National Biotechnology Conference 2009 Preliminary Program - (Page 6) CONFERENCE PROGRAM - MONDAY 3:30 pm - 5:00 pm 3:30 pm - 5:00 pm 3:30 pm - 5:00 pm Ask The Regulatory Agency Experts: FDA & EMEA ROUNDTABLE This Roundtable session will include experts from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and the Mental Health Rehabilitation Workers (MHRW) to speak about key regulatory issues and answer questions from the audience. The session will be designed to allow the experts to present a brief summary of key areas of interest to the regulatory agencies and then answer questions from the audience. The audience will be encouraged to submit questions in advance to help facilitate the expert’s ability to provide value-added input. Moderator Robert Bell, Ph.D. Drug and Biologics Consulting Group How to Define Reference Standards for Biologics: Scientific and Regulatory Considerations ROUNDTABLE Interviewing and Networking Skills ROUNDTABLE Biologic Product Development Issues Daniel Takefman, Ph.D. (Invited) U.S. Food and Drug Administration Clinical Regulatory Considerations for Biologics Peter Bross, M.D., Ph.D. (Invited) U.S. Food and Drug Administration Toxicology Concerns with Early Stage Biologics FDA Speaker to be Determined 3:30 pm - 5:00 pm Utility of Biomarkers for Drug Development (Qxology) ROUNDTABLE The need for biomarkers that can accurately assess the behavior and utility of new biologics is a critical need. This session will explore new innovative approaches to finding these elusive but necessary tools. Moderator Steven W. Martin, Ph.D. Pfizer The use of reference standards is important for the development of biological products. Compared to small molecule drugs, biological products are more complex and usually have variability associated with structural heterogeneity. The quality of biological products may depend on the condition of the source active substance, manufacturing processes, impurities levels and other factors. The reference standard material for biologics is prepared either within the company (internal standard) or supplied by organizations such as the United States Pharmacopeia (USP) and the World Health Organization (WHO) (external standard). Changing a reference standard lot or source is not uncommon for biologic manufacturers during the product development process or after regulatory approval for marketing. In this context, concerns have been raised with respect to the suitability and availability of reference standards for biosimilars or follow-on biologics. Equally of concern is the shift in quality of internal standards used by the brand name product manufacturers resulting in a brand name product quality shift. In light of the availability of modern science and technology tools, there is a need to re-examine the current practices and requirements of reference standards for biologics. A variety of approaches may be possible for defining these reference materials in terms of their quality and functionality. There is an urgent need to harmonize the biological standard specifications globally. This roundtable will invite experts from industry and regulatory agencies to provide their views and explore ways to better define reference standards for biologics globally based on the current science and analytical support. Moderators Mei-Ling Chen, Ph.D. (Invited) U.S. Food and Drug Administration Raja Velagapudi, Ph.D. Barr Pharmaceuticals This session is intended to introduce and reinforce interviewing and networking skills and concepts that improve the chance of successfully obtaining a pharmaceutical sciences position in academia or industry when nearing the completion of a student’s educational degree. This roundtable is structured to complement the companion SPOD-sponsored roundtable, “Careers in Pharmaceutical Sciences”. Utilizing a roundtable format, audience participation shall be encouraged as the panel of speakers discuss successful, as well as unsuccessful approaches to interviewing and establishing a network of colleagues to enrich the scope of potential career opportunities. Representatives from human resources, senior management and academic faculty will facilitate the discussion of such topics as establishing a first impression, communication skills, preparation of a resume, a typical interview day, search modes, interview do’s & don’ts, etc. Moderator William Nowatzke, Ph.D. CEDRA Corporation Interviewing and Networking Skills: An Industry Perspective Ronald Bowsher, Ph.D. Millipore Corporation Interviewing and Networking Skills: An Academic Perspective Gregory Knipp, Ph.D. Purdue University Interviewing and Networking Skills: A Student’s Perspective Vanja Petrovic, Ph.D. University of Toronto 5:00 pm – 6:00 pm Contributed Papers Reception Biomarkers Relating to PK Assessments David Lau, Ph.D. Rigel Title to be Announced Barry Cherney, Ph.D. (Invited) U.S. Food and Drug Administration Title to be Announced Tina Morris, Ph.D. United States Pharmacopeia Biomarkers: Non-invasive Visualization of Target Organ Functions Brian R. Moyer, M.S. Health and Human Services Title to be Announced Ivana Knezevic, Ph.D. World Health Organization Biomarkers of Cancer Diagnostics John Barrett, Ph.D. Molecular Insight Pharmaceuticals, Inc. 2009 AAPS NATIONAL BIOTECHNOLOGY CONFERENCE 6 PRELIMINARY PROGRAM
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