Joint Fellowship Training Program Fellows M. Stacey Ricci, Sc.D. Phone:   301-827-0830 E-Mail:   Stacey.ricci@fda.hhs.gov Professional Background Dr. Ricci received her Sc.D. in Molecular Toxicology from Tulane University and completed post-doctoral training in the Department of Medicine (Hematology/Oncology) at the University of Pennsylvania. She began the NCI-FDA Oncology Product Research/Review Fellowship program in October 2005. Research Interests Dr. Ricci's research background includes expertise in cancer biology and toxicology, with particular emphasis on many of the molecular signaling pathways relevant to cancer and chemotherapeutic drugs. As a graduate student, she focused on mechanisms of action of environmental carcinogens, specifically how cytochrome P450 expression and estrogenic signaling modulate the effects of dioxin. As a post-doctoral researcher, she studied the basic signaling mechanisms relevant to targeting cancer cell death pathways. In particular, she studied the mechanisms of tumor cell resistance to TRAIL (Tumor Necrosis Factor- Related Apoptosis-Inducing Ligand), a biological drug candidate currently in clinical trials. Her work led to the discovery that cancer cells expressing oncogenic levels of c-Myc are particularly susceptible to TRAIL-induced death. This work may translate to the use of c-Myc as a biomarker to help identify patients who are good candidates for TRAIL therapy. In addition, she identified a previously unknown TRAIL resistance mechanism that holds potential to be a target for disruption by the recently approved chemotherapeutic agent sorafenib, thereby enhancing cancer cell sensitivity to TRAIL-induced apoptosis. Dr. Ricci's interests in performing translation cancer research and desire to help expedite the movement of laboratory discoveries into cancer survival gains in the clinic, led her to the NCI-FDA Fellowship. As an NCI-FDA Fellow, she is currently being trained to review INDs for targeted biologic oncology drugs in FDA's Division of Monoclonal Antibodies. In addition, she is performing research examining the role that p63, a p53 family member, plays in squamous cell carcinoma oncogenesis and in the response of these tumors to current standard-of-care chemotherapy . Fellowship Experiences "The NCI-FDA Fellowship has been a wonderful opportunity to gain a thorough understanding of the FDA review process. Regulatory review training has included both a broad swath exposure to pharmacology/toxicology and clinical trail requirements for IND applications, and a greater focus on learning the safety concerns that drive regulatory requirements for biological drug product manufacturing processes. The training offered by the NCI-FDA Fellowship has provided me the opportunity to learn the process of moving a promising preclinical cancer therapeutic agent into a safe, and effective clinical trial." Career Goals "My overall career goal is to help put effective targeted cancer therapies into clinical use. Receiving the training offered by the NCI-FDA Fellowship has definitely helped with my goal to become a translational cancer researcher."

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