Speaker Profiles

Amy Abernethy, MD

Associate Professor of Medicine, Division of Medical Oncology, Department of Medicine, Duke University School of Medicine, Director, Duke Cancer Care Research Program
Amy P. Abernethy, MD, is a tenured Associate Professor in Duke University Schools of Medicine and Nursing, the Director of the Duke Cancer Care Research Program, and a medical oncologist and palliative medicine physician. Dr. Abernethy is an internationally recognized expert in health services research and delivery in patient-centered cancer care. She is an appointee to the Institute of Medicine’s National Cancer Policy Forum, President-Elect of the American Academy of Hospice & Palliative Medicine, on the Board of Directors for the Personalized Medicine Coalition, on the Advisory Board for the Rapid Learning System for Cancer for the American Society of Clinical Oncology, and Co-Chair of the National Institutes of Health funded Palliative Care Research Cooperative Group. Dr. Abernethy participates integrally in international discussions about reforming the evidence development system, presenting a model for rapid learning healthcare by coordinating clinical and research functions to better serve patients’ needs in an evidence-driven, cost-effective, and patient-centered manner.

Barbara Isquith Arone, MS

Director of Professional Services, Quintiles Outcome
Ms. Arone is Director of Professional Services at Quintiles Outcome in Cambridge MA. She joined Quintiles Outcome in 2002 and has managed or overseen more than 50 registries or post approval projects in her time with the company. These projects have represented the full spectrum of post approval research, including pregnancy registries, orphan disease registries, product and drug safety registries, as well as quality improvement programs. She has operational excellence in both prospective and retrospective data collection methods in North America and globally, including the EU, Central and South America as well as Asia. Currently Ms. Arone oversees a group of departments responsible for registry study design, database development, EDC deployment, data management, analysis, reporting, and medical writing.

Ms. Arone is a 1994 graduate of Brown University. She holds a Masters of Sciences in Human Genetics from Sarah Lawrence College, and is a board certified Genetic Counselor. Ms. Arone has additional previous clinical and research experience from her 6 years of clinical genetics at Columbia Presbyterian Medical Center in New York and New England Medical Center in Boston.

Elise Berliner, PhD

Director of the Technology Assessment Program, Agency for Healthcare Research and Quality (AHRQ)
Elise Berliner, PhD, is the Director of the Technology Assessment Program at the Agency for Healthcare Research and Quality (AHRQ). The Technology Assessment program provides technology assessments to the Centers for Medicare & Medicaid Services (CMS) to inform Medicare coverage decisions and other policy issues.

Prior to joining AHRQ, Dr. Berliner worked as a consultant to pharmaceutical and medical device companies on cost-effectiveness and outcomes research, technology assessment and reimbursement planning. Dr. Berliner also has several years of experience in research and development at a number of innovative medical technology companies. She was a Congressional Fellow at the Office of Technology Assessment.

Dr. Berliner received her PhD in biophysics from Brandeis University.

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

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 a Fellow of the Royal College of Physicians of Edinburgh, the International Society of Pharmacoepidemiology and the Faculty of Pharmaceutical Medicine. She is currently President Elect of ISPE.

Michelle Bulliard, RN, BScN, MICR

Vice President Clinical Operations, Regional Managing Director Europe
Ms. Michelle Bulliard is the Vice President Clinical Operations, Regional Managing Director Europe for Quintiles Outcome, a leading provider for patient registries, studies, and technologies for evaluating real-world outcomes. In her current role for Quintiles Outcome, she is responsible for corporate strategic planning and program development, as well as for providing consultation to key clients, and oversight for patient registries and healthcare provider quality-measurement programs.

Ms. Bulliard has more than 15 years of experience in running clinical studies including patient registries and other complex real-world studies. Her extensive global portfolio includes many large and successful programs with a range of clients including life sciences and healthcare organizations. Before joining Outcome, Ms. Bulliard served as Clinical Study Manager with Spine, Biologics & Navigation and Cardiac Surgery businesses at Medtronic International Trading Sarl. Prior to Medtronic, she worked for Covance as Manager Covance Central Diagnostics developing their European operations for centralized cardiovascular monitoring in clinical research. She has also held positions with, Merck Serono (formerly Serono International) as a Medical Research Scientist, and ICON Clinical Research as Project Manager after practicing for 8 years as a Registered General Nurse specializing in intensive care.

Ms. Bulliard holds a Bachelor of Nursing Studies Honours degree from Dr Steeven’s Hospital/Trinity College in Dublin, Ireland).

Elisa Cascade, MBA

Vice President of Global Operations, MediGuard
Elisa Cascade, Vice President of Global Operations, MediGuard, has over 20 years of experience in conducting research for pharmaceutical, medical device, and biotechnology firms. She currently runs the global operations for Quintiles Digital Patient Unit including MediGuard.org and ClinicalResearch.com. Combined, these communities have over 2.7 million patient members in the US, UK, France, Germany, Spain, and Australia who have consented to participate in research activities. Over the past few years, Elisa has overseen the development of protocols, questionnaires, analysis plans, and final reports for over 300 direct-to-patient research projects including: market research, clinical trial feasibility, patient recruitment, observational research studies, and patient adherence programs. Prior to joining Quintiles Digital Patient Unit, Elisa was responsible for the launch of MediGuard.org, worked at Quintiles in the Late Phase study group, and was a Medical Technology consultant with The Lewin Group. She holds a Master of Business Administration from the Wharton School of Business.

David Cooper, MD MBA

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 J. Dal Pan, MD, MHS

Director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration
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. 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 Dreyer, MPH, PhD

Global Chief of Scientific Affairs Real-World & Late Phase Research, Quintiles Outcome
Dr. Nancy Dreyer is Chief of Scientific Affairs, Real-World and Late Phase Research at Quintiles Outcome, a leading provider of strategies and information-based solutions for marketed drugs and medical devices. She leads a team of researchers 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 by the US Agency for Healthcare Research and Quality. This handbook was first published in 2007 and then updated in 2010. She also has taken a leadership role in developing guidance on Good Research Practices for Observational Studies of Comparative Effectiveness (see www.graceprinciples.org), and in 2009 was named as an Alternate Steering Committee Member for the European Medicines Agency’s PROTECT Project for the Innovative Medicines Initiative. In addition Dreyer was recognized by the trade journal, Pharmavoice, in 2007 as one of the 100 most inspiring people in the pharmaceutical and life sciences industry.

Dr. Dreyer has more than 25 years of experience in epidemiologic research, having done studies on occupational and environemntal exposures, consumer products and medical drugs and devices. She trained at the University of North Carolina in Chapel Hill, earning a masters degree and doctorate in Epidemiology. She is a Fellow and Board Member of the International Society of Pharmacoepidemiology. She is a member of the Drug Information Association Real World Outcomes Task Force, and ISPOR’s Prospective Observational Clinical Studies Task Force. Her experience includes CEO of Epidemiology Resources, Inc., a job she held from the company’s inception through its acquisition 20 years later by UnitedHealth Group. In that role, she launched and published the peer reviewed journal, Epidemiology, for its first ten years, and led the New England Epidemiology Institute, a summer program which trained more than 5000 scientists through collaboration with international medical schools and schools of public health. Dr. Dreyer spent five years as a senior executive at UnitedHealth Group’s subsidiary, Ingenix/i3 Research.

Dr. Dreyer is also a member of the University of North Carolina School of Public Health Dean’s Advisory Council and was a Consumer Representative in radiopharmaceuticals for the FDA.

Robert W. Dubois, MD, PhD

Chief Science Officer, National Pharmaceutical Council
Robert W. Dubois, MD, PhD, joined the National Pharmaceutical Council (NPC) in October 2010 as its Chief Science Officer. In this role, he oversees NPC’s research on policy issues related to the harmonization, dissemination, and communication of comparative effectiveness research, as well as on how health outcomes are valued.

Dr. Dubois, who is is board certified in internal medicine, brings more than 25 years of experience in health services research and comparative clinical effectiveness. He has co-founded and led various health care research organizations in developing quality research with practical application. Most recently, he was the chief medical officer at Cerner LifeSciences, where he focused on comparative effectiveness and the use of an electronic health records infrastructure to implement clinical change.

Prior to joining Cerner in 2001, Dr. Dubois co-founded Protocare Sciences and was its executive vice president, chief medical officer, and later its chief executive officer. Throughout his career, Dr. Dubois’ primary interest has centered on defining “what works” in health care and finding ways for that evidence to inform health care decision making. He is a recognized expert in the areas of defining best practice, disease management and appropriateness of care. He has authored more than 100 peer-reviewed articles on comparative effectiveness, evidence-based medicine, the development of practice guidelines, and determining the optimal use of high cost medical services.

Dr. Dubois received his AB from Harvard College, his MD from the Johns Hopkins School of Medicine and his PhD in Health Policy from the RAND Graduate School.

Richard Gliklich, MD

Summit Director; Associate Professor, Harvard Medical School; President, Quintiles Outcome 
Dr. Richard Gliklich is President of Quintiles Outcome, the leading provider for services and technologies for real-world and late phase research.

Dr. Gliklich focuses on clinical research on the effectiveness, safety and quality of care. Dr. Gliklich is a principal investigator and senior editor of the first and second editions of the landmark publication by the U.S. Agency for Healthcare Research and Quality (AHRQ) handbook “Registries for Evaluating Patient Outcomes: A User’s Guide.” Some of the programs developed by Dr. Gliklich include the American Heart Association’s Get With The Guidelines® registries in cardiovascular disease, heart failure, and stroke, which involve more than 2,500 U.S. hospitals and more than two million patients, and received the 2004 Innovation Award from the U.S. Department of Health and Human Services and the 2007 eHealth Initiative Award.

Dr. Gliklich is a frequently invited speaker on post-approval programs and registries, and has served on numerous advisory boards. He is the director of an annual international conference at Harvard, focusing on post-approval studies, registries and risk management (Post-Approval Summit). He has authored more than 100 academic publications, with a large number of articles on patient registries and patient reported outcomes. Dr. Gliklich is the editor of a textbook on the practical value of real-world clinical data in medical practice, “Profiting from Quality: Outcomes strategies for medical practice,” published by Jossey-Bass, Inc., in 1999. He is a Principal Investigator (PI) for the Outcome DEcIDE Center under the Agency for Healthcare Research and Quality’s Effective Healthcare Program. In 2010, he was recognized by the trade journal PharmaVoice as one of the 100 most inspiring people in the pharmaceutical and life sciences industry.

A graduate of Yale University and Harvard Medical School, Dr. Gliklich is also a former Charles A. Dana Scholar at the University of Pennsylvania School of Medicine in outcomes research. In addition to his work at Outcome, Dr. Gliklich is a practicing physician and Professor at Harvard Medical School.

Robert Hauser, PharmD, PhD

Senior Director, Quality and Guidelines, American Society of Clinical Oncology
Dr. Hauser joined ASCO in 2011 as the Senior Director of the Quality Department. He has more than 15 years of progressively responsible experience in health economic and strategy planning services related to clinical trial development, oncology registries, EMR systems, informatics, and business development. In his most recent position as Director of Operations and Informatics at the International Oncology Network (ION), he was responsible for developing strategy for the use of informatics data, providing analytics for Oncology Managed Care Initiatives, and for developing proposals, budgets, and the execution of projects from inception to completion. He spent six years as Vice President and Chief Operating Officer for the Geriatric Oncology Consortium, Inc., a 501(c)(3) organization where he managed daily business operations as well as business development and fundraising activities. He also spent two years with the research/consulting firm Abt Associates where he helped conduct economic and strategic planning for major pharmaceutical and medical device clients.

Dr. Hauser lives in Maryland and received his post-graduate education at the University of Texas-Austin. His PhD dissertation focused on the treatment of metastatic breast cancer patients. While working on his PhD, Dr. Hauser had clinical responsibilities at Southwest Regional Cancer Center and Owen Healthcare, both based in Austin.

Clifford Ko, MD, MS, MSHS, FACS

Director, Division of Research and Optimal Patient Care, American College of Surgeons
Dr. Clifford Ko is the Director of the Division of Research and Optimal Patient Care at the American College of Surgeons (ACS). This Division houses all the quality evaluation/improvement programs at the ACS, including the National Surgical Quality Improvement Program (NSQIP), the Cancer Approvals Program, the Trauma Center Verification Program, and the Bariatric Surgery Center Network Accreditation Program. Dr. Ko is also the Director of ACS NSQIP.

Dr. Ko’s academic appointment is Professor of Surgery and Health Services in the UCLA Schools of Medicine and Public Health and he holds the Robert and Kelly Day Chair in Surgical Outcomes. He is also a research affiliate at the RAND Corporation. Clinically, he is an operating colorectal surgeon and recently was chosen as one of the top surgeons in Los Angeles. Dr. Ko is double board-certified (general and colorectal surgery) and a formally trained health services researcher. He is considered one of the leading surgical health services researchers investigating quality and quality improvement with over 150 peer reviewed publications and has received research funding as a Principal Investigator from the NIH, CDC, VA, and American Cancer Society. Recently, Dr. Ko led the California Collaborative on Surgical Quality Improvement.

Dr. Ko graduated with his MD from the University of Chicago Pritzker School of Medicine, where he also received his MS in Biological/Medical Ethics. In 2001, Dr. Ko received his MSHS from UCLA in Health Services Research.

Dr. Ken Lee

Dr. Ken Lee recently joined Quintiles Drug Development Asia to head up their Site Services group, where he is responsible for study feasibilities and site identification, management and training. In addition, the group coordinates the Quintiles Prime and Partner Sites Program in Asia. Prior to this, he held the position of Head of Medical Affairs Oncology for Region Europe / Canada and Emerging Markets at Bayer based in Berlin. He obtained his medical qualification from the University of Melbourne, Australia in 1998 and worked in a variety of areas in internal medicine before joining the pharmaceutical industry in 2002. From here, Ken has held different country and headquarter positions including medical affairs and commercial operations in 6 countries across 3 continents. He has at various times covered Asia, Middle East, Africa, Russia, CIS and Europe. In most of these positions, the management of post approval trials has been a major feature of his responsibilities.

Flora Lum, MD

Executive Director, The H. Dunbar Hoskins Jr., M.D. Center for Quality Eye Care, American Academy of Ophthalmology
Dr. Lum is the Executive Director of the H. Dunbar Hoskins MD Center for Quality Eye Care, the Foundation of the American Academy of Ophthalmology, and the Policy Director for Quality of Care and Knowledge Base Development for the American Academy of Ophthalmology. She works with the Director and Advisory Board of the Hoskins Center to develop new quality and public health activities, including a data registry for the collection of performance measures and a vision screening program, EyeSmart™ EyeCheck, to identify individuals with visual impairment. She serves as co-Principal Investigator for the Agency for Healthcare Research and Quality (AHRQ)- funded grant, RiGOR, Registry in Glaucoma Outcomes Research, A Prospective Observational Study Comparing the Effectiveness of Treatment Strategies for Primary Open-Angle Glaucoma. She oversees the quality of care and evidence-based activities of the Hoskins Center, including Preferred Practice Patterns and Ophthalmic Technology Assessments and performance measures which are incorporated into the Centers for Medicare and Medicaid Services’ Physicians Quality Reporting System, and the Practicing Ophthalmologists Learning System, upon which the Maintenance of Certification examination is based. She has directed the Academy’s health information technology activities, including development of Digital Imaging and Communications in Medicine (DICOM) standards, Systematized Nomenclature for Medicine (SNOMED) terminology, and Integrating the Healthcare Enterprise (IHE) Eye Care testing and demonstrations as well as development of criteria for ophthalmology-specific electronic health records.

Bruce C. Marshall, MD

Vice President of Clinical Affairs, Cystic Fibrosis Foundation
Upon graduation from Johns Hopkins University and the University of Maryland Medical School, Dr. Marshall completed an internship and residency in internal medicine at the University of Rochester and a pulmonary fellowship at Boston University. He began his career as a bench scientist at the University of Utah and secured Career Development awards from the National Institutes of Health and the Veteran’s Administration. His interests, however, shifted to clinical research and quality improvement. His clinical research experience includes interventional and observational research. He was co-principal investigator on a multi-center randomized controlled trial which showed the benefit of chronic azithromycin in CF patients chronically infected with Pseudomonas aeruginosa (PA). This work has had a major impact on clinical care with nearly two-thirds of CF patients infected with PA now on chronic azithromycin therapy. His contributions in epidemiological and observational research include the development of a survival model for CF and the application of that model to an analysis of the risks and benefits of lung transplantation. This work pointed out the significant risk associated with performing lung transplantation too early in the disease process.

Dr. Marshall joined the Cystic Fibrosis Foundation in 2002 to lead their nascent quality improvement effort. Working with colleagues at Dartmouth Medical School and with broad input from the CF community, he developed and implemented a strategic plan to accelerate improvement in CF care. Key tactical elements of the CF Foundation’s QI initiative include: 1) “learn by doing” QI collaboratives to develop leadership in the CF community, 2) driving the importance of a partnership between the health care team, patients and their families. From the realization that partners share information freely, the CF Foundation was among the first health organizations to publically share risk-adjusted clinical outcomes for all care centers, 3) a benchmarking initiative to identify and disseminate “best practices” at centers with outstanding outcomes and 4) creating the framework for the development of evidence-based clinical practice guidelines for CF care which has resulted in multiple peer-reviewed publications over the last several years, 5) transformation of the patient registry in 2003 from an annual aggregation of data for national level reporting to a secure, web-enabled application with data entry throughout the year, patient and center level reports and a query tool to assist the care teams with patient management. Key outcomes such as FEV1 percent predicted, a key measure of pulmonary disease severity, and BMI, a key measure of nutritional status, have improved markedly over the last decade. Through this collective effort, quality improvement and patient-centered care have become an integral component of CF care across the country and others in Europe and Australasia are following the lead. The National Committee for Quality Assurance has recognized the CF Foundation for the impact of their QI initiative (2009 Annual Award Winner).

Dr. Marshall recently led the successful rebuild of the CF Foundation’s patient registry on a technology platform that is compliant with FDA standards for data integrity. The CF Foundation is collaborating with pharmaceutical sponsors in using the patient registry for post-FDA approval observational studies. This provides a mechanism for the CF Foundation to play an important role in ensuring the safety of newly approved therapies in clinical practice as well as a revenue source to offset some of the costs of operating the care center network and patient registry.

Jeanenne J. Nelson, PhD

Director of Oncology Epidemiology, Worldwide Epidemiology, GlaxoSmithKline
Jeanenne J. Nelson is Director of Oncology Epidemiology in the Worldwide Epidemiology department at GlaxoSmithKline. She leads a team of seven cancer-specialty epidemiologists to provide population-based evidence on disease and treatment to influence decision-making from early phase drug discovery through late stage clinical development to medical practice. Her team is active in post-market risk identification and risk-benefit assessment and conducts pharmacoepidemiology studies using data sources from cancer registries linked with health insurance claims, electronic health records from various settings such as oncology community practices, UK general practice physician networks, and HMOs, as well as de novo registries and prospective cohort studies.

Dr. Nelson began her career at the Collaborative Studies Coordinating Center at the Gillings School of Global Public Heath, the University of North Carolina at Chapel Hill, where she served as primary statistician on a number of sentinel NIH collaborative studies, including the Coronary Primary Prevention Trial, the Lipids Research Clinics Program, the Asymptomatic Carotid Artery Study and the Atherosclerosis Risk in Communities study. Subsequently, Dr. Nelson spent several years at Quintiles as the primary statistician and epidemiologist for cardiovascular disease, working closely with independent safety and data monitoring committees in evaluating safety signals and early efficacy and futility methods and data.

Prior to cancer research at GlaxoSmithKline, Dr. Nelson focused on cardiovascular epidemiology and conducted a large beta blocker drug registry for heart failure among patients in a population-based setting. She also partnered with the University of Cambridge on the Lp-PLA2 Studies Collaboration to explore the role of a potential novel risk marker for coronary heart disease by pooling individual records from over 79,000 participants in 32 prospective studies.

Dr. Nelson received her BS in Mathematics, her MSPH in Biostatistics and her PhD in Epidemiology from the University of North Carolina at Chapel Hill. She has published numerous scientific articles.

Irving M. Pike, MD, FACG, FASGE

Director and President, GI Quality Improvement Consortium (GIQuIC)
Dr. Pike is a graduate of the Medical College of Georgia. He completed his Internal Medicine Residency and Gastroenterology Fellowship at the University of Texas Health Science Center Dallas, Parkland Memorial Hospital. He practiced gastroenterology in Virginia Beach, Virginia from1983-2012.

Dr. Pike has served on the executive committee of the Virginia Beach Medical Society as well as serving the society in a term as president. Dr. Pike has chaired committees, special interest groups and task forces for the American College of Gastroenterology (“ACG”) and the American Society for Gastrointestinal Endoscopy (“ASGE”) (both Section 501(c)(3) organizations). He currently is a Trustee of the ACG.

Dr. Pike also has twelve years of experience as a physician executive with Sentara Health Care in southeastern Virginia. He currently is president of the Gastroenterology Quality Improvement Consortium, Ltd (GIQuIC). Dr. Pike is the Chief Medical Officer for John Muir Health in Northern California.

Terrie Reed, MSIE

Senior Public Health Analyst and Associate Director Informatics, Center for Devices and Radiological Health, Food and Drug Administration
Terrie Reed, MS Industrial Engineering is Associate Director of Informatics at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Surveillance and Biometrics (OSB). Ms. Reed leads an Informatics staff on projects related to the incorporation of data exchange and vocabulary standards into FDA data submissions and leads the internal FDA implementation efforts for integration of UDI into FDA regulatory processes.

Michael Rosenblatt, MD

Executive Vice President and Chief Medical Officer, Merck
Scientist, academic, hospital, and global healthcare company executive, Michael Rosenblatt, MD, is executive vice president and chief medical officer at Merck. He is the company’s primary external advocate on medical issues and the independent voice of the patient inside Merck.

Dr. Rosenblatt previously was Dean of Tufts University School of Medicine, the George R. Minot Professor of Medicine at Harvard Medical School, and president of Beth Israel Deaconess Medical Center (BIDMC). He was the Harvard faculty dean and senior vice president for academic programs at CareGroup and BIDMC. He was also director of the Harvard-MIT Division of Health Sciences and Technology.

Prior to these leadership positions, he was senior vice president for research at Merck where he co-led the worldwide development team for alendronate (FOSAMAX). Earlier, he was chief of the Endocrine Unit at the Massachusetts General Hospital.

In 2011 he served as a consultant to the U.S. President's Council of Advisors on Science and Technology.

Dr. Rosenblatt was elected to the American Society of Clinical Investigation and the Association of American Physicians, is a fellow of the American Association for the Advancement of Science and the American College of Physicians, and served as the president of the American Society of Bone and Mineral Research.

He received his undergraduate degree summa cum laude from Columbia University and his MD magna cum laude from Harvard Medical School.

John Santa, MD, MPH

Director, Consumer Reports Health Ratings Center, Consumers Union
John Santa is the Director of the Consumer Reports Health Ratings Center. The Ratings Center focuses on explicit approaches for evaluating and comparing health services, products, institutions and practitioners. Since coming to Consumer Reports, Dr. Santa has represented consumers in multiple venues across the industry. He has previously worked in leadership positions for hospitals, physician groups and health insurers. Dr Santa was the administrator of the Office of Oregon Health Policy and Research from 2000 to 2003. He helped organize and implement an evidence-based approach to prescription drug purchasing that eventually came to be known as the Drug Effectiveness Review Project. He practiced primary care internal medicine from 1976 to 1992 and 2003 to 2008 in several settings, most recently at the Portland, Oregon VA.

Sebastian Schneeweiss, MD, ScD

Associate Professor of Epidemiology, Harvard School of Public Health, Associate Professor of Medicine, Harvard Medical School
Sebastian Schneeweiss is Associate Professor of Medicine and Epidemiology at Harvard Medical School and Vice Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women’s Hospital.

He is Principal Investigator of the BWH DEcIDE Research Center on Comparative Effectiveness Research and the DEcIDE Methods Center both funded by AHRQ and Director of the Harvard-Brigham Drug Safety Research Center funded by FDA/CDER. His research is funded by multiple NIH grants and focuses on the comparative effectiveness and safety of biopharmaceuticals and analytic methods to improve the validity of epidemiologic studies using complex healthcare databases.

Dr. Schneeweiss is Past President of the International Society for Pharmacoepidemiology and is Fellow of the American College of Epidemiology, the American College of Clinical Pharmacology, and the International Society for Pharmacoepidemiology. He is voting consultant to the FDA Drug Safety and Risk Management Advisory Committee and member of the Methods Committee of the Patient Centered Outcomes Research Institute.

He received his medical training at the University of Munich Medical School and his doctoral degree in Pharmacoepidemiology from Harvard.

Joe V. Selby MD, MPH

Executive Director, Patient-Centered Outcomes Research Institute (PCORI)
Joe V. Selby, MD, MPH, is the first Executive Director of the Patient-Centered Outcomes Research Institute (PCORI). A family physician, clinical epidemiologist and health services researcher, he has more than 35 years of experience in patient care, research and administration. He will identify strategic issues and opportunities for PCORI and implement and administer programs authorized by the PCORI Board of Governors.

Building on the work of the Board and interim staff, Selby will lead the organizational development of PCORI, which was established by Congress through the 2010 Patient Protection and Affordable Care Act. In addition to creating an organizational structure to carry out a national research agenda, Selby will lead PCORI’s external communications, including work to establish effective two-way communication channels with the public and stakeholders about PCORI’s work.

Selby joined PCORI from Kaiser Permanente, Northern California, where he was Director of the Division of Research for 13 years and oversaw a department of more than 50 investigators and 500 research staff working on more than 250 ongoing studies. He was with Kaiser Permanente for 27 years. An accomplished researcher, Selby has authored more than 200 peer-reviewed articles and continues to conduct research, primarily in the areas of diabetes outcomes and quality improvement. His publications cover a spectrum of topics, including effectiveness studies of colorectal cancer screening strategies; treatment effectiveness, population management and disparities in diabetes mellitus; primary care delivery and quality measurement.

Selby was elected to membership in the Institute of Medicine in 2009 and was a member of the Agency for Healthcare Research and Quality study section for Health Care Quality and Effectiveness from 1999- 2003. A native of Fulton, Missouri, Selby received his medical degree from Northwestern University and his master’s in public health from the University of California, Berkeley. He was a commissioned officer in the Public Health Service from 1976-1983 and received the Commissioned Officer’s Award in 1981.

He serves as Lecturer in the Department of Epidemiology and Biostatistics, University of California, San Francisco School of Medicine, and as a Consulting Professor, Health Research and Policy, Stanford University School of Medicine.

Selby was appointed PCORI executive director on May 16, 2011, and formally begins his duties on July 1, 2011

Paul Stang, PhD

Senior Director of Epidemiology, Johnson & Johnson; Research Investigator, Observational Medical Outcomes Partnership
Dr. Stang has held a number of positions over the past 25 years in epidemiology and pharmacoepidemiology, including the past five years as Senior Director of Epidemiology at J&J. Currently, he also serves as a Research Investigator for the Foundation for the National Institutes of Health’s Observational Medical Outcomes Partnership (OMOP). Prior to joining J&J, Dr. Stang was a Vice-President at Cerner Corporation, which he joined after co-founding and serving as the Chief Scientific Officer of Galt Associates, a health care consulting and informatics start-up that was acquired by Cerner. He previously served in positions at other health care companies and academic medical centers. He holds adjunct faculty appointments at a number of institutions and is an elected Fellow of the International Society for Pharmacoepidemiology.

Dr. Stang has published widely in epidemiology, health outcomes, impact of health on productivity, and communications. He holds degrees from UNC-Chapel Hill and SUNY-Stony Brook.

Brian Strom, MD, MPH

George S. Pepper, Professor of Public Health and Preventative Medicine in Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania
Dr. Brian Strom is George S. Pepper Professor of Public Health and Preventive Medicine, Founding Chair and Professor of Biostatistics & Epidemiology, Professor of Medicine, Professor of Pharmacology, Founding Director of the Center for Clinical Epidemiology & Biostatistics, Founding Director of the Graduate Group in Epidemiology & Biostatistics, Vice Dean for Institutional Affairs, School of Medicine, and Senior Advisor to the Provost for Global Health Initiatives, at the University of Pennsylvania.

Although Dr. Strom's interests span many areas of clinical epidemiology, his major research interest is in the field of pharmacoepidemiology. He is editor of the field's major text (now going into its fifth edition), and is now Editor-in-Chief for Pharmacoepidemiology and Drug Safety, the official journal of the International Society for Pharmacoepidemiology. He is best known as a founder of the field of pharmacoepidemiology and a pioneer in using large automated databases for research. As one of many specific contributions, his work was pivotal in getting the American Heart Association and American Dental Association to reverse 50 years of guidelines, and recommend against use of antibiotics to prevent infective endocarditis, instead of recommending for this widespread practice.

Dr. Strom has been a consultant to NIH, FDA, CDC, USP, AAMC, JCAHO, foreign governments, most major pharmaceutical manufacturers, and many law firms. Dr. Strom is and has been involved with many associations, including the American Epidemiology Society, and is one of a handful of clinical epidemiologists ever elected to the American Society of Clinical Investigation and American Association of Physicians.

Dr. Strom received the 2003 Rawls-Palmer Progress in Medicine Award from the American Society for Clinical Pharmacology & Therapeutics, the Naomi M. Kanof Clinical Investigator Award of the Society for Investigative Dermatology, the George S. Pepper Professorship of Public Health and Preventive Medicine, and in 2006 he received the Sustained Scientific Excellence Award from the International Society for Pharmacoepidemiology. In addition, he was named the 2008 recipient of the John Phillips Memorial Award for Outstanding Work in Clinical Medicine. Dr. Strom has written more than 550 papers, he has been principal investigator for more than 250 grants, including over $89 million in direct costs alone, and has been invited to more than 390 talks outside his local area, including being the keynote speaker for numerous international meetings.

Dr. Strom earned a BS in Molecular Biophysics and Biochemistry from Yale University, an MD degree from the Johns Hopkins University School of Medicine, and an MPH in Epidemiology from the University of California, Berkeley. He completed his internship and residency in Internal Medicine and an NIH fellowship in Clinical Pharmacology at the University of California, San Francisco.

Priscilla Velentgas, MS, PhD

Director of Epidemiology, Quintiles Outcome
Dr. Priscilla Velentgas is a Director of Epidemiology at Quintiles Outcome and is responsible for scientific leadership including proposal and protocol development, analysis and interpretation of outcomes and safety studies, as well as senior project guidance and business development support.

Dr. Velentgas joined Quintiles Outcome in May 2009 after having worked with Dr. Dreyer for many years, and develops study concepts, creates protocols, and leads scientific work in a variety of areas, including disease registries and observational studies of drug and vaccine comparative effectiveness and safety. Dr. Velentgas is an experienced pharmacoepidemiologist and has conducted numerous studies of the safety of newly introduced vaccines and therapeutics. She has specific expertise in the use of automated health care claims data and implementation of distributed research networks. Prior to joining Outcome, she has been a faculty member in the Harvard Medical School Department of Ambulatory Care and Prevention, and a Director of Epidemiology for Genzyme and i3 Drug Safety. Dr. Velentgas’ experience also includes postdoctoral work and Fred Hutchinson Cancer Research Center and the University of Washington in cancer and cardiovascular epidemiology.

Dr. Velentgas received her MS and PhD in Epidemiology from the University of Washington School of Public Health and Community Medicine. She is based in Cambridge, MA.

Samuel Wagner, PhD, RPh

Executive Director, Oncology, Global Health Economics and Outcomes Research, Bristol-Myers Squibb
Samuel Wagner has more than eighteen years of experience in health services and outcomes research, with ten years in industry. Beginning his pharmaceutical industry career at Pharmacia Corporation, Samuel held roles of increasing responsibility, working in health economics and outcomes research. After Pfizer acquired Pharmacia, he supported primarily oncology outcomes research. Samuel later joined AstraZeneca as Director of Health Economics and Outcomes Research and team leader for the respiratory franchise and also led a field-based team of outcomes experts aligned to US health plans. More recently, Samuel was Vice President, Science and Strategy with Consumer Health Sciences International, a division of KantarHealth where he led mostly ePRO initiatives. He is currently Executive Director (Oncology), Global Health Economics and Outcomes Research at Bristol-Myers Squibb in Lawrenceville, NJ.

Samuel received a BSc with a major in chemistry, biochemistry and mathematics, a BPharm, MPharm and PhD, with a focus in pharmacoepidemiology and pharmaceutical economics from Northwest University in South Africa. He also completed a post-doctoral fellowship with the University of Minnesota, where he still holds adjunct faculty positions. His work has been widely published.

Paul Wicks, PhD

Director of Research and Development, PatientsLikeMe
Paul Wicks, Ph.D., is the Director of Research and Development (R&D) at PatientsLikeMe. An internationally recognized expert in psychological aspects of neurodegenerative conditions, Dr. Wicks is responsible for shaping the scientific and medical validity of the PatientsLikeMe platform. As R&D director, he leads a team of experts charged with conducting scientific research that generates insights from the personal health data shared by patient members.

Under Dr. Wicks’ direction, the PatientsLikeMe R&D team has produced over fifteen peer-reviewed publications, which have appeared in major scientific journals such as Nature Biotechnology, Clinical Investigation, Journal of Medical Internet Research, and European Journal of Neurology. Highlights include an innovative patient-led trial of lithium use in ALS, a survey of off-label drug use, and development of patient-reported outcome measures for people with multiple sclerosis. In addition to working with elite research organizations, including Johns Hopkins, Oxford University, and ALS Untangled, the R&D team also provides professional services to the company’s commercial partners.

Prior to joining PatientsLikeMe, Dr. Wicks worked directly with patients from around the world, studying cognition in rare forms of ALS and the psychological consequences of Parkinson’s disease. Those research findings have also been published in numerous peer-reviewed journals. A frequent conference presenter on the power of personalized medicine in improving health outcomes, Dr. Wicks has twice won the British Neuropsychiatry Association prize for best speaker and was awarded "TR35 Humanitarian of the Year" by MIT's Technology Review magazine.