IOTF Mentors: Track 1 and Track 2
While at FDA, fellows will each be assigned a mentor who will be a senior member of FDA scientific review staff. Fellows will be matched with a mentor through a process of mutual selection. Examples of FDA Track 1 and 2 cancer training opportunities are below. If you are interested in other Track 1 or 2 Malignant Hematology and Oncology opportunities at FDA, you may contact: Dr. Jennifer Gao or Dr. Kelly Norsworthy.
Peter Bross, M.D.
Clinical Oncology Reviewer and Team Leader, Office of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), FDA
Regulatory training for clinical oncologists
Research Project Summary
Analysis of early phase clinical oncology trials of cellular, tissue and gene therapies, especially cancer vaccines, to examine the trial design, eligibility criteria, dose escalation schema, definition of dose limiting toxicities, study endpoints in relationship to decision making for late phase trials. Analysis of late phase clinical oncology trials of cellular, tissue and gene therapies, especially cancer vaccines, to examine the trial design, utilization of comparator arms, primary endpoints and secondary endpoints. Development of biomarkers in clinical trials (in collaboration with Dr. Raj Puri). Development of paradigm of companion assay therapeutic - device combination.
Proposed Project for IOTF Fellow
Preparing research results for meeting abstracts and/or manuscripts for publication Gain considerable knowledge in regulatory activities as described below
- Pre-IND and IND reviews and meetings with sponsors
- End of phase II and pre-pivotal trial protocol review
- Pre-BLA clinical review
- Additional regulatory activities including Fast Track designation, special protocol assessments, 'emergency' IND's, patient reported outcome assessment
Kelly Norsworthy, M.D.
Clinical Team Leader, Division of Hematologic Malignancies I (DHMI), CDER, FDA
Novel therapeutics for hematologic malignancies: meta-analysis of clinical data from FDA submissions
Research Project Summary
To provide clinical oncologists with an extensive training opportunity in clinical trials design and implementation as well as regulatory foundation related to oncologic product development with an emphasis on treatment of patients with acute leukemia, myelodysplastic syndrome, or chronic myeloid leukemia. Analysis of late phase clinical oncology trials of cancer therapeutics to examine the trial design, primary endpoints, and secondary endpoints. We seek to retrospectively analyze trial-level and patient-level data from clinical trials of hematologic malignancies submitted to the FDA. Results will lead to a better understanding of clinical endpoints and safety and potentially inform clinical trial design to support safe and effective drug approvals for patients with hematologic malignancies.
Proposed project for IOTF Fellow
The fellow will collect and analyze outcomes data from prior regulatory submissions. They will prepare and present the research results in the form of a meeting abstract and/or manuscript for publication.
The fellow will learn about the multidisciplinary review of new drug applications (NDAs), biologics license applications (BLAs), and investigational new drug (IND) submissions for oncology products, focusing on clinically relevant endpoints and clinical design aspects of the review process. Other regulatory exposure will include meetings with sponsors, expedited program reviews (e.g. fast track and breakthrough therapy designation), and attendance at meetings, seminars and conferences within the Oncology Center of Excellence.