Patient-Reported Outcomes (PRO) Consortium Workshop Speaker Bios

SPEAKERS:

ShaAvhrée Buckman, MD, PhD, FAAP
Director, Office of Translation Sciences, Center for Drug Evaluation and Research, Food and Drug Administration

ShaAvhrée Buckman is currently the Director of the Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). OTS is comprised of the Office of Biostatistics and the Office of Clinical Pharmacology. OTS provides oversight to CDER research involving human subjects as well as CDER regulatory science research. OTS is responsible for providing coordination for Critical Path initiatives across CDER in partnership with individual CDER offices. Dr. Buckman served as Deputy Director for OTS prior to accepting the position as Director. Before joining OTS, Dr. Buckman served as a medical team leader in the Division of Pediatric Drug Development, Office of Counter Terrorism and Pediatric Drug Development, CDER. Dr. Buckman received her MD and PhD degrees (with an emphasis on molecular cell biology) from Washington University School of Medicine. Dr. Buckman completed Pediatric specialty training at Baylor College of Medicine.

 

Laurie Beth Burke, RPh, MPH
Director, Study Endpoints and Labeling Development, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration

Laurie Beth Burke, RPh, MPH, leads the Study Endpoints and Label Development Team (SEALD) in the Office of New Drugs, Center for Drug Evaluation and Research, FDA. Ms. Burke's team advises the 17 OND review divisions in matters of regulatory policy pertaining to the development and validation of study endpoints. This advice addresses matters of clinical study protocol design, analysis, and interpretation of study endpoints to support drug development, labeling, and promotion. She also leads policy initiatives to increase the quality and consistency of drug labeling. Before taking this position in 2002, Ms. Burke led a group within the Division of Drug Marketing, Advertising, and Communications (DDMAC) in matters of regulatory policy development regarding the use of patient-reported outcomes in labeling and advertisements. In addition, she led the implementation of two FDA Modernization Act-related policies: industry dissemination of unapproved/new use information, and evidence standards for health care economic information disseminated to managed care. Ms. Burke joined the Public Health Service and the FDA upon graduation from Kansas University School of Pharmacy. Her Master's in Epidemiology is from the Uniformed Services University of Public Health Sciences.

Stephen Joel Coons, PhD
Director, Patient-Reported Outcomes Consortium, Critical Path Institute

Stephen Joel Coons is Director of the Patient-Reported Outcomes Consortium at the Critical Path Institute. Prior to joining C-Path, he was a professor in the College of Pharmacy and the Mel & Enid Zuckerman College of Public Health at the University of Arizona in Tucson. In addition, he served as co-director of the Arizona Cancer Center's Behavioral Measurements Shared Service. After receiving a BS degree in pharmacy from the University of Connecticut, Dr. Coons completed a hospital pharmacy residency at the VA Medical Center in Phoenix and earned an MS degree in pharmacy, an MEd degree in higher education, and a PhD in pharmacy (administrative and behavioral sciences) at the UA. His post-doctoral training in health outcomes research was completed at the University of California, San Diego (UCSD). Previous academic appointments have been in the colleges of pharmacy, medicine, and allied health professions at the University of Kentucky, and in the Division of Health Care Sciences at the UCSD School of Medicine. Stephen holds a part-time faculty position at the UA and is a fellow in the American Association of Pharmaceutical Scientists. For the past two decades, the primary focus of his research has been the measurement of patient-reported outcomes.

Maria Isaac, MASc, MD, PhD
Scientific Administrator, Science Advice & Orphan Drugs Sector (SAOD), European Medicines Agency (EMA)

Dr. Maria Isaac is a member of the Scientific Advice team at the European Medicines Agency (EMA) with over 15 years of international experience in academic, clinical, and regulatory fields. A native of Spain, Dr. Isaac qualified in medicine at the University of the Basque Country and obtained a master's degree from Temple University in Philadelphia (USA). She obtained her PhD in psychopharmacology, along with a postgraduate diploma in economics, from Birkbeck College at the University of London (Guy's Hospital 1998). At the EMA, Dr. Isaac has developed and maintained her interest in the clinical impact of innovative and advanced treatments with particular emphasis on biomarkers and new methodologies, not only for mental and neurological illness, though disorders of the nervous system remain her passion. As an honorary senior lecturer in psychiatry at the Institute of Psychiatry (a position she continues to hold), she built a clinical research program and was the Co-Director of the Psychopharmacology Evaluation Unit at University Hospital Lewisham, a unit that quickly achieved international recognition for its approach to novel pharmacological treatments of depression and the psychiatric aspects of chronic pain. Her career has focused on novel and innovative pharmacological, economic, and clinical treatment of mental illness.

Priti Jhingran, PhD
Director, US Health Outcomes, GlaxoSmithKline

Priti Jhingran is a Director in US Health Outcomes at GlaxoSmithKline, responsible for many therapy areas. Dr. Jhingran specializes in economic and patient outcome research for drug registration and public health interventions. Dr Jhingran received her Bachelor of Science in Pharmacy in India in 1987. She received her doctorate in Pharmacy and Health Care Administration from Northeast Louisiana University, Monroe, Louisiana, in 1993. She has been with GSK for over 15 years and has actively participated in many cross-pharmaceutical teams, including Health Outcomes Technical Group (HOTG), ISPOR Council, and the Ad Hoc Economic Working Group. She took the lead for the PRO Consortium project for HOTG and was instrumental in the conceptualization of the initiative. Dr. Jhingran was appointed as the co-director of the PRO Consortium in May 2009.

Nancy Kline Leidy, PhD
Senior Vice President, Scientific Affairs, and Senior Research Leader, United BioSource Corporation (UBC)

Nancy Kline Leidy has over 25 years of experience in clinical and health outcomes research, specializing in instrument development and the design and data analysis of clinical trials involving clinical, patient-reported, and functional outcomes assessment. She has presented her work internationally and published over 90 papers in refereed journals, books, and monographs, including the American Journal of Respiratory and Critical Care Medicine, European Respiratory Journal, PharmacoEconomics, Value in Health, and Quality of Life Research, among others. She is an active member of the American Thoracic Society (ATS) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and holds memberships in numerous other organizations. Dr. Leidy has been the recipient of many awards, and has served as a distinguished lecturer at universities throughout the U.S. She is currently principal investigator of the EXACT-PRO Initiative (EXAcerbations of Chronic Pulmonary Disease Tool), a multi-sponsor project bringing together clinical, methodological, measurement, and FDA regulatory experts to develop a standardized patient-reported outcome measure for evaluating exacerbations of chronic obstructive pulmonary disease (COPD). She earned her Bachelor of Science degree from Michigan State University, her Master's degree from the University of Washington in Seattle, and her PhD from the University of Michigan.

 

Wendy R. Sanhai, PhD
Senior Scientific Advisor, Office of Chief Scientist, Office of the Commissioner, Food and Drug Administration

Dr. Wendy Sanhai has a PhD in biochemistry and structural biology from the School of Medicine, State University of New York at Buffalo, and completed her Executive MBA at the University of Maryland's Smith School of Business. As Senior Scientific Advisor, Office of the Commissioner, FDA, Dr. Sanhai is responsible for the development, implementation, and management of scientific initiatives and strategic alliances consistent with the agency's public health mission. Dr. Sanhai serves as a Lead Federal Liaison for the FDA on a number of scientific consortia and committees. She is the recipient of the Commissioner's Leveraging/Collaboration Award, FDA, in 2005, 2006, and again in 2008. Dr. Sanhai held positions as a faculty member at the University of Maryland School of Medicine, and as a technology transfer specialist and patent advisor at the National Institutes of Health's Office of the Director, Office of Technology Transfer, where she managed a technology transfer portfolio of over 300 NIH invention families. Dr. Sanhai was the previous Director of Public Private Partnerships at the Foundation for NIH.

 

Robert J. Temple, MD
Deputy Center Director for Clinical Science, Center for Drug Evaluation and Research, Food and Drug Administration

Dr. Robert Temple was recently appointed Deputy Center Director for Clinical Science of FDA's Center for Drug Evaluation and Research, and is also Acting Director of the Office of Drug Evaluation I (ODE-I). He has served in this capacity since the office's establishment in 1995. Dr. Temple received his medical degree from the New York University School of Medicine in 1967. In 1972, he joined CDER as a Review Medical Officer in the Division of Metabolic and Endocrine Drug Products. He later moved into the position of Director of the Division of Cardio-Renal Drug Products. In his current position, Dr. Temple oversees ODE-1, which is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products. Dr. Temple has a long-standing interest in the design and conduct of clinical trials, and has written extensively on this subject, especially on choice of control group in clinical trials, evaluation of active control trials, trials to evaluate dose-response, and trials using "enrichment" designs.

Raymond L. Woosley, MD, PhD
President and CEO, Critical Path Institute

Dr. Raymond Woosley is the founding President, Chief Executive Officer, and Chairman of the Board of Critical Path Institute , headquartered in Tucson, Arizona. Dr. Woosley is also the Director of the Arizona Center for Education and Research on Therapeutics (AZ CERT), funded by a grant to C-Path from the Agency for Healthcare Research and Quality (AHRQ). Prior to founding C-Path, Dr. Woosley was Vice President for The University of Arizona (UA) Health Sciences Center and Dean of the UA College of Medicine. Prior to his move to Arizona, he was Associate Dean for Clinical Research and Chair of the Department of Pharmacology at Georgetown University School of Medicine. Dr. Woosley was a professor at Vanderbilt University Medical School, and served as the first US scientist for GlaxoSmithKline's initial US operations. Dr. Woosley earned his PhD in Pharmacology from the University of Louisville, his MD from the University of Miami, and completed post-doctoral training in pharmacology, internal medicine, and clinical pharmacology. His research has been published in over 265 peer-reviewed publications and 50 book chapters. He is a member of the National Academy of Science's Institute of Medicine's Drug Forum.