CONFERENCE SERIES: Biomarkers & Diagnostics
Recorded at: ADAPT Congress
Digital Course: Personalized Medicine
About this Product:
Pharmaceutical companies face the need to adjust their strategies, starting from target identification and validation, through clinical trials, approval processes, and marketing, in order to fit into the new concept of personalized medicine. Successful collaboration with diagnostics partners has become a cornerstone in the efforts to bring tailored therapies to the market. The Personalized Medicine program presents solutions and case studies for successful implementation of personalized medicine principles throughout the entire process of bringing a safe and effective drug to the market.
About this Product:
Over 211 Minutes
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Conference At A Glance:
A Model for Developing Companion Diagnostics in Pharma
Werner Verbiest, Head of the Companion Diagnostics Center of Excellence, Johnson & Johnson
The formation of a Companion Diagnostics Center of Excellence in the Janssen Pharmaceutical companies of Johnson & Johnson will be discussed. The important linkages that have been created with the therapeutic areas, the functional groups, and other stakeholders within J&J will be presented. In addition, the importance of connecting the product development, regulatory, partnering and commercial strategies will be highlighted. Lessons learned from case studies will be presented.
Biography: Werner Verbiest has a combined Masters in Biology and Biotechnology from the University of Antwerp (Belgium, EU) and a post graduate degree in Business Management / MBA from the University of Utrecht (The Netherlands, EU).
Werner was one of the first Virco employees and has been critically involved in the growth and development of the company since its inception. He has been actively involved in all phases of HIV clinical trial implementation and resistance test development, and has contributed numerous papers and presentations on antiretroviral resistance. Virco’s primary focus is in laboratory testing for viral resistance to HIV drugs that are used in treating HIV/AIDS patients. Virco’s world-class technology allows physicians to select the very best antiviral therapy and to make timely therapeutic changes when resistant strains emerge.
Werner joined Johnson & Johnson in 1991 with the International Clinical R&D group of the Janssen Research Foundation, where he was active in HIV drug development and Hepatitis B therapeutic vaccine development. In 1998, he joined Virco as Project Director, Business Development. He was promoted to Managing Director, Virco Ireland Ltd. in 2002 and was given the additional responsibilities of Vice President, New Products Marketing and Pharma Business in the same year. Since Johnson & Johnson’s acquisition of Virco, Werner has played an important role in aligning Virco into the pharmaceutical strategy and as such plays a leading role in personalized medicine especially through his leadership of Johnson and Johnson’s Companion Diagnostics Center of Excellence.
He is currently General Manager of Virco, Veridex and Johnson and Johnson’s Companion Diagnostics Center of Excellence.
Translational Informatics in Personalized Medicine
Eric D. Perakslis, Ph.D., Vice President, Research & Development IT, Johnson & Johnson Pharmaceuticals Research and Development
Realizing the utility of personalized medicine has proven quite elusive. At J&J, we are taking a very integrated approach to population science and personalized medicine that incorporates the disparate aspects of epidemiology, statistics, companion diagnostics and targeted therapies.
Biography: Eric is currently Vice President of R&D Information Technology at Johnson & Johnson Pharmaceuticals R&D and is a member of the Corporate Office of Science and Technology. Eric is in his thirteenth year at J&J and has held the posts of Vice President R&D Informatics, Vice president and Chief Information Officer, Director of Research Information Technology as well as assistant Director and Director of Drug Discovery Research prior to his current role. Before joining J&J, Eric was the Group leader of Scientific Computing at ArQule Inc. and he began his professional career with the Army Corps of Engineers.
The Impact of Personalized Medicine on Benefit-Risk Planning and Management
Michael Forstner, Ph.D., Integrated Safety Risk Manager, PDS, Roche
The increasing importance of personalized medicine is changing our view on the comparative benefit-risk profile of medicines. While the advantage of identifying patients who would benefit most from a given treatment is obvious, there is also the additional benefit of finding patients who would experience inappropriate levels of harm. The co-development of therapeutics and diagnostics is creating new risk factors that have to be appropriately analyzed and managed in order to ensure the best level of protection to the patient and ensure the viability of the drug.
Biography: Dr. Michael Forstner is Integrated Safety Risk Manager at F. Hoffmann-La Roche in Basel. In this role his main duties are to develop and implement processes for the coherent and consistent global management of drug safety risks together with his colleagues at other Roche drug development sites. These processes include data-driven, integrated safety management planning, the development of integrated solutions for signal detection, the implementation of meaningful benefit-risk assessment processes, and developing methods for a systematic approach to identifying, assessing and improving drug safety risks.
Michael is also the Leader of the Global Risk Management Planning Work Group, a cross-functional global committee within Roche to develop, implement and oversee efficient processes for the development, tracking and update of risk management plans, their global harmonization and coherence, and their comparability to US REMSs.
Prior to joining Roche, Dr. Forstner worked in a variety of positions in pharmaceutical R&D at Pharmacia (Nerviano, Italy) and Novartis (Basel, Switzerland), and in drug liability risk management at Zurich Financial Services. He studied biochemistry and medicine in Graz, Austria, holds a Ph.D. in biochemistry from the Swiss Federal Institute of Technology Zurich, Switzerland, did postdoctoral work at UC Berkeley/Lawrence Livermore National Laboratory, California, in the area of structural enzymology and biophysics, and was Assistant Professor of Molecular Structural Biology at Sveriges Lantbruksuniversitetet in Uppsala, Sweden.
Investing in Personalized Medicine: A Payer’s Perspective
Richard K. Schatzberg, President and CEO, Generation Health
Understand how genetic benefit management (GBM) helps healthcare payers manage the increasingly complex field of genetic testing. The presentation will review how to gain meaningful diagnostic insights and provide clinical and economic benefits to patients, healthcare providers, and payers including:
- Analyzing current utilization of genetic testing and approaches to optimizing plan design and medical coverage policies,
- Selecting the most effective and efficient testing technologies from the broad array of marketed tests and labs.
Biography: Richard K. Schatzberg is Co-Founder, President and CEO of Generation Health, a genetics benefit manager (GBM). Rick began working on the GBM concept in the Spring of 2008 and helped to formally launch the company in November of 2008 with three other co-founders and with the backing of Highland Capital Partners. He was Generation Health’s Chief Marketing Officer from November 2008 through December 2009. In January 2010 he became President and CEO of Generation Health.
Prior to joining Generation Health, Rick served on the board of directors for Relay Health, a health care company which provides patients with a secure, private way to communicate with their doctors. Rick worked for Medco Health Solutions from 1983 through 2001, holding a variety of executive positions, including heading several departments (Member Services, Marketing, Account Management, Business Development, and Sales). Additionally Rick was a member of Medco’s four-person Executive Committee, which had responsibility for setting the company’s business strategy. He holds a BA from Columbia University in liberal arts.
Clinical and Economic Challenges Facing Pharmacogenomics
Joshua P. Cohen, Ph.D., Research Assistant Professor, Tufts Center for the Study of Drug Development
Pharmacogenomics explores the ways in which genetic variations can be used to predict whether an individual patient will benefit from a drug, have a bad response, or no response at all. Accordingly, therapies may be tailored to certain genetic characteristics of individual patients or subpopulations, drawing on data gathered from a variety of sources, including tests for biomarkers. In this talk, I will examine the clinical and economic challenges that face developers of and payers for personalized drugs and companion diagnostics.
Biography: Dr. Joshua Cohen joined the Tufts Center for the Study of Drug Development (CSDD) in September 1999. He utilizes his background in economics to examine public policy issues that concern prescription drug reimbursement and market access. His areas of research include pharmacy benefits management as it relates to the Medicare prescription drug benefit and health care reform, trends in personalized medicine, comparative effectiveness research, off-label use reimbursement, market access to oncology drugs in the U.S. and Europe, the role of clinical and cost-effectiveness in clinical practice guideline development, the composition of the World Health Organization’s Essential Drug List, drug development targeting neglected diseases, and decisions by drug regulatory agencies regarding prescription to over-the-counter switches.
Cohen publishes in both medical and economics journals, including Pharmacoeconomics, the British Medical Journal, Nature Biotechnology, the Journal of the American Medical Association, the Journal of the National Cancer Institute, the American Journal of Therapeutics, Applied Health Economics and Policy, PLoS ONE, the European Journal of Health Economics, and the Journal of Health, Politics, and Law. Cohen presents his work at a wide variety of international trade and academic conferences, including meetings sponsored by the Drug Information Association, the European Medical Decision-Making Society, the World Health Organization, the International Society for Pharmacoeconomic Outcomes Research, Central Business Intelligence, NextLevel Pharma, Institute for International Research, and the National Health Policy Forum. Prior to joining Tufts CSDD, Dr. Cohen was a postdoctoral fellow at the Veterans Affairs Medical Center in Philadelphia, where he simultaneously served as research fellow at the University of Pennsylvania's Leonard Davis Institute for Health Economics. His postdoctoral research examined the use of decision-analytic models in bioethics.
Dr. Cohen received his doctoral degree in economics from the University of Amsterdam in 1997. His dissertation analyzed methods with which health and experimental economists measure consumer utility. Between 1995 and 1997 he worked on his dissertation research at Harvard University as a visiting research fellow.
Somatic Mutation Analysis in Personalized Medicine
Scott D. Patterson, Ph.D., Executive Director, Medical Sciences, Amgen
Research examining additional genes for somatic mutations using next generation sequencing has been conducted in an attempt to further refine the patient selection criteria. The presentation will discuss these results and the path to KRAS as a companion diagnostic.
Biography: Dr. Scott Patterson is an Executive Director in the Medical Sciences function at Amgen leading the Molecular Sciences department (including the Computational Biology department) since 2003. His departments are responsible for the implementation of Amgen’s biomarker strategy from first-in-human studies through to companion diagnostics including the development of KRAS as a predictive biomarker for Vectibix® therapy. He has published extensively in the field of proteomics and biomarkers and is a frequent guest lecturer. He was previously Vice President of Proteomics at the Celera Genomics Group and the Chief Scientific Officer of Farmal Biomedicines, LLC. While at Celera he established the company's initial foray into identification of cell surface targets for oncology, a number of which have been licensed. Dr. Patterson was at Amgen from 1993–2000 ultimately leading the Department of Biochemistry and Genetics. His academic career, which encompassed work on analytical protein chemistry applications and apoptosis, began at The University of Queensland where he received his Ph.D. and B.Sc. and held positions of increasing responsibility over a period of 11 years, culminating in that of Senior Research Officer. In 1991 he joined the faculty of Cold Spring Harbor Laboratory, New York.
Development of a K-Ras Diagnostic: A Regulatory and Project Management Perspective
Guy C. Ruble, Pharm.D., Director, Global Regulatory Affairs, U.S., Oncology, Eli Lilly and Co.
The role of K-Ras mutations as a predictor for Erbitux® (cetuximab), efficacy in metastatic colorectal cancer is well known. This review of the K-Ras story will address 3 key points:
- A historical overview of the clinical studies that provided the data for the correlation of clinical response to the K-Ras mutation status,
- The regulatory pathway that resulted in changes to the Erbitux® label,
- The journey in the development of a commercially available diagnostic.
Biography: Dr. Ruble is currently employed with Eli Lilly and Company and has worked in a variety of roles within clinical research and development over the last 14 years. Since 2006, he has worked in Global Regulatory Affairs at Lilly and currently holds the position of Director with the Oncology Business Unit. Dr. Ruble has developed expertise in FDA drug and diagnostic regulations while supporting both IND and NDA regulatory filings in the US. He received his B.S. in Pharmacy (1992) and his Doctor of Pharmacy (1995) both from Purdue University, School of Pharmacy.
Epiphany from the Ewe: Revolutionizing Treatment for Basal Cell Carcinoma
Glen Weiss, M.D., Co-Head, Lung Cancer Unit, Translational Genomics Research Institute (TGen); Director, Thoracic Oncology, TGen Clinical Research Services at Scottsdale Healthcare
This presentation will highlight the identification of the Hedgehog pathway, how discovery of this pathway led to development of novel agents that target it, and clinical results from at least two of these Hedgehog pathway inhibitors that demonstrated promising clinical benefit.
Biography: Dr. Glen Weiss is a physician-scientist with a joint appointment at TGen Clinical Research Services at the Virginia G. Piper Cancer Center at Scottsdale Healthcare and TGen. He is board certified in internal medicine and medical oncology. Serving as an interface between laboratory investigators and clinical research aspects, Dr. Weiss helps accelerate clinical application of new developments in cancer therapy and diagnostics. He sees and enrolls patients in early-phase clinical studies and is actively involved in laboratory research in the Lung Cancer Unit in the Cancer and Cell Biology Division at TGen.
About ADAPT Congress:
Old notions of personalized medicine are changing from nice to have, to necessary to have. The benefits to the patient, as well as the business opportunities a targeted therapy approach present are driving this change. The ADAPT 2011 Congress brings together senior executives and key strategic players from across Pharma, Diagnostic, Clinical and Informatics to work together to shape the future of personalized medicine towards a targeted approach. Case studies, discussion groups, short courses and technology highlights will explore the relationship between biomarkers and the promise of personalized therapy, how circulating tumor cells (CTCs) could better track the progression of cancer, and adaptive trials that bring targeted therapies to market.