Staring Into the Valley of Death?
NIH RAID to the Rescue

by Richard V. Smerbeck

THE "VALLEY OF DEATH" is a familiar phrase amongst many small R&D firms. It describes the time during product development when a project has progressed far enough along so that investment money is required to move it ahead. Unfortunately, as is often the case, potential investors, partners and large companies feel that the project is too early in development to risk investment.

In the case of a start-up drug/biologic business, the valley of death is typically encountered during the pre-clinical stage of development. In the preclinical stage, data to support the safe testing of a drug or biologic in humans is collected. Without such data, a company cannot file their Investigational New Drug (IND) application, get approval from FDA and start clinical testing. Most potential investors in small pharmaceutical businesses consider the risk too great to consider investing until the company has a fileable IND.

The cost of developing a drug or biologic is formidable. It’s not unusual to spend $20 million or more to bring a new chemical entity (NCE) through the preclinical phase of drug development. This level of funding is beyond the means of most small pharmaceutical companies. With investment funding in short supply, many promising therapies do not make it from the bench to the clinical trials. To mitigate the funding shortfalls available privately, the National Institutes of Health (NIH) established the Rapid Access to Interventional Development (RAID) program as a part of the most current NIH Roadmap for Medical Research.

RAID Services

In the RAID program, the NIH makes its own preclinical drug development resources available to individuals, academic researchers and small businesses. If accepted into the RAID program, these services are free of charge to the grantee.

The NIH RAID program will provide some or all of the services listed on the following page to the grantee. The program also provides the project management and quality resources to ensure that the Good Laboratory Practices and Good Manufacturing Practices are followed – making the results suitable for inclusion in the IND application.

RAID Application Process

The RAID program, while open to all qualified applicants, does have a thorough selection process. According to Dr. David Badman, NIH RAID Program Coordinator, an applicant will need a compound or biologic that is “druggable.” That is, the compound has to have the characteristics that will allow it be evaluated and ultimately approved by the FDA as a drug. Some examples of druggable characteristics include single molecular entity, known synthetic route and/or administered via pharmaceutically accepted means. A clear intellectual property strategy should be in place – the applicant must have the right to develop the molecule. Strong animal efficacy data should also be in hand. Dr. Badman suggests that the study and results should be of “peer-reviewed publication quality.”

Once a potential applicant reaches that point, the RAID staff urges the applicant to contact the RAID representative from the appropriate Institute within NIH to determine if the project is potentially supportable.

For the Institute or Center to support the RAID program an application process must be completed. Details of the application process can be found at: grants.nih.gov/grants/guide/pa-files/PAR-09-027.html.

The scientific merit of an application is determined by a Special Emphasis Panel (SEP) formed by NIH’s Center for Scientific Review. If the SEP determines that a program has sufficient scientific and technical merit, then the relevant Institute or Center has the option to recommend that the applicant be invited to present the program at a meeting at the NIH. At that meeting, an agreement will be reached as to what services are needed. These services are costed out by NIH staff.

Guidelines for RAID Funding

NIH Application Tips

• A registration process is necessary before submission and applicants are highly enouraged to start the process at least four (4) weeks prior to the grant submission date.
• Applications must be submitted electronically through Grants.gov (www.grants.gov) using the SF424 Research and Related (Ramp;R) froms and the SF424 (R&R) Application Guide. Applications may not be submitted in paper format.
• The FOA must be read in conjunction with the application guidelines included with the announcement in Grants.gove/Apply for Grants.