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Phase IIB Competing Renewal Awards

Description:

NIDA will accept SBIR/STTR Phase IIB Competing Renewalgrant applications from Phase II SBIR/STTR awardees to continue the processof developing products that require approval of a Federal regulatory agency. Such products include, but are not limited to: drugs, vaccines, medical implants, or other treatment or diagnostic tools that require FDA approval. This renewal grant should allow small businesses to get to a stage where interest and investment by third parties is more likely.

Transitioning a new molecular entity from preclinical to the clinical phase of development, requires large-scale production of the new molecular entity and toxicity testing, activities which are both costly and time consuming. The cost and time constraints imposed by advanced stage development of a new molecular entity pose significant obstacles for small businesses. Although Phase I and Phase II SBIR support is sufficient for initial discovery efforts (e.g., compound synthesis and some in vitro and in vivo preclinical pharmacological testing), it is neither adequate to support necessary developmental preclinical work needed to comply with the FDA regulations , nor sufficient to conduct clinical trials.

The purpose of Phase II Competing Renewal Award is to provide Phase II awardees a chance for another three years of support. It is recognized that an award of this type may not support the entire medications development timeline for any given drug. The Competing Renewal grant will however, provide small businesses with opportunity to further advance the development of its product /medication from the preclinical to the clinical stage, which will aid in attracting interest and investment by third, parties, and provide an important sustained resource for new pharmaceuticals aimed at the safe and effective treatment of substance abuse.

Please contact Kris Bough (contact information provided below) before beginning the process of putting an application together. Prospective applicants are strongly encouraged to contact NIH staff prior to submission of a Phase IIB Competing Renewal application and to submit a letter of intent that includes the following information:

·       Descriptive title of the proposed research

·       Name, address, and telephone number of the Principal Investigator

·       Names of other key personnel

·       Participating institutions

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and plan the review. It is expected that only a portion of NIDA SBIR/STTR Phase II awards will be eligible for a Phase IIB Competing Renewal grant.

The following examples would make appropriate topics for proposed SBIR or STTR Phase IIB Competing Renewal projects. These are meant for illustrative purposes only and are not exclusive of other appropriate activities.

Research and development efforts can be focused on medications for the treatment of cocaine, methamphetamine, and other stimulant abuse, as well as towards opiate, prescription opiates, cannabis, PCP or club drugs. The medications under development should be targeted towards attainment of abstinence and/or relapse prevention.

·       Preclinical studies, including pharmacology and toxicology, beyond those conducted under the initial SBIR Phase I and Phase II grants. The studies conducted under the previous grants should be sufficient to provide a sound rationale for continued development of the entity or entities.

·       Completion of studies as required by the FDA for an IND application.

·       Human laboratory clinical trials to determine a medication's safety profile, metabolism, cardiovascular effects, interaction with drugs of abuse, etc.

·       Clinical studies to assess the efficacy of the medication under development.

Kristopher Bough, Ph.D.

Program Officer, Medications Research Grants Branch (MRGB)

Div. of Pharmacotherapies and Medical Consequences of Drug Abuse

NIH - National Institute on Drug Abuse (NIDA)

6001 Executive Boulevard

Room 4153, MSC 9551

Bethesda, MD 20892

  Express mail/courier use: Rockville, MD 20852

Tel: 301-443-9800, Fax: 301-443-9649

Email: boughk@mail.nih.gov

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