National Biotechnology Conference 2009 Preliminary Program - (Page 14) CONFERENCE PROGRAM - WEDNESDAY Tech Transfer by Design: Applying Operational Excellence to the Tech Transfer Process Chris Driscoll, M.S. Tunnell Consulting Title to be Announced Steven Kozlowski, M.D. (Invited) U.S. Food and Drug Administration Moderators James Chesko, Ph.D. IDRI Wim Jiskoot, Ph.D. Leiden University From Contact, Through Contract, to cGMP Production: The Business of Tech Transfer Joost Quaadgras, Ph.D. Pfizer 9:00 am - 11:30 am Vaccine Adjuvants and Delivery SYMPOSIUM Toll-like Receptor 4 Agonists as Vaccine Adjuvants and Monotherapeutic Agents Steve Reed, Ph.D. IDRI 9:00 am - 11:30 am Raising the Bar on Analytical Comparability: Looking Closer at Structurefunction Relationship HOT TOPIC Current biophysical and biological analytical methodologies have significantly improved our understanding of protein structure to function relationships. However, increasing technical and regulatory demands are being placed on our ability to understand finer structural detail of impact, or lack thereof, on functionalities. This topic would be designed to overview hot areas of structure-to-function characterization needs in protein therapeutics, describe current approaches and identify gaps and look at new and emerging analytical technologies that may be applicable to addressing the gaps. Speakers to be Announced Wednesday Morning Symposia Funded by a Grant From 9:00 am - 11:30 am QbD as Applied to Analytical Methodologies and Control Strategies for Biologics SYMPOSIUM Moderators Stephen T. Colgan, Ph.D. Pfizer Richard Lowenthal, Ph.D., M.B.A. Pacific-Link Consulting Identification of Critical Quality Attributes of Monoclonal Antibodies Paul Motchnik, Ph.D. Genentech Application of QbD Principles to Biologics Analytical Methods John Ludwig, Ph.D. Pfizer Vaccines have historically proven to be a costeffective way of improving public health that has a profound impact upon both the quality and span of human life. The scourge of many infectious diseases has been relegated to the annals of history books, although emerging threats such as pandemic flu and SARS continue. Developing vaccines that are effective, safe and deliverable to population in a timely manner remains an ongoing challenge to biotechnology companies. Recent advances in immunology such as the role of toll-like receptor (TLR) signaling in the innate immune system and induction of an adaptive immune response have led to the development of many novel adjuvants including CpG oligonucleotide sequences (TLR9), small molecule TLR 7/8 agonists, TLR4 adjuvants such as MPL and its derivatives. These adjuvant components may form an essential part of modern vaccines along with recombinant protein antigens selected by genomic sequencing methods, given by an appropriate route of administration through a delivery vehicle such as alum, emulsions, microparticles and liposomes. Adjuvant discovery research faces challenges of obtaining regulatory approval for molecules that may need to elicit a degree of irritation and immune stimulation for efficacy while maintaining an acceptable safety profile for properties such as cytokine release. The underlying mechanisms influencing the interaction with the cells of both the humoral and cell-mediated branches of the immune system, especially the professional antigen presenting cells such as dendritic cells and macrophages is still not well understood. Properties of antigens that confer immunogenicity and ultimately bring about a protective immune response are equally important. The role of three dimensional epitope structure and accessibility and influence of aggregation and association upon immunogenicity is starting to be questioned for both therapeutic and prophylactic proteins. Finally, the role of formulation and delivery upon the disposition of antigens and co-stimulation by adjuvants is likely to be a key factor in the production of effective, new vaccines. Through antigen-presenting cells (APC) targeting and enhanced stability, delivery systems may provide the harmonizing element to combine the diverse biochemical entities of a vaccine while synergistically enhancing their safety and efficacy. Nonparenteral Antigen Delivery: Challenges and Opportunities Wim Jiskoot, Ph.D. Leiden University Characterization of Antigens, Adjuvants and Delivery Systems in Modern Vaccines James Chesko, Ph.D. IDRI Historical Development of Adjuvants and Delivery Systems for Vaccines Manmohan Singh, Ph.D. Novartis Regulatory Perspectives on New Adjuvants and Vaccines Elizabeth Sutkowski, Ph.D. (Invited) U.S. Food and Drug Administration 9:00 am - 11:30 am Wednesday Morning Symposia Funded by a Grant From Aptamers as Therapeutic, Drug Delivery and Diagnostic Agents SYMPOSIUM Aptamers are single stranded folded oligonucleotides that bind to molecular protein targets with high affinity and specificity. Aptamers have unique tertiary structures which allow them to fold into stable scaffolds and allow for molecular Title to be Announced Christopher C. Joneckis, Ph.D. (Invited) U.S. Food and Drug Administration 2009 AAPS NATIONAL BIOTECHNOLOGY CONFERENCE 14 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.