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Sessions address Pharmaceutical Excipients, Emerging Partnership Models, Drug Delivery Strategies, and more
November 1, 2017
By: Kristin Brooks
Managing Editor, Contract Pharma
The 2017 AAPS Annual Meeting and Exposition will be held November 12-15, at the San Diego Convention Center in California. The meeting focuses on drug development and delivery, manufacturing and packaging, and offers themed programming focused on new technologies, emerging partnership models, and advanced therapeutics. The meeting will feature more than 100 scientific sessions, 2,200 posters, workshops and the following short course themes: Advanced Formulation Characterization Approaches; Patient-Centered Innovations in Healthcare Technology; Products for Pediatrics: It’s Not Child’s Play; Improving Inter-organization Collaboration; and Cancer Moonshot: Emerging Modalities for Oncology. Additionally, the exhibition provides access to more than 450 companies offering contract development, manufacturing and packaging services, as well as supplies, and equipment across the drug development continuum. Session Highlights Analytical Methods for Predicting Protein Stability in Lyophilized Formulations, Marcus Cicerone, Ph.D., National Institute of Standards and Technology; Eric Munson, Ph.D., University Of Kentucky, Elizabeth Topp, Ph.D., Purdue University, 1:20 p.m. – 3:40 p.m. Nov 13, Room 23 Process Validation Lifecycle Approach (Pros and Cons)—Challenges and Opportunities, Hal Baseman, Chief Operating Officer, ValSource LLC; Zhihao (Peter) Qiu, Ph.D., Branch Chief, U.S. Food and Drug Administration, 1:40 p.m. – 3:40 p.m. Nov 13, Room 28AB Regulatory Overview of Change Management—Comparability Protocols and Change Plans, Pramod Kotwal, Ph.D., Merck & Co., Inc.; Susan Rosencrance, Ph.D., U.S. Food and Drug Administration, 7:30 a.m. – 8:45 a.m., Nov 14, Room 24 Manufacture ADCs through Collaboration and Integrated Supply Chain, Michael Hay, Ph.D., Senior Research Investigator, Bristol-Myers Squibb Company; Aditya Wakankar, Ph.D., Director, Drug Product Manufacturing & Development, Portola Pharmaceuticals, Inc.; Cynthia Wooge, Ph.D., Head of Process & Technology, MilliporeSigma, 9:40 a.m. – 12:00 p.m. Nov 14, Room 33 Drug Discovery and/or Development: To Outsource or Not? Greg Kupp, M.S., Vice President and Chief Operating Officer, Pace Analytical Life Sciences; David Wagner, Ph.D., Manager, Global Spectroscopy US, GlaxoSmithKline plc, 1:40 p.m. – 3:40 p.m. Nov 14, Room 29CD Strategies for Outsourcing Biomarker Analysis, Patrick Bennett, M.S., M.B.A., Executive Director, PPD, Inc.; Richard LeLacheur, Ph.D., Senior Director, Bioanalytical Operations, Charles River Laboratories, Inc.; Rourick Robyn, Ph.D., Sr. Scientific Manager, Genentech, Inc., 9:40 a.m. – 12:00 p.m., Nov 15, Room 33 Short Courses: Short Course 1: Pharmaceutical Excipients—Biopharmaceutical, QC and Regulatory Considerations Short Course 2: Innovative Drug Delivery Strategies in Treatment and Prevention of Infections Short Course 3: Emerging Partnership Models between Emerging Companies, CDMOs, and Big Pharma Short Course 4: Predictive Dissolution Modeling: Next-Generation Development and Release Strategy Short Course 5: Overcoming the Russian Roulette Approach to Oral Anticancer Drug Regimens Short Course 6: Targeted Oncolytic Virotherapies—An Emerging Modality for Precision Cancer Medicine Plenary Sessions Solving Problems with Regenerative Engineering, presented by Cato T. Laurencin, M.D., Ph.D., 9:00 a.m. – 9:30 a.m., Nov 13, Ballroom 20ABC Leading Through Adversity and Change, presented by Rolf Benirschke, Co-Founder and Chief Patient Officer, Legacy Health Strategies, 9:30 a.m. – 10:00 a.m., Nov 13, Ballroom 20ABC Keynotes Using H/D Exchange to Predict Protein Stability in Lyophilized Formulations, presented by Eric Munson, Ph.D., University of Kentucky. Wearable Diagnostics as an Opportunity for Physicians, Patient, Industry, and Healthcare Providers, presented by Sven Stegemann, Ph.D. of Capsugel How to Make Formulation Development Patient Centric: Towards Evidence Based Medicines for Children, presented by Catherine Tuleu, Ph.D., of the University of College London. Academia and Industry Collaborations in Pharmaceutical Sciences: A Two Way Street for Learning and Translation, presented by Uday Kompella, Ph.D. of the University of Colorado Denver Immunogenicity Assessment Methodologies for Chimeric-Antigen-Receptor Modified T-Cell Therapy, presented by Boris Gorovits, Ph.D., of Pfizer Inc. Exhibition Schedule: Monday, November 13, 10:30 – 5:00 p.m. Tuesday, November 14, 8:30 a.m. – 5:00 p.m. Wednesday, November 15, 8:30 a.m. – 1:30 p.m.
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