Notice Number: NOT-RM-08-005

Key Dates
Release Date: November 21, 2007

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

Purpose

The purpose of this Notice is to update potential applicants to the NIH-RAID Pilot (http://nihroadmap.nih.gov/raid), a component of the NIH Roadmap for Medical Research (http://nihroadmap.nih.gov), on changes to program scope and procedures.  The NIH-RAID Pilot accepts applications under PAR-07-358 (http://grants.nih.gov/grants/guide/pa-files/PAR-07-358.html).  Successful applicants are awarded no-cost access to government contract resources for completion of specific tasks in the pipeline for the preclinical development of therapeutics.  Available services and application procedures are described in PAR-07-358.  The NIH-RAID Pilot has implemented the following changes to these services and procedures.

• Available services include the manufacture of Phase I drug supplies.  The NIH-RAID Pilot will now consider requests for manufacture of material for any clinical study.  Exceptions will be granted based upon program priorities and availability of resources.
• Available services include synthesis of small molecules, oligonucleotides, and peptides, isolation and characterization of natural products, and later-stage preclinical development tasks for these classes of candidate therapeutics, such as formulation, pharmacology, and toxicology.  The NIH-RAID Pilot will now consider requests for services to support later-stage preclinical development of monoclonal antibodies, recombinant proteins, and gene therapy agents.  Requests for synthesis of monoclonal antibodies, recombinant proteins, and gene therapy agents will not be considered.  Exceptions will be granted based upon program priorities and availability of resources.
• Available services include product development planning.  Product development plans may now be requested without submitting an application under PAR-07-358 if no other NIH-RAID Pilot services are requested.  These requests may be sent by email to the NIH-RAID Pilot on or before the dates established for NIH-RAID Pilot applications.  Requests should be limited to five pages and include information on the lead indication, the planned clinical use, and the evidence for efficacy.  Additional information on the candidate therapeutic, if available, should also be included.  Decisions on requests for product development plans will be based upon program priorities and availability of resources.

Inquiries

Applicants requesting exceptions to the available services described in PAR-07-358 are encouraged to contact the NIH-RAID Pilot Program Office before submitting an application.  Direct questions about this Notice to:

Tony Jackson
NIH-RAID Pilot Program Office
6001 Executive Boulevard, Room 2141
Bethesda, MD 20892
Telephone: (301) 594-4660
Email: [email protected]