Drug-Diagnostic Co-Development: Biomarkers in Personalized Medicine DVD
About the DVD:
Presentations selected from the Executive Summit at the Seventh Annual Biomarker World Congress address issues in drug-diagnostic co-development and implementation of personalized medicine. From understanding the challenges in transforming the efficiency of personalized healthcare to practical considerations in incorporating biomarkers into drug development programs, representatives from both diagnostic and pharmaceutical companies present their perspectives on strategies that will support successful partnerships in this area. Further topics in pharmacogenomic biomarkers and patient selection illustrate issues and lessons learned from recent clinical development.
About the Conference:
The signature event in Cambridge Healthtech Institute’s Biomarker Series, The Biomarker World Congress 2011 is dedicated to all areas of biomarker research spanning the pharmaceutical and diagnostic pipeline. The meeting brings together a unique and international mix of large and medium pharmaceutical, biotech and diagnostics companies, leading universities and clinical research institutions, government and national labs, CROs, emerging companies and tool providers—making the Congress a perfect meeting-place to share experience, foster collaborations across industry and academia, and evaluate emerging technologies. The Congress also offers a balance of scientific sessions covering the latest research and strategic presentations and brainstorming sessions for the decision makers. Now in its seventh year, the Biomarker World Congress is the leading annual meeting dedicated to biomarker research and implementation that consistently delivers a cutting-edge agenda, 400+ senior delegates, and a sold-out exhibit hall.
About the DVD:
Over 270 Minutes
Site License: $1380
Agenda At A Glance:
STRATEGIES FOR DRUG-DIAGNOSTIC CO-DEVELOPMENT
Top 10 Changes Needed in Drug-Diagnostic Co-Development
Glenn A. Miller, Ph.D., VP & Head, Personalized Healthcare and Biomarker Strategy, Portfolio and Alliances, AstraZeneca Pharmaceuticals
Companies have been engaged in drug-diagnostic co-development for over a decade, yet the number of marketed drugs with successful companion diagnostics remains low. What would have to change to transform the efficiency of personalized healthcare? A group of leaders across the industry proposed far-reaching changes: consolidation of communication, creative thinking and innovative collaboration, better tools for early drug development, pragmatic ways to test for biomarkers, higher rates of consent for biomarker testing, patient selection to increase probability of success, increased incentives, openness to value-based pricing and improved economic models. This talk will explore these ideas further and illustrate them with relevant examples.
Biography: Dr. Glenn Miller is Vice President and Head of Personalized Healthcare and Biomarkers Strategy, Portfolio and Alliances for AstraZeneca Pharmaceuticals. In this role Dr. Miller directs the strategy and creates and manages the alliances important to AstraZeneca’s personalized healthcare goals across all therapeutic areas globally. Prior to this position he was Vice President and General Manager of Genzyme Analytical Services, a division of Genzyme Genetics, providing pathology-based pre-clinical and clinical trial services to the pharmaceutical and biotechnology community worldwide. Dr. Miller also led the Research and Development efforts of Genzyme Genetics where he was involved in the personalized medicine strategy and development efforts for Genzyme products in all therapeutic areas. He has published and spoken nationally and internationally on the topics of genetics, genomics and personalized medicine.
Strategies for Successful Partnering and Co-Development from an IVD Industry Perspective
Iain D. Miller, Ph.D., Executive Director, Theranostics Strategy and Business Development, bioMerieux
The speaker will discuss bioMerieux’s successful theranostic partnering strategy. With two partnerships with GSK and others including Merck and Ipsen, bioMerieux has developed a real-world knowledge of win-win deal terms, co-development strategies and alliance management. The speaker will discuss specific case studies illustrating bioMerieux’s approach and will comment on the likely future evolution of partnering in this field.
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.
Rx/Dx Companion Products: Partnerships that Meet the Challenges
Andrea H. Lauber, Ph.D., Head, Transactions for Clinical Biomarkers and Pharmacodiagnostics, Strategic Transactions Group, Bristol-Myers Squibb
The value of therapeutics (Rx) and companion diagnostics (Dx) is recognized as central to the delivery of personalized medicine. Development of Rx/Dx products often requires that partners from different sectors of our industry align to co-develop separate, eventually interrelated, assets. The discussion will address strategies that support successful partnerships in this emerging space.
Biography: Dr. Lauber handles business development strategies, activities and transactions for Clinical Biomarkers and Pharmacodiagnostics and related therapeutic areas. She is part of the BMS Pharmacodiagnostics Center of Excellence, 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 nonprofit 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.
BIOMARKERS AS DECISION-MAKING TOOLS
Applied Biomarkers: Where We Need More Research and Where We Don’t
Felix W. Frueh, President, Medco Research Institute, Medco Health Solutions, Inc.
Biomarkers are useful for disease diagnosis and prognosis, monitoring disease progression and response to treatment, and in drug selection. However, new biomarkers are held to high standards of evidence to demonstrate their utility. Criteria for assessing applied biomarkers, whether for safety or efficacy, will be addressed, as well as what type of research will be needed in the future.
Biography: Felix Frueh is President of the Medco Research Institute™, where he leads Medco’s peer-reviewed research initiatives and collaborations in the areas of personalized medicine, comparative effectiveness and chronic conditions, examining how the newest developments in science can improve the safety and efficacy of prescription drug care. Frueh joined Medco in 2008 as vice president of Medco’s personalized medicine research and development organization. Prior to joining Medco, Frueh was Associate Director for Genomics at the U.S. Food and Drug Administration (FDA), where he built and led the core genomics review team in the Center for Drug Evaluation and Research (CDER), and chaired the first FDA-wide, interdisciplinary pharmacogenomics review group (IPRG). Prior to the FDA, he was Managing Partner at Stepoutside Consulting, LLC, and held senior positions at Transgenomic and Protogene Laboratories. Frueh has published numerous peer-reviewed articles and is a frequent invited speaker at national and international conferences. He has been a member of various working groups on genetics and genomics at the FDA and at the Department of Health and Human Services (DHHS), and is a Member of the Board of the Personalized Medicine Coalition. Felix Frueh is an Adjunct Faculty member at the Institute for Pharmacogenomics and Individualized Therapy (IPIT) at the University of North Carolina (UNC) and has held faculty appointments in the Departments of Pharmacology and Medicine at Georgetown University in Washington DC. He was a postdoctoral fellow at Stanford University and the University of Basel, Switzerland, where he also received his Ph.D. in biochemistry.
Personalized Medicine: Use of Biomarkers for Clinical Decision Making
Dominic Spinella, Ph.D., Executive Director, Translational Medicine, Pfizer
Biomarkers are widely used in the clinical development of drugs, as pharmacodynamic endpoints to prove drug/target interaction and help select dose and schedule, as decision-making surrogates for clinical benefit, and as tools for identifying patients who should or should not receive specific drugs. This talk will describe actual and hypothetical case studies to illustrate some practical aspects and points to consider when incorporating biomarkers into drug development programs, from the initial process of biomarker qualification and validation, to discrimination between predictive and prognostic biomarkers, to aspects of biomarker assays as they relate to patient selection and clinical decision making.
Biography: Dom Spinella is head of Translational and Molecular Medicine for the Pfizer Biotherapeutics Division. He formerly headed Translational Medicine for Pfizer Oncology and led the clinical and translational biomarker work for the company’s oncology portfolio. He also serves on several national and international cancer biomarker development bodies, including the Cancer Steering Committee of the NIH Biomarkers Consortium, the AACR/FDA/NCI/Cancer Biomarkers Collaborative (CBC) and the AACR Scientific Review Committee for Molecular Diagnostics in Cancer Therapeutic Development. He is an author or co-author of more than 50 peer-reviewed articles and abstracts, and principle or co-inventor of a dozen issued or pending patents. Dom received his BS degree in Biology from Syracuse University in 1976 and his M.S. (1980) and Ph.D. degrees (1982) in genetics and immunology respectively from Rutgers University. He completed his post-doctoral training in molecular immunology as a Howard Hughes fellow at the Washington University School of Medicine in St. Louis. He spent several years on the faculty of the Departments of Medicine and Microbiology & Immunology at the University of Tennessee Medical School in Memphis before joining the Biotech/Pharma industry in 1991. Dom joined Pfizer in 2004 as the La Jolla site head of Experimental Medicine. Prior to this, he spent eight years at Chugai Pharmaceuticals USA (until their merger with Roche), in positions of increasing responsibility, most recently as Vice President of Exploratory Research.
Biomarkers for Patient Selection: Issues and Lessons Learned
Wei Zhou, M.D., Ph.D., Director, Molecular Epidemiology Research, Pfizer
Biomarkers used for patient selection may be based on 1) better response observed among the biomarker positive group in pre-clinical or early phase trials, or 2) retrospective analysis of existing clinical trial data. For the first category, common issues may include results extrapolation from pre-clinical data, using convenient, small sample size, and non-representative patient samples, or questionable/incomplete clinical information. For the second category, common issues may include retrospective analysis without a priori hypothesis, and “false positive” results from multiple comparisons. Using real examples, I will discuss these issues and lessons learned from recent clinical development.
Biography: Wei Zhou, M.D., Ph.D., is currently the Director of Molecular Epidemiology Research at Pfizer Oncology. Dr. Zhou’s current job role includes the design and implementation of de novo molecular epidemiology studies of novel biomarkers, to help target patient selection in early phase development and health outcome/economic analysis for reimbursement purposes. He also provides strategic epidemiology support for tumor strategy teams. Before joined Pfizer, Dr. Zhou was a Senior Epidemiologist at Merck & Co., Inc (December 2006 - May 2010). He designed and finished the first international medical charts review study at Merck, and helped the oncology franchise make critical go-no go decisions on several early phase development programs. His leadership and critical contributions to drug development have earned him the Merck Special Achievement Award, Key Team Player of Early Development Team, and Award for Excellence. Dr. Zhou was a Research Scientist at Harvard School of Public Health between June 1999 and December, 2007. He has served as the principal investigator and co-investigator for a number of projects on gene-environment interactions in the development and progress of different cancers. Dr. Zhou received his M.D. from West China University of Medical Sciences in 1994 and Ph.D of Environmental Health from Shanghai Medical University in 1998. He was the recipient of the John E. Fogarty International Training and Research Program. He has published more than 70 peer-reviewed manuscripts and book chapters, more than 40 meeting abstracts, and held two press releases at the AACR annual meetings. He has served as reviewer for various cancer journals.
IMPLEMENTING PERSONALIZED MEDICINE
Integrating Discoveries in Basic, Clinical and Population Sciences to Advance Predictive Cancer Care
Andrew N. Freedman, Ph.D., Chief, Clinical and Translational Epidemiology Branch, Division of Cancer Control and Population Sciences, National Cancer Institute
To fully realize the potential of personalized cancer treatment, it will be essential to connect and integrate basic discoveries in drug development and pharmacogenomic variability, outcome and genomic data from randomized clinical trials, and data on the effects of drugs and their interactions with genomic variants in large heterogeneous patient populations. In this talk we will present recent research findings that illustrate how pharmacogenomic marker discoveries from clinical trials and observational studies can lead to both clinical utility and novel insights into the underlying biology of drug response phenotypes.
Biography: Dr. Freedman is the Chief of the Epidemiology and Genetics Research Program's (EGRP) Clinical and Translational Epidemiology Branch (CTEB). He oversees EGRP's research portfolio and initiatives that focus on factors that influence cancer progression, recurrence, new primary cancers, survival and other treatment outcomes, and factors associated with cancer development among individuals with underlying diseases and conditions. In 1997, Dr. Freedman joined NCI's Division of Cancer Control and Population Sciences (DCCPS) as a molecular epidemiologist in the Applied Research Program's (ARP) Risk Factor Monitoring and Methods Branch. He developed and supported a program of research in cancer risk prediction, genetic susceptibility testing, pharmacoepidemiology and pharmacogenomics, and managed research contracts, interagency and cooperative agreements, and a grant portfolio pertaining to these research areas. Dr. Freedman also directed multidisciplinary molecular, clinical, and translational epidemiology studies within the HMO Cancer Research Network (CRN); Department of Veterans Affairs medical system; NCI's Surveillance, Epidemiology, and End Results (SEER) Program; and the NIH-AARP Diet and Health Study. He is internationally recognized for his work in molecular cancer epidemiology and cancer risk prediction. In the areas of pharmacoepidemiology and pharmacogenomics, Dr. Freedman has developed research collaborations with several NIH Institutes and Centers and other agencies within the U.S. Department of Health and Human Services (HHS). He is Chair of the Trans-NCI Pharmacoepidemiology and Pharmacogenomics Working Group, and represents NCI on the Trans-NIH Pharmacogenomics Working Group and the Institute of Medicine (IOM) Roundtable on Translating Genomic-Based Research for Health. Before joining DCCPS, Dr. Freedman was a Postdoctoral Research Fellow in the Genetic Epidemiology Branch of NCI's Division of Cancer Epidemiology and Genetics (DCEG).
Clinical Pharmacogenomic Testing for Clopidogrel and Treatment for Hepatitis C
Alan H. B. Wu, Ph.D., Professor, Laboratory Medicine; Chief, Clinical Chemistry, Toxicology and Pharmacogenomics Laboratories, University of California, San Francisco
In March 2010, the FDA announced a black box warning for clopidogrel recommending pharmacogenomic testing. Unfortunately, the warning did not describe how therapy should be altered for variants. In November 2010, the GRAVITAS study showed that doubling the plavix dose had no effect on outcomes, therefore alternate drugs should be considered. In 2009, investigators demonstrated that for chronic hepatitis C, IL28B SNPs predicted treatment outcomes for pegylated interferon alfa and ribavirin. Non-responders should not be treated, or be given novel protease inhibitor therapies in addition to the traditional dual therapy.
Biography: Alan H. B. Wu, Ph.D., is Chief of Clinical Chemistry and Toxicology at San Francisco General Hospital and Professor of Laboratory Medicine, University of California, San Francisco. He received B.S. degrees in chemistry and biology at Purdue University, West Lafayette, Indiana, and a Ph.D. degree in analytical chemistry at the University of Illinois, Champaign-Urbana, Illinois. He completed a postdoctoral fellowship in clinical chemistry at Hartford Hospital. He is certified by the American Board of Clinical Chemistry in Clinical Chemistry and Toxicological Chemistry. Dr. Wu’s research interest has been in three areas within the field of clinical chemistry laboratory. He has been involved at the national and international levels with development and use of biochemical markers for cardiovascular disease including CK-MB, myoglobin, troponin, B-type natriuretic peptide, and markers of myocardial ischemia, and stroke. He also has a long history of analytical, clinical, and forensic toxicology. In both of these areas, Dr. Wu has co-authored the National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines. More recently, Dr. Wu has developed research and clinical programs in pharmacogenomics in support of the UCSF clinical pharmacogenomics laboratory. Among the areas of interest are pharmacogenomics for anticoagulants, especially warfarin, chemotherapeutics (tamoxefin, irinotecan), and drugs that can induce hypersensitivity reactions (abacavir, anticonvulsants).
Prognosis and Core Processes in Metastatic Breast Cancer: Correlation of a Composite Metastasis Score (cMS) and Oncotype Dx® Recurrence Score
Andrew Grupe, Ph.D., Senior Director, Pharmacogenomics, Celera
Different gene expression sets have been reported to reproducibly assess the metastatic potential of early stage operable breast tumors. An explanation for this apparent counter-intuitive observation is that the disparate genes of different signatures query common pathways or core biological processes. The most rigorous comparative analysis of expression signatures requires profiling of the same tumor samples. The irreplaceable nature of archived samples with long-term follow-up discourages duplicate testing for what are expected to be similar signatures, so we chose to carry out a statistical concordance study. Specifically, we sought to compare a composite metastasis score (cMS) consisting of a previously reported metastasis score (MS), a proliferation index, plus progesterone receptor with the Oncotype Dx® Recurrence Score (RS) and component constituents of these scores using a contemporary sample set. We further examined the correlation of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) results with the Oncotype DX® assay.
Biography: Andrew Grupe has spent over 17 years working in the diagnostics, biotechnology and pharmaceutical industries. Throughout his career Andrew’s work has contributed to understanding the molecular causes of disease and treatment response. Andrew has been with Celera since 2001, where he serves as the Senior Director for Pharmacogenomics. His team applies next generation sequencing, genotyping, and expression profiling in collaborations with pharma to identify and validate predictive biomarkers. Before taking on the pharmacogenomics responsibilities, he served as Director of Celera’s CNS Research Group and studied genetic variants that contribute to Alzheimer’s disease and Parkinson’s disease. His group described the results of these studies in the scientific literature. Between 1996 and 2001 he was a principal scientist at Roche in Palo Alto where his group identified novel drug targets through genetic and gene expression analyses of murine model systems for human diseases and advanced small molecules to proof of principle in animal models up to early toxicity screening. Prior to Roche, Andrew held a postdoctoral position at Genentech in the Endocrinology department, where he developed cell and animal models to analyze the contribution of specific proteins to diabetes. Andrew graduated with a Ph.D. in 1991 from the Department of Chemistry at the University of Bochum, Germany, and spent one year at the Center for Molecular Neurobiology at the Universitaetsklinik Hamburg Eppendorf in Hamburg, Germany, to study the molecular function of potassium channels with Professor Olaf Pongs.