IOTF Mentors: Track 1 and Track 2

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


Brian Booth

Deputy Director, Division of Clinical Pharmacology 5, Center for Drug Evaluation and Research (CDER), FDA
brian.booth@fda.hhs.gov
301-796-1508

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


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.

Senior Medical Officer, Office of Hematology and Oncology Products, FDA
Sean.Khozin@fda.hhs.gov

301-796-1435

Program

Information Exchange and Data Transformation (INFORMED) initiative

Research Project Summary

In collaboration with Idea Lab at the Department of Health and Human Services, FDA Office of Hematology and Oncology Products has launched the INFORMED initiative to develop new mechanisms for the transformation and scientific exploration of the large and growing repository of the clinical trial data submitted as part of marketing applications. This project enables generation of new knowledge by allowing FDA scientists to test new hypotheses on aggregated and standardized datasets using novel computational methods for data analysis. For example, the system can be used to understand risk of adverse events that occur infrequently in a single clinical trial but can be characterized by analyzing aggregate datasets or to assess the ability of new endpoints to predict clinical benefit across multiple datasets/clinical trials.

Proposed Project for IOTF Fellow

Development of new computational methods for conducting meta=analyses using clinical trial data.

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 ondoloby products, docusing on the computational aspects of the review process.


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

Chief, Oncology Branch, Division of Clinical Evaluation, Pharmacology and Toxicology, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research (CBER), FDA
ke.liu@fda.hhs.gov
301-827-9084

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

Mercedes Serabian, M.S., DABT

Chief, Pharmacology/Toxicology Branch; FDA/CBER/OCTGT/DCEPT
mercedes.serabian@fda.hhs.gov
301-827-5102

Program

Regulatory training for clinical oncologists

Research Project Summary

Analysis of the various tumor-bearing animal models that are used for "efficacy" studies for various tumor vaccines, to include 1) the types of tumors evaluated in animals and their relevancy to the intended clinical indication, 2) the dosing schemes used in the animals and their relevancy to the clinical situation, 3) the endpoints gathered in the animal studies and their relevancy to the clinical outcome, 4) the toxicities observed in the animals and their relevancy to clinical outcome, and 5) the overall predictability of the model to the clinical outcome.

Regulatory Activity

  • IND reviews
  • Pre-preIND interactions with sponsors
  • PreIND meetings with sponsors

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