Notice Number: NOT-HL-16-472
Key Dates
Release Date: November 23, 2016
Response Date: February 17, 2017
None
Issued by
National Heart, Lung, and Blood Institute (NHLBI)
Purpose
This request for information (RFI) seeks comments regarding early translational research activities supported by NHLBI.
Background
NHLBI seeks to facilitate and accelerate the development of new clinical interventions by bridging the gaps between mechanistic, discovery, and early translational research. This includes providing appropriate mechanisms to support investigator-initiated research, addressing resource and knowledge gaps, and creating initiatives to support career development of translational scientists and biomedical entrepreneurs.
The NHLBI is considering providing support for the earliest phases of developing a target/compound/biologic for use as a therapy or diagnostic. It is envisioned that projects assisted by such a program would be investigator-initiated grants of relatively short duration, designed to answer one to two specific questions (which may or may not be hypothesis driven), and focused on whether the target in question is reasonable to pursue as a therapy or diagnostic.
One current NHLBI strategy to facilitate translational research has been the development of research resource programs that provide translational services to meritorious projects at no charge to the investigator. These programs include SMARTT, (www.nhlbismartt.org), GTRP (www.gtrp.org), and PACT (www.pactgroup.net ) and are focused on advancing projects that are beyond the target qualification phase by providing assistance with IND enabling studies. The NHLBI is seeking input on the next iteration of these programs and whether there is a need for NHLBI to provide access to expert consultative services.
NHLBI would also like input on the need for investigator training programs in translational research. Such programs could include short courses on distinct topics such as regulatory matters, entrepreneurial education programs like I-Corps (www.nsf.gov/news/special_reports/i-corps/), or longer term support such as a sabbatical or fellowship to gain a broad range of experience. Understanding what investigators see as their training and educational needs will help NHLBI to better address those needs.
Information Requested
Please respond by identifying what you consider to be the major early translational needs of the NHLBI research community that could be addressed by NHLBI through grants, contracts, expertise, or resources.
Information is being sought on the need for support of early translational studies that may include the following:
- Development of screening assays
- High Throughput Screening
- Hit-to-Lead services
- Lead (target) optimization
- In vitro target qualification
- Expert consultant services
- Animal model development
- Mechanism of action
- Development of reagents for use in testing target levels and/ or activity (e.g. antibodies, RNAi)
- Assessment of target distribution and localization in situ development of in vitro systems to determine target activity, ideally with potential for conversion to high-throughput format
- Preliminary pharmacokinetics
- In vivo efficacy studies
- Preformulation - determination of drug target levels at efficacious doses and maximum tolerated dose
Information is also being sought on the need for NHLBI to support workforce development programs related to translational research and entrepreneurial education
Responses
All responses to this RFI must be submitted via email to Translational_Research@mail.nih.gov by February 17, 2017. Please include this RFI number (NOT-HL-16-472) in the subject line of your response. Response to this RFI is voluntary. After February 17, 2017, responses will no longer be considered, and the email box will be closed
This RFI is for planning purposes only and should not be construed as a solicitation for applications or as an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the United States Government will not pay for the preparation of any information submitted or for its use of that information.
Responses will be compiled and shared internally and with the National Heart, Lung, and Blood Advisory Council, with one or more subcommittees of the Council, and with scientific working groups convened by the NHLBI, as appropriate. In all cases where responses are shared, the names of the respondents will be withheld.
We look forward to your input and hope that you will share this document with your colleagues. Thank you very much for your help.
Inquiries
Please direct inquiries to one of the following NHLBI staff members:
Kurt Marek, Ph.D
Office of Translational Alliances and Coordination
Email: marekkw@nhlbi.nih.gov
Cheryl McDonald, MD
Division of Cardiovascular Sciences
Email: McDonalC@nhlbi.nih.gov
Traci Heath Mondoro, Ph.D.
Division of Blood Diseases and Resources
Email: mondorot@nhlbi.nih.gov
Patricia Noel, Ph.D.
Division of Lung Diseases
Email: noelp@nhlbi.nih.gov
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