National Biotechnology Conference 2009 Preliminary Program - (Page 10) CONFERENCE PROGRAM - TUESDAY the designed proteins, and their in vitro, and in vivo tests. As a perfect fit to the concept of AAPS’ Drug Discovery and Delivery Interface (D3I) Initiative, this symposium will be valuable for all scientists and graduate students who are interested in protein engineering. Moderator Chang-Guo Zhan, Ph.D. University of Kentucky Moderators Richard Lowenthal, Ph.D., M.B.A. Pacific-Link Consulting Noemi C. Guma, Ph.D. Sanofi-Aventis practitioners dedicated to these challenges have demonstrated impressive progress including definitive LC/MS quantitation of biomolecules to the accustomed 4/6/15 rules of small molecule bioanalysis. Understanding that biomarkers may need a more fit-for-purpose assay validation, the measurement of large molecule endogenous compounds has also attracted the attention of the bioanalytical scientist with access to LC/MS equipment. Many unique challenges are associated with these assays including the lack of well characterized standards, analyte-free matrix or regulatory guidance. This is an emerging field of bioanalytical science where those with good analytical thought processes are setting the standards. Some innovative strategies specific to LC/MS techniques are becoming recognized for biomarker measurements. Included in this are the use of surrogate matrices and quantitation against calibration curves prepared from stable labeled versions of the analyte. Triple quadrupole instruments remain the mainstay of quantitative LC/MS but the introduction of linear ion trap instruments has also expanded the application options. LC/MS offers the ability to address multiple biomarker analytes in the same assay without unique “multiplexing” approaches. Add to this the developments in rapid chromatography (e.g. Ultra Performance Liquid Chromatography) and nanospray techniques and it is clear that LC/MS is establishing itself as an important tool for the analysis of biomolecules and has a great future. Moderator Steve Lowes, Ph.D. Advion BioServices, Inc. Toxicology Considerations for Early Stage Biologic Pharmaceutical Products: Choosing a Relevant Species Jeanine L. Bussiere, Ph.D. Amgen, Inc. Computational Design of Novel Protein-protein Interactions David Baker, Ph.D. University of Washington Engineering and Selection of Targeted Gene Modification Reagents Using Homing Endonuclease Scaffolds Barry Stoddard, Ph.D. Fred Hutchinson Cancer Research Center Starting Dose Selection in Early Stage Development of Biologic Pharmaceutical Products Peter Bross, M.D., Ph.D. (Invited) U.S. Food and Drug Administration Exploratory INDs: How Do They Work for Biologics? Richard Lowenthal, Ph.D., M.B.A. Pacific-Link Consulting Computational Design and Testing of Proteins Targeting Viral Peptides Zhiping Weng, Ph.D. Boston University Phase I INDs for Biologics: How Much Data is Adequate? Ronald Marchesani, Ph.D. Biologics Consulting Group, Inc. Amino Acid Engineering of Antibodies and Other Protein Drugs for Optimal Therapeutic Effect David E. Szymkowski, Ph.D. Xencor, Inc. 1:00 pm - 3:30 pm Discovery of Novel Protein Drugs via Computational Design Chang-Guo Zhan, Ph.D. University of Kentucky LC/MS Techniques for Quantitation of Biological Therapeutics and Biomarkers SYMPOSIUM 1:00 pm - 3:30 pm Accelerating the Time to First in Man INDs for Biologics SYMPOSIUM Efforts to compress timelines in pharmaceutical development have become more critical to spare patent life and to maximizing the return on investment. The importance of early evaluation of drugs and biologics coming out of discovery is also critical to managing development costs and accelerating the drug development process. There are several regulatory initiatives to help companies accelerate early drug development including the exploratory IND concept, toxicology initiatives and phase I and II initiatives. These concepts may be particularly useful for the development of novel biologics, yet are underutilized in the biotechnology industry. This symposium will focus on key opportunities to accelerate biologic development by utilizing these regulatory initiatives. Bioanalytical LC/MS approaches are typically associated with quantitation of small molecule xenobiotics and often in support of PK studies. The application of LC/MS to larger biomolecules is well established as a qualitative tool, but the need for definitive quantitation of these analytes has spurred some innovative developments in this technique that can approach the performance of immunoassays. In addition, LC/MS is now finding application in measuring levels of endogenous biomarker compounds in a variety of biological matrices and even the investigation of anti-drug antibodies for immunogenicity determinations. The combination of immunochemistry with LC/MS detection is an exciting area of bioanalytical development. Advances in immobilized ligand capture technologies and/or immunoaffinity columns offer excellent sample preparation strategies. When combined with LC/MS detection, significant increases in sensitivity and assay selectivity can result along with advantages typically associated with small molecule quantitation. This symposium will focus on the latest advances in the application of LC/MS to the quantitation of biomolecules. Several approaches including MS detection of the intact biomolecules or a diagnostic peptide fragment have become popular. The latest Absolute Quantitation of Protein Therapeutics and Biomarkers Ziping Yang, Ph.D. Novartis Challenges in the Validation of LC/MS Methods for Protein Quantitation Steve Pleasance, Ph.D. Quotient Bioresearch Assay Development for Low Abundance Protein Biomarkers Using Immunoaffinity Enrichment and Nanoflow LC-MRM Hendrik Neubert, Ph.D. Pfizer The Use of Affinity Capture LC/MS to Characterize Intact Antibodydrug Conjugate Therapeutics In Vivo During Drug Development Surinder Kauer, Ph.D. Genentech 2009 AAPS NATIONAL BIOTECHNOLOGY CONFERENCE 10 PRELIMINARY PROGRAM
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