FDA Approval Pathways 101

Clay Alspach, J.D., is a principal based in Washington, D.C. Clay specializes in federal health care policy and advocacy related to the FDA, Medicare, Medicaid, private health insurance and digital health. Prior to joining Leavitt Partners, Clay served as Chief Health Counsel for Chairman Fred Upton of the U.S. House of Representatives Energy and Commerce Committee. During seven years with the committee, he managed, provided strategic direction, and served as the principal representative for the committee on all of its health care-related work. Clay spearheaded legislative initiatives that successfully reformed the SGR (MACRA), reauthorized FDA user fees (FDASIA), and established a national system for drug supply chain security (Drug Quality and Security Act). Clay also led the committee’s legislative accomplishments on biopreparedness and security, public and private medical research, controlled substance and DEA matters, and the 21st Century Cures Act. Prior to this service for the committee, Clay clerked for the Honorable Ronald L. Buckwalter of the U.S. District Court for the Eastern District of Pennsylvania and worked as a litigator in private law practice. He also worked as a legislative clerk at the committee from 1999 to 2000 under Chairman Thomas J. Bliley (R-VA). Clay received his bachelors of arts cum laude from the University of Richmond and holds a juris doctor from the University of Texas at Austin.

Contact: clay.alspach@leavittpartners.com

Kelly L. George, Ph.D., RAC, supports clients in navigating the FDA policy environment for drugs, biologics, and medical devices. She applies scientific and regulatory understanding to overarching drug development strategies towards establishing quality, safety and efficacy for FDA products (pre/post)approval while balancing the impact on patient access, time to market entry, cost of drug development, and the creation of a sustainable market. Prior to joining Avalere, Kelly focused on pipeline technologies in pre-FDA approval phases of development at the Innovation Institute. Before that, she worked as a scientific consultant with Fourth River Solutions where she focused on business strategy development and in-depth market analysis.Kelly has a Ph.D. in bioanalytical chemistry from the University of Pittsburgh, a BS in biology from James Madison University and a regulatory affairs certification.

Contact: kgeorge@Avalere.com

Reshma Ramachandran, M.D., MPP, (VA Scholar) is a board-certified family physician and second-year fellow within the Yale National Clinician Scholars Program. Her research focuses on the realignment of incentives for healthcare stakeholders including pharmaceutical companies, hospitals, and universities towards prioritizing equitable patient access to safe, effective health technologies. Prior to this role, Reshma worked as research faculty as part of the Innovation + Design Enabling Access (IDEA) Initiative at the Johns Hopkins Bloomberg School of Public Health, where she focused on policies to address the global challenge of antimicrobial resistance and unaffordable access to prescription drugs. Dr. Ramachandran trained in both medicine at the Alpert Medical School at Brown University and in public policy at the Harvard Kennedy School of Government. She completed her family medicine residency at Kaiser Permanente Los Angeles Medical Center. Previously, she served as the first PharmFree Fellow with the American Medical Student Association focused on removing the undue influence of pharmaceutical companies on prescribing behavior and medical education. She is part of the National Steering Committee for the Doctors for America Drug Affordability Action Team. She also is a board member of Universities Allied for Essential Medicines (UAEM) North America and the American Medical Student Association Foundation.

Contact: reshma.ramachandran@yale.edu

Ameet Sarpatwari, Ph.D., J.D., is an assistant professor of Medicine at Harvard Medical School and the Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. His research draws upon his interdisciplinary training as an epidemiologist and lawyer and focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes.​Dr. Sarpatwari completed his undergraduate studies at the University of Virginia, where he was a Jefferson Scholar. He subsequently studied epidemiology at the University of Cambridge and law at the University of Maryland, where he was a John L. Thomas Leadership Scholar. Dr. Sarpatwari’s current work focuses on risk evaluation and mitigation strategies, biosimilars, orphan drug policy, and drug development and pricing. In addition to his work with the Center for Bioethics, he also serves as a Faculty Affiliate with the Department of Health Policy and Management at the Harvard T.H. Chan School of Public Health, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Behavioral Insights Group at the Harvard Kennedy School. He teaches an annual course on public health law at the Chan School.

Marta E. Wosińska, Ph.D., is a visiting fellow at the USC-Brookings Schaeffer Initiative on Health Policy. She is a healthcare economist with a particular expertise in prescription drugs and experience spanning academia and federal government. Dr. Wosińska’s government experience includes serving as director of the Bureau of Economics at the Federal Trade Commission, chief healthcare economist in the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services, and director of economics staff at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation & Research. Dr. Wosińska also served as economic advisor to the U.S. Senate Finance Committee, providing drug market analysis and expert guidance for the Committee’s bipartisan investigative and legislative work on drug pricing. Among academic institutions, she was consulting professor and deputy director for policy at the Duke-Margolis Center for Health Policy at Duke University and an assistant professor of marketing at the Harvard Business School.

Contact: mwosinkska@brookings.edu

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