CDER Leadership Bios

Amy Comstock Rick, J.D. Associate Director for Rare Disease Strategy Amy Comstock Rick, J.D., is CDER’s Associate Director for Rare Disease Strategy and the Director of Strategic Coalitions for FDA’s Rare Disease Innovation Hub (the Hub). She serves in a cross-cutting role across FDA’s Center for Drug Evaluations and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to facilitate implementation of the Hub. More about Amy Comstock Rick, J.D. Theresa M. Mullin, Ph.D. Associate Director for Strategic Initiatives Theresa Mullin, Ph.D., serves as CDER’s Associate Director for Strategic Initiatives. She oversees areas of strategic interest to external stakeholders. She leads the Patient-Focused Drug Development (PFDD) initiative, which includes work related to the FDA Reauthorization Act (FDARA) and implementation of the 21st Century Cures Act. She also leads CDER’s International Program. More about Theresa M. Mullin Ph.D. Patrick Raulerson, J.D. Director, Office of Regulatory Policy As Director of CDER’s Office of Regulatory Policy (ORP), Patrick Raulerson, J.D., provides leadership and guidance to the Center regarding policies and procedures related to the regulation of human drugs. He is also the chair of CDER’s Strategic Policy Council. More about Patrick Raulerson, J.D. Mary T. Thanh Hai, M.D. Director, Office of New Drugs Mary Thanh Hai, M.D. serves as the Director of the Office of New Drugs (OND) in the Center for Drug Evaluation and research. OND oversees the clinical and nonclinical investigations supporting drug development programs for prescription drugs and therapeutic biologics and non-prescription drugs. More about Mary T. Thanh Hai, M.D. ShaAvhree Buckman-Garner, M.D., Ph.D., FAAP Director, Office of Translational Sciences ShaAvhrée Buckman-Garner, M.D., Ph.D., FAAP is the Director of CDER's Office of Translational Sciences (OTS). OTS is comprised of the Office of Biostatistics, Office of Clinical Pharmacology, Office of Computational Science, Office of Study Integrity and Surveillance, provides oversight to CDER research involving human subjects, the CDER ORISE Program, as well as CDER regulatory science research. OTS is responsible for providing coordination for Critical Path initiatives across CDER in partnership with individual CDER offices. More about ShaAvhree Buckman-Garner MD, Ph.D., FAAP Carter Beach, J.D. Director, Office of Executive Programs As Director of the Office of Executive Programs (OEP), Carter Beach oversees a variety of programs for the Center for Drug Evaluation and Research (CDER), including executive operations, legislative affairs, project management, learning and organizational development, the scientific advisory committee program, product jurisdiction and combination products, and formal dispute resolution and ombudsman services. More about Carter Beach, R.Ph. Gerald J. Dal Pan, M.D., M.H.S. Director, Office of Surveillance and Epidemiology Gerald J. Dal Pan became the Director of the Office of Surveillance and Epidemiology (known then as the Office of Drug Safety) in November 2005. Before that, he was the Director of the Division of Surveillance, Research, and Communication Support. More about Gerald J. Pan, M.D., M.H.S. M. Khair ElZarrad, Ph.D., M.P.H. Director, Office of Medical Policy M. Khair ElZarrad, Ph.D., M.P.H., is the Director of the Office of Medical Policy (OMP) in FDA’s Center for Drug Evaluation and Research (CDER). He has served as the Deputy Director of OMP since 2017. More about M. Khair ElZarrad, Ph.D., M.P.H. Eric Stone, M.B.A. Director, Office of Management Eric Stone is Director of CDER's Office of Management. He also serves as the CDER Executive Officer and CDER’s Associate Director for Management. He leads the center’s administrative management operations, which includes more than 5,000 employees and an annual budget of more than $1 billion, comprised of a mix of congressional appropriations and multiple user fee programs. Under Mr. Stone’s leadership, the Office of Management staff manages all aspects of: ethics management, human capital management, financial management (including budget formulation, user-fee collection, and budget execution), acquisition management, employee safety, and facilities management. More about Eric Stone, M.B.A. Sridhar Mantha, M.B.A., M.S., B.Tech. Director, Office of Strategic Programs Sridhar (Sri) Mantha, M.B.A., M.S., B.Tech., serves as Director of CDER’s Office of Strategic Programs (OSP). OSP plays a lead role in many of the center’s strategic initiatives and modernization efforts, including development of benefit-risk and other decision support tools, data standardization, data governance, lean process management, program analysis, enterprise informatics, resource capacity planning, and major user fee negotiations. OSP leads implementation of CDER’s business informatics governance function in support of business modernization objectives. More about Sridhar Mantha, M.B.A., M.S., B.Tech. Jill Furman, J.D. Director, Office of Compliance Jill Furman, J.D., serves as the Director of the Office of Compliance in the Center for Drug Evaluation and Research (CDER). The Office of Compliance is charged with protecting the public from poor quality, unsafe, and ineffective drug products through proactive compliance strategies and risk-based enforcement actions. More about Jill Furman, J.D.