Modeling Webinar Announcement

Multi-Discipline Model-Based Drug Development to Improve "Accelerate/Go/No Go" Decisions for New Products These live webinars will show how modern modeling techniques can be used to avoid incorrect drug development decisions, tackle costs, and assess value. The expert speakers will survey the uses of model-based drug development, particularly its role in improving decisions about accelerating, continuing or canceling a drug's development. To register, contact Shimon Cohen at 973-387-8655, or [email protected] Modeling is sometimes broken down into biological modeling (mechanisms), statistical modeling (assessment), pharmacometric modeling (PK/PD and clinical trial simulation), and economic modeling (value) and expert speakers in each area will conduct the web-based instruction. The webinars will be conducted during the weeks of April 26 and May 3. Each webinar will be 90 minutes in duration with about 70 minutes of presentation and 20 minutes for Q&A. The prerequisite to benefit from these webinars is knowledge of drug development for regulatory approval. Mathematical knowledge is not a prerequisite! Target audience: Clinicians, pharmacologists, pharmacometricians, statisticians, global marketers, and finance specialists working in clinical development. 1. Modeling disease mechanisms - Matthew Onsum, Ph.D., Principal Scientist, Merrimack Pharmaceuticals 2. Modeling for statistical study design and assessment - Alun Bedding, Ph.D., Early Phase Consultant, Biostatistics Development Partners, GlaxoSmithKline 3. Modeling for PK/PD and clinical trials simulation - Kenneth G. Kowalski, President & CEO, A2PG - Ann Arbor Pharmacometrics Group, Inc. 4. Modeling product economic value - Sean Hu, MBA, Ph.D., Leader, Personalized Medicine Strategy, IMS Health Program chair - Michael Palmer, President, Adaptive Pharmacogenomics, LLC Objectives 1. To survey case studies demonstrating the utility of modern model-based drug development methods such as disease modeling, adaptive and Bayesian study designs, prediction of study operating characteristics and results and product valuation. 2. To give attendees the opportunity to hear from and ask questions of experienced and well-respected experts in biological, statistical, pharmacometric, and economic modeling. These are modeling methods used today to rein in rising costs, maximize product value, and get relief from painful clinical study failures. 3. To prepare attendees for interactions with the FDA, which is increasingly pushing industry to adopt model-based drug development methods in order to increase the efficiency of drug development and the reliability of marketed medicines. Dates and topics (all webinars will be from 11:30 a.m. to 1:00 p.m., Eastern time): April 26 -- Modeling disease mechanisms April 27 -- Modeling for statistical study design and assessment May 4 -- Modeling for for PK/PD and clinical trials simulation May 5 -- Modeling product economic value Cost $1047 for the complete series of four webinars. Unlimited number of viewers per login! $349 for each webinar. Unlimited number of viewers per login! Instructor bios Matthew Onsum, Ph.D. Principal Scientist, Merrimack Pharmaceuticals Dr. Onsum received his B.S., M.S. and Ph.D. degrees in Mechanical Engineering from the University of California, Berkeley, in 2000, 2002 and 2005, respectively. His doctoral work, under the supervision of Adam Arkin and Kameshwar Poolla, used both computational and wet biology to study how immune cells track and capture invading microbes. Additionally, he was a member of the Alliance for Cellular Signaling where he developed models of GPCR mediated calcium signaling and model validation software. He spent two years at AstraZeneca R&D Boston, where he used model simulations to help identify new drug targets. He is currently at Merrimack Pharmaceuticals where he is using computational biology to identify predictive biomarkers for oncology drugs. Alun W. Bedding, Ph.D. Director and Early Phase Consultant, Biostatistics and Programming Development Partners, GlaxoSmithKline Research & Development Alun Bedding has worked in the pharmaceutical industry for 20 years, specialising in early phase development, Bayesian methodology and adaptive designs. In his role at GlaxoSmithKline he acts as a consultant in early phase development covering all therapeutic areas, as well as being an expert in adaptive designs and Bayesian methodology. He has been involved in industry wide initiatives looking at the implementation of adaptive designs and Bayesian methods. He has contributed presentations to many international conferences on Phase I studies, Bayesian methods and adaptive designs, and has published several papers in these areas. Alun has a PhD from Reading University. Kenneth G. Kowalski, MS President and CEO, A2PG - Ann Arbor Pharmacometrics Group, Inc. Kenneth G. Kowalski, M.S., is a cofounder as well as President and CEO of the Ann Arbor Pharmacometrics Group (A2PG), a consulting company providing pharmacometrics services to the pharmaceutical industry. He received his B.S. in Mathematics in 1980 and a M.S. in Statistics in 1982 from Northern Illinois University. Ken has 28 years of experience working in the pharmaceutical industry as a statistician and pharmacometrician. Prior to joining A2PG, Ken was a Senior Director of Pharmacometrics at Pfizer R&D based in Ann Arbor, MI. Prior to joining Pfizer he held various positions within the Statistics Department at G.D. Searle and Company. He has published over 50 articles, abstracts, and book chapters with a focus on PK/PD modeling and clinical trial simulations. Ken is an editorial advisory board member for the Journal of Pharmacokinetics and Pharmacodynamics. He is a member of the American Statistical Association (ASA), American Society of Clinical Pharmacology and Therapeutics (ASCPT) and the American Association of Pharmaceutical Scientists (AAPS). Sean Hu, MBA, Ph.D. Leader, Personalized Medicine Strategy, IMS Health Dr. Sean Hu has been with IMS Management Consulting for about five years, and is currently leading personalized medicine strategy at IMS Health and a member of the newly formed IMS Innovation Lab. Over the years, Dr. Hu has advised pharma/biotech clients extensively on a variety of strategy related topics, including corporate, portfolio, and drug / diagnostics development & commercialization strategies, utilizing rigorous analytical and modeling approaches. Prior to IMS, as part of his 18+ years experience in life sciences Dr. Hu worked in a number of functional areas in both the pharma and biotech industries, including business development, marketing & sales services and R&D operations. Dr. Hu also holds a PhD in Genomics from New York University, and an MBA from Wharton. Michael C. Palmer President, Adaptive Pharmacogenomics, LLC Michael Palmer has been working with the U.S. Food and Drug Administration (FDA) since 2005 on software tools to help assess the cost and complexity of clinical trials. Michael graduated from the University of Michigan with an MS in biostatistics in 1979 and has worked in clinical research and development in the pharmaceutical industry since then. He and Cecilia A. Hale, Ph.D. founded Adaptive Pharmacogenomics in 2007. About Adaptive Pharmacogenomics, LLC In 2005, Adaptive Pharmacogenomics, LLC scientists and software engineers began working with the United States Food and Drug Administration (FDA) to develop a pharmacogenomic clinical study design (PCSD) software tool. The first version of that software was delivered to FDA in 2005 and an enhanced version was delivered and evaluated at FDA the following year. Earlier, at the beginning of FDA's Critical Path initiative, pharmacogenomics (PG) was identified as a way to improve the safety and efficacy of medicines and to reduce attrition in clinical development. FDA's sponsorship of the software tool's development demonstrated their commitment to translating advances in basic biomedical research into new drug and biologic products to improve the health and well-being of Americans. In 2008, FDA signed a Cooperative Research and Development Agreement (CRADA) with Adaptive Pharmacogenomics, LLC and GlaxoSmithKline (GSK). The objective of the CRADA is to enhance the PCSD tool with technology developed by GSK and Adaptive Pharmacogenomics and to web-enable the tool. To register, contact Shimon Cohen at 973-387-8655, or [email protected] Kenneth G. Kowalski President & CEO A2PG - Ann Arbor Pharmacometrics Group, Inc. 110 E. Miller Ave., Garden Suite Ann Arbor, MI 48104 Work: 734-274-8255 Cell: 248-207-5082 Fax: 734-913-0230 [email protected]