Request for Information (RFI): NHLBI/NCI RAID Program for Heart, Lung, and Blood Disorders

We appreciate your comments by March 21, 2008.

• 1a. Do you think there is an unmet need that a NHBLI/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
  Comment:
• 3b. Please indicate if you are working with biologics or small molecules or both.
  • Biologics Only
  • Small Molecules Only
  • Both
  Comment:
• 4a. Do you think there is a need for a short duration, modest budget and 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: