National Biotechnology Conference 2009 Preliminary Program - (Page 4) CONFERENCE PROGRAM - SUNDAY AND MONDAY Sunday, June 21 7:00 am – 5:00 pm 1:00 pm - 3:30 pm 1:00 pm - 3:30 pm Registration Monday, June 22 7:00 am – 5:30 pm Follow-on Biologics: The Role of Analytical Characterization in Determining Equivalence and Clinical Relevance SYMPOSIUM Controlled Release Drug Delivery Strategies for Biotech-derived Compounds SYMPOSIUM Registration 8:30 am – 11:30 am Plenary Session Funded by a Grant From Welcome and Opening Remarks John Lisack, Jr. AAPS Executive President Pat DeLuca, Ph.D. 2009 AAPS President Introduction Andrew Vick, Ph.D. 2009 AAPS NBC Program Chair Clay B. Siegall, Ph.D. Seattle Genetics, Inc. Steven Gillis, Ph.D. ARCH Venture Partners 10:30 am – 6:00 pm AAPS Exposition 10:30 am – 6:00 pm AAPS Career Center 12:00 pm – 6:00 pm Contributed Papers Poster Session 12:00 pm – 1:00 pm With the first generation of biological therapeutics coming off patent, there is a strong drive to bring follow-on biological products to the market. However, as compared to their small molecule counterparts whose comparability can be established in a straightforward manner, follow-on biologics pose significant challenges. Even when manufactured using the same production processes, follow-on biologics are never identical to the originator product, yet may produce the desired therapeutic outcome. How does one demonstrate comparability? Analytical investigations of the final biological therapeutic product present some fundamental challenges to even the modern analytical laboratory, but recent advances in technology and process are addressing this need. Likewise, measuring the in vivo levels in support of clinical bioequivalence assessments are clearly unique to biologics. This symposium proposes to address the following topics: production and quality issues in developing biosimilar products. Focusing on challenges in characterization of follow-on biological products, and what aspects are critical for showing similarity between biological products. Critical pharmacokinetics and pharmacodynamics for biosimilar products with the considerations for the analysis of data on follow-on biologics and study design considerations. Regulatory pathways of Europe vs. United States; the similarities and differences between the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). A European case study from Alpheon and overcoming challenges and obstacles for EMEA approval. Moderator Chris Beaver, Ph.D. MDS Pharma Services This symposium will focus on current and novel approaches to delivery of biological therapeutics. As a majority of the biotech-derived compounds are delivered parenterally, much of the product development research is geared toward reducing the frequency of injections or finding alternatives to injections altogether. This has resulted in a few sustained release injectable products that have been approved or are currently under development. While progress has been made in developing products in this area, there is a need for additional research to enhance understanding in this area. Topics that will be presented include a historical perspective and recent advances in parenteral controlled release drug delivery, alternatives to parenteral injectable formulations and manufacturing and regulatory issues with respect to controlled release parenteral dosage forms. In addition, in vitro and in vivo testing methods and specifications for controlled release parenteral products will also be addressed. Moderators John R. Crison, Ph.D., R.Ph. Simulations Plus Christopher A. Rhodes, Ph.D. Amylin Pharmaceuticals Controlled Release Formulation Strategies, Alternatives to Injectable Sustained Release Formulations: Is There a Role for Oral in Biologics Delivery? Christopher A. Rhodes, Ph.D. Amylin Pharmaceuticals Performance of Modified Release Parenteral Products: A Regulatory Perspective Mei-Ling Chen, Ph.D. (Invited) U.S. Food and Drug Administration BioTalk Join conference symposia and roundtable speakers to share ideas, experiences, and pose questions about the speakers’ research and presentations. All attendees at the National Biotechnology Conference are invited to participate in this event. BioTalk is an informal luncheon networking opportunity in the exhibit hall. Tables will be identified with the speaker’s topic. Share ideas about complementary technology, new business ideas, or simply pose questions to clarify the speakers’ presentation. Lunch will be available for purchase in the exhibit hall. Transformation of Raw Material Sourced from Asia into Finished Products in Europe Maan Zrein, Ph.D. Hikma France Sustained Circulation Through Covalent Modification as an Alternative to Parenteral Controlled Release Formulation: Recombinant Protein Sequences with PEG-like Properties for Half-life Extension Timothy Riley, Ph.D. Nektar Therapeutics Approaches to Selecting the Appropriate Biomarkers for Biosimilar/Biogeneric Clinical Development Elliot Offman, M.S. MDS Pharma Services Transdermal Microporation as an Alternative to Injectable Sustained Release Formulation Mark Prausnitz, Ph.D. Georgia Tech University Biosimilars: What are the Regulatory Paths? Gonesh Venkataraman MDS Pharma Services In Vitro Test Methods for Predicting In Vivo Performance of Modified Release Biological Parenteral Products Susan D'Souza, Ph.D. Sepracor 2009 AAPS NATIONAL BIOTECHNOLOGY CONFERENCE 4 PRELIMINARY PROGRAM
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