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  1. FDA Memoranda of Understanding

MOU 225-17-010

MEMORANDUM OF UNDERSTANDING BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF NEW DRUGS
OFFICE OF ANTIMICROBIAL PRODUCTS DIVISION OF ANTIVIRAL PRODUCTS AND
CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF TRANSLATIONAL SCIENCE OFFICE OF CLINICAL PHARMACOLOGY
AND
HEPATITIS C THERAPEUTIC REGISTRY AND RESEARCH NETWORK (HCV­ TARGET) BY AND THROUGH ITS COLLABORATION WITH UNIVERSITY OF FLORIDA AND UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL

I. Purpose

The United States Food and Drug Administration (FDA) and the University of Florida and the University of North Carolina at Chapel Hill Hepatitis C Therapeutic Registry and Research Network (hereafter "HCV-TARGET"), a cooperative academic consortium with principal investigators funded through a National Institute of Health (NIH) Clinical and Translational Science Award, share interests in promoting scientific research in the areas of hepatitis C drug development. This Memorandum of Understanding (MOU) establishes the terms for collaboration between FDA and HCV-TARGET (hereafter "the Parties") to promote these shared interests, which can be pursued through a variety of programs including collaborative
research.

II. Background

In fulfilling its responsibilities, 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, and medical devices and the safety and security of foods, cosmetics, and radiological products.

HCV-TARGET is an academic consortium of leading hepatitis C virus (HCV) investigators  who are charged with establishing a common research database and conducting a longitudinal observational study to evaluate use of approved direct acting antiviral agents for the treatment of hepatitis C in clinical practice.  The  HCV-TARGET  consortium  headed  by  a Steering Committee of hepatology experts, includes  the  Clinical  Coordinating  Center based at the University of Florida (under the direction of UF Principal Investigator: Dr. David R. Nelson, MD) and a Data Coordinating Center based at the University of North Carolina, Chapel Hill (under the direction of UNC Principal Investigator: Dr. Michael W. Fried, MD), and has forged key partnerships from academic centers, community sites, and private industry. Through this collaboration, the FDA will have access to the HCV­TARGET database to inform potential risks and benefits of newly approved HCV drugs in an actual clinical use setting and can gain knowledge through professional collaboration with leading clinical experts in hepatology.

The HCV-TARGET Consortium  will conduct  a  longitudinal,  observational  study  based on a carefully maintained research registry of patients treated with HCV therapies that will be designed to rapidly inform strategies for better management of populations represented and underrepresented in clinical trials, identify and  remediate  gaps relative  to treatment guidelines, describe adverse event management to optimize treatment, and serve as the core resource for collaborative translational studies utilizing biospecimens and clinical data from diverse patient populations. Patient characteristics such as age, race, ethnicity, comorbidity, disease and treatment status, and treatment emergent outcomes, such as resistance persistence, virologic breakthrough, and adverse event management and surveillance, will also be examined. Additional primary and secondary study aims are as follows:

Primary aims:

1. Provide baseline and treatment response data to better inform safety and efficacy of direct-acting antiviral (DAA) regimens.
2. To identify candidates for enrollment in future clinical trials. HCV-TARGET will also develop a well-characterized cohort of DAA treatment failures.
3. Establish and maintain data, a specimen bank, and other resources for ancillary studies of the pathogenesis, diagnosis, natural history and treatment of HCV infection.


Secondary aims:

1. Report sustained virologic response (SVR) rates and safety in under-represented and special populations.
2. Provide surveillance of drug-drug interact ions.
3. Describe treatment and management adherence.
4. Develop pretreatment education in HCV patient population.

III. Statement of Authority

FDA has authority to enter into this memorandum of understanding pursuant to Section 1003(b)(4).

IV. Substance of Agreement

This MOU forms the basis for development of scientific collaborations, outreach and  educational initiatives and intellectual partnerships between FDA and HCV-TARGET. The types of initiatives expected to develop from this MOU include, but are not limited to:

  1. Opportunities for FDA staff to serve as members of the Advisory Council for HCV-TARGET.
  2. Research collaborations using the HCV-TARGET data base;
  3. Opportunities to convene joint meetings for education and research;
  4. Opportunities to develop pilot projects to enhance the utility of HCV­ TARGET/FDA interaction;
  5. Development of an infrastructure for training and peer-to-peer interactions between FDA reviewers and academic clinicians

Under this MOU, FDA and HCV-TARGET will seek opportunities to participate together in collaborative research and training as permitted under appropriate statutory authority. Before any specific collaboration is initiated or implemented, the Parties shall identify priorities and topics of mutual interest, and develop separate, written agreements for collaboration and sharing of resources. Where applicable, these agreements shall incorporate by reference this MOU. FDA may enter into a contract or cooperative research agreement with HCV-TARGET, or issue a grant to HCV-TARGET, to the extent authorized by law and available appropriations. The terms and conditions of any such agreements or awards will comply with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within the FDA.

The foregoing represents the broad outline of the agreements of the Parties to engage in collaborative research and training efforts. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds and are further subject to applicable statutes and regulations. This MOU does not affect or supersede any existing or future arrangements among the Parties and does not affect the ability of the Parties to enter into other agreements or arrangements related to this MOU.

The parties acknowledge and agree that this MOU does not authorize FDA to share confidential or trade secret information with HCV-TARGET.

V. General Provisions

  1. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, which are to  be made in compliance with U.S. Government patent regulations and any other applicable statutes and regulations.
  2. Institutions within the HCV-TARGET and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
  3. Access to non-public information shall be governed by separate Confidentiality Disclosure Agreements that comply with pertinent laws and regulations, including, as applicable, 21 U.S.C. 3310), 21 U.S.C. 360j(c), 18 U.S.C. 1905, and 21 C.F.R. Part 20.
  4. Each Party will comply with the other Party's security procedures and policies regarding access to and use of facilities. Either Party may restrict or limit access to its property and facilities at any time and for any reason. The HCV-TARGET individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
  5. As research projects are developed, details will be agreed to in advance under other agreements as appropriate and in compliance with all applicable federal requirements.
  6. 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 into other agreements or arrangements related to this MOU. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and HCV-TARGET operate.

VI. Resource Obligations

This MOU represents the broad outline of the FDA and HCV-TARGET's intent to collaborate in areas of mutual interest. It does not create binding, enforceable obligations against any Party. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds.

VII. Liaison Officers

The individual to whom all inquiries to FDA should be addressed is:

Name: Poonam Mishra, M.D., MPH Deputy Division Director (Safety) Division of Antiviral Products Office of New Drugs
U.S. Food and Drug Administration 10903 New Hampshire Avenue White Oak 22 I Room 6100
Silver Spring, MD 20993 Tel: 301-796-4274Fax:
email: Poonam.Mishra@fda.hhs.gov

The individual to whom all inquiries to HCV-TARGET should be addressed is:

David R. Nelson, M.D., Professor of Medicine
Division of Gastroenterology, Hepatology, and Nutrition Department of Medicine
University of Florida
Gainesville, Florida 32610-0214
Phone: (352) 273-9500
Fax: (352) 392-7393
nelsodr@medicine.unfl.edu

For University of Florida administrative purposes:

Stephanie Gray, Director of Research
Office of Research, Division of Sponsored Research 219 Grinter Hall
Gainesville. FL  32611
Phone:  352-392-3516
Fax: 352-392-3516
ufproposals@ufl.edu

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

VIII. Term, Termination, and Modification:

This agreement becomes effective upon acceptance by both Parties and will continue in effect for three (3) years.  It may be renewed by mutual written agreement of both Parties.  It may be modified at any time by mutual written agreement of both Parties. It may be terminated for any reason, by either Party upon 60-day advance written notice to the other.

IX.  Statutes, Regulations, Rules, and Policies

This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules, and policies under which FDA and HCV-TARGET operate.

APPROVED AND ACCEPTED FOR THE UNIVERSITY OF FLORIDA

/S/
Anthe Hoffman
Assistant Director of Research
Date: 2-8-2017

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL

/S/
[signature illegible]
For
Terry Magnuson
Vice Chancellor for Research
Date: 2-2-2017

READ AND ACKNOLWEDGED BY: HCV-TARGET Principal Investigators

 /S/
 David Nelson, M.D.
 Director, University of Florida
 Clinical and Translational Science Institute
 University of Florida
Date: 2-8-2017

/S/
Michael W. Fried, M.D.
Director of Hepatology
University of North Carolina
Date: 2-2-2017

APPROVED AND ACCEPTED FOR THE U.S. FOOD AND DRUG ADMINISTRATION

/S/
Janet Woodcock, M.D.
Director, Center for Drug Evaluation and Research
FDA
Date: 2-16-2017