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MOU 225-16-001

MEMORANDUM OF UNDERSTANDING BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION
AND DUKE UNIVERSITY
FOR THE CENTER FOR DRUG EVALUATION AND RESEARCH CONSORTIUM

 
I.                 Purpose
 
This MOU establishes the framework for collaborations between the Food and Drug Administration (FDA) and Duke University (Duke), that may involve additional partners and will be implemented through separate agreements. This collaboration between the Parties shall be known as the Cardiac Safety Research Consortium (CSRC). The Parties anticipate that ideas and concepts will be developed by the steering committees and research teams. Such concepts and ideas may lead to partnerships that will be approve by an Executive Committee (EC) and implemented through separate agreements. FDA and Duke agree to collaborate with the terms and conditions of this Memorandum of Understanding (MOU), through steering committees and technical working groups to develop strategic plans, set priorities, and leverage resources and expertise from multiple stakeholders. The goals of this collaboration are to identify indicators of cardiovascular risk, predict adverse cardiovascular events associated with therapeutic interventions, and improve the clinical utility of biomarker technologies as diagnostic and assessment tools that facilitate developing safer and more effective cardiovascular therapies, diagnostic and assessment tools.
 
II.               Background
 
Food and Drug Administration
 
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, FDA, among other things, directs it 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, dietary supplements, cosmetics, and radiological products. 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, 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 DU will contribute to FDA’s mission.
 
FDA has a unique perspective on research and development and in-depth understanding of clinical trial design, regulatory policy, and scientific know-how in reviewing Medical Products (1). FDA is interested in working with stakeholders, under its public health mission to improve patient care and stimulate innovation in medical product development, and biomarker development for use in assessing the safety and efficacy of products under its regulatory jurisdiction.

 

FDA and Duke have each agreed to leverage their existing resources and expertise, working with multiple public and private partners to further research and developing pre-competitive diagnostic and assessment tools in cardiovascular disease to advance public health. Extensive cross-sector and multi-disciplinary efforts are needed to develop and to understand the clinical utility of a new generation of biomarkers(2) and other technologies, which can be used for detection, early diagnosis, proposals and clinical assessment tools in cardiovascular research and clinical decision-making. Such new cardiovascular assessment tools, including biomarkers, if clinically qualified to predict and assess therapeutic responses to clinical trials, have the potential to be adopted for use in patient management, medical product development and for regulatory decision=making by FDA.

 Duke University
 
Duke is a tax-exempt research and education institution, inclusive of the Duke Clinical Research Institute (DCRI). DCRI’s mission is to develop and share knowledge to improve patient care around the world through innovative clinical research. Duke started and maintains one of the nation’s first cardiovascular computerized clinical databases, said cardiovascular database being sustained for over 30years as one of the world’s largest repositories of follow-up on patients with carefully documented coronary heart diseases. DCRI has evolved to an organization with major efforts in clinical trials, outcomes research and health policy.
 
III.                 Substance of Agreement
 
The Parties will form steering committees, technical working groups, and an Executive Committee (EC) to develop concepts for implementation as CSRC projects. Under the framework of this MOU, These collaborative efforts will be developed under separate agreements that specific policies, terms and responsibilities of each party. The EC Steering committee and research teams shall consider approaches for developing and applying diagnostic and clinical assessment tools or biomarker technologies that enhance diagnostic or therapeutic strategies for various forms of cardiovascular disease. Specific areas of scientific activities will include, but will not be limited to, the following to:
 
1.      Create an ECG library from clinical trials that could be used for identifying early predictors of cardiac risk (Cardia Risk ECG Library);
2.      Utilize the Cardia Risk ECG Library to qualify new ECG biomarkers of cardiac risk and crease a set of ECG reference standards;
 
3.      Solicit feedback from the scientific community, generate consensus, and publish consensus statements regarding critical –cross-cutting public health issues related to cardiac safety and medical products.
 
4.      Develop additional predictive and evaluative tools to facilitate regulatory and clinical decision-making and future medical product development, considering public health, and
 
5.      Develop standards, nomenclature and tools to facilitate and accelerate the creating standards, and the evidence base for, new diagnostics and assessment tools, and develop educational tools to make this information more widely available to researchers, clinicians, and patients.
 
Scientific Oversight Committee and Research Teams
 
The Scientific Oversight Committee (SOC) and research teams shall be responsible for developing and prioritizing concepts, developing feasibility plans for specific projects, preparing white papers on scientific rationale, evaluating existing knowledge gaps and availably technologies, addressing general concepts in experimental design, preparing protocols to evaluate biomarkers in clinical trials, developing milestones, and outlining approaches for assessing progress. Moreover, the SOC and research teams shall consider developing standards, nomenclature, and tools to facilitate and accelerate developing and evidence base for, new diagnostics, basement tools, and medical products. From this process, the SOC and research tem will aim to increase the scientific knowledgebase for cardiovascular disease and public health and enhance the cardiovascular safety of medical products. The steering committees and research teams will include representatives from each Party as well as public and private partners and will met or teleconference monthly. The SOC and research teems chairs ill report to the EC, which will make the final decisions on projects that will be implemented. A meeting (face-to-face or teleconference) of the steering committees and working groups will be held at least quarterly to discuss programs, develop consensus on working group activities, and foster communications and directions for facilitating projects.
 
Priority Projects
 
Priority projects that emerge from the SOC and research teams will be publicized as areas of interest of the CSRC intending to involve participation and input from public and private sector partners. Through this process, the CSRC will seek to engage the private sector in implementing research.
 
The FDA may perform certain research projects directly with DCRI or through other collaborations through separate agreements. The private sector may perform project directly or may fund the research that may be administered, nagged and facilitated through DCRI and governed by separate agreements. While Federal agencies are involved in implementing any project, each agency is bound by all applicable federal statutes, regulations, and policies and required to act within its statutory authority.
 
Special Projects
 
If implementing specific project involves working with the non-federal sector, the Parties will facilitate dialogue with the appropriate collaborators or other partners of interest, consistent with all applicable statutes, regulations and policies and their legal authorities. Such interactions, facilitated and governed by separate agreements, may include various stakeholders.
 
The private sector, including industry, academia, non-profit organizations and others have expressed interest in working with FDA and Duke to further develop cardiovascular biomarkers and associated technologies to enhance diagnostics and therapeutic development of medical products.
 
IV.               General provisions
 
1.      Rights to any inventions from collaborative research will be determined by the separate written research agreements governing the effort, based on current U.S. Government patient regulations and any other applicable statutes and regulations.
 
2.      Institutions within Duke and FDA may decide to enter Cooperative Research and Development Agreements (CRADAs) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
 
3.      Proprietary and nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclose agreements or to the extent, such disclosure is permitted by law.
 
4.      Each Party will comply with the other Parity’s security procedures and policies regarding access to and use of facilities. Either Party may restrict or limit access to its property and facilities for any reason. Duke individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
 
5.      It is recognized that FDA and institutions within Duke will share expenses and may require compensation of either Party by the other. As research project are developed, details of how costs are to be shared will be agreed to in advance under other contractual mechanisms as appropriate and to compliance with all applicable federal requirements.
 
6.      Any notice or other communication required or permitted under this MOU shall be in writing and will be deemed given by the date is received and accepted by the receiving party.
 
V.              Resource Obligations
 
This MOU represents the broad outline of the FDA and Dukes’ intent to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to available personnel, resources, and funds. This MOU does not create binding, enforceable obligations against any Party. This MOU does not affect or supersede by existing or future agreements of arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU.
 
VI.              Liaison Officers
 
Notices or formal communications by this MOU should be sent to:
 
Food and Drug Administration
 
Norman Stockbridge, M.D., Ph.D.
Director
Division of Cardiovascular and Renal Products
Office of Drug Evaluation I
Center for Drug Evaluation and Research
10903 New Hampshire Ave
Silver Spring, MD 20993
Telephone – 301-796-2240
FAX – 301-796-9841
 
DCRI
 
Mitchell Krucoff, M.D.,
Professor of Medicine
Division of Cardiology
Department of Medicine
Duke University School of Medicine
DUMC Box 3968
Durham, NC 27710
Telephone – 919-286-6860
FAX – 919-286-6861
 
Send Copy to:
 
Anna Park, RPh. RAC
Senior Regulatory Project Manager
Division of Cardiovascular and Renal Products
Office of Drug Evaluation and Research
Telephone – 301-796-1129
FAX – 301-796-9841
 
Duke University
 
Gavin Foltz, J.D.
Associate Dean and Executive Director
Duke University Medical Center
Corporate Research Collaborations
Telephone – 919-681-0846
 
Each party may designate new liaisons by notifying the other Party’s administrative liaison in writing. If an individual designated as a liaison under the agreement become 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.
 
VII.               Term, Termination and Modifications
 
1.      This MOU constitutes the entire agreement between the Parties regarding the CSRC.
2.      There are no representations, warranties, agreements or understandings, express or implied, written or oral between the Parties regarding the subject matter of this MU that are not fully expressed herein.
3.      No supplements, amendments, or modifications to this MU shall be binding unless executed in writing by the Parties; such modifications are to take the form of amendments.
4.      This MOU, when accepted by the Parties, will have an effective date from the date of the last to sign and will remain in effect indefinitely from the effective date unless modified or terminated. Either party may terminate this MOU upon sixty 60 -days written notice.
 
VIII xc.              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 Duke operate.
 
Signatures of Responsible Parties
 
U.S. Food and Drug Administration
 
 
Luciana Borio, M.D.
Acting Chief Scientist
U.S. Food and Drug Administration
 
October 20, 2015
 
Duke University
 
Gavin Foltz, J.D.
Associate Dean and Executive Director
Duke University Medical Center
Corporate Research Collaborations
 
October 15, 2015
 
 ____________________________________________
(1)Medical Products Include Drug and Biological Products and Medical Devices
 
(2)Biological marker (biomarker) is a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic response to a therapeutic intervention. Clin Pharmacal Ther 2001:69:89-95.

 

Page Last Updated: 01/25/2018
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