Notice Number: NOT-HL-08-111
Key Dates
Release Date: February 15, 2008
Opening Date: February 15 2008
Response Date: March 21, 2008
After March 21, 2008, responses will no longer be considered, and the web link and email box will be closed.
Issued by
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/)
Purpose
This request for information (RFI) seeks comments regarding establishment of a NHLBI Program to offer access to the services of the National Cancer Institute’s (NCI) Rapid Access to Interventional Development (RAID) Program to the NHLBI scientific community.
Background
The NHLBI is considering joining the NCI RAID Program that provides contract services to aid in the translation to the clinic of therapeutic inventions originating in academia. To help the Institute gauge the amount and kinds of support needed, NHLBI invites scientists to consider the services listed at the DPT link (http://dtp.nci.nih.gov/docs/raid/raid_pp.html) and to indicate the types of services and agents that are needed and likely to be used to improve diagnosis, treatment, and prevention of heart, lung, and blood disorders.
As an additional part of this program, the NHLBI is also considering providing support for the pre-clinical validation phase of developing a target/compound for therapy. It is envisioned that projects assisted by such a program would be 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.
Information Requested
Please respond by identifying what you consider to be the major opportunities that could be addressed by this program and indicating potential services and reagents that would be helpful in moving basic discoveries to the clinic. Note that gene and cellular therapy-related services are supported by other NHLBI targeted programs (http://www.gtrp.org and http://www.pactgroup.net/ and would not be eligible for this program.
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.
Responses
To respond by March 21, 2008, please complete and submit the form on line at: http://apps.nhlbi.nih.gov/survey/RAID
Or send a letter, fax, or email to:
Request for Information:
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8125
Bethesda, MD 20892- 7940
Fax: (301) 480-7971
Email: [email protected]
On your response please answer the following (and include the Notice number HL-08-111 in the subject line):
1a. Do you think there is an unmet need that a NHLBI/NCI RAID program could fill in the heart, lung, and blood research communities?
_Yes __ No __No Opinion
Additional Comment: ____________
1b. Please specify your primary research community.
____Heart ____Lung ____Blood
2. Please indicate which RAID services would be useful. Examples of RAID services are listed below and are also available at http://dtp.nci.nih.gov/docs/raid/raid_pp.html
Please check as many as needed and list any other needed services that are missing from the list.
___ Definition of optimization of dose and schedule for in vivo activity
___Development of pharmacology assays
___Conduct of pharmacology studies with a pre-determined assay
___Acquisition of bulk substance (GMP and non-GMP)
___Scale-up production from lab-scale to clinical trials lot scale
___Development of suitable formulations
___Development of analytical methods for bulk substances
___Production of dosage forms
___Stability assurance of dosage forms
___Range-finding initial toxicology
___IND-directed toxicology, with correlative pharmacology and histopathology
Other, please specify ____________________________________________
3a. Should these services be provided for both biologics and small molecules, just biologics, just small molecules?
___ Biologics Only ___ Small Molecules Only ____ Both
3b. Please indicate if you are working with biologics or small molecules or both.
___ Biologics Only ___ Small Molecules Only ____ Both
4a. Do you think there is a need for a short duration, modest budget, grant program to support preclinical validation studies that would complement the RAID program?
__Yes __ No
4b. Please indicate the types of studies that you would conduct that could utilize such a program. Please check all that would apply. Examples of research that can be supported by a pre-clinical validation research grant program include, but are not limited to:
___Clinical studies for characterization of target levels and/or activity correlating with development of disease and/or disease progression, specific pathology, or severity
___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 determination of maximum tolerated dose.
Other, please specify ____________________________________________
Inquiries
Traci Heath Mondoro, Ph.D.
Acting Branch Chief
Thrombosis and Hemostasis Branch
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Room 9174, MSC 9750
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: 301-435-0052
FAX: 301-480-0867
email: [email protected]
and Human Services (HHS)
