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Cancer Therapy Evaluation Program (CTEP)
Last Updated: 10/19/15

Staff, Pictures and Bios

Jan Casadei, Ph.D., Chief, Regulatory Affairs Branch

Jan Casadei, Ph.D. joined the National Cancer Institute in 1991 and became Chief of the Regulatory Affairs Branch in 2008. Her area of expertise covers FDA regulations, policies and guidelines for the conduct of clinical studies with investigational agents. More…

Sherry Ansher, Ph.D., Associate Chief, Agreement Coordination Group

Sherry Ansher is the Associate Chief of the Agreement Coordination Group in the Regulatory Affairs Branch. Dr. Ansher joined CTEP in 1994 after spending a year in the Grants Associates Program of the NIH as the Coordinator of Research and Development Agreements. More…

Rita Misra, Ph.D., M.P.H., Toxicologist, Associate Chief, Drug Regulatory Group

Rita Misra is the Associate Chief of the Drug Regulatory Group in the Regulatory Affairs Branch. She joined RAB/CTEP in 2001 as a Senior Regulatory Scientist. Dr. Misra has a B.A. in Biochemistry from Rutgers University and a Ph.D. in Environmental Toxicology from Cornell University. More…

Massimo Cardinali, M.D., Senior Regulatory Affairs Manager

Massimo Cardinali, M.D. joined the Drug Regulatory Group in the Regulatory Affairs Branch in 2014. Dr. Cardinali graduated from the Medical School of the University of Pisa, Italy, in 1984. In 1986, after completing his residency in the Nuclear Medicine Department of the University of Pisa, he moved to NIH to conduct basic research in Oncology. More…

Jason Denner, B.S., Regulatory Program Specialist, R&D Agreements

Jason Denner is a Regulatory Program Specialist in the Regulatory Affairs Branch. He has been working with RAB since 2003 and has also supported other programs within the division during that time. Jason earned his B.S. degree from the University of Baltimore with a major in Health Systems Management. More…

Michael Pelekis, Ph.D., M.B.A., Regulatory Affairs Manager

Michael Pelekis supports the interactions between the CTEP and the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiologic Health (CDRH) of the FDA. More…

Bhanu Ramineni, M.S., M.S., Regulatory Affairs Specialist

Bhanu Ramineni joined the Drug Regulatory Group in the Regulatory Affairs Branch in 2010. She holds two Master’s degrees: one in Environmental Sciences from Nagarjuna University, India and a second one in Biochemistry and Molecular Biology with a specialization in Biotechnology from Georgetown University. More…

Julie Rhie, Ph.D., Pharmacologist, Senior Regulatory Affairs Scientist

Julie Rhie joined the Regulatory Affairs Branch in 2001. Her role within RAB includes acting as a regulatory liaison for CTEP with the FDA and as an internal regulatory policy advisor. More…

Karen Said, B.A., Executive Assistant

Karen Said joined the Regulatory Affairs Branch in March of 2012 and serves as the Executive Assistant and Office Manager. She attended Hampshire College in Amherst, MA and graduated with a B.A. degree in Liberal Arts and a concentration in Nutrition. More…

Lora Spencer, J.D., M.B.A., R&D Agreements Advisor

Lora Spencer is the Research and Development Agreements Advisor, in the Agreements Coordination Group, Regulatory Affairs Branch (RAB). Lora, with over ten years experience in the bio-pharmaceutical industry, joined the NCI in 2015 after spending two years at the NIH in the Presidential Management Fellows Program, the federal government's flagship leadership development program. More…

Jian Zhang, Ph.D., Senior Specialist, R&D Agreements

Jian Qiao Zhang received his Ph.D. in Biochemistry from the University of Nottingham, UK. Dr. Zhang completed his postdoctoral training at the NIH and the American Red Cross focusing on protein-protein interactions and cancer research. More…

About the Branch Chief

Jan Casadei, PhD Jan Casadei, PhD joined the National Cancer Institute in 1991, where she is now chief of the Regulatory Affairs Branch, CTEP. Her area of expertise covers FDA regulations, policies and guidelines for the conduct of clinical studies with investigational agents. As the chief of the Regulatory Affairs Branch, Dr. Casadei is responsible for facilitating the development of promising investigational anti-cancer agents, by providing regulatory/IND support More…