Notice of NCATS Interest in Receiving Letters Requesting Permission to Submit Applications to Support Annual Microphysiological Systems Scientific Conferences (U13)

Notice Number: NOT-TR-20-005

Key Dates
Release Date: January 23, 2020

Related Announcements
PA-18-648: NIH Support for Conferences and Scientific Meetings (Parent R13 Clinical Trial Not Allowed)

Issued by
National Center for Advancing Translational Sciences (NCATS)

Purpose

The purpose of this notice is to encourage the submission of permission-to-submit letters for conference grant (U13) applications seeking funding for the support of annual scientific conferences that will 1) serve as the main conduit for the latest research and technology developments, and data sharing in microphysiological systems (MPS) to include tissue chips, organoids, and other 3-D bio-fabricated models; 2) promote international standardization and harmonization of MPS technologies; and 3) establish a training environment for the next generation of MPS scientists. Such a conference is expected to be the “go-to” meeting for investigators, regulators, industry, pharma and other stakeholders in the field.

Once permission to submit is obtained, applications should be submitted for the August 12, 2020 receipt date under PA-18-648: NIH Support for Conferences and Scientific Meetings (Parent R13 Clinical Trial Not Allowed).

Background

Tremendous progress has been made towards the development of MPS for a number of human organs and organ systems in a relatively short period of time. The list for the number of organs and tissues being represented in these MPS platforms continues to grow, along with their integration into multiple organ combinations or towards a more representative human-body-on-chip system. The rapid growth in tissue- and organs-on-chip technologies, and its convergence with other 3-D model (spheroids, organoids, and bioprinted tissue constructs) development are enabling more human-relevant and physiologically meaningful predictive tools for safety and efficacy assessments in drug development. Microphysiological systems, once used to described only tissue-and organs-on-chips, can now include other 3-D constructs in microfluidic culture chambers. The synergistic engineering of these technologies can lead to a more a streamlined drug discovery and development process from early to late stage pre-clinical studies. However, despite these advances, there is no international scientific conference that is dedicated to this area. As these fields continue to rapidly develop worldwide, it necessitates a need for an international scientific conference and perhaps a professional society devoted to MPS that will facilitate international collaborative research efforts, harmonization of regulatory standards and requirements, the training of new investigators, coordination between funding agencies, and foster the sharing of data and resources amongst the growing number of stakeholders.

The five-year NIH and DARPA partnership that started in 2012 served to catalyze the development of MPS and demonstrate proof of principle that such in vitro tools can truly recapitulate human physiology and response to drugs. Partnerships with other institutes and centers at the NIH not only provided additional funding opportunities for tissue chip development but also contributed operationally through the trans-NIH working group that helps in the oversight and management of the various awards (see https://ncats.nih.gov/tissuechip/projects). The FDA is key in providing insight as to how tissue chips could potentially inform regulatory decision-making, and how the technology can best be positioned during the drug discovery and development process. A very productive partnership has been built with the International Consortium for Innovation and Quality (IQ Consortium) MPS Affiliate that provides a unified voice from the pharma industry in working with NIH, FDA and tissue chip developers towards implementation and qualification of MPS models as in vitro tools for drug development. There are currently more than 20 companies within this MPS affiliate (see https://www.iqmps.org/about-us) for cross-pharma collaboration and data sharing that seeks to facilitate expeditious uptake and impact of MPS in industry. Physiological characterization and validation have been key components of the NCATS Tissue Chips for Drug Screening program where tissue chip developers have been required to demonstrate the appropriate physiological functionality of organ systems, and replicate human responses to known pharmacological agents through a reference set of compounds. The analytical validation step requires a demonstration of transfer of the technology and reproducibility of findings between the tissue chip developers and independent sites. To this end, NCATS established the Tissue Chip Testing Centers (TCTCs) and a Microphysiological Systems Database Center with the goals of assessing the reproducibility and portability of the various tissue chip platforms. The parameters assessed by TCTCs include organ functionality and predictive value for toxicity data demonstrated in the tissue chip developers’ laboratories. The TCTCs also document best practices and standardizing procedures based on validation set of compounds, assays and biomarkers recommended by the FDA and IQ Consortium relevant to preclinical drug development. Another noteworthy partnership by NCATS is with the International Space Station U.S. National Laboratory with the goals of 1) better understanding the role of microgravity environment on modeling human health and diseases, in particular aging, and 2) to rapidly evolve tissue chip technology through miniaturization and automation of the instrumentations that support the chips. The field has clearly grown internationally and beyond the NIH supported MPS programs demonstrating that an annual scientific conference that is associated with a professional society are needed to further catalyze and galvanize this field. International interest was evident by the widely attended Keystone Symposia on Organs- and Tissues-on-Chips held in 2018.

Description

Applicants should identify an appropriate venue for the meeting and handle all meeting publicity and logistics including but not limited to developing a meeting agenda, working with site hosts and vendors before and during the meeting, arranging for audio-visual needs, registering meeting attendees, arranging travel for plenary speakers and travel scholarship winners for junior and new investigators, preparing meeting and outreach materials, and conducting a post-meeting survey of attendees.

Successful applicants are expected to work in consultation with NCATS Program staff to establish an organizing committee with representation from across the MPS research community and other stakeholders. The MPS Organizing Committee will identify one or more themes for the annual meetings; design the program format that is comprised of a mix of invited plenary lectures, submitted symposia, and poster sessions, and may involve more innovative components as well; develop strategies to publicize the meeting and inviting submissions through various outreach activities; identify and invite plenary speakers; and constitute a Program Review Working Group, with additional members if necessary, to peer review submissions and select trainees and young investigators for travel awards.

Funding Mechanism

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for defining objectives and approaches, and planning, conducting, analyzing, and publishing results, interpretations, and conclusions of the conference.

Awardees are responsible for identifying specific milestones for conferences that will be supported during the project period, when multi-year conferences are supported.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. Substantial involvement as a partner would include, for example, assisting in planning the agenda, selecting speakers, determining the content of the meeting, or determining the acceptability of submitted abstracts. Substantial involvement would not include serving as an invited speaker or providing limited advice.

Budget and Duration of Award

Application budgets should reflect the actual needs of the proposed project but should not exceed $450,000 total costs over three years, with no more than $150,000 total costs requested annually. NCATS anticipates that the outcome—an international scientific conference devoted to MPS—will be self-sustaining through registration fees and sponsorship after a brief period of NCATS support. Registration costs for attendees, which have typically included attendance and refreshments, should not exceed $300 for each meeting during the period of NCATS support.

Applications for up to three years in duration will be accepted to support the MPS annual conference.

Permission to Submit Letter

The conference grant application is required to contain a permission-to-submit letter from NCATS’ conference grant contact below:

National Center for Advancing Translational Sciences (NCATS) Referral Office

Telephone: 301-435-0827

E-mail: ncatsreferral@mail.nih.gov

Applicants are urged to initiate contact well in advance of the chosen application receipt date. Please note that agreement to accept an application does not guarantee funding.

Receipt Date

Applications should be submitted to the Parent R13 Announcement PA-18-648, https://grants.nih.gov/grants/guide/pa-files/PA-18-648.html for the August 12, 2020 receipt date.

Inquiries

Please direct all inquiries to:

Danilo A. Tagle, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8064
Email: danilo.tagle@nih.gov