FDA Approval Pathways 101

Speakers

Clay Alspach, J.D.
Leavitt Partners, Principal
clay.alspach@leavittpartners.com

Kelly George, Ph.D.
Avalere, Principal
KGeorge@Avalere.com

Reshma Ramachandran, M.D. MPP
Yale School of Medicine, Physician- Fellow
reshma.ramachandran@yale.edu

Ameet Sarpatwari, Ph.D., J.D.
Assistant Professor of Medicine, Harvard Medical School
Associate Epidemiologist, Brigham and Women’s Hospital
Assistant Director, Program on Regulation, Therapeutics, And Law
Asarpatwari@bwh.harvard.edu

Marta Wosińska, Ph.D.
Visiting Fellow, Brookings
mwosinska@brrokings.edu

Experts and Analysts

Kirsten Axelsen, M.S.
American Enterprise Institute, Nonresident Fellow
Kirsten.axelsen@aei.org

Craig Burns, Ph.D.
America’s Health Insurance Plan, Vice President of Research
cburns@ahip.org

Sean Dickson, J.D., MPH
West Health Policy Center, Director Health Policy
Sdickinson@westhealth.org

Stacie B. Dusetzina, Ph.D.
Vanderbilt University, Associate Professor Health Policy
S.dusetzina@vanderbilt.edu

Andrea Noda, MPP
Arnold Ventures, VP of Health Care- Drug Pricing
anoda@arnoldventures.org

Rachel L. Sher, J.D. MPH
Manatt, Partner
Rsher@manatt.com

Kirk Williamson, M.A.
Arnold Ventures, Health Care Manager
Kwilliamson@arnoldventures.org

Government

Sally Choe, Ph.D.
FDA Center for Drug Evaluation and Research (CDER), Director of Generic Drugs
Sally.choe@fda.hhs.org

Nathan S. Ivey, Ph.D.
FDA, Regulatory Programs Staff
Nathan.ivey@fda.hhs.org

Erica Blake Payne, J.D.
FDA, Regulatory Council Office of Generic Drug Policy
erica.payne@fda.hhs.org

Stakeholders

Craig Burns, Ph.D.
Jasper Therapeutics, Vice President of Program Management
Cburns@jaspertherapeutics.com

Heather Foster, MPH
Association for Community Affiliated Plans, Vice President of Marketplace Policy
hfoster@communityplans.net

Allison Herrity, MPH
National Organization for Rare Disorders, Policy Analyst
aherrity@raredisseases.org

Mark Howell, J.D.
American Hospital Association, Director of Policy and Patient Safety
mhowell@aha.org

Christine Aguiar Lynch, MPH
Association for Community Affiliated Plans, Vice President of Medicare and MLTSS Policy
Clynch@communityplans.net

Monet Stanford, Pharm.D.
Association for Accessible Medicines, Director of Policy
Mstanford@accesiblemeds.org

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