Engaging Patients in Payer and CMS Decisions to Shape Access to Innovative Medicines

June Cha is a policy director at FasterCures, Milken Institute Health. She brings decades of experience in infectious diseases research, non-profit, multilateral, and bilateral organizations, government, and the pharmaceutical industry, where she has focused on US and global health policy and program strategies across the healthcare ecosystem. Cha has in-depth knowledge and experience in medical product research and development, pharmaceutical regulatory laws, regulations, and policy, and has led efforts to promote sustainable and equitable healthcare. Most recently, Cha worked with the Bill and Melinda Gates Foundation and the African Union Development Agency to provide program and policy strategies for creating a continental safety monitoring platform in Africa. She also worked in the pharmaceutical industry as a regulatory policy professional, collaborating with stakeholders from patient organizations, non-profits, trade associations, and the government to advance scientifically sound and innovative regulatory science. Before joining the industry, Cha served as a public health advisor at the US Department of Health and Human Services, leading the strategic planning and review process to ensure the advancement of women’s health issues. She began her policy career at global health organizations advocating efficient HIV prevention policy for mothers and children in Sub-Saharan Africa. Cha received a PhD in Biochemistry from the University of Notre Dame and an MPH in Global Public Health Leadership from New York University.

Lee A Fleisher, MD, ML (Masters in Law) is the Founding Principal and CEO at Rubrum Advising, LLC, a consulting firm dedicated to identifying strategic pathways, including regulatory counsel, to ensure the highest quality care is adopted and diffused across the healthcare sector. From July 2020-July 2023, he was the Chief Medical Officer and Director of the Center for Clinical Standards and Quality for the Centers for Medicare and Medicaid Services. In this capacity, he was responsible for executing all national clinical, quality, and safety standards for healthcare facilities and providers, as well as establishing coverage determinations for items and services that improve health outcomes for Medicare beneficiaries. He serves as a Senior Advisor of the Bipartisan Policy Center and FasterCures of the Milken Institute, Senior Fellow of the Leonard Davis Institute of Health Economics and Visiting Fellow of the Duke-Margolis Center. He is a member of the Steering Committee of CHAI (Coalition of Health AI), consultant to the FDA Digital Health Advisory Committee and a member of the HITAC of the ONC. From 2004 through July 2020, he was the Robert D. Dripps Professor and Chair of Anesthesiology and Critical Care and Professor of Medicine at the University of Pennsylvania and is currently Emeritus Professor and continues to practice clinically. In 2007, he was elected to membership of the National Academy of Medicine.

Campbell Hutton, is Senior Vice President, Global Advocacy at Breakthrough T1D, a non-profit organization whose mission is to accelerate life-changing breakthroughs to cure, prevent and treat type 1 diabetes (T1D) and its complications. In her role she oversees the regulatory affairs and health policy teams within the Advocacy Department as well as the advocacy work in the European Union (EU). Ms. Hutton joined Breakthrough T1D in 2009 as Director, Regulatory Affairs – Medical Devices and since that time has focused on shaping policies that will accelerate the research, development, approval and availability of innovative T1D therapies. Prior to joining JDRF, Ms. Hutton was Vice President, Strategic Consulting Group at Becker & Associates Consulting, a boutique scientific consulting firm in Washington, D.C. Ms. Hutton holds a bachelor’s degree in biology from Washington and Lee University and a master’s degree in public health from the Gillings School of Global Public Health at the University of North Carolina, Chapel Hill.