Speaker Profiles

Marc Berger, MD

Vice President, Global Health Outcomes, Eli Lilly and Company
Marc L. Berger, M.D. is Vice President, Global Health Outcomes. In this role, he is responsible for leading an organization within Lilly Research Laboratories whose mission is to provide expertise and scientific information that enables Lilly to develop and provide products that deliver better patient outcomes and are valued by payers and providers.

A native of New York, he joined Lilly in April 2007 after retiring from Merck & Co., Inc. where he held the position of Vice President, Outcomes Research and Management. He holds an M.D. degree from Johns Hopkins University School of Medicine and has adjunct appointments as Senior Fellow at the Leonard Davis Institute at the Wharton School of the University of Pennsylvania and Professor in the Department of Health Policy and Administration at the University of North Carolina at Chapel Hill School of Public Health. He has served on the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) for the Center for Medicare & Medicaid Services (CMS), the board of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the steering committee for the Agency for Health Care Research and Quality (AHRQ) Centers for Research and Education on Therapeutics (CERTs), and the board of the Health Industry Forum of the Heller School for Social Policy and Management at Brandeis University; additionally he has been active contributor to the Institute of Medicine (IOM) Roundtable on Evidence-based Medicine. Currently, he is a member of the editorial advisory board of Value in Health. Marc has published widely in peer-reviewed journals in health services research, outcomes research, health economics, and health policy.

Marc Berthiaume, MD

Director, Marketed Pharmaceuticals and Medical Devices Bureau, Health Canada
Dr Berthiaume received his M.D. from the University of Montreal in 1990, and completed his residency in family medicine in 1992. He practiced family medicine from 1992 to 2002.

He joined the Marketed Health Products Directorate of the Health Products and Food Branch (Health Canada) in 2003, and was appointed in 2005 as Director of the Marketed Pharmaceuticals and Medical Devices Bureau, the organization involved in post-market safety risk assessment and management for pharmaceuticals and medical devices in Canada. He continues to practice clinical medicine on a part time basis. He completed in 2007 a Certificate in Pharmacoepidemiology and Pharmacovigilance at the London School of Hygiene and Tropical Medicine.

Dr. Stella Blackburn, MB BS MA MSc FRCP(Ed) FISPE FFPM DLSHTM Dip Pharm Med

European Medicines Agency Risk Management Development and Scientific Lead, European Medicines Agency
Stella Blackburn qualified in Medicine from Cambridge University and Guy’s Hospital Medical School. Following a short spell in hospital medicine (mainly oncology) she joined the pharmaceutical industry where she worked for 11 years, initially in pharmacovigilance but latterly in pharmacoepidemiology where she was involved in studies using the GPRD database and was at one time on the management board of GPRD. She has an MSc in Epidemiology from the London School of Hygiene and Tropical Medicine.

In 1997 she joined the European Medicines Agency. Following the first re-structuring of the EMEA, she became Specialised Group Leader for the cardiovascular, oncology, haematology and diagnostics group in the pharmacovigilance, post-authorisation safety and efficacy sector. From May 2004 – September 2009 she was the EMEA risk management co-ordinator and was lead author of the EU risk management guideline. Since September 2009 her role involves developing the Agency’s policy and procedures for risk management as well as being heavily involved in PROTECT and other scientific projects. She is on the Steering Group for the European Network of Centres of Pharmacoepidemiology and Pharmacovigilance.

She was involved in setting up the Pharmacovigilance and Pharmacoepidemiology course at the LSHTM where she is an honorary lecturer, and was Deputy Academic Registrar on the Board of the Faculty of Pharmaceutical Medicine for four years. She is currently on the Board of ISPE and is a Fellow of the Royal College of Physicians of Edinburgh, the International Society of Pharmacoepidemiology and the Faculty of Pharmaceutical Medicine.

Patrick Conway, MD, MSc

Chief Medical Officer, Office of the Secretary, U.S. Department of Health and Human Services
Patrick Conway, MD, MSc., is currently Chief Medical Officer at the Department of Health and Human Services (HHS) in the Office of the Assistant Secretary for Planning and Evaluation, the policy division for the Office of the Secretary. In 2007-08, he was a White House Fellow assigned to the Office of Secretary in HHS and the Director of the Agency for Healthcare Research and Quality. As Chief Medical Officer, he has a portfolio of work focused primarily on quality measurement and links to payment, health information technology, and research and evaluation across the entire Department. He is also currently Executive Director of the Federal Coordinating Council on Comparative Effectiveness Research coordinating investment of the $1.1 billion for this type of research in the Recovery Act. He is a practicing pediatric hospitalist and health services researcher focused on improving health care quality. He was a Robert Wood Johnson Clinical Scholar and completed a Master’s of Science focused on health services research at the University of Pennsylvania. Previously, he was a management consultant at McKinsey & Company, serving senior management of mainly health care clients on strategy projects. He has published articles in journals such as JAMA, New England Journal of Medicine, and Pediatrics and given national presentations on topics including health care policy, quality of care, adherence to evidence-based medicine, hospitalist systems, and nurse staffing. He currently practices at Children’s National Medical Center and is on leave from a faculty position at Cincinnati Children’s Hospital. He completed pediatrics residency at Children’s Hospital Boston.

David Cooper, MD, MBA

Senior Director, Medical Affairs, Novo Nordisk
Dr. Cooper is Director, Medical Affairs for Novo Nordisk Inc. He is responsible for providing medical affairs support around current and future products in hemophilia and hemostasis for the US affiliate, including developing data sources to support post marketing surveillance requirements in rare bleeding disorders.

Over the past 10 years, he transitioned from the practice of Neurosurgery to working in industry, serving initially as a medical strategy consultant on the vendor side across various therapeutic areas. For the past 4 years, he has been working within the Medical Affairs group at Novo Nordisk supporting the Biopharmaceuticals division, where responsibilities include phase IV programs, registries, advisory boards, and serving as chair of the Biopharm Investigator Initiated Studies Committee. He was recently recognized as the 2009 NNI Biopharm Employee of the Year. He is currently a member of the International Society on Thrombosis and Hemostasis, World Federation of Hemophilia, Congress of Neurological Surgeons, American Heart Association and the International Society for Pharmacoepidemiology and Outcomes Research.

Dr. Cooper obtained is BA in Chemistry from Cornell University, his MD from the Weill Medical College of Cornell University, and his MBA from the Johnson Graduate School of Management at Cornell University.

Gerald Dal Pan, MD, MHS

Director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food And Drug Administration (FDA)
Gerald J. Dal Pan, MD, MHS became the Director of the Office of Surveillance and Epidemiology (known then as the Office of Drug Safety) in FDA’s Center for Drug Evaluation and Research in November 2005. Prior to that, he was the Director of the Division of Surveillance, Research, and Communication Support in CDER's Office of Drug Safety, a position he held since December 2003. He received his medical degree from Columbia University, and his Master's degree in clinical epidemiology from Johns Hopkins University. He trained in Internal Medicine at the Hospital of the University of Pennsylvania, and in Neurology at Johns Hopkins Hospital. He is board certified in Internal Medicine and Neurology. He was an instructor in the Neurology Department at Johns Hopkins. He next worked for Guilford Pharmaceuticals in Baltimore, and then for HHI Clinical Research and Statistical Services in Hunt Valley, MD. He joined the FDA in July 2000 as a medical officer in the Division of Anesthetic, Critical Care, and Addiction Drug Products.

Nancy A. Dreyer, MPH, PhD, FISPE

Chief of Scientific Affairs and Senior Vice President, Outcome
Nancy Dreyer is Chief of Scientific Affairs and Senior Vice President at Outcome Sciences Inc., a leading provider of strategies and information-based solutions for marketed drugs and medical devices. She leads a team of scientists who design, conduct and interpret observational research on comparative effectiveness and safety, and quality improvement programs.

Her recent accomplishments include serving as a senior editor and co-author of the handbook “Registries for Evaluating Patient Outcomes: A User’s Guide” commissioned and published in 2007 by the U.S. Agency for Healthcare Research and Quality. More recently, she has taken a lead role in coordinating the development of Good Research Practices for Observational Studies of Comparative Effectiveness (see www.graceprinciples.org).

Mark Fishman, MD

President, Novartis Institute for Biomedical Research
Mark C. Fishman, M.D. is President of the Novartis Institutes for BioMedical Research (NIBR) and a Member of the Executive Committee of Novartis. He leads all worldwide discovery and early clinical activities of Novartis from the new research headquarters in Cambridge, Massachusetts. The goal of NIBR scientists is to change the practice of medicine, focusing on therapeutics for diseases, no matter how rare, where suffering is great and the scientific underpinnings strong. This approach has increased dramatically the number of new drugs entering and transitioning though clinical trials, especially using biological therapuetics. New medicines from these recent efforts have reached registration for cancer, autoimmune, and respiratory diseases.

Prior to joining Novartis, Dr. Fishman was Professor of Medicine at Harvard Medical School, Chief of Cardiology at the Massachusetts General Hospital (MGH) and the founding Director of the Cardiovascular Research Center of the MGH. During that time he trained more than 80 post-doctoral fellows and students, as well as clinical Cardiology fellows. His lab's discoveries opened a new field of biology. Through the use of genetic screens in the zebrafish, they discovered many of the fundamental principles, and genes, that fashion form and function of vertebrate organ systems.

Dr. Fishman has been honored by many awards and distinguished lectureships, and is a Fellow of the American Academy of Arts and Sciences, and the Institutes of Medicine of the National Academies (USA).

Sarah Garner, BPharm, MRPharmS, PhD

Associate Director Research and Development, National Institute for Health and Clinical Excellence (NICE)
Dr Sarah Garner is the Associate Director for Research and Development at the UK’s National Institute for Health and Clinical Excellence (NICE) and has been awarded a 2010 Harkness Fellowship. Sarah is on the recently formed Regulation of Medicines Review Panel which carries out independent reviews of UK licensing authority decisions.

A pharmacist, Sarah has specialised in medicines management and has a PhD in Health Technology Assessment from the University of Nottingham. Sarah has worked at NICE since 2000, initially as an analyst and then as a Technical Adviser on the Technology Appraisals team undertaking many of NICE’s cancer appraisals. She is also an Editor for the Cochrane Skin Group and on the UK’s Medicine’s Forum. Sarah has a special interest in antimicrobials, which led to her appointment as Pharmacist Lead for the UK Department of Health Advisory Committee on Antimicrobial Resistance. Sarah has undertaken a number of health services research projects that have used databases, including the General Practice Research Database. In 2002, she co-authored a Department of Health funded report into “Disease Registers in England” which examined how registers are used in the UK. Sarah is co-author a chapter on assessing the quality of registers in the AHRQ handbook “Registries for Evaluating Patient Outcomes: A User's Guide”.

Richard Gliklich, MD

Summit Director; Associate Professor, Harvard Medical School; President, Outcome
Dr. Gliklich is Director of the Fifth Annual Post-Approval Summit® and an Associate Professor at Harvard Medical School. A graduate of Yale University and Harvard Medical School, he is also a former Charles A. Dana Scholar at the University of Pennsylvania in health services and outcomes research and founded the Clinical Outcomes Research Unit at the Massachusetts Eye and Ear Infirmary in 1993 where he maintains a clinical practice.

Since 1998, Dr. Gliklich has served as president of Outcome, which is the leading provider of patient registries, studies, and integrated technologies for evaluating real-world research. Dr. Gliklich is a frequently invited speaker on post-approval research and patient registries and has served on numerous advisory boards. He has published extensively in the areas of outcomes assessment and patient registries as well as in the clinical area of diseases of the head and neck. He is a senior editor and author of the Agency for Research and Quality (AHRQ) handbook "Registries for Evaluating Patient Outcomes: A User's Guide". He is editor of a textbook on outcomes and performance measurement in clinical practice, "Profiting from Quality: Outcome Strategies for Medical Practice" (Jossey-Bass, Inc., 1999).

Dr. Gliklich focuses on post-approval research programs, in particular observational research on effectiveness, safety and quality of care. Some of the programs developed by Dr. Gliklich include the American Heart Association's Get With The Guidelines(sm) registries in cardiovascular disease and stroke, which involve more than 1000 U.S. hospitals, have enrolled hundreds of thousands of patients, and which received the 2004 Innovation Award from the Department of Health and Human Services. He has also worked extensively in the area of information technology for post-approval research and is a member of the American Heart Association's Heart IT Task force.

He is a Principal Investigator (PI) for the Outcome DEcIDE Center, one of 13 DEcIDE centers under the Agency for Healthcare Research and Quality's Effective Healthcare Program (www.effectivehealthcare.ahrq.gov) and the PI for the project "Registries for Evaluating Patient Outcomes". Dr. Gliklich previously led the Outcomes Symposium at Harvard in 1999 and annually hosts the Post-Approval Summit since its inception.

Michael Ibara, PharmD

Head of Pharmacovigilance Information Management, Pfizer, Inc.
Michael Ibara is currently Head of Pharmacovigilance Information Management Pfizer, and is devoted to improving safety surveillance in the age of digital healthcare. Throughout his career Michael has focused on the interface between business, technology and knowledge as it applies to pharmacovigilance and related disciplines.

Early in his career he established one of the first global contract pharmacovigilance functions and consulted on large-scale system implementation and database construction for pharmacovigilance. He was also head of Drug Safety for a Biotech company specializing in oncology and aids drugs.

At Pfizer he lead implementation of an electronic submissions system and has managed the implementation of large-scale safety technologies. Three years ago he began research on the implications for pharmacovigilance of the electronic medical record and Health2.0, and the possibility of improving public health through novel approaches to pharmacovigilance.

His recent work includes designing and co-leading the ASTER project, a collaboration between Partners Healthcare, CDISC, CRIX international, Pfizer, and FDA – to explore a new model for postmarketing safety.

Michael received his Pharm.D. degree from the University of Michigan and completed a Fellowship in Drug Research and Development with Burroughs Wellcome, Inc. and the University of North Carolina.

Richard E. Kuntz, MD

Senior Vice President of Strategy and Scientific Operations, Medtronic
Dr. Rick Kuntz is Senior Vice President of Strategy and Scientific Operations at Medtronic, Inc. In this role, which he assumed in August 2009, Kuntz oversees the company’s global regulatory affairs, health policy and reimbursement, clinical research activities, ventures and new therapies, strategy and innovation, corporate development, and acquisitions, integrations and divestitures functions.

Kuntz joined Medtronic in October 2005, as Senior Vice President and President of Medtronic Neuromodulation, which encompasses the company’s products and therapies used in the treatment of chronic pain, movement disorders, spasticity, overactive bladder and urinary retention, benign prostatic hyperplasia, and gastroparesis. In this role he was responsible for the research, development, operations and product sales and marketing for each of these therapeutic areas worldwide.

Kuntz brings to Medtronic a broad background and expertise in many different areas of healthcare. Prior to Medtronic he was the Founder and Chief Scientific Officer of the Harvard Clinical Research Institute (HCRI), a university-based contract research organization which coordinates National Institutes of Health (NIH) and industry clinical trials with the United States Food and Drug Administration (FDA). Kuntz has directed over 100 multicenter clinical trials and has authored more than 200 original publications. His major interests are traditional and alternative clinical trial design and biostatistics.

Kuntz also served as Associate Professor of Medicine at Harvard Medical School, Chief of the Division of Clinical Biometrics, and an interventional cardiologist in the division of cardiovascular diseases at the Brigham and Women’s Hospital in Boston, MA.

Kuntz graduated from Miami University, and received his medical degree from Case Western Reserve University School of Medicine. He completed his residency in internal medicine at the University of Texas Southwestern Medical School, and then completed fellowships in cardiovascular diseases and interventional cardiology at the Beth Israel Hospital and Harvard Medical School, Boston. Kuntz received his master’s of science in biostatistics from the Harvard School of Public Health.

Leanne Larson, MHA

Senior Vice President, Strategic Development, Outcome
Ms. Larson is Vice President of Strategic Development at Outcome Sciences Inc., a leading provider of strategies and information-based solutions for marketed drugs and medical devices. She is responsible for corporate strategic planning and program development, as well as for providing consultation to key clients, and senior oversight for patient registries and healthcare provider quality-measurement programs.

Ms. Larson has more than 15 years of experience in patient registries and other real-world and comparative effectiveness studies. Her extensive portfolio includes many large and successful programs with a range of clients including life sciences and healthcare organizations. Before joining OUTCOME, Ms. Larson served as Vice President at Sg2 Healthcare Intelligence, where she led the Cancer Intelligence Program, providing clinical and operational guidance to hospital cancer programs. Prior to Sg2, she worked for over 14 years at ICON Lifecycle Sciences Group, leading the Registry Consulting group and establishing and managing their patient registry and consulting services for the biopharmaceutical and medical device industries. Ms. Larson has also held positions in Ernst & Young’s Life Sciences and Pharmaceuticals consulting practice, as well as Merck and Co.’s Health Sciences-Digestive Disease group.

In addition to designing and managing real-world studies for a range of global clients, Ms Larson has also been prominent in developing and teaching best practices for patient registries. Ms. Larson is a Charter Member of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) and chaired the ISPOR Patient Registries Special Interest Group, Registry Design and Operations Working Group. She is also an Instructor in Health Service Systems at the Keller Graduate School of Management, as well as an Invited Reviewer for The Center for Disease Control and Prevention (CDC).

Ms. Larson received her Master of Health Administration (MHA) from Governors State University and a Bachelor of Science in Community Health from the University of Illinois.

Freda Lewis-Hall, MD, FAPA

Chief Medical Officer and Senior Vice President, Pfizer
Dr. Lewis-Hall was appointed Chief Medical Officer and Senior Vice President at Pfizer in 2009 and is responsible for enterprise-wide medical, patient safety, regulatory affairs and quality assurance as well as outreach to doctors and other medical professionals.

Prior to joining the Pfizer leadership team, Dr. Lewis-Hall was responsible for medical and regulatory affairs at Cambridge, Mass.-based Vertex Pharmaceuticals Inc. Previously, she served as Senior Vice President of Medical Affairs at Bristol-Myers Squibb, Vice President of Research and Development at Pharmacia, and Product Team Leader at Eli Lilly and Company, where she was involved in the development and launch of dozens of new drugs over the last decade. Previously, Dr. Lewis-Hall held leadership positions at the National Institute of Mental Health and the Howard University College of Medicine and maintained a private practice in both the District of Columbia and the U.S. Virgin Islands.

Dr. Lewis-Hall received her Bachelor of Arts and Sciences from The Johns Hopkins University and her Medical Doctorate from Howard University Hospital and College of Medicine.

Bruce Marshall, MD

Vice President of Clinical Affairs, Cystic Fibrosis Foundation
Bruce C. Marshall, MD earned his B.A. at Johns Hopkins University, his medical degree at the University of Maryland School of Medicine. He did internal medicine housestaff training at Strong Memorial Hospital, University of Rochester and a pulmonary fellowship at the Boston University School of Medicine. He was an Associate Professor of Medicine at the University of Utah Health Sciences Center and the Adult CF Program Director at that institution from 1988 to 2002. His research interests centered around CF related epidemiologic and clinical research. Dr. Marshall joined the Cystic Fibrosis Foundation at their National Office in Bethesda, Maryland, in August 2002. He is the Vice President of Clinical Affairs and oversees the care center network, clinical practice guidelines, patient and family resources as well as the work of the Clinical Research, Patient Registry, and Center Committees. His primary responsibility at the Foundation is to lead their quality improvement initiative. Dr. Marshall also holds the appointment of Associate Professor of Medicine at The Johns Hopkins University School of Medicine, Baltimore, Maryland.

Sharon-Lise Normand, PhD

Professor of Health Care Policy, Harvard Medical School and Harvard School of Public Health
Sharon-Lise Normand, Ph.D., is Professor of Health Care Policy (Biostatistics) in the Department of Health Care Policy at Harvard Medical School and Professor in the Department of Biostatistics at the Harvard School of Public Health. Her research focuses on the development of statistical methods for health services and outcomes research, primarily using Bayesian approaches, including causal inference, provider profiling, item response theory analyses, latent variables analyses, multiple informants analyses, and evaluation of medical devices in randomized and non-randomized settings. She is currently President of the Eastern North American Region of the International Biometrics Society. She serves on several task forces for the American Heart Association and the American College of Cardiology, is a consultant to the US Food and Drug Administration’s Circulatory System Devices Advisory Panel, and is Director of Mass-DAC, a data coordinating center that monitors the quality of all adult cardiac surgeries and coronary interventions in Massachusetts’ acute care hospitals. Dr. Normand has served on several editorial boards including Biometrics, Statistics in Medicine, Health Services and Outcomes Research Methodology, Psychiatric Services, and Cardiovascular Quality and Outcomes. She earned her Ph.D. in Biostatistics from the University of Toronto, holds a Masters of Science as well as a Bachelor of Science degree in Statistics, and completed a post-doctoral fellowship in Health Care Policy at Harvard Medical School. She is a Fellow of the American Statistical Association, a Fellow of the American College of Cardiology, a Fellow of the American Heart Association, and an Associate of the Society of Thoracic Surgeons.

Michael Rosenblatt, MD

Executive Vice President and Chief Medical Officer, Merck & Co., Inc.
Dr. Rosenblatt is Executive Vice President and Chief Medical Officer of Merck & Co., Inc. Previously he served as Dean of Tufts University School of Medicine. Prior to that, he held the appointment of George R. Minot Professor of Medicine at Harvard Medical School and Chief of the Division of Bone and Mineral Metabolism Research at Beth Israel Deaconess Medical Center (BIDMC). He served as the President of BIDMC from 1999-2001. Previously, he was the Harvard Faculty Dean and Senior Vice President for Academic Programs at CareGroup and BIDMC and a founder of the Carl J. Shapiro Institute for Education and Research at Harvard Medical School and BIDMC, a joint venture whose mission is to manage the academic enterprise and promote academic innovation.

Prior to that, he served as Director of the Harvard-MIT Division of Health Sciences and Technology, during which time he led a medical education organization for M.D., Ph.D., and M.D.-Ph.D. training jointly sponsored by Harvard and MIT. And earlier, he was Senior Vice President for Research at Merck Sharp & Dohme Research Laboratories where he co-led the worldwide development team for alendronate (FOSAMAX), Merck's bisphosphonate for osteoporosis and bone disorders. In addition, he directed drug discovery efforts in molecular biology, bone biology and calcium metabolism, virology, cancer research, lipid metabolism, and cardiovascular research in the United States, Japan, and Italy. In leading most of Merck's international research efforts, he established two major basic research institutes, one in Tsukuba, Japan, and one near Rome, Italy. He also headed Merck Research's worldwide University and Industry Relations Department.

He is the recipient of the Fuller Albright Award for his work on parathyroid hormone and the Vincent du Vigneaud Award in peptide chemistry and biology, and the Chairman’s Award from Merck. His research is in the field of hormonal regulation of calcium metabolism, osteoporosis, and cancer metastasis to bone. His major research projects are in the design of peptide hormone antagonists for parathyroid hormone and the tumor-secreted parathyroid hormone-like protein, isolation/characterization of receptors and mapping hormone—receptor interactions, elucidating the mechanisms by which breast cancer “homes” to bone, and osteoporosis and bone biology.

He has been an active participant in the biotechnology industry, serving on the board of directors and scientific advisory boards of several biotech companies. He was a scientific founder of ProScript, the company that discovered bortezomib (Velcade), now Millennium Pharmaceutical’s drug for multiple myeloma and other malignancies. He was chair of the Board of Scientific Counselors of the National Institute of Diabetes and Digestive and Kidney Diseases of the NIH. He has been elected to the American Society of Clinical Investigation, the Association of American Physicians, to Fellowship in the American Association for the Advancement of Science and the American College of Physicians, and the presidency of the American Society of Bone and Mineral Research. He has testified before a Senate Hearing on U.S. biomedical research priorities in 1997.

From 1981 to 1984, he served as Chief of the Endocrine Unit, Massachusetts General Hospital. He received his undergraduate degree summa cum laude from Columbia and his M.D. magna cum laude from Harvard. His internship, residency, and endocrinology training were all at the Massachusetts General Hospital.

Eleanor Segal, MD

Vice President, Medical Safety Officer, Actelion Pharmaceuticals
Dr. Eleanor Segal (“Ellie”) is a family physician and geriatrician who was a clinician/teacher for over 20 years before joining the pharmaceutical industry (Syntex) in 1991. A graduate of the University of Michigan Medical School, she is board-certified in family medicine, a Fellow of the American Academy of Family Practice, holds a Certificate of Added Qualifications in Geriatric Medicine and is a Clinical Professor at Stanford University School of Medicine, where she taught several courses, the most notable a course in “Rural Health”.

She has written a chapter on common medical problems of geriatric patients for the third edition of “Practical Gerontology” (Carstensen et al, 1996), as well as an article for the Journal of Drug Safety (Risk Management in the Postmarketing Period) along with other articles on medical communication and risk management programs. She is particularly interested in both the issues surrounding communication between physicians and patients and the safety of pharmaceutical agents as used in the aging population.

Before moving to Switzerland in 2001 to join Actelion Pharmaceuticals Ltd. as VP and Head of the Global Drug Safety department, which she started, she was Sr. Director of the joint departments of Drug Safety and Pharmacovigilance and Clinical Quality Assurance at Chiron USA, a consultant in pharmacovigilance for Hoffman-La Roche and head of Drug Safety and Quality Management for Sequus Pharmaceuticals. After nine years at Actelion, she currently is the Medical Safety Officer, reporting into the Office of the Chief Medical Officer, dividing her time between California and Basel.

Fadia Shaya, PhD, MPH

Associate Director, Center on Drugs and Public Policy, Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy
Fadia T. Shaya PhD, MPH, is Associate Professor, in Outcomes Research at the University of Maryland School of Pharmacy, and in Epidemiology and Preventive Medicine at the University of Maryland School of Medicine. She is also Associate Director for the Center on Drugs and Public Policy in the Department of Pharmaceutical Health Services Research. She has consulted at the Johns Hopkins Bayview Medical Center; and at the Health Planning Commission in Paris, France.

Dr. Shaya has built research capacity to support all stages of drug development, from pre-clinical to post-marketing. She has experience in developing clinical, economic, decision analysis and budget impact models. She works with state, commercial and Medicare Part D plans, to guide drug formulary management, reimbursement and pricing decision-making. Her extra-mural research is supported by federal, commercial and foundation grants. She consults on matters of appropriate drug prescribing, pricing and policy issues.

A member of the Pharmacy and Therapeutics committee at CareFirst BlueCross BlueShield, and the State Department of Health and Mental Hygiene, she also serves on the Editorial Advisory Boards of the Journal of Medical Economics, the Journal of Managed Care Pharmacy, Expert Review in Pharmacoeconomics and Outcomes Research, and P&T. She is a reviewer for and has published in peer-reviewed journals, including CHEST, Circulation, The Lancet, Health Affairs and Archives of Internal Medicine. She also serves as an ad-hoc reviewer for AHRQ HSR study section, Her current research focuses on comparative effectiveness and formulary decision-making. She is regularly an invited speaker at national and international pricing, scientific and policy meetings.

Dr. Shaya heads the MVP (Men’s Cardiovascular Health) Program and is the Co-PI of a multi-million grant from the National Heart, Lung, and Blood Institute, to develop and implement a research partnership program with University of Maryland and Bon Secours Baltimore Health System. In large part, her translational medicine work is based on public-private partnerships and community engagement initiatives.

Dr. Shaya serves on the Board of the Delmarva Foundation for Medical Care, Inc. and on the Community Advisory Board of Sinai Hospital, Baltimore.

Dr.Shaya obtained her PhD from the Johns Hopkins Bloomberg School of Public Health, her health economics degree from the Sorbonne University Paris-IX Dauphine and her MPH from the American University of Beirut.

Barry M. Straube, MD

Director and Chief Clinical Officer, Office of Clinical Standards and Quality, Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services
Barry M. Straube, M.D, Director of the Office of Clinical Standards and Quality (OCSQ) and Chief Medical Officer (CMO) at the Centers for Medicare and Medicaid Services (CMS), oversees CMS quality policy portfolio, including national coverage policies and quality standards for Medicare and Medicaid ; quality measurement and public reporting; and the Quality Improvement Organization (QIO) program. Dr. Straube is senior advisor to the Administrator on clinical and scientific policy. He received an A.B. degree from Princeton University and an M.D. degree from the University of Michigan Medical School. He completed an internal medicine residency at California Pacific Medical Center and served as a Renal Fellow at Tufts University-New England Medical Center. He is board-certified in Internal Medicine and Nephrology.

Sean Tunis, MD, MSc

Founder and Director, Center for Medical Technology Policy
Dr Sean Tunis, MD, MSc. is the Founder and Director of the Center for Medical Technology Policy in San Francisco, where he works with health care decision makers, experts and stakeholders to improve the value of clinical research on new and existing medical technologies. He consults with a range of domestic and international health care organizations on issues of comparative effectiveness, evidence based medicine, clinical research and technology policy.

Through September of 2005, Dr. Tunis was the Director of the Office of Clinical Standards and Quality and Chief Medical Officer at the Centers for Medicare and Medicaid Services (CMS). In this role, he had lead responsibility for clinical policy and quality for the Medicare and Medicaid programs, which provide health coverage to over 100 million US citizens. Dr. Tunis supervised the development of national coverage policies, quality standards for Medicare and Medicaid providers; quality measurement and public reporting initiatives, and the Quality Improvement Organization program. As Chief Medical Officer, Dr. Tunis served as the senior advisor to the CMS Administrator on clinical and scientific policy. He also co-chaired the CMS Council on Technology and Innovation

Dr. Tunis joined CMS in 2000 as the Director of the Coverage and Analysis Group. Before joining CMS, Dr. Tunis was a senior research scientist with the Technology Assessment Group, where his focus was on the design and implementation of prospective comparative effectiveness trials and clinical registries. Dr. Tunis also served as the Director of the Health Program at the Congressional Office of Technology Assessment and as a health policy advisor to the U.S. Senate Committee on Labor and Human Resources, where he participated in policy development regarding pharmaceutical and device regulation.

He received a B.S. degree in Biology and History of Science from the Cornell University School of Agriculture, and a medical degree and masters in Health Services Research from the Stanford University School of Medicine. Dr. Tunis did his residency training at UCLA and the University of Maryland in Emergency Medicine and Internal Medicine. He is board certified in Internal Medicine and holds adjunct faculty positions at Johns Hopkins and Stanford University Schools of Medicine.