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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 five 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

Sean Khozin, M.D., M.P.H.

Director, FDA INFORMED, Associate Director, FDA Oncology Center of Excellence
Sean.Khozin@fda.hhs.gov

301-796-1435

Program

Information Exchange and Data Transformation (INFORMED) initiative

Research Project Summary

Launched in collaboration with the U.S. Department of Health and Human Services’ Innovation, Design, Entrepreneurship and Action (IDEA) Lab, Information Exchange and Data Transformation (INFORMED) is an incubator for collaborative oncology regulatory science research focused on supporting innovations that enhance FDA’s mission of promotion and protection of the public health. Drawing from the expertise of a diverse group of oncologists, data scientists, statisticians, and entrepreneurs-in-residence, INFORMED is expanding organizational and technical infrastructure for big data analytics and examining modern approaches in evidence generation to support regulatory decisions. Special emphasis is placed on systems thinking in oncology regulatory science research to facilitate development and adoption of new solutions for improving efficiency, reliability, and productivity in a broad range of workflows related to oncology drug development and regulatory decision making.

The research portfolio of INFORMED includes investigations into the use of real world data for clinical evidence generation and prospective pragmatic clinical trials, testing the utility of biosensors and the internet of things to quantify intrinsic and extrinsic (e.g., environmental) factors influencing the patient’s experience, identifying opportunities for machine learning and artificial intelligence to improve existing practices, and exploring the utility of emerging technologies such as blockchain to enable secure exchange of health data at scale. In addition, INFORMED is actively pursuing the development of programs to support creation of a knowledgeable, sustainable, and agile data science workforce capable of addressing the needs of cancer patients in today’s technology-driven and connected world.

Additional information:

Proposed Project for IOTF Fellow

Development of new computational and advanced analytical methods for conducting meta-analyses using big data of large variety.

Regulatory Activity

The fellow will learn about the multidisciplinary review of new drug applications (NDAs), biologics license applications (BLAs), and investigational new drugs (INDs) for oncology products, focusing on the computational and analytical aspects of the review process.


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; Acting Associate Director for Cell and Gene Therapies, Oncology Center of Excellence, FDA
ke.liu@fda.hhs.gov
240-402-8325

Progam

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.

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 (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 work.

  • 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
  • Attendance in meetings, seminars and conferences within oncology office, FDA and NCI.

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