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  6. MOU 225-20-013
  1. Non-Profit and Other MOUs

MOU 225-20-013

Memorandum of Understanding Between the American Association for Cancer Research and the U.S. Department of Health and Human Services, Food and Drug Administration, Oncology Center of Excellence

I. Purpose

The Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) and the American Association for Cancer Research (AACR) agree to establish the FDA-AACR Oncology Educational Fellowship, as well as other collaborative educational efforts, as appropriate. The FDA and AACR share interests in promoting scientific progress through exchange of scientific knowledge in oncology education, collaborative learning, and research. Both institutions foresee benefits from the mutual exchange of educational expertise in translational oncology drug development and regulatory policy. This Memorandum of Understanding (MOU) establishes the terms for this Fellowship program and provides a basis for other related efforts to promote these shared, mutual interests in collaborative education and learning.

II. Background

The FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.). In fulfilling its responsibilities under the Act, the FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods, dietary supplements, and cosmetics. The FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. To accomplish its mission, the FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues. Increased development of research, education, and outreach partnerships within the AACR will greatly contribute to the FDA’s mission.

The mission of the OCE is to achieve patient-centered regulatory decision-making through innovation and collaboration. The OCE’s vision is to create a unified and collaborative scientific environment to advance the development and regulation of oncology products for patients with cancer. The OCE leverages the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, devices, and diagnostics. The OCE helps expedite development of medical products for solid tumors and hematologic malignancies and supports an integrated approach to their clinical evaluation. Proactive scientific education and collaboration with the AACR is consistent with the OCE’s vision and mission.

The mission of the American Association for Cancer Research is to prevent and cure all cancers through research, education, communication, collaboration, research funding, and advocacy. The AACR's vision includes that all cancer patients will have lifelong access to high-quality, effective, affordable, and compassionate care. Through its programs and services, the AACR fosters research in cancer and the related sciences; accelerates the dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances the understanding of cancer etiology, prevention, detection, diagnosis, and treatment of cancer throughout the world.

The FDA and AACR intend to leverage their combined strengths for the joint development of the Fellowship, and other related efforts, to educate and provide career development for the selected Fellows through collaborative learning and other training experiences, thereby fostering a greater understanding of oncology drug development and regulatory policy.

The OCE and AACR have complementary missions and rely on the expertise of hematologists/oncologists and scientists that are well-trained in the fundamentals of drug and diagnostic development and approval. Such individuals work in every sector, from academia to industry to government to clinical practice. This Fellowship and other joint efforts will help to fill an existing critical gap in hematology/oncology training, providing fellowship and PhD candidates education relating to, among other things, regulatory science and the oncology drug approval process.

III. Substance of Agreement

This MOU is the foundation for the development of the FDA-AACR Oncology Educational Fellowship, as well as other educational initiatives between the OCE and AACR. The objective of these efforts is to educate Fellows about oncology drug development and regulatory policy. Educational topics may include:

  • Oncology drug regulation.
  • The Investigational New Drug (IND) process.
  • The New Drug Application (NDA) and Biologic License Application (BLA) process.
  • Expedited drug development pathways.
  • Pharmacology and toxicology considerations in early phase clinical trials.
  • Clinical pharmacology considerations throughout oncology drug development.
  • Statistical considerations in late phase clinical trials.
  • Clinical trial design and efficacy endpoint considerations.
  • Companion diagnostics, biomarkers, and precision oncology.
  • Oncology disease area subject matters (clinical practice, biomarker development, etc.).

The following individuals may apply for this Fellowship: current hematology/oncology fellows (medical, surgical, and pediatric fellows), PhD candidates, or early-career faculty with a background in hematology/oncology and an MD, MD/PhD, or PhD. Current hematology/oncology fellows must have completed at least one year of fellowship training in an accredited U.S. training program and be in good standing in their fellowship programs.
Early-career faculty must be within 5 years of starting their faculty appointment.

The FDA and AACR will jointly review the applications and select up to 10-15 Fellows per year, with a 1-year Fellowship duration, unless extended by joint agreement of the OCE and AACR. The Fellowship pilot will be for 1 year and can be extended for up to 5 years total by joint agreement of the OCE and AACR.

Roles and Responsibilities of the Parties

  • The AACR will be responsible for:
    • Advertisement and promotion of the Fellowship
    • Development of Fellowship application materials
    • Coordinating the Fellowship application process
    • Providing input on Fellowship applicants
    • Jointly with the OCE, deciding on the acceptance of Fellows
    • Notification of accepted and not accepted Fellows
  • The FDA will be responsible for:
    • Providing input on Fellowship applicants
    • Jointly with AACR, deciding on the acceptance of Fellows
    • Providing educational materials and teaching to selected Fellows on regulatory policy and oncology drug development, using only publicly available documents and materials. This may be in person or virtual.

At this stage, OCE and AACR contemplate having Fellows who will not be regularly resident at FDA for the term of their fellowship. If, at a later time, OCE and AACR decide to pursue in person Fellows resident at FDA, they will execute an appropriate addendum to the MOU, or a separate MOU, covering such Fellows.

The sharing of non-public information is not permitted under the terms of this MOU, including FDA non-public information, confidential commercial and/or trade secret information in FDA’s possession, and/or AACR non-public information, OCE staff participating in this Fellowship program, or in other joint educational efforts with AACR, including interacting with Fellows, shall not further release, publish, or disclose FDA non-public information, and/or or confidential commercial or trade secret information, and they shall protect such information in accordance with the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentiality of privileged information.

IV. Promotional Activity

The AACR has no commercial products or commercial services and will not use the Fellowship as a vehicle to sell or promote commercial products or commercial services. The use of the FDA and/or AACR logo will be consistent with the FDA and AACR’s logo policies.

V. Fellowship Publicity and Endorsement

The AACR agrees not to use the name of the FDA or any of the FDA components, except in factual publicity for the Fellowship. Such factual publicity shall not imply that the involvement of the FDA serves as an endorsement of the general policies, activities, or products of the AACR. Where confusion could result, publicity should be accompanied by a disclaimer to the effect that no endorsement is intended. The AACR will clear all publicity materials with the FDA to ensure compliance with this paragraph.

VI. Termination

Non-adherence to the terms of this agreement may result in the FDA terminating the agreement.

VII. Resource Obligations

This MOU represents the broad outline of the FDA and AACR’s intent to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds. This MOU does not create binding, enforceable obligations against either Party. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other  agreements  or  arrangements  related  to  this  MOU. Separate additional educational activities may be planned (e.g., workshop, lectures, etc.).

VIII. Liaison Officers

For the AACR:

Jon Retzlaff
American Association for Cancer Research 1401 H Street, NW Suite 740
Washington DC 20005
Phone: 202-898-6499
Email: jon.retzlaff@aacr.org

For the FDA/OCE:

Jennifer Gao
Oncology Center of Excellence
Building 22, Room 2135
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
jennifer.gao@fda.hhs.gov

Each Party may designate new liaisons at any time by notifying the other Party's administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Parties will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.

IX. Terms, Termination and Modification

This agreement, when accepted by all partners, will have an effective period of performance from the date of the latest signature until September 30, 2025 and may be modified or terminated by mutual written consent of the Partners or may be terminated by either Partner(s) upon a 14-day advance written notice to the other.

Approved and Accepted by the American Association for Cancer Research

/s/

Margaret Foti, PhD, MD (hc)
Chief Executive Officer
American Association for Cancer Research
June 1, 2020

Approved and Accepted by the Food and Drug Administration

/s/

Richard Pazdur, M.D.
Director, Oncology Center of Excellence
Food and Drug Administration
June 1, 2020
 

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