Memorandum of Understanding
The Food and Drug Administration
The National Cancer Institute
The National Institute of Standards and Technology
Nanotechnology Characterization Laboratory
Related Nanotechnology Activities
Whereas extensive cross-sector and multi-disciplinary efforts are needed to understand and develop nanotechnology-based platforms and tools for cancer research as well as diagnostic and therapeutic applications;
Whereas the FDA, NCI, and NIST, hereafter referred to as the Parties, find that it is in the best interests of the three Parties (NCI is an institute within an agency, NIH) to develop a partnership that leverages each Party's core expertise and resources to facilitate nanotechnology development that will lead to new clinical products;
Whereas FDA, with its unique perspective on research and development activities and in-depth understanding of clinical trial design, regulatory policy, and scientific know-how in reviewing medical products, is interested in anticipating the impact of nanotechnology development and facilitating regulatory review and evaluation of new medical products that incorporate nanotechnology by working to clearly establish the critical path for such impending applications;
Whereas NCI, with its significant cancer research infrastructure and advanced technology programmatic investments, is interested in eliminating suffering and death due to cancer and seeks to develop technologies to improve the detection, diagnosis, treatment, and prevention of cancer;
Whereas NIST, with it world-class metrology facilities and standardization capabilities and expertise, is interested in improving translational research, commercialization, and national economy overall;
Whereas the private sector has expressed interest in further scientific exploration and nanotechnology development for novel diagnostic and therapeutic application;
Whereas FDA and NCI formed an Interagency Oncology Task Force (IOTF) in 2003 whose nanotechnology subcommittee, with a mission to foster greater understanding of the biomedical applications of nanotechnology, directly supports this Memorandum of Understanding (MOU) to support collaborations on oncology-related issues in nanotechnology development for clinical benefit, and standardization of approaches for evaluating nanotechnology devices and materials for cancer diagnosis and treatment;
Now, therefore, the Parties agree to collaborate through working groups and steering committees to develop strategic plans, set priorities, and leverage resources and expertise from multiple sources, including the private sector, toward the goal of facilitating the development of nanotechnologies that constitute novel research tools and safer, more effective cancer therapies by establishing a framework for effective risk identification, assessment, and evaluation of emerging products based on nanotechnology. This MOU sets forth the framework for collaboration among the Parties and for pursuing specific collaborative projects that may involve additional partners and will be implemented through separate agreements, as needed. This collaboration among the Parties will be focused primarily on the Nanotechnology Characterization Laboratory (NCL) and directly related activities. The Parties anticipate that concepts developed and activities undertaken under the auspices of this MOU may lead to partnerships that will be implemented through separate agreements.
The Parties agree as follows:
RESPONSIBILITIES OF THE PARTIES
In order to pursue the goals described above, the Parties agree to work through the process described below.
1. The Parties will collaborate on nanotechnology characterization and related development activities, primarily in the context of the NCI's NCL. Through this collaboration, the Parties intend to share best practices and know-how with each other, and will provide access to data regarding the assessment tools for use in FDA's regulatory evaluation and guidance development to facilitate cancer drug development. The close collaboration among the Parties, including sharing of data, characterization approaches, and best practices, is expected to a) support understanding and resolution of potential implications of nanotechnology-based products for clinical application; b) facilitate the development of measurement methods and standard protocols appropriate to innovative and disruptive technologies; and c) facilitate transfer of cancer science and engineering discovery and development through commercialization, with the measurement science and standards programs and regulatory science and evaluation policy development.
2. Within the framework of this MOU, related collaborations and separate agreements may be developed as appropriate, and may include, but may not be limited to the following areas and activities, as time and staff resources permit:
i. Development and refinement of the preclinical and early clinical pathway(s) for nanotechnology-based drugs and diagnostic devices to guide NCI-supported technology development leading to medical products;
ii. Development and validation of standards, risk/benefit analyses and other evaluative tools to identify risks and assess safety and efficacy in newly emerging nanotechnology-based products
iii. Development of publicly available master files containing data e.g. protocols, assay cascades … and other pre-competitive tools developed collaboratively by the Parties and that may guide further development of the field.
iv. Development, validation and assessment of assays and other appropriate test methods, including close review and input from all Parties prior to standardization of those assays;
v. Development of joint research programs that fund academic scientists or trainees identified under the joint IOTF training program to perform research at FDA and NIST in collaboration with FDA and NIST scientists, respectively, as well as potential research collaborations in the NCL by FDA and NIST scientists.
vi. Representation for each agency on the Nanotechnology Characterization Laboratory Scientific Oversight Committee.
vii. Development of scientific collaborations to capitalize on opportunities generated by NCL activities.
3. Additional concepts or ideas for developing collaborations or activities involving joint projects or integrated approaches to conducting science or technology development specifically aimed at commercializing products will be formally presented by submission of concepts to the designated contact from each Party. These designated contacts will meet quarterly to review progress and address new opportunities for collaboration. When necessary, technical and programmatic advisory working groups made up of employees from the respective agencies may be assembled to make formal recommendations for collaboration. The designated contacts shall obtain appropriate agreement by each agency, in writing, on each significant activity to be undertaken pursuant to this MOU, including agreement on the scope of work; tasks, deliverables (if any) and delivery dates; anticipated products and outcomes; periods of performance; levels of funding and resources to be provided for each activity by the Parties; parameters of data sharing in compliance with all applicable statutory and regulatory requirements; and any other appropriate and necessary aspects of mutual activities. The designated contacts shall seek to resolve any dispute concerning the MOU through good-faith discussions.
4. To the extent that implementation of specific projects involves working with the non-federal government sector, the Parties will, consistent with all applicable statutory and regulatory requirements, facilitate dialogue with the appropriate potential collaborators or partners of interest, and commemorate agreements with non-federal entities in writing. Such interactions with the non-federal government sector may include a range of stakeholders, such as private non-profit organizations, industry, industry trade organizations, academic institutions, professional organizations, and patient advocacy groups.
5. In addition to nanotechnology characterization activities, the Parties will collectively develop and validate standards, nomenclature, assessment tools, and toxicology approaches to facilitate and accelerate the development of, and the evidence base for, new diagnostics and anticancer drugs within the applicable statutory and regulatory framework . The parties will also develop educational tools to make this information more widely available to patients, clinicians and researchers.
1. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements, or to the extent such disclosure is permitted by law.
2. It is understood that while the Parties have aligned interest, there may be opportunities for independent collaborations and activities outside the scope of this MOU, but which are under their respective public health missions. As such, the Parties may, as appropriate, enter into independent negotiations and agreements with prospective partner/s. All such agreements shall be in writing and in compliance with all applicable legal requirements.
3. A member of the NCL Scientific Oversight Committee, shall recuse himself from any review of data if such a representative is involved in related activities or agreements with outside partners.
4. Materials being analyzed/studied under the terms and conditions of this MOU may be shared among the Parties and such transfers will be under a separate material transfer agreements (MTA).
5. Rights to intellectual property developed during the course of research under this agreement will be addressed in separate project-specific implementing agreements
6. Any notice or other communication required or permitted under this MOU shall be in writing and will be deemed given as of the date it is received and accepted by the receiving party.
Notices or formal communications pursuant to this MOU should be sent to:
Wendy R. Sanhai, Ph.D.
Senior Scientific Advisor
Office of the Commissioner, FDA
5600 Fishers Lane HZ-1
Rockville, MD. 20857
Phone: (301) 827-7867, Fax (301) 443-9718
Gregory J. Downing, D.O., Ph.D.
Director, Office of Technology and Industrial Relations
Office of the Director, NCI
31 Center Drive
MSC 2580 - Room 10A52
Bethesda, MD 20892
Telephone: (301) 496-1550, Fax: (301) 496-7807
Debra Kaiser, Ph.D.
Chief, Ceramics Division
Materials Science and Engineering Laboratory, NIST
100 Bureau Drive, Stop 8522
Gaithersburg, MD 20899
Telephone: (301) 975-6119, Fax: (301) 975-5334
TERM, TERMINATION AND MODIFICATIONS
1. This MOU constitutes the entire agreement among the Parties pertaining to NCL and nanotechnology-related activities.
2. There are no representations, warranties, agreements or understandings, express or implied, written or oral between the Parties hereto relating to the subject matter of this MOU that are not fully expressed herein.
3. No supplements, amendments or modifications to this MOU shall be binding unless executed in writing, with thirty (30) days advance notice, and by mutual consent of 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 date of the last to sign and will remain in effect for three (3) calendar years from the effective date unless modified or terminated.
Approved and Accepted
Signed by: Anna D. Barker, Ph.D.
Date: June 15, 2006
Approved and Accepted
Signed by: William Jeffrey, Ph.D.
Date: June 19, 2006
Approved and Accepted
Signed by: Janet Woodcock, M.D.
Date: June 22, 2006