeutic Development ROUNDTABLE As macromolecules, all biological products can potentially trigger unwanted immune responses ranging from no effects to significant impacts on product safety and efficacy, and in some cases, it can be serious and life threatening. Assessment of immunogenicity is an important aspect during the development. In recent years, the immunogenicity has been a great concern for manufacturers, regulatory agencies and clinicians and a lot of effort has been put to pursue new technologies or new assay platforms to improve the immunogenicity assay sensitivities and drug tolerance. Most importantly, the impact of anti-drug antibodies (ADA) on the PK/PD, and clinical consequence has recently become a great area to explore. The focus of this session is to discuss the impact of ADA on the PK and PD profile. Discussing points including at what level of ADA, PK/PD profile changes will be clinically significant; will the low affinity antibodies cast impact on PK and PD parameters? When the drug concentration is high, does it need a higher level of ADA in order to have any PK and PD impact? Moderators Dong Geng, Ph.D. Bristol-Myers Squibb Patick Liu, Ph.D., M.D. Genentech Technologies that generate label-free, kineticsbased binding data on drug-target interactions are often used in biotherapeutic discovery and development. Data from these systems may be used for selecting a lead candidate molecule, or for comparability assessments. However, accurate data may be hard to obtain due to the intrinsic complexity of biological interactions. It is important to acquire quality molecular interaction data from a well-established label free technology. Over the past five years a The Diversity of Immune Response and its Impact on PK Profiling Lorin Roskos, Ph.D. MedImmune Case Studies of ADA Impact on PK/PD Meena Subramanyam, Ph.D. Biogen Idec 2009 AAPS NATIONAL BIOTECHNOLOGY CONFERENCE 11 PRELIMINARY PROGRAM
For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.