Panel 2: Introduction to the Regulatory Process

John M. O'Brien, PharmD, MPH, is the president and chief executive officer of the National Pharmaceutical Council (NPC), which sponsors and participates in research on the appropriate use of pharmaceuticals and the clinical and economic value of pharmaceutical innovation. Dr. O’Brien’s broad experience spans the private sector, academia, and government. Before joining NPC, Dr. O’Brien was senior advisor to the. U.S. Secretary of Health and Human Services and Deputy Assistant Secretary of Planning and Evaluation (health policy). Dr. O’Brien earned his doctorate in pharmacy at Nova Southeastern University, his master’s degree in public health at the Johns Hopkins Bloomberg School of Public Health and studied pharmacy and public policy at the University of Florida. Dr. O’Brien has served on the boards of Pharmacy Quality Solutions, Kennedy Center Circles, and the Congressional Chorus.

Mike Park is a partner in Alston & Bird’s Health Care Legislative & Public Policy Group. He has more than 20 years of health law and policy experience. He focuses his practice on representing health care providers, insurers, and manufacturers before Congress and the administration on a wide range of health care legislative and regulatory issues and also counsels clients in connection with congressional investigations. Before joining Alston & Bird, Mr. Park served as health policy counsel to Senator Charles Grassley (R-IA) during his tenure as Chairman of the Senate Committee on Finance, where he developed legislation on issues including Medicare payment policy, health information technology, and program integrity and conducted congressional investigations on public and private health care stakeholders. Mr. Park also served as a policy coordinator in the U.S. Department of Health and Human Services Office of the Secretary, as a project officer for Medicare payment demonstration programs at the Centers for Medicare & Medicaid Services, and as a health research analyst at the Center for Studying Health System Change. He currently serves as an adjunct faculty member at George Washington University’s School of Public Health. He received his bachelor’s degree from Connecticut College, his juris doctorate degree from Penn State Dickinson School of Law, and his master’s in public health from Columbia University.

Kristi Martin offers policy expertise and strategic counsel to advance impactful health policy, with a focus on improving health and well-being through practical solutions. She has dedicated over 20 years to this work, gaining valuable experience in the public sector, private sector, and philanthropy. Currently, she is a Director at Camber Collective -- a strategy consulting firm that pairs analytic rigor and a human-centered approach grounded in equity to disrupt the status quo. Throughout her career, Kristi has held significant roles that demonstrate her expertise. Most recently, she served as Chief of Staff and Senior Advisor to the Deputy Administrator in the Center for Medicare at the Centers for Medicare & Medicaid Services (CMS). In this capacity, she was instrumental in advancing regulatory policy in Medicare and implementing the Inflation Reduction Act, including the Medicare Drug Price Negotiation Program. Her efforts contributed to the successful negotiation of the first set of drug prices under the program, resulting in substantial savings for Medicare beneficiaries and the program. Prior to her role at CMS, Kristi served as the Vice President for Health Care at Arnold Ventures, where she led the philanthropy's prescription drug pricing portfolio. She also held the position of Managing Director of Waxman Strategies' health practice, working closely with Congressman Henry Waxman on health policy outcomes. Notably, as a Senior Advisor in the Obama administration's Office of Health Reform, she oversaw the implementation of cross-cutting departmental public health and prevention initiatives under the Affordable Care Act. Kristi is a proud Wildcat from the University of Kentucky earning a bachelor's and a master's degree in health communication as well as a Master of Public Administration from the George Washington University.