Notice Number: NOT-TR-14-008
Key Dates
Release Date:
July 2, 2014
Response Due Date: July 31, 2014
None
Issued by
National Center for Advancing Translational Sciences (NCATS)
Purpose
The National Center for Advancing Translational Sciences (NCATS) seeks information from key stakeholders regarding potential public-private partnerships for the commercialization of organ system platforms (i.e., "organs on chips"), bioengineered platforms, and related items (e.g., cell sources, perfusion media, pumps) developed by the NIH-supported investigators of the Micro-physiological Systems Program (MPS). Key stakeholders include investigators who are funded to develop organ system platforms or related components, potential commercial partners, funding and regulatory agencies. Specifically, the NCATS requests information regarding the types of public-private partnerships that are most effective for product development, distribution and commercialization; and ideas for how best to disseminate information regarding the availability of organ system platforms to a targeted, relevant audience.
Background
The MPS Program is the collaborative effort of the NIH, Defense Advanced Research Project Agency (DARPA) and U.S. Food and Drug Administration (FDA). The Program's objective is to develop human organ systems on bioengineered platforms that mimic the key features of in vivo physiology to facilitate drug screening on human tissue. The initial goal is to generate 3-dimensional (3-D) models of the major organ systems from human cell sources, with the ultimate goal of integrating all organ systems into a "human on a chip." The 3-D models are developed on bioengineered platforms, allowing reproduction of critical molecular, anatomical and physiological features that mediate organ function, and allowing for efficient monitoring of function (e.g., gene expression, Ca2+ imaging, contractility). The long term objective is to bridge the gap between pre-clinical testing in animals and human clinical trials, thus reducing the use of animals and the cost and time needed for drug development.
The NIH previously issued two MPS-related Funding Opportunity Announcements (RFA-RM-11-001, RFA-RM-11-022). The NIH supports MPS investigative teams to develop individual or multi-organ system platforms, while the FDA provides input regarding regulatory requirements related to the potential use of the organ system platforms for drug testing and approval. The MPS investigative teams have been highly successful in developing viable organ system platforms, and now are preparing to integrate these into multi-organ platforms. As part of the development process, some investigators developed productive public-private relationships with industry partners, greatly facilitating platform development. The NCATS recognizes that coordinating the efforts of academic scientists with those of the private sector (e.g., biotechnology firms, pharmaceutical companies, industry) may be the most efficient approach to broader implementation of the organ system platforms and to their refinement. Among the goals of the MPS Program are: a) identifying those approaches to public-private partnerships that are the most productive, and b) preparing to make the organ system platforms commercially available via industry partnerships while maintaining accessibility for non-profit and publicly supported investigators, consistent with NIH policies.
Information Requested
To achieve these goals, the NCATS requests information from key stakeholders regarding private sector partnerships related to the distribution, use and refinement of the organ system platforms, devices engineered in conjunction with the platforms, or perfusion media. Key stakeholders include the investigators who are funded by the NIH to develop tissue system platforms or related components, potential partners in the private sector, funding and regulatory agencies. NCATS requests comments to include, but not limited to, the following areas:
- Suggestions for model approaches to the development of public-private partnerships to facilitate development and implementation of the organ system platforms
- Key characteristics of public-private relationships that promote efficient development of useful platforms
- Features of relationships that are most attractive to the private sector
- Barriers to successful public-private partnerships
- Relationship of platforms' users to the MPS Consortium
- Agreements related to intellectual property (IP) rights, copyright issues, and business models to further commercialize platforms and related items
- Ideas for possible models or scenarios for the further development or improvement of commercialized organ system platforms
- Definition of responsibilities related to technical support of the platforms
- Definition of limitations and responsibilities related to users' feedback regarding the organ systems or platforms
- Ideas for making the availability of organ system platforms known to interested parties
- How to identify and target appropriate users (both academic and "for profit" groups) for notification of the platforms' availability
- How to validate and characterize platforms in ways relevant to users
- How to facilitate input from the regulatory agencies at all stages of development and distribution
- Continued inclusion of input from regulatory agencies as organ system platforms continue to develop
- Integration of user and regulatory agency feedback as platforms are implemented by industry partners
How to Submit a Response
You can respond to any or all of the items, above; you are not required to respond to all. Please limit your response to 750 words or less.
All responses must be submitted via email (NCATSMPS@mail.nih.gov) to Dr. Danilo Tagle or Dr. Kristin Fabre by July 31, 2014. Please include the Notice number NOT-TR-14-008 in the subject line. You will receive electronic confirmation that your response has been received, but the NIH will not provide any further feedback.
Response to this RFI is voluntary. Any information submitted will be reviewed by NIH staff, and may be made available to working groups or project teams convened by the NIH. Proprietary, classified, confidential, or sensitive information should not be included in responses. The NIH reserves the right to use any non-proprietary technical information in resultant summaries or reports, and may use the information gathered to develop further initiatives or contracts.
This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, NIH, or individual NIH Institutes and Centers.Inquiries
Please direct all inquiries to:
Danilo A. Tagle, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8064
Email: NCATSMPS@mail.nih.gov
Kristin Fabre, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-7609
Email: NCATSMPS@mail.nih.gov
and Human Services (HHS)
