FAST Congress

CONFERENCE SERIES: Biomarkers & Diagnostics

Recorded at: ADAPT Congress

Digital Course: Drug-Diagnostic Co-Development: Implementing Personalized Medicine DVD Cover Image This digital course features seven presentations from CHI’s ADAPT 2010 Congress and provides a comprehensive overview of strategies in drug-diagnostic co-development and personalized medicine implementation from the perspective of pharma and diagnostic companies, regulatory and government agencies, and collaboratives. If you couldn’t attend the conference, the digital course offers a convenient multi-media alternative, allowing you to learn from the experts in the comfort of your own office and on your own schedule.



About this Product:
7 Presentations
Over 191 Slides
226 Minutes
Individual Copy: $345
Site License: $1380

Presentations Include: 

Achieving Success in Personalized Healthcare: The Role of Partnerships
Ruth E. March, Ph.D., Personalized Healthcare Leader, AstraZeneca
Personalized healthcare may prove one of the key ways in which the pharmaceutical industry can meet its growing challenges, but there are few examples of successful drug-diagnostic co-development. What are the key success factors and potential pitfalls of personalized healthcare development? How can pharmaceutical companies best use the expertise of partners and diagnostic companies to deliver personalized healthcare medicines to patients? This talk will use historical examples and emerging case studies from AstraZeneca to illustrate these points.

Biography: Ruth March has led the AstraZeneca Personalized Healthcare Team since its formation in November 2007.  She gained her Ph.D. in the immunology of rheumatoid arthritis, and then spent over nine years in research into human genetics at the Universities of London and Oxford, specializing in the genetics of autoimmune disease.  She was a University Lecturer in Genetics before joining AstraZeneca (then Zeneca) to work on pharmacogenetics in 1998.  Ruth was a co-founder of AZ’s Pharmacogenetics Partnership, and has over 40 publications in the field of pharmacogenetics and personalized medicine. In this role, Ruth has led the development of AstraZeneca’s personalized healthcare strategy and worked with disease area and drug project teams to implement their personalized healthcare plans. Ruth is based at AstraZeneca’s Alderley Park site in the U.K.

Challenges of Rx/Dx Partnering: Co-Development and Commercialization of Companion Products
Andrea H. Lauber, Ph.D., Head, Transactions for Clinical Biomarkers and Pharmacodiagnostics, Strategy, Alliance Management and Transactions Group, Bristol-Myers Squibb Co.
Partnering to co-develop and commercialize therapeutics and companion diagnostics is critical to enable delivery of personalized medicine. Typically, Rx companies partner with other Rx companies to create products of similar types and value proposition.  However, companion products require collaboration between Rx and Dx partners, whose products have different value propositions and hurdles.  Alignment of partners who will develop separate but interrelated products will be discussed and various considerations explored.

Biography: Dr. Lauber handles business development strategies, activities and transactions for Clinical Biomarkers and Pharmacodiagnostics and related therapeutic areas.  She is a member of the BMS Pharmacodiagnostics Team, a matrixed cross-functional group responsible for guiding strategy and development of companion diagnostics.   Prior to rejoining BMS in 2007, Dr. Lauber held business development, transactional and consulting positions in the industrial and non-profit Life Science sectors including: Chief Business Development Officer for The Broad Institute of Harvard and MIT, Executive Director of Strategic Alliances Management and Strategic Alliances Manager for Oncology at Novartis Institutes of Biomedical Research.  Previously at BMS, Dr. Lauber was responsible for licensing and business development activities across functional areas. From 1996-2000 she was  Biotechnology Specialist at Mayo Medical Ventures, the business development, licensing and venture group at Mayo Clinic.  Dr. Lauber received her Ph.D. in Neuroscience from the University of California, Riverside and held scientific research positions at The Rockefeller University, The Lombardi Cancer Center at Georgetown University Medical Center, and Mayo Clinic.  Her particular interests are in personalized medicine and in establishing effective collaborations that help drive development of new therapies to benefit patient care.

Successful Partnering Strategies: Learnings from a Leading Global IVD Company
Iain D. Miller, Ph.D., Executive Director, Theranostics Strategy and Business Development, bioMerieux
The speaker will discuss bioMerieux's strategy for successful companion diagnostic test development. The talk will discuss recent market developments and the evolving commercial landscape. Partnering and alliance management strategies will be reviewed, with reference to bioMerieux's co-development alliances with pharmaceutical partners.

Biography: Iain Miller is responsible for oncology strategy and theranostics at bioMerieux, which he joined in 2007. At bioMerieux, his objectives include forging partnerships with leading pharmaceutical and academic organizations, together with driving the company's strategy in the oncology marketplace.  Iain has worked in a commercial capacity in the Boston-area biotechnology community for nearly 20 years. Most recently, he has held senior business development positions at US Genomics, personalized medicine pioneer Variagenics, Candela Corporation, and Boston Consulting Group life science venture ActiveCyte. In the mid-1990s, he also managed technology partnering for Massachusetts General Hospital, and has founded two life science ventures.  Iain holds a Ph.D. in Biomedical Engineering from the University of Strathclyde, an M.B.A. from Edinburgh Business School and a bachelor’s degree in Physics from the University of Glasgow.

Personalized Medicine, Companion Diagnostics and Regulatory Considerations
Živana Težak, Ph.D., Associate Director for Science and Technology, Personalized Medicine/OIVD/CDRH, U.S. Food and Drug Administration
The U.S. FDA evaluates many of the products that will ultimately allow personalized medicine to be successfully implemented.  This talk will focus on regulatory and scientific issues in personalized medicine, in particular on the diagnostic part, including companion and novel diagnostic devices.  There are a number of approaches for clinical study designs used to evaluate companion diagnostic assays that may include specific diagnostic and therapeutic considerations.  FDA faces evolving regulatory challenges for in vitro diagnostic assays, including further development of the regulatory structure for companion diagnostics and clarity on co-development issues.  The talk will describe some FDA efforts to integrate the various medical product regulatory authorities in order to improve clarity and efficiency in regulating personalized medicine products. 

Biography: Živana Težak is an Associate Director for Science and Technology in the Office of In Vitro Diagnostic Device (IVD) Evaluation and Safety, Personalized Medicine Staff, at the Center for Devices and Radiological Health, Food and Drug Administration (FDA). Prior to joining the FDA in 2004, as a scientific reviewer in microbiology, genomics and molecular biology, Dr. Težak held several research and development scientist positions with biotechnology industry, in bioinformatics and array developer companies. Dr. Težak received a Ph.D. in Biochemistry/Molecular Biology from Florida State University in 1997. From 1998 to 2001 she was a research fellow at the University of Pittsburgh Medical Center and Children's National Medical Center, Research Center for Genetic Medicine, working on research projects in human genetics, gene therapy, and high-throughput screening technologies.  Her work resulted in a number of publications in peer-reviewed journals, book chapters and proceedings.

Personalized Medicine: Opportunities and Challenges
Edward Abrahams, Ph.D., Executive Director, Personalized Medicine Coalition 
The talk will focus on public policy and strategies to overcome barriers that influence development, investment and adoption of personalized medicine products.

Biography: Edward Abrahams, Ph.D., is president of the Personalized Medicine Coalition (PMC).  Representing a broad spectrum of academic, industrial, patient, provider and payer communities, PMC seeks to advance the understanding and adoption of personalized medicine concepts and products for the benefit of patients. It has grown from its original 18 founding members in November 2004 to over 175 today.  Previously Dr. Abrahams was Executive Director of the Pennsylvania Biotechnology Association, where he spearheaded the successful effort that led to the Commonwealth of Pennsylvania’s investment of $200 million to commercialize biotechnology in the state.  Earlier he had been Assistant Vice President for Federal Relations at the University of Pennsylvania and held a senior administrative position at Brown University.  Dr. Abrahams worked for seven years for the U.S. Congress, including as a legislative assistant to Senator Lloyd Bentsen, an economist for the Joint Economic Committee under the chairmanship of Representative Lee Hamilton, and as an AAAS Congressional Fellow for the House Committee on the Interior.  The author of numerous essays, Dr. Abrahams serves as senior editor of Personalized Medicine and has also taught history and public policy at Brown University and the University of Pennsylvania.

Commercial Plan Sponsors View of Personalized Medicine: Budget Buster or Realistic Clinical Solution
F. Randy Vogenberg, Ph.D., Principal and Senior Scholar, Institute for Integrated Healthcare and Jefferson School of Population Health
Commercial private plan sponsors represent more than 50% of payers for medicines' insurance. Their view impacts access and reimbursement for all medicines along with their development. This presentation will explore and provide insight into strategy and benefit design considerations important for accelerating the future of personalized medicine.

Biography: Dr. F. Randy Vogenberg is Principal, Institute for Integrated Healthcare, Sharon, MA; and Executive Director, Biologic Finance and Access Council (BFAC), a program of the Jefferson School of Population Health, Philadelphia, PA.  His professional experience includes business coalition and Fortune 500 employer benefit consultation; National Practice Leader for Aon Consulting Worldwide; hospital and managed care research; and strategic consulting on organizational development, medical-legal or economic issues in health care. His pharmacy practice experience includes community, hospital, long term care, Veterans Administration, and public health work.  A frequent speaker and author focusing on integrated health, wellness and contemporary hospital or managed care issues, he has authored several books, including Managing Pharmacy Benefits and a just released eLearning program on “Specialty Pharmacy and Biotechnology Medication Coverage” for the International Foundation of Employee Benefit Plans.  In academia, he co-developed and produced the first computer-based interactive learning course on managed care that was used in over 20 Colleges of Pharmacy. More recently, he was the lead investigator for the evidence-based economic evaluation of thrombosis prophylaxis in U.S. hospitals that resulted in several professional publications and presentations throughout the U.S.  Dr. Vogenberg is an Editorial Board member of several national peer-reviewed professional journals, including P&T, Biotechnology Healthcare, Drug Benefit Trends and American Health & Drug Benefits.  As a nationally recognized expert on health systems and quality, he currently has an academic appointment at the University of Rhode Island College of Pharmacy, as well as Senior Fellow with the School of Population Health, Thomas Jefferson University, Philadelphia, PA.  Dr. Vogenberg holds a Bachelor of Science degree in Pharmacy and a Doctorate in Health Care Management. Additionally, he completed an ASHP Accredited Pharmacy Residency at the Brigham & Women’s Hospital/Harvard Medical School, Boston.

Fulfilling the Promise of a Sequenced Human Genome
Eric D. Green, M.D., Ph.D., Director, National Human Genome Research Institute, National Institutes of Health
The Human Genome Project’s completion of the human genome sequence in 2003 was a scientific achievement of historic proportions. It also signified a critical transition, as this new foundation of genetic information started to be used in powerful ways by researchers and clinicians to tackle increasingly complex problems in biomedicine. Current efforts in genomics research are focused on using genomic data and technologies to acquire a deeper understanding of biology and to uncover the genetic basis of human disease. Together, these pursuits are moving us down an exciting path towards genomic medicine and fulfilling the promise of a sequenced human genome.

Biography: Eric D. Green, M.D., Ph.D. is the Director of the National Human Genome Research Institute (NHGRI) at the National Institutes of Health (NIH) in Bethesda, Maryland, a position he had held since late 2009. Previously, he served as the NHGRI Scientific Director (2002-2009), Chief of the NHGRI Genome Technology Branch (1996-2009), and Director of the NIH Intramural Sequencing Center (1997-2009). Dr. Green received his B.S. degree from the University of Wisconsin-Madison in 1981, and his M.D. and Ph.D. degrees from Washington University in 1987. He subsequently trained in clinical pathology. Since the early 1990s, Dr. Green has been extensively involved in efforts to map, sequence and understand eukaryotic genomes. His work included significant, start-to-finish involvement in the Human Genome Project, and more recently has involved several major efforts that utilize large-scale DNA sequencing to address important problems in genomics, genetics and biomedicine.

This digital course was recorded at:
ADAPT 2010 Congress: Accelerating Development & Advancing Personalized Therapy
September 13-16, 2010, Washington, D.C.