National Biotechnology Conference 2009 Preliminary Program - (Page 7) CONFERENCE PROGRAM - TUESDAY Tuesday, June 23 7:30 am – 8:30 pm De Novo Design of Novel Enzyme Catalysts David Baker, Ph.D. University of Washington considered and addressed for a successful implementation of a biochemical binding assay as a surrogate potency assay for product release. Moderators Kathleen Clouse, Ph.D. U.S. Food and Drug Administration Kaz Reynhardt, Ph.D. Amgen Inc. Registration AAPS Mentoring Breakfast Funded by a Grant From Designing a Human Serum Enzyme with Novel Interaction Capability Wenling E. Chang, Ph.D. The MITRE Corporation 7:30 am - 8:30 am 7:30 am - 8:30 am Regulatory Perspective Kathleen Clouse, Ph.D. (Invited) U.S. Food and Drug Administration Maintaining Ligand Binding Assays for the Long Term Support of Programs SUNRISE SESSION Fast to POC in Biologics Development SUNRISE SESSION How to Replace Bioassays with Binding Assays: But is it Worth it? Anthony Mire-Sluis, Ph.D. Amgen, Inc Many biotherapeutics have post marketing commitments and post marketing safety reporting which often include immunogenicity. It is a challenge to maintain assay performance and continuity for over a period of years. The challenges that face these types of assays are the availability of the reagents, the maintainence of the clones and the validation of these assays with the new reagents. A discussion on the effect of these issues on the PK assays, as well as immunogenicity assays will be discussed. Moderators Binodh S. DeSilva, Ph.D. Amgen, Inc. Susan Richards, Ph.D. Genzyme Biopharma industry is facing rising challenges to increase productivity and shortening cycle time of product development. Technical challenges in formulation, analytical and manufacturing that can cause delays in early stage development will be discussed. This session will also highlight strategies and recent advances to overcome technical as well as regulatory issues and speed up product development. Moderator Tapan K. Das, Ph.D. Pfizer When a Binding Assay is a Better Option Meena Subramanyam, Ph.D. Biogen Idec 9:00 am - 10:30 am Careers in Pharmaceutical Sciences ROUNDTABLE Fast to Phase I: CMC Approaches to Biologics Development Olivier Laurent, Ph.D. CovX Long Term Support of Pharmacokinetic Assays Hossein Salimi-Moosavi, Ph.D. Amgen, Inc. How Can Technological Advances Enable Fast to Decision Strategies? Kevin King, Ph.D. Pfizer Long Term Support of Immunogenicity Assays Valerie Theobald, M.S. Genzyme Tuesday Morning Roundtables Funded by a Grant From 9:00 am - 10:30 am 7:30 am - 8:30 am Structure-and-Mechanismbased Computational Design of Protein Engineering SUNRISE SESSION Replacing a Cell-based Potency Assay with an In Vitro Binding Assay: When and How it Can be Justified as a Better Option ROUNDTABLE Pharmaceutical sciences students often question which career path to pursue after graduation. Obtaining the confidence and skills necessary to successfully compete in industry and academia may require additional mentoring, yet opportunities such as post-docs may delay the establishment of a career. Furthermore, some employers offering interim post-graduation opportunities may have policies prohibiting permanent employment at that institution. This interactive session is intended to foster an open dialogue between a panel of established professionals and attendees who are contemplating entering or changing careers. This session will enable students to ask questions to a diverse panel of the most common pharmaceutical professional occupations. The panel is designed to generate discussion from a broad pool of opinions, being composed of representatives from big and small pharma, contract research organizations, academia, etc. Moderator Tarik A. Khan, M.S. University of Texas Rational design of protein engineering based on protein structure and mechanism has recently resulted in impressive outcomes in protein drug discovery and development. The lectures in this sunrise session will demonstrate how structure-and-mechanismbased computational design of protein engineering can be performed to improve the functions or stability of protein drugs. Moderator Chang-Guo Zhan, Ph.D. University of Kentucky The biological potency assay is a critical product release test. Ideally, it models the proposed mechanism of action (MOA) of the drug, and exhibits stability indicating characteristics. However, it is not always possible to model the MOA, and the potency assay may not be stability indicative. In these and other instances, a biochemical binding assay may be considered as a suitable and superior alternative; both stability indicating and assessing key aspects of product functionality. This round table will discuss the issues that need to be Career Paths in Big Pharma Russell S. Weiner, Ph.D. Bristol-Myers Squibb, Inc. Careers in CROs, Generics, and Small Pharma Robert G. Bell, Ph.D. Drug & Biotechnology Development, LLC Career Paths in Academia Bozena Michniak-Kohn, Ph.D. Rutgers, The State University of New Jersey 2009 AAPS NATIONAL BIOTECHNOLOGY CONFERENCE 7 PRELIMINARY PROGRAM
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