2022 Roundtable Discussion

James G. (Jim) Scott, President & CEO of Applied Policy, founded the company in 2009 from a desire to apply his in-depth knowledge of federal health policy and help healthcare providers and companies succeed.  As a respected member of the health policy community, he offers valuable experience and access to key players in government and industry.

Prior to founding Applied Policy, Jim helped introduce optimal Medicare coding and coverage for all Hoffmann-La Roche pharmaceutical products.  While at Roche, he also worked to resolve Medicare and Medicaid reimbursement issues at federal level and served as the pharmaceutical manufacturer’s principal contact with the Centers for Medicare & Medicaid Services (CMS). 

Jim served as Senior Legislative Advisor at CMS, advising the CMS Administrator on congressional intent in implementing the Medicare Modernization Act of 2003 and engaging Members of Congress in the implementation process.  He received agency-wide awards for his work with Congress in 2005 leading to successful implementation of the new Medicare prescription drug benefit and with congressional appropriators on the FY 2006 President’s Budget request.

Prior to his service with CMS, Jim was an Assistant Counsel with the Office of the Legislative Counsel of the U.S. Senate, where he was a principal drafter of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 along with other Medicare legislation.  Jim and his work were recognized through the unanimous passage of a Senate Resolution and in numerous statements by Senators and Representatives printed in the Congressional Record.

Jim serves on the Board of Directors of the Alliance for Aging Research, founded the Northern Virginia Health Policy Forum and is a member of the Steering Committee of the Partnership for a Healthier Alexandria.

Dr. Doug Jacobs is the Chief Transformation Officer in the Center for Medicare at the Centers for Medicare and Medicaid Services (CMS). At CMS he is helping lead Medicare’s efforts to promote value-based care, advance health equity, and encourage delivery system transformation. He most recently served as the Chief Medical Officer and Chief Innovation Officer for the Pennsylvania Department of Human Services, helping to oversee the state Medicaid and human services programs amidst the pandemic for the 16,000 person state agency. He was tapped by Governor Wolf to lead the state’s Whole Person Health Reform initiative, which included expanding value-based care, promoting health equity, and addressing the social determinants of health. Under his leadership, the Department of Human Services created Pennsylvania’s first equity incentive program in Medicaid, established new rules incorporate community-based organizations to address the social determinants of health, and oversaw Medicaid’s increasing movement towards value-based care. He also helped lead the COVID-19 response for the agency, creating programs to protect long-term care facilities and roll out the COVID-19 vaccine to vulnerable populations. Dr. Jacobs is a practicing board-certified internal medicine physician and is an Assistant Professor of Clinical Medicine at the Penn State Hershey Medical Center. He is also an avid writer, having published pieces in the New England Journal of Medicine, Journal of the American Medical Association, New York Times, and Washington Post. He trained in Internal Medicine Primary Care at the Brigham and Women’s Hospital and served as Chief Resident at the West Roxbury VA hospital, received his MD at the University of California San Francisco School of Medicine, his MPH at the Harvard T.H. Chan School of Public Health, and his Bachelor’s in Sciences from Brown University.

Dr. Kraus serves as Vice President, Clinical Development Therapeutic Head, Central Nervous System, at Otsuka. In his role, he is responsible for the design and oversight of all clinical research programs and protocols, and he participates in due diligence of potential acquisitions, in-licensing or joint-development programs for clinical viability and the potential for commercial success. Dr. Kraus has over 25 years of experience in clinical, academic, and pharmaceutical medicine and drug development. He has worked in multiple settings within the pharmaceutical industry, including large Pharma (GSK), clinical research organizations (ICON, Parexel) and biotech (Brii Biosciences).

Throughout his career, Dr. Kraus has led, contributed to, or managed drug development programs across several psychiatric, neurological, and rare diseases, including schizophrenia, major depressive disorder, anxiety disorders, bipolar disorder, Duchene muscular dystrophy, amyotrophic lateral sclerosis, myasthenia gravis, multiple sclerosis, epilepsy, Parkinson’s disease, Alzheimer’s disease, neuropathic pain and neuroinjury. He has substantial regulatory engagement experience, including with Food and Drug Administration, Pharmaceutical and Medical Device Agency, European Medicines Agency, and Paediatric Committee.

Dr. Kraus received his MD and PhD (neurobiology) from Duke University in Durham, NC. He completed his psychiatry residency training at the University of North Carolina, Chapel Hill, NC, where he was also Chief Resident. Following residency training, he joined the faculty of UNC where he was an Associate Professor, Associate Director of Residency Training and Associate Director/Director of the Psychiatry Clinical Research Unit. He also served as Chief, Adult Psychiatry, of Dorothea Dix Hospital in Raleigh, NC, at the time the largest public hospital in the state.  He is a Diplomate, American Board of Psychiatry & Neurology, and a Distinguished Fellow of the American Psychiatric Association.

Greg Gierer, MPP, joined the Better Medicare Alliance as Vice President of Policy and Research in September 2021, bringing nearly 25 years of policy and advocacy experience to the role. 

His post at Better Medicare Alliance follows leadership roles with some of the nation’s leading health care associations including the Pharmaceutical Research (PhRMA) and Manufacturers of America and the Blue Cross and Blue Shield Association (BCBSA).  Greg most recently served as Senior Vice President for Policy at America’s Health Insurance Plans (AHIP).  He began his career on Capitol Hill as an aide to U.S. Senator Christopher J. Dodd (D-CT).

Greg is a graduate of Providence College and earned his master’s degree in public policy (MPP) from Georgetown University.  He also served on the Cancer Support Community’s Cancer Policy Institute Advisory Board.

A Connecticut native, Greg resides in Leesburg, Virginia with his wife and three children.

Sue Peschin, MHS, is president and CEO of the Alliance for Aging Research, the leading nonprofit organization dedicated to accelerating the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health. The Alliance’s vision is to create a culture that respects aging as a greater good and values investments that advance independence, dignity, and equity. Ms. Peschin has led efforts to increase federal investment in aging research; raise awareness of geriatric cardiovascular diseases; develop an older patient and family caregiver research engagement network called Talk NERDY to Me (NERDY-Nurturing Engagement in Research and Development with You); advocate for patient affordability and equity-based value frameworks; and improve Medicare treatment access. Ms. Peschin serves on the Boards of: Heart Valve Voice U.S.; the National Health Council; the Committee for Advancement of Respite Research; the Preparedness and Treatment Equity Coalition; and Voices of Alzheimer’s; as well as on the Science Advisory Board for the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI); the USP Council of the Convention (CoC); and on the UMD Claude D. Pepper Older Americans Independence Center Community Advisory Board. Previously, Sue served in senior roles at the Alzheimer’s Foundation of America, Consumer Federation of America, Hadassah, and the Violence Policy Center. Ms. Peschin earned a B.A. in Sociology from Brandeis University, and a M.H.S. degree in Health Policy from the Johns Hopkins University Bloomberg School of Public Health. Sue lives in Rockville, MD with her husband Steven, and sons Max and Nathan.

Dr. Robert M. Califf was confirmed earlier this year as the 25th Commissioner of Food and Drugs.

As Commissioner, Dr. Califf oversees the full breadth of the FDA portfolio and execution of the Federal Food, Drug, and Cosmetic Act and other applicable laws. This includes assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices; the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation; and the regulation of tobacco products.

Dr. Califf has had a long and distinguished career as a physician, researcher, and leader in the fields of science and medicine.  He is a nationally recognized expert in cardiovascular medicine, health outcomes research, health care quality, and clinical research, and a leader in the growing field of translational research, which is key to ensuring that advances in science translate into medical care.

This is Dr. Califf’s second stint as Commissioner.  He also served in 2016 as the 22^nd Commissioner.  Before assuming the position at that time, he served as the FDA’s Deputy Commissioner for Medical Products and Tobacco.

Prior to rejoining the FDA in 2022, Dr. Califf was head of medical strategy and Senior Advisor at Alphabet Inc., contributing to strategy and policy for its health subsidiaries Verily Life Sciences and Google Health. He joined Alphabet in 2019, after serving as a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and was the founding director of the Duke Clinical Research Institute.

Dr. Califf is a graduate of Duke University School of Medicine. He completed a residency in internal medicine at the University of California, San Francisco and a fellowship in cardiology at Duke.

Michael Irizarry, M.D., M.P.H., is Senior Vice President of Clinical Research and Deputy Chief Clinical Officer of the Alzheimer’s Disease and Brain Health, Eisai Inc. He is responsible for the overall strategy and clinical development of the company’s neurosciences portfolio, including clinical pharmacology and translational medicine.

Dr. Irizarry joined Eisai in September 2018 as Vice President of Clinical Research, Epilepsy/Sleep, in which he led the clinical development of Eisai’s Epilepsy and Sleep/Wake programs, including regulatory submissions for compounds that received regulatory approvals to treat epilepsy and insomnia. He was named Vice President of Clinical Research for Eisai’s neuroscience business in May 2019, and soon promoted to his current dual role in April 2020.

Prior to joining Eisai, Dr. Irizarry served as Vice President, Early Clinical Development, Neurosciences at Eli Lilly, responsible for the Phase 1 and 2 neurosciences portfolio. His focus was on neurodegeneration advancing molecules from candidate selection to investigational new drug applications, up through proof-of-concept studies. Before joining Eli Lilly, he was Acting Vice President, World-Wide Epidemiology at GlaxoSmithKline, where his team of more than 60 epidemiologists and database analysts supported clinical trial planning; safety and effectiveness studies; and oversight and application of in-house claim databases and electronic health records.

Dr. Irizarry earned undergraduate and medical degrees from Georgetown University, and a Masters of Public Health (M.P.H.) degree from the Harvard School of Public Health. He completed his neurology residency and Memory Disorders Fellowship at Massachusetts General Hospital, and continued as a member of the Harvard Medical School faculty at the Massachusetts Alzheimer’s Disease Research Center. His research has encompassed molecular mechanisms, clinical-pathological correlations, animal models, biomarkers, and epidemiology of neurodegenerative diseases, especially Alzheimer’s disease.

Focused on improving health outcomes for people living with rare diseases by advancing the development of treatment and diagnostic opportunities for rare disease patients through science-driven public policy, Annie’s work includes building strong partnerships with policy makers, federal agencies, Industry, and alliances. 

Annie has served within the community for nearly three decades through her roles with the EveryLife Foundation, Parent Project Muscular Dystrophy (PPMD) and the Muscular Dystrophy Association (MDA). In that time she helped lead legislative efforts around passage and implementation of the MD-CARE Act (2001, 2008, 2014), the Patient Focused Impact Assessment Act (PFIA) which became the Patient Experience Data provision within the 21^st Century Cures Act (sec 3001), engagement with the FDA and Industry around regulatory policy and therapeutic pipelines, led access efforts as the first therapies were approved in Duchenne, and engaged with ICER around the development of the modified framework for the valuation of ultra-rare diseases. Since joining EveryLife in 2018, Annie has led the National Economic Burden of Rare Disease study, the development of the ICD Code Roadmap, the broad community collaboration to develop the Guide to Patient Involvement in Rare Disease Therapy Involvement, organization engagement in PDUFA VII, community advocacy for the Speeding Therapy Access Today Act (STAT Act), and federal and state newborn screening efforts.

Annie’s community roles include service on the Board of Directors of CureSMA, the Patient Driven Values in Healthcare Evaluation (PAVE) Steering Committee, the Patient Centered- Core Impact Set (PC-CIS) Steering Committee, the National Health Council’s PCORI Valuation Group, the Innovation and Value Initiative (IVI) Patient Advisory Committee, the National Duchenne Newborn Screening Pilot Steering Committee, the Institute for Gene Therapies (IGT) Patient Advocacy Advisory Council, and as a member of the NIH National Center for Advancing Translational Sciences (NCATS) Advisory Council and the Cures Accelerator Network (CAN) Advisory Board.