Bryan R. Luce, PhD, MBA

PACE Initiative Chair

Senior Vice-President, Science Policy, United BioSource Corporation

Bryan R. Luce, PhD, MBA, is Senior Vice President, Science Policy for United BioSource Corporation (UBC). Dr. Luce founded MEDTAP® International (now part of UBC), serving as its Chairman, President, and CEO until 2002. Previously, he held positions as Director of Battelle’s Centers for Public Health Research and Evaluation, Director of the Office of Research and Demonstrations, Centers for Medicare and Medicaid Services, and Senior Analyst, Office of Technology Assessment (OTA) of the United States Congress.

Dr. Luce is a consultant to numerous government agencies as well as pharmaceutical and device firms worldwide, a member or chair of socioeconomic and public health policy advisory boards for several leading pharmaceutical companies, and recently was a member of the Medicare Evidence Development & Coverage Advisory Committee (MedCAC). He is a Senior Scholar with the Department of Health Policy, Jefferson Medical College, an Adjunct Senior Fellow at the Leonard Davis Institute, University of Pennsylvania, and has authored more than ninety scientific publications, including three textbooks on technology assessment, health policy, and cost-effectiveness analysis. He founded the Bayesian Initiative in Health Economics and Outcomes Research. He is a Past President of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and, in 2008, received the Society’s Avedis Donabedian Outcomes Research Lifetime Achievement Award. A former Special Forces Officer, Dr. Luce holds the rank as Lieutenant Colonel (Retired), Medical Service Corps, US Army Reserves. His undergraduate and master’s training were at the Universities of Vermont and Massachusetts at Amherst. He received his doctorate from the School of Public Health at the University of California at Los Angeles (UCLA).

Donald A. Berry, PhD

Head, Division of Quantitative Sciences

Professor and Frank T. McGraw Memorial Chair for Cancer Research

Chairman, Department of Biostatistics, MD Anderson

Donald A. Berry holds the Frank T. McGraw Memorial Chair for Cancer Research at The University of Texas M. D. Anderson Cancer Center, where he is Head of the Division of Quantitative Sciences and Chairman of the Department of Biostatistics. In addition, he serves as the faculty statistician on the Breast Cancer Committee of the Cancer and Leukemia Group B (CALGB), a national oncology group. Through Berry Consultants, LLC he has consulted with many pharmaceutical and medical device companies on clinical trial design and analysis issues.

He is well known as a developer of adaptive designs that minimize sample size while having a greater chance of detecting true signals of drug activity, efficiently using information that accrues over the course of the trial. He is also co-developer (with Giovanni Parmigiani) of BRCAPRO, a widely used program that provides individuals’ probabilities of carrying mutations of breast and ovarian cancer susceptibility genes BRCA1 and BRCA2.

Dr. Berry received his Ph.D. in statistics from Yale University, and previously served on the faculty at the University of Minnesota and at Duke University, where he held the Edger Thompson Professorship in the College of Arts and Sciences. Dr. Berry is the author of more than 250 published articles as well as several books on biostatistics. In the last two years he has had first-authored publications in the New England Journal of Medicine, the Journal of the American Medical Association, and Nature Reviews Drug Discovery, and two senior-authored articles in the New England Journal of Medicine. Dr. Berry has been the principal investigator for numerous medical research programs funded by the National Institutes of Health, the National Cancer Institute, and the National Science Foundation. He is a Fellow of the American Statistical Association and of the Institute of Mathematical Statistics.

Don Buesching, PhD

Acting Director, Center of Excellence in Epidemiology and Health Services Research in Global Health Outcomes, Eli Lilly and Company

Don joined Eli Lilly and Company in 1993 as a Health Outcomes Research Scientist, Division of Global Health Outcomes Research, where he focused on economic and quality of life research for central nervous system products. In 1995, Don became scientific team leader for the neuroscience area in Global Health Outcomes Research. In 1999, Don joined the New Product Research area in Lilly’s US Outcomes Research group as a Senior Health Outcomes Research Scientist.  In 2001, he became Director of USOR and in 2004 was appointed to the first Research Advisor role within the health outcomes function at Lilly.

Currently Don is serving as the Acting Director for the newly created Center of Excellence in Epidemiology and Health Services Research in Global Health Outcomes at Lilly. Don holds a Ph.D. in medical sociology from the University of Illinois, Urbana.

Jaime Caro, MDCM, FRCPC, FACP

Senior Vice President, Health Economics, United BioSource Corporation

His initial work in theoretical epidemiology led to applied research for the Health Technology Assessment Council of Quebec, a pioneer in the then nascent field. This early interest in the proper approach to evaluating health care interventions has resulted in efforts to help government organizations in countries as diverse as Germany and Colombia develop and implement their methodologies; and to appointments on the steering committees of various global initiatives to address specific diseases.

In addition to Dr. Caro’s work and publications on more than 100 disease models, he has continued active research on methods for modeling diseases and the application of epidemiologic concepts to economic studies. This has included the development of approaches for dealing with complex time dependencies and the transfer of modeling techniques from other fields to medicine—modifying discrete event simulation for use in economic and risk-benefit analyses and the modeling of adaptive clinical trials. More recently, he has focused on the development of a suitable metric to guide health care decisions.

Steven Goodman, MD, MHS, PhD

Professor of Oncology, Center for Clinical Trials and the Berman Bioethics Institute, Johns Hopkins School of Medicine

Editor, Clinical Trials: Journal of the Society for Clinical Trials

Senior Statistical Editor, Annals of Internal Medicine

 At Johns Hopkins, Dr. Goodman is on the core faculties of the Center for Clinical Trials and the Berman Bioethics Institute. He was a co-director of the Johns Hopkins Evidence-Based Practice Center, and teaches a wide range of courses in the Bloomberg School of Public Health on evidence synthesis, epidemiology and clinical research methods.

 Dr. Goodman received his AB from Harvard College, MD from New York University, completed a pediatric residency at Washington University in St. Louis, and received an MHS in Biostatistics and PhD in Epidemiology from Johns Hopkins University. He is board-certified in pediatrics.

Murray N. Ross, PhD

Vice President, Kaiser Foundation Health Plan, Inc.

 Director, Kaiser Permanente Institute for Health Policy

Dr. Ross brings the valuable ability to absorb and synthesize complex health care issues, and to explain the practical implications of market developments and public policies to government leaders and health care industry decision makers.  As a result, he is sought after as a speaker to national and international audiences on a wide range of health care topics. He holds a wealth of knowledge of the intricacies of Medicare and advises KP's leadership on business and public policy issues arising from ongoing changes in that program. His current policy research focuses on how the U.S. health system can make more effective use of new drugs, devices, and medical procedures and how to encourage greater integration of care delivery to improve quality.  Dr. Ross holds a number of internal and external advisory positions.

Before joining Kaiser Permanente in 2002, Dr. Ross spent most of his professional career as a policy advisor to the United States Congress. He served almost five years as the executive director of the Medicare Payment Advisory Commission, an influential nonpartisan agency charged with making recommendations on Medicare policy issues to the Congress. Previously, he spent nine years at the Congressional Budget Office, lastly heading up the group charged with assessing the budgetary impact of legislative proposals affecting the Medicare and Medicaid programs.

Dr. Ross earned his doctorate in economics from the University of Maryland, College Park, and completed his undergraduate work in economics at Arizona State University.  He enjoys running, writing, and traveling.

J. Sanford (Sandy) Schwartz, MD

Leon Hess Professor of Medicine, Health Care Management & Economics

Senior Fellow & Former Director, Leonard Davis Institute University of Pennsylvania

Sandy has served as an advisor or consultant to a broad spectrum of organizations including: Agency for Healthcare Policy and Research, Centers for Disease Control, Department of Defense, Food and Drug Administration, Healthcare Financing Administration, Institute of Medicine, National Institutes of Health, National Library of Medicine, U.S. Congress Office of Technology Assessment, U.S. Preventative Services Task Force, Veterans Administration, World Health Organization, as well as numerous pharmaceutical and medical device companies.

Dr. Schwartz holds an AB from the University of Rochester and an MD from the University of Pennsylvania.

Sean Tunis, MD

Director, Center for Medical Technology Policy

Former CMS Chief Medical Officer

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 Lewin 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 History of Science from Cornell University, 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 School of Medicine.

Gail R. Wilensky, PhD

Senior Fellow, Project Hope

Former CMS Administrator

Dr. Wilensky is a Commissioner on the WHO’s Commission on the Social Determinants of Health, is co-chair of the Department of Defense task force on the Future of Military Health Care, is Vice Chair of the Maryland Health Care Commission and serves as a trustee of the Combined Benefits Fund of the United Mineworkers of America and the National Opinion Research Center. She is an elected member of the Institute of Medicine and has served two terms on its governing council. She is a former chair of the board of directors of Academy Health, a former trustee of the American Heart Association and a current or former director on numerous other organizations. She is also a director on several corporate boards.

From 1990 – 1992, she was Administrator of the Health Care Financing Administration, directing the Medicare and Medicaid programs. She also served as Deputy Assistant to President (GHW) Bush for Policy Development, advising him on health and welfare issues from 1992 to 1993.

From 1997 to 2001, she chaired the Medicare Payment Advisory Commission, which advises Congress on payment and other issues relating to Medicare, and from 1995 to 1997, she chaired the Physician Payment Review Commission. From 2001 to 2003, she co-chaired the President’s Task Force to Improve Health Care Delivery for Our Nation’s Veterans, which covered health care for both veterans and military retirees. In 2007, she served as a Commissioner on the President’s Commission on Care for America’s Returning Wounded Warriors.