MEMORANDUM OF UNDERSTANDING
BETWEEN THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION OFFICE OF THE CHIEF SCIENTIST AND
THE AVICENNA ALLIANCE FOR PREDICTIVE MEDICINE ASBL
The United States Food and Drug Administration's (FDA) Office of the Chief Scientist and the Avicenna Alliance for Predictive Medicine ASBL (Avicenna Alliance) share interests in promoting progress in the application of computer modelling and simulation in healthcare through the exchange knowledge, information, case studies and policy. FDA and Avicenna Alliance foresee benefits from the mutual exchange of knowledge, information, case studies, policy, training and research expertise in computational modelling and simulation as applied to healthcare in its broadest sense. This Memorandum of Understanding (MOU) establishes the term s for collaboration to promote these shared interests. Both FDA and Avicenna Alliance are referred to individually as a "Party" and
collectively as the "Parties."
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 is responsible for, among other things, protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products. 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. In particular, FDA must stay current with advances and innovations in in silica medicine through modelling and simulation which may enhance the FDA's ability to evaluate medical products. To that end, FDA recently formed a working group on modelling and simulation. The working group intends to:
• Raise awareness of the successes, challenges and opportunities for modelling and simulation to advance regulatory science at the FDA;
• Create an environment for enhanced communication and coordination on cross cutting modeling and simulation efforts at FDA with academic researchers, industry collaborators (as appropriate),
and inter-agency modelling and simulation groups;
• Promote consistent decision making related to modelling and simulation across the FDA by developing credibility principles that can be applied to a wide-range of disciplines;
• Serve a scientific advocacy role by raising issues, solutions, and information relevant to modelling and simulation to the appropriate level within the FDA; and
• Serve as a resource of and for expertise on modelling and simulation on current and emerging technologies for the FDA, and national and international organizations pursuing similar activities
These objectives motivated the working group to form a collaborative partnership with the Avicenna Alliance.
The Avicenna Alliance is a not-for-profit organisation registered under Belgian Law that is a partnership between healthcare industries and academic researchers represented by the members of the Virtual Physiological Human Institute for Biomedical Research. Its Mission is to work with policy makers, regulators, clinicians and patient groups to promote the application of modelling and simulation in healthcare and, through the provision of expert guidance, validated and verified to inform the development of policies on in silica medicine, thus helping to address the regulatory hurdles presented by these emerging technologies. Its Objectives are to:
1. Focus on providing input to the development of a policy framework to support the development and application of computational modelling and simulation in healthcare;
2. Collaborate with experts and regulatory agencies outside the EU to work towards a harmonisation of emerging policies, thus ensuring market accessibility and delivery of therapeutic products to
patients irrespective of territory;
3. Work with regulatory agencies to validate computational modelling and simulation technologies in the context of respective healthcare sectors (biomedical devices, pharmaceuticals, etc.);
4. Work strategically across all relevant healthcare industry sectors where the application of computational modelling and simulation will benefit; and
5. Provide expert input on computational modelling and simulation to European Commission consultations as and when relevant.
III. Substance of the Understanding
This MOU forms the basis for collaboration between FDA and the Avicenna Alliance. The intent is to enable the development of scientific collaborations, outreach, educational initiatives, and intellectual partnerships between the Parties. The types of collaborations expected to develop between the Parties include, but are not necessarily limited to, the following:
1. FDA will provide the Avicenna Alliance with technical assistance and FDA's perspective on issues relating to in silica medicine by serving as a non-voting "observer member" ofthe Avicenna Alliance and as a non-voting observer in quarterly Avicenna Alliance Board meetings;
2. When requested by FDA, Avicenna Alliance will provide technical assistance and perspective relating to FDA activities relevant to in silica medicine; and
3. As time, resources, and legal constraints permit, FDA may participate in research projects, advisory boards and panels, workshops and research consortia that are sponsored , conducted, or otherwise controlled by the Avicenna Alliance.
Under this MOU,joint efforts will be undertaken to support collaborative research and training as permitted under appropriate statutory authority. Before any specific collaboration is initiated or implemented, the Parties shall identify priorities, topics of mutual interest,and develop separate, written agreements for collaboration and sharing of resources. Where applicable, these agreements
shall incorporate this MOU by reference.
The terms and conditions of any such agreements will comply with applicable federal law and regulations,and shall be negotiated and executed by appropriate representatives of institutions within the Avicenna Alliance and FDA.
IV. General Provisions
A. 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.
B. Members of the Avicenna Alliance and the FDA may decide to enter Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
C. Proprietary or non-public information will not be disclosed under this MOU, unless such disclosure is permitted by law and such disclosure is governed by appropriate confidentiality disclosure agreements.
D. 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 for any reason. The Avicenna Alliance members participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
E. As research projects a re developed, details will be agreed to in advance under other agreements as appropriate.
V. Resource Obligations
This MOU represents the broad outline of the FDA and the Avicenna Alliance's intent to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to available resources. It 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.
VI. Liaison Officer
FDA: The individual to whom all inquiries to FDA should be addressed is:
Tina M. Morrison, Ph.D.
Avicenna Alliance: The individual to whom all inquiries to the Avicenna Alliance should be addressed is:
Adriano M. Henney, Ph.D.
Each Party may designate new liaisons by notifying the other Party's liaison in writing. If an individual designated as a liaison under this agree(rlent becomes unavailable to fulfil those functions, the Parties will name a new liaison within two weeks and notify the other Party through the designated administrative liaison.
VII. Term, Termination, and Modification:
This agreement becomes effective upon acceptance by both Parties and will continue in effect for five (5) years. It may be renewed by mutual written agreement of both Parties. It may be modified
by the mutual written agreement of both Parties . Either Party may terminate it upon 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 and the Avicenna Alliance operate.
APPROVED AND ACCEPTED FOR THE AVICENNA ALLIANCE
Adriano M. Henney, PhD
May 15, 2017
APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
Luciana Borio, MD
Acting Chief Scientist
May 30, 2017