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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 one of three mentors from the list below through a process of mutual selection. Mentors are listed in alphabetical order by last name.


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
peter.bross@fda.hhs.gov

301-827-5378

Program

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

Regulatory Activity

  • 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

Ke Liu, M.D., Ph.D.

Chief, Oncology Branch, Division of Clinical Evaluation, Pharmacology and Toxicology, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research (CBER), FDA;

Associate Director for Cell and Gene Therapies, Oncology Center of Excellence (OCE), Office of the Commissioner, FDA
ke.liu@fda.hhs.gov
240-402-8325

Program

Regulatory training for clinical oncologists

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 cancer vaccine, gene and cell therapies for cancer.

To provide hand-on experience from the regulatory perspective on the FDA’s fundamental role in ensuring the safety and efficacy of medical products through multiple interactions with professionals from other disciplines such as clinical pharmacology, toxicology, biostatistics, and chemistry, manufacturing and control.

To provide an opportunity for clinical oncologists in expanding their vision and insights for oncology product development through multiple interactions with stakeholders such as NCI, other FDA centers (OCE, CDRH and CDER), industry and patient advocacy community.

Proposed project for IOTF Fellow

Research projects will be individualized dependent on fellows’ background and interests.

Regulatory Activity

Fellows are expected to perform the following activities, in addition to their continued clinical activities at the NIH clinical center. Opportunity exists to publish the results of regulatory aspects of their review and research work at FDA.

  • Meetings with sponsors (Pre-IND, End of Phase I, II, Pre-Phase 3, Pre-BLA)
  • Special protocol assessment
  • Fast track designation
  • Breakthrough designation
  • Regenerative medicine advanced therapy designation
  • BLA and sBLA reviews
  • Participating in and organizing meetings, seminars and conferences within OCE, CBER, OTAT, FDA and NCI.

Kelly Norsworthy, M.D.

Acting Clinical Team Leader, Division of Hematologic Malignancies I (DHMI), CDER, FDA
Kelly.Norsworthy@fda.hhs.gov

301-348-1937

Program

Response Rate, Event-Free Survival, and Overall Survival in High-Risk Myelodysplastic Syndrome: Trial-Level and Patient-Level Analyses

Research Project Summary

To speed the development of novel therapeutics, sponsors have proposed using surrogate endpoints for OS in high-risk MDS clinical trials, such as overall response rate (ORR) and event free survival (EFS). We seek to retrospectively analyze trial-level and patient-level associations between ORR, EFS, and OS in high-risk MDS trials submitted to the FDA. Results will lead to a better understanding of high-risk MDS endpoints and potentially inform clinical trial design to accelerate drug approvals for MDS.

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.

Regulatory Activity

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.

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