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 Translational Sciences, Office Of Clinical Pharmacology And Institute of Quantitative Systems Pharmacology
The United States Food and Drug Administration (FDA) and the Institute of Quantitative Systems Pharmacology (IQSP) (the Parties) have a shared interest in scientific progress in the diverse disciplines that directly and indirectly affect human and animal health and medicine. The Parties also endorse scientific training for faculty, students, and staff to foster a well-grounded foundation in interdisciplinary fields in which academia and government share mutual interest. This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote these shared interests, which can be pursued through a variety of programs including collaborative research, public outreach, extension activities, cooperative international initiatives, disciplinary training, and exchange of scientists and staff, including sabbaticals, postdoctoral fellowships, and student internships.
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 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, 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 with IQSP will greatly contribute to FDA’s mission. FDA’s Centers and Offices are described in Appendix A.
IQSP is a nonprofit institute founded in 2016 by Professor Jessie Au, focusing on computation and modeling to interpret, interrogate and integrate drug effects on multiple scales (molecule, cellular, organ, whole organism, time, space), with the goal of being able to forecast treatment outcomes, stimulate and facilitate inter-institutional collaborations. Quantitative systems pharmacology (QSP) is highly transdisciplinary and requires knowledge in diverse scientific fields including biology, physics, chemistry, pharmacology, pharmaceutical sciences, computational modeling, engineering, clinical sciences, and regulatory sciences. IQSP was developed in recognition of the high failure rate in drug development, a major problem in health care, and because there is an unmet need for more cost-effective and more efficient drug development.
III. Substance of Agreement:
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and IQSP. The types of activities expected to develop from this MOU include, but are not necessarily limited to, the following:
1. Personnel exchanges between IQSP’s faculty and staff, and FDA's scientists and staff as permitted by the Intergovernmental Personnel Act;
2. Opportunities to apply for a joint fellowship program at FDA to advance student and faculty education. One mechanism to enroll students/post-doctoral trainees/residents from IQSP into a joint fellowship program at FDA may be through the Oak Ridge Institute for Science and Education (ORISE) fellowship program. If prospective fellows or faculty enter the program through the ORISE fellowship mechanism, FDA and IQSP will adhere to the respective Agency Centers’ ORISE fellowship rules and regulations. Fellows or faculty members entering the program must agree to the ORISE terms of the appointment which will be outlined in an offer of appointment letter;
3. Educational opportunities for qualified students (graduate and undergraduate), staff members, and faculty members in the Parties' laboratories, classrooms, clinical settings and offices;
4. Opportunities for FDA personnel to serve as adjunct faculty, advisory board members, and dissertation advisors at IQSP;
5. Joint meetings for education and research; Development of regular workshops where IQSP’s faculty and staff and FDA's scientists and staff share information about ongoing research, education, extension, and outreach efforts of mutual interest.
6. Research collaborations;
7. Cooperative international activities including outreach;
8. Access to unique facilities and equipment for scientific endeavors
IV. General Provisions:
1. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.
2. IQSP and FDA may decide to enter supplemental agreements that may include cooperative research and development agreements ("CRADAs”). The terms of such CRADAs will address Intellectual Property rights.
3. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements and to the extent such disclosure is permitted by law.
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. IQSP individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
5. It is recognized that from time to time FDA and IQSP will be sharing in expenses and may require compensation of either Party by the other. As research projects are developed, details of how costs are to be shared will be agreed to in advance under other contractual mechanisms as appropriate and in compliance with all applicable federal requirements.
V. Resource Obligations:
This MOU represents the broad outline of the FDA and IQSP 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 any 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.
A. For the Institute of Quantitative Systems Pharmacology
Individual Name: Jessie Au, Pharm.D., Ph.D.
Title: Founder of Institute of Quantitative Systems Pharmacology, Research Professor and Mosier Endowed Chair in Pharmaceutical Sciences, Department of Pharmaceutical Sciences, The University of Oklahoma, OK, Chair Professor in Systems Pharmacology, Taipei Medical University, Taipei, Taiwan, and Distinguished University Professor Emeritus at The Ohio State University, Columbus Ohio
Address: 1815 Aston Ave, Suite #107, Carlsbad, CA 92008
E-mail firstname.lastname@example.org and email@example.com
B. For the Food and Drug Administration:
Individual Name: Padmaja Mummaneni, Ph.D.
Title: Consumer Safety Officer, Regulatory Health Project Manager, Contract Officer Representative (COR)
Organization: Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology
Address: 10903 New Hampshire Avenue White Oak Building 51, Room 2164, Silver Spring, MD 20993-0002
Telephone Number: 301-796-2027
Each Party may designate new contacts at any time by notifying the other Party's contact in writing. If, at any time, an individual designated as a contact under this agreement becomes unavailable to fulfill those functions, the Parties will name a new contact within 2weeks and notify the other Party through the designated contact.
VII. Term, 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 five years (5) and may be modified or terminated by mutual written consent the partners or may be terminated by either Partner(s) upon a 60-day advance written notice to the other.
VIII. 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 IQSPoperate.
Approved and Accepted for the Institute of Quantitative Systems Pharmacology
M. Guillaume Wientjes, Ph.D.
June 19, 2018
Approved and Accepted for the Food and Drug Administration
Janet Woodcock, MD
Director, CDER, FDA
June 20, 2018