2018 Roundtable Discussion

Susan Peschin, MHS, is president and CEO at the Alliance for Aging Research. The Alliance for Aging Research is dedicated to accelerating the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health. For more than 30 years, the Alliance has guided efforts to substantially increase funding and focus for aging at the NIH, FDA, AHRQ, and CDC; built influential coalitions to guide groundbreaking regulatory improvements for age-related diseases; and created award-winning, high-impact educational materials to improve the health and well-being of older adults and their family caregivers.

Since 2012, Ms. Peschin has been a driving force in the growth and success of the organization. Under her leadership, the Alliance has remained strong in these priorities and continued to build on its reputation as a forward-thinking public policy and health education organization. As president and CEO, she leads the strategic development and implementation of Alliance initiatives, as well as manages Board governance and organizational operations. As a thought leader on many aging-related issues, she has led the Alliance in efforts to: boost older adult immunization rates; increase NIH Alzheimer’s disease and aging research funding; raise awareness of geriatric cardiac issues; develop a senior patient and family caregiver network through a PCORI engagement grant; and co-organize a first-ever NIH geroscience summit. She participates in major industry and policy symposiums around the country each year, and has published opinion pieces in news outlets nationwide.

Ms. Peschin currently serves on the Board of Heart Valve Voice U.S. and the National Council on Patient Information and Education; on the World Economic Forum’s Council on Human Enhancement; on the National Advisory Council for the National Institute on Aging at the NIH; on the Steering Committee for the Coalition for Imaging & Bioengineering Research; and as a member of the Lifespan Domain Task Force for the Clinical & Translational Science Award program, funded by NCATS at the NIH.

Ms. Peschin earned a BA in Sociology from Brandeis University, and a MHS degree in Health Policy from the Johns Hopkins University Bloomberg School of Public Health.

Amy Bassano is the Deputy Director of the Center for Medicare and Medicaid Innovation (CMMI) at the Centers for Medicare and Medicaid Services. Prior to assuming this position in April 2016, Ms. Bassano was the Director of the Patient Care Models Group at CMMI leading CMS’s efforts on bundled payments including the Bundled Payments for Care Improvement (BPCI) Initiative and the Comprehensive Care for Joint Replacement (CJR) model and the development of physician specialty models such as the Oncology Care Model. In addition, she was responsible for the Home Health Value Based Purchasing Model and the Medicare Care Choices Model. Ms. Bassano also held senior management positions in the Center for Medicare at CMS overseeing Medicare payment policy for a variety of areas including inpatient and outpatient hospitals, physicians, ambulatory surgical centers, clinical laboratories, and Part B drugs. Prior to her tenure at CMS, Ms. Bassano was a Program Examiner at the Office of Management and Budget where she was the lead Medicare analyst on Medicare Part B and D issues. Ms. Bassano has an MA in Policy Studies from Johns Hopkins University and a BA in history from Tufts University.

Arlene S. Bierman, MD, MS, leads the work of CEPI, which consists of five divisions: the Evidence-Based Practice Center Program; the U.S. Preventive Services Task Force Program; the Division of Decision Science and Patient Engagement; the Division of Health Information Technology; and the Division of Practice Improvement, as well as the National Center for Excellence in Primary Care Research. Dr. Bierman is a general internist, geriatrician, and health services researcher, whose work has focused on improving access, quality, and outcomes of health care for older adults with chronic illness in disadvantaged populations. Dr. Bierman has also developed strategies for using performance measurement as a tool for knowledge translation and has conducted research to increase policymakers’ use of evidence.

As a tenured professor, she held appointments in health policy, evaluation, and management; public health; medicine; and nursing at the University of Toronto, where she was the inaugural holder of the Ontario Women’s Health Council Chair in Women’s Health and a senior scientist in the Li Ka Shing Knowledge Institute at St. Michael’s Hospital. Dr. Bierman was also principal investigator for the Project for an Ontario Women’s Health Evidence-Based Report Card (POWER) study, which provided actionable data to help policymakers and health care providers improve health and reduce health inequities in Ontario.

Dr. Bierman has served on many advisory committees, including the Geriatric Measurement Advisory Panel of the National Committee for Quality Assurance and the boards of Health Quality Ontario and the National Center of Excellence National Initiative for Care of the Elderly (NICE). She received her MD degree from the University of North Carolina School of Medicine in Chapel Hill where she was a Morehead Fellow. She completed fellowships in outcomes research at Dartmouth Medical School and community and preventive medicine at the Mount Sinai School of Medicine. She also served as an Atlantic Philanthropies Health and Aging Policy Fellow/American Political Science Foundation Congressional/Fellow.

A family physician, clinical epidemiologist, and health services researcher, Selby has more than 35 years of experience in patient care, research, and administration. He is responsible for identifying strategic issues and opportunities for PCORI and implementing and administering programs authorized by the PCORI Board of Governors.

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 members 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 to 2003.

A native of Fulton, Missouri, Selby received his MD from Northwestern University and his MPH from the University of California, Berkeley. He was a commissioned officer in the Public Health Service Corps from 1976 to 1983 and received the Commissioned Officer’s Award in 1981.

Barry Liden is Vice President of Patient Engagement for Edwards Lifesciences (NYSE:EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring. He is responsible for helping the Irvine, California-based company engage with, learn from and empower patients and their families to improve the healthcare experience. Liden joined Edwards in 2002 as Director of Global Communications, responsible for the company’s external public relations, and has served in a number of public affairs positions, most recently as Vice President of Government Affairs, responsible for public policy development and advocacy.

Before joining Edwards, Liden served for three years as Vice President for public affairs at Rogers & Associates, the largest privately-owned strategic public relations agency on the West coast, and for four years as Principal at Dallas-based Bustin & Co., an integrated marketing consultancy. He began his public affairs career in 1990 as the Director of Government Relations for the Los Angeles Area Chamber of Commerce, responsible for transportation and environmental policy development and advocacy for the greater L.A. business community.

For more than 25 years, Liden has integrated public policy, government relations, marketing, public relations and crisis management practices to provide strategic solutions to his clients and employers’ challenges. He enjoyed sharing this experience with public relations undergraduate students at the University of Southern California as an adjunct faculty member in the Annenberg School for Communications for seven years before moving to the Washington, D.C. area in 2007.

Liden has a bachelor of science in public administration from the University of Southern California, and a juris doctor from Loyola Law School of Los Angeles. He lives in Garrett Park, Maryland with his wife Tracy and three sons, Jack, Nick and Luke.

Susan Peschin, MHS, is president and CEO at the Alliance for Aging Research. The Alliance for Aging Research is dedicated to accelerating the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health. For more than 30 years, the Alliance has guided efforts to substantially increase funding and focus for aging at the NIH, FDA, AHRQ, and CDC; built influential coalitions to guide groundbreaking regulatory improvements for age-related diseases; and created award-winning, high-impact educational materials to improve the health and well-being of older adults and their family caregivers.

Since 2012, Ms. Peschin has been a driving force in the growth and success of the organization. Under her leadership, the Alliance has remained strong in these priorities and continued to build on its reputation as a forward-thinking public policy and health education organization. As president and CEO, she leads the strategic development and implementation of Alliance initiatives, as well as manages Board governance and organizational operations. As a thought leader on many aging-related issues, she has led the Alliance in efforts to: boost older adult immunization rates; increase NIH Alzheimer’s disease and aging research funding; raise awareness of geriatric cardiac issues; develop a senior patient and family caregiver network through a PCORI engagement grant; and co-organize a first-ever NIH geroscience summit. She participates in major industry and policy symposiums around the country each year, and has published opinion pieces in news outlets nationwide.

Ms. Peschin currently serves on the Board of Heart Valve Voice U.S. and the National Council on Patient Information and Education; on the World Economic Forum’s Council on Human Enhancement; on the National Advisory Council for the National Institute on Aging at the NIH; on the Steering Committee for the Coalition for Imaging & Bioengineering Research; and as a member of the Lifespan Domain Task Force for the Clinical & Translational Science Award program, funded by NCATS at the NIH.

Ms. Peschin earned a BA in Sociology from Brandeis University, and a MHS degree in Health Policy from the Johns Hopkins University Bloomberg School of Public Health.

Jeffrey E. Shuren became the director of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) in January 2010. He previously served as Acting Center Director, beginning in September 2009. The center is responsible for assuring the safety, effectiveness, and quality of medical devices; assuring the safety of radiation-emitting products (such as cell phones and microwave ovens); and fostering device innovation.

“Our center experts and programs help get safe and effective technology to patients and health care professionals on a daily basis,” says Dr. Shuren. “Rapid technological advances enable us to approve such innovations as a diagnostic test for the H1N1 influenza virus, an expandable prosthetic rib for children with abnormal growth conditions, and a test that can help detect ovarian cancer.”

Dr. Shuren received his BS and MD degrees from Northwestern University under its Honors Program in Medical Education. He completed his medical internship at Beth Israel Hospital in Boston, his neurology residency at Tufts New England Medical Center, and a fellowship in behavioral neurology and neuropsychology at the University of Florida. He received his JD from the University of Michigan.

Dr. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy.

Dr. Shuren has served in a leadership role at FDA or on behalf of the agency on numerous initiatives, including:

• reauthorization of the Medical Device User Fee Act, which dramatically shortens review times for device applications;
• creation of the Sentinel Initiative, which works toward a national electronic system for monitoring medical product safety;
• development of FDA’s Pandemic Influenza Preparedness Strategic Plan;
• development of FDA’s Counterfeit Drug Task Force Report;
• development of the Interagency Food Safety Working Report to the President;
• implementation of FDA provisions of the Medicare Prescription Drug Improvement and Modernization Act; and,
• development and implementation of the Interagency Import Safety Working Group’s Report to the President: Action Plan for Import Safety.

From 1999 to 2000, Dr. Shuren served as a detailee on Senator Edward Kennedy’s staff on the Senate Health, Education, Labor, and Pensions Committee. From 1998 to 2003, he also was a staff volunteer in the National Institutes of Health’s Cognitive Neuroscience Section where he supervised and designed clinical studies on human reasoning.

As director of the Division of Items and Devices, Coverage and Analysis Group at the Centers for Medicare and Medicaid Services, Dr. Shuren oversaw the development of Medicare national coverage determinations for drugs, biologics, and non-implantable devices.

Peter P. Stein, MD, is the Deputy Director of the Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA).

Peter earned his medical degree from University of Pennsylvania and trained at Yale-New Haven Hospital in internal medicine, and in endocrinology and metabolism. He was on faculty at Yale in the Section of Endocrinology and served as the associate program director for the Primary Care Residency Program. Subsequently, Peter was the section chief for endocrinology and the program director for internal medicine residency program at the Medical College of Georgia. Peter joined Bristol-Myers Squibb in 1999, subsequently working at Merck, Janssen, and finishing his career in industry at Merck as Vice-president for late-stage development in Diabetes and Endocrinology. During his industry career, Peter led development programs for several currently approved diabetes medications, and has worked on a wide range of programs from discovery through early and late clinical development. He is a clinical associate professor at the Robert Wood Johnson Medical School, where he maintained a practice in endocrinology for many years. Peter joined FDA in late 2016 as the Deputy Director, Office of New Drugs, CDER.

Daily Discoveries. Dr. Eva Kohegyi specializes in research for medications in neurologic and psychiatric indications, where she works to find treatments for patients with Alzheimer’s, Tourette’s disease, schizophrenia, bipolar disorder and other illnesses of the central nervous system. Today, she is responsible for global clinical development of the assigned programs for Otsuka, where she designs and implements clinical trial programs, as well as works to ensure the scientific integrity of research methodologies and submissions to regulatory authorities until the new medications could get to the pharmacies.

The Driving Force. For most of her life, Kohegyi knew she wanted to work in medicine, and many people told her that she was destined to become a psychiatrist because of her keen interest in mental health. She has also been personally touched by many of the diseases she works to treat today: Her uncle has schizophrenia, her father battled depression and her son has ADHD. Every day, Kohegyi goes to work motivated to make a difference in the lives of people with similar conditions.

Personal motivation and patience is essential to the arduous research process. “Biopharmaceutical research is not instant gratification,” Kohegyi says. “It sounds easy, but some of the studies take five or six years, and the whole time we don’t know if at the end we’ll have a positive result or not.”

Alzheimer’s, for example, has few treatments options, but the biopharmaceutical industry is tirelessly working to find ways to improve patients’ lives. It’s an exhausting process, says Kohegyi. “So many companies are trying to find a treatment for Alzheimer’s. All of the researchers are looking at the news thinking, ‘Come on, anybody – any company – please just find a positive study. Just have a medication out there so that we know we are on the right path.’”

Challenges, Chances and Looking Forward. Kohegyi says that in an area like Alzheimer’s treatment, researchers may need fundamentally new models of disease. It will likely take efforts from countless more scientists before a workable solution is found, but the rapid pace of innovation keeps Kohegyi hopeful.

“We are still here. We can still run new clinical studies, and we have brand-new opportunities with digital medicine, personalized treatment and artificial intelligence. With these new technologies, we can identify ways to conduct clinical research to be more efficient, faster and more effective.”