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MOU 225-23-003

MEMORANDUM OF UNDERSTANDING
BETWEEN
THE NATIONAL INSTITUTES OF HEALTH (NCATS)
AND THE FOOD AND DRUG ADMINISTRATION (FDA)

For the
Microphysiological Systems Program

I. PURPOSE

This Memorandum of Understanding (MOU) sets forth an overarching framework of partnership between the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), through its Office of the Chief Scientist (collectively referred to as the “Parties”). To effectuate this purpose, the Parties hereby enter into a non-exclusive, non-binding Memorandum of Understanding to promote the advancement of Microphysiological Systems.

NCATS and FDA share a common interest and goal to accelerate the translational use of Microphsyiological Systems (MPS) as a New Approach Methodologies (NAMs), so that NAMs may help bring FDA-regulated products to market faster, with improved efficacy, or prevent products with increased harmful risk from reaching the market. Translation and adoption of NAMs could also contribute to advances to replace, reduce, and/or refine animal testing.  Each agency, operating under its own authority, intends to have specific roles in promoting this shared interest. This MOU provides a framework between NCATS and FDA for coordination and collaborative efforts towards widespread use of MPS in advancing novel therapies that are safe and effective, and in biomedical research for understanding pathophysiology and modeling of human diseases/conditions.  It also provides the principles and procedures by which the parties involved intend to manage and share expertise and information to increase collaboration and strategic planning.

II. BACKGROUND

While animal models have established value in biomedical research, they also have limitations in being able to reliably predict human physiological responses to various perturbations. Microphysiological systems (MPS) hold promise to overcome some of these limitations as a New Approach

MPS are an emerging technology that holds the potential to increase translation, efficiency, efficacy, and safety of candidate therapeutics, and potentially become an integral part of the drug development process. Per FDA definition, MPS “uses microscale cell culture platform for in vitro modeling of functional features of a specific tissue or organ of human or animal origin by exposing cells to a microenvironment that mimics the physiological aspects important for their function or pathophysiological condition. MPS design may aim to provide and support cultured cells with physical (e.g., temperature, pH and oxygen)/biochemical/electrical/mechanical (e.g., flow or stretch)/structural/morphological conditions and recapitulate a set of specific properties that define a healthy or diseased organ or tissue function. MPS platforms may comprise mono-cultures, co-cultures of multiple cell types, maintenance of explants derived from tissues/organs, and/or inclusion of organoid cell formations” (from https://www.fda.gov/science-research/about-science-research-fda/advancing-alternative-methods-fda). The adoption of MPS into the drug development process is expected to permit humanized in vitro cell assays that predict human physiology more accurately in situations where species differences are an issue. They may also replace time-consuming and expensive animal experiments, giving patients earlier access to more effective and safer medications. An integral step in the widespread adoption and industrial use of MPS is its regulatory acceptance by the FDA and other global regulatory agencies.

NCATS provide leadership and support of the Tissue Chips for Drug Screening program https://ncats.nih.gov/tissuechip/about in the implementation and adoption of this technology in the drug development process. Tissue chips have emerged as a leading in vitro NAMs that are more predictive of human response in the safety and efficacy assessment of leading therapeutics. 
FDA has had a long-standing commitment to promote the development and use of new technologies to better predict human and animal responses to substances relevant to its regulatory mission.  As part of efforts to further the goals of the FDA Predictive Toxicology Roadmap https://www.fda.gov/science-research/about-science-research-fda/fdas-predictive-toxicology-roadmap, FDA launched its Alternative Methods Working Group https://www.fda.gov/science-research/about-science-research-fda/advancing-alternative-methods-fda. 

III. SUBSTANCE OF AGREEMENT

The NIH NCATS and FDA intend to collaborate and coordinate efforts that will promote and accelerate the translational use of MPS. These collaborative efforts include:

  • Developing programs that advance translation and adoption of MPS, including federal grants programs
  • Develop opportunities, such as workshops, that would bring together stakeholders to discuss progress of the MPS translational programs and generate new ways to advance NAMs
  • Engaging in additional activities, where appropriate, to promote NAMs

This MOU does not alter existing NCATS or NIH and industry authorities, command relationships, or privacy, civil liberties, and other oversight relationships. In establishing a proposed framework to provide mutually beneficial logistical and operational support, this MOU is not intended to replicate or aggregate unnecessarily the diverse organizational structures of the NIH NCATS and FDA in scientific research. NCATS and FDA agree that before any specific, MPS-related collaborative initiative or project is initiated or implemented, the Parties shall identify priorities, topics of mutual interest, and develop separate, written agreements, such as a Letter of Agreement, to describe collaboration and sharing of resources. These agreements will incorporate by reference this MOU. NCATS and FDA may enter into additional agreements to the extent authorized by law and available resources.

IV. General Provisions

1. Term, Termination, and Modification. This MOU becomes effective on the date of the last signature and shall remain in full force and effect, unless modified or terminated. The Agreement may be modified or terminated by mutual written consent the Parties. No amendment or modification of this MOU shall be valid or binding unless made in writing and signed by authorized representatives of both parties. Either Party may unilaterally terminate this MOU by providing written a 60 day advance written notice to the other Party of its intent to terminate the MOU.

2. Resource Obligations. All activities undertaken pursuant this MOU are subject to the availability of personnel, resources, and funds. This MOU does not create binding, enforceable obligations against any Party. This MOU will be subject to the applicable policies, rules, regulations, and statutes under which FDA and NIH operate. None of the activities outlined in this memorandum currently requires the exchange of funds between NCATS and FDA. If transfer of funds is deemed to be required in the future, the Partner(s) may enter an interagency agreement by Section 601 of the Economy Act of 1932, as amended (31 U.S.C. 1535).

3. Governing Law. This MOU shall be governed by U.S. Federal Law as applied in the Federal Courts of the District of Columbia.

4. Entire Agreement. This MOU incorporates all Exhibits and Schedules (if any) hereto and constitutes the entire agreement and understanding between the Parties in respect of the subject matter hereof and replaces in its entirety any prior discussions, negotiations, agreements or other arrangements in relation to the subject matter, whether written or oral.

5. Intellectual Property. The Parties agree that inventorship of any patentable matter, created by any of the participants pursuant to the terms of this MOU, will be determined in accordance with U.S. patent laws.

6. Confidential Information. The NCATS is the custodian of information that is owned by NIH NCATS Tissue Chip Investigators. NCATS will not, as part of the activities covered by this MOU, share with other parties to the MOU any information that is confidential or trade secret, unless permitted to do so by the NIH NCATS Tissue Chip Investigators, under a separate confidentiality agreement. The Parties to this MOU will not disclose to any third party any nonpublic information that a party (DISCLOSING PARTY) provides to the other Party (RECEIVING PARTY), which the DISCLOSING PARTY reasonably considers to be of a confidential, proprietary or trade secret nature, including but not limited to, financial statements and projections, customer and supplier information, research, designs, plans, compilations, methods, techniques, processes, procedures, and know-how, whether in tangible or intangible form. Additionally, FDA does not intend to exchange nonpublic information under this MOU. Exchange of non-public information shall be governed by separate Confidentiality Agreements in which the Parties will agree and certify in writing that they shall not further release, publish or disclose such information and that they shall protect such information in accordance with the provisions of 21 U.S.C. § 331;18 U.S.C. § 1905; 21 C.F.R. Parts 20 and 21; 45 C.F.R. Parts 5 and 5b; 42 U.S.C. § 242m, 42 U.S.C. § 241(d), and other pertinent laws and regulations governing the confidentiality of such information.

Additionally, the Parties will ensure that staff will comply with their respective policies and procedures for Conflict of Interest management.

7. Counterparts. This MOU may be executed in counterparts, each of which shall be deemed to be an original and all of which together shall constitute a single document. The Parties agree that future NCATS and FDA MPS related projects may be covered under this MOU by attaching Letter(s) of Agreement. Instructions regarding information to include in the Letter(s) of Agreement is outlined in Appendix A. The Parties acknowledge and agree that the exchange of electronic or fax signatures will have the same meaning as the Parties’ signatures would have if signed in hard copy form.

8. Authority. FDA has authority to enter into this agreement pursuant to 21 USC §393(b) and (c). NCATS, as a component of the NIH, has the authority to enter into this agreement pursuant to Section 479 of the Public Health Service (PHS) Act, 42 U.S.C. § 287, and Section 301 of the PHS Act, 42 U.S.C. § 241.

9. Notices and Meetings. All notices pertaining to or required by this MOU will be in writing, signed by an authorized representative of the notifying Party, and delivered by registered or certified mail, email or facsimile, or express/overnight delivery service and sent to the other Party at the address designated in Paragraph 10.

10. Points of Contact. The following individuals are designated points of contact for the MOU:

The names of NCATS and FDA staff listed below represent the current persons in these assigned roles at the date of signing of this MOU. Additional NIH staff may be drawn to provide scientific expertise on organ/tissue physiology as needed.

Scientific / Research Contacts for NIH:

Danilo A. Tagle, Ph.D.
NCATS/NIH
6701 Democracy Blvd Suite 900, Bethesda, MD 20892-3874
Phone: (301) 594-8064
Email: [email protected]

FDA Point of Contact:

Khaled Bouri, Ph.D; MPH
ORSI/OCS/OC/FDA
10903 New Hampshire Ave, Silver Spring, MD 20993
Phone: (301) 796-8476
Email: [email protected]

11. Use of Name; Press Releases. By entering into this MOU, neither NCATS nor FDA directly or indirectly endorse any product or service that is or will be provided by the Party. Neither Party will in any way state or imply that the other Party or any of its organizational units or employees endorses any product or service. Each Party agrees to provide proposed press releases that reference or rely upon the work under this MOU to the other Party for review and comment at least seven (7) days prior to publication.

12. Other Agreements. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties. This MOU in no way restricts either Party from participating in any activity with other Public or Private agencies, organizations or individuals.

APPROVED AND ACCEPTED FOR

THE NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES, NIH 

By: /s/
Keith Lamirande
Executive Officer
Date: 01/12/2023
                     
APPROVED AND ACCEPTED FOR

THE FOOD AND DRUG ADMINISTRATION

By: /s/
Namandjé Bumpus, Ph.D.
Chief Scientist
Date: 01/12/2023    

Appendix A

Addendum Instructions for new Letter(s) of Agreement for MPS related NCATS and FDA Initiatives/Activities under this MOU (FDA MOU 225-23-003) 

I. Title of Initiative

II. Background of Initiative:

III. Purpose:

IV. Project Workplan:

V. Responsibilities of Parties:

a. NCATS:

b. FDA:

c. Additional Parties if appropriate:

 

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