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

John K. Leighton, Ph.D.

Acting Director, Division of Hematology Oncology Toxicology, Office of Hematology and Oncology Products Office of New Drugs, Center for Drug Research and Evaluation (CDER), FDA
john.leighton@fda.hhs.gov

301-796-2230

Program

Development of anticancer drugs

Proposed Project for IOTF Fellow

The Fellow would be expected to contribute to the regulatory function of the Division (i.e., review pharmacology and toxicology of INDs and NDAs) and develop a research project of archival records that would be of mutual benefit and interest to the Fellow and the Division. Laboratory-based research that would enhance the interaction.

Regulatory Activity

The US FDA, Center for Drug Evaluation and Research, Office of Oncology Drug Products reviews and evaluates scientific data submitted by pharmaceutical manufacturers in support of Investigational New Drug (INDs), New Drug Applications (NDAs) and Biologic License Applications (BLA) involving anticancer therapies. Based on the submitted data, the Office authorizes initiation of clinical trials and recommends marketing approval of new drugs for human use, or new uses for already marketed drug and biological products.

The IOTF Fellow in pharmacology/toxicology, working in a multidisciplinary environment that includes chemists, medical officers, and clinical pharmacologists would have a unique opportunity to provide scientific guidance to pharmaceutical manufacturers about the design of translational studies for therapies to treat or prevent cancer. Fellows engage in the review of relevant literature articles and submitted nonclinical data that support an IND, NDA or BLA. Fellows would be expected to attend internal FDA meetings with the drug product review team, working groups that address cross-center topics, meetings with application sponsors, and expert Advisory Committee meetings convened to discuss NDAs, BLAs and policy issues. Participation in committees that investigate scientific issues related to incorporation of emerging technologies in the regulatory process, such as toxicogenomics and nanotechnology, are also encouraged. Archival research on topics of mutual interest to the Fellow and the Office related to pharmacology and toxicology of oncology products and publication of findings is encouraged.


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.

Pengfei Song, Ph.D.

Team Leader, Division of Clinical Pharmacology 5, Center for Drug Evaluation and Research (CDER), FDA
pengfei.song@fda.hhs.gov
301-796-0801

Program

Clinical Pharmacology in Oncology Drug Regulation

Proposed Project for IOTF Fellow

Project 1: Design and Analysis of Pediatric Trials It is known that developing drugs for pediatric indications in oncology is a particular challenge. These challenges range from recruitment to disease diversity. Innovative clinical trial designs and more powerful analyses could help FDA and sponsors in bringing safe and effective treatments to market successfully. Analysis of pediatric data submitted to the FDA would provide valuable insights towards achieving this objective. The results of the analyses could be used to simulate various drug development paradigms.

Project 2: Innovative Quantitative Methods to Analyze Pivotal Trial Data Repeated measures of desired and undesired effects are collected in almost all clinical trials. Conventionally the time to a particular event is analyzed for the control and test treatments. All data between randomization and that time are ignored. The primary aim of the proposed simulation experiments is to assess the properties of the longitudinal data analysis methods that utilize all the data collected during pivotal trials. These properties will be compared to those of the conventional methods.

Regulatory Activity

Review and provide input on INDs ranging from the preclinical stage to post-approval commitments (Phase 1 to Phase 4). Opportunity to apply knowledge gained from research project(s) to specific applications. Attend internal meetings and meetings with sponsors. Participate in the NDA review process. Participate in courses/workshops at CDER/FDA Attend professional meetings and help to coordinate interactions with professional societies such as AACR, ASCO, ASCPT, ACCP, AAPS