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Speaker Biosketches and Disclosures


Moderator


Elise Berliner, Ph.D.,
received her doctorate in biophysics from Brandeis University and was a Congressional Fellow at the Office of Technology Assessment. Prior to joining AHRQ, she worked as a consultant to pharmaceutical and medical device companies on cost-effectiveness and outcomes research, technology assessment and reimbursement planning. She also has several years of experience in research and development at a number of medical technology companies working on innovations such as high speed magnetic resonance imaging, flow cytometry and neural-network based automated microscopy. Dr. Berliner's program areas are: technology assessment, methods of systematic review, medical devices and other medical technologies.

Disclosure: Dr. Berliner reports that she has nothing to disclose.


Speakers


Richard Gliklich, M.D.,
is President of Outcome, the leading provider for patient registries, studies, and technologies for evaluating real-world outcomes.

Dr. Gliklich focuses on clinical research on the effectiveness, safety and quality of care. Dr. Gliklich was principal investigator and senior editor 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,” now in its second edition. 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 one 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 90 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, one of 13 DEcIDE centers under the Agency for Healthcare Research and Quality’s Effective Healthcare Program. 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 a Professor at Harvard Medical School.

Disclosure: Ownership interest – Outcome Sciences, Inc., which provides patient registry services and produced the AHRQ-funded, Registries for Evaluating Patient Outcomes: A User’s Guide: 2nd Edition.

Nancy Dreyer, M.P.H., Ph.D., 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 epidemiologists, outcomes researchers, and biostatisticians who design, conduct, and interpret observational research on comparative effectiveness and safety, and quality improvement programs.

Dr. Dreyer has more than 25 years of experience in pharmacoepidemiologic research. 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 lead role in developing guidance on Good Research Practices for Observational Studies of Comparative Effectiveness (see www.graceprinciples.org Exit Disclaimer), and in 2009 was named as a Steering Committee Member for the European Medicines Agency’s PROTECT Project for the Innovative Medicines Initiative.

In addition to her work at Outcome, Dr. Dreyer is a Fellow and Board Member of the International Society of Pharmacoepidemiology. She is sits on the Drug Information Association Real World Outcomes Task Force, and ISPOR’s Prospective Observational Clinical Studies Task Force. She is also a member of the University of North Carolina School of Public Health Dean’s Advisory Council and has served on the boards of the Drug Research Group and the Board of Overseers for the Heller School for Social Policy and Management at Brandeis. Also she was a Consumer Representative in radiopharmaceuticals for the FDA.

She trained at the University of North Carolina in Chapel Hill, earning a masters degree and doctorate in Epidemiology. Her experience includes founding and leading Epidemiology Resources, Inc. as CEO, 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, an internationally renowned postgraduate summer program. Dr. Dreyer also spent five years as a senior executive at UnitedHealth Group’s subsidiary, Ingenix/i3 Research. In 2007 Dreyer was recognized by the trade journal, Pharmavoice, as one of the 100 most inspiring people in the pharmaceutical and life sciences industry.

Disclosure: Ownership interest – Outcome Sciences, Inc., which provides patient registry services and produced the AHRQ-funded, Registries for Evaluating Patient Outcomes: A User’s Guide: 2nd Edition.