Investigational New Drug Toxicology for Drugs to Treat Alzheimer's Disease and Other Aging-Related Diseases

This Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Institute of Aging (NIA) or the National Institutes of Health (NIH). The purpose of this Sources Sought Notice is to identify qualified small businesses including 8(a), HUBZone, Women Owned Small business, Small disadvantaged Business, and/or Service-Disabled Veteran-owned business concerns that are interested in and capable of performing the work described herein. Teaming and partnering among small businesses is encouraged. The NIA does not intend to award a contract on the basis of responses to this Sources Sought Notice, nor otherwise pay for the preparation of any information submitted. As a result of this Sources Sought Notice, the NIA may issue a Request for Proposal (RFP). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NIA shall arise as a result of a response to this Sources Sought Notice or the NIA's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. If an RFP is issued, it is anticipated that one (1), cost-reimbursement, completion type contract will be awarded for a period of five (5) years with an option for yearly extensions up to two (2) additional years and/or additional quantities. This contract may include incentives, award fees, and/or be performance based. The National Institute of Aging (NIA) is seeking qualified small businesses to provide support to the Intramural Research Branch (IRB), of the National Institutes of Aging (NIA) within the NIH, to provide drug development and toxicology screening support as described below. This is a re-competition of the current contract with SRI International, Inc. which ends in September, 2009. This is the third re-competition of this contract. Efforts in developing and testing new drugs for the prevention and treatment of the cognitive impairment and behavioral symptoms associated with Alzheimer's disease (AD) represent a major programmatic activity of the National Institute on Aging (NIA) but continue to be hindered by the lack of access of many academic investigators and small businesses to animal testing facilities to evaluate the preclinical toxicology of potential therapeutics. The present paucity of compounds which can uniformly slow or reverse the progression of AD or ameliorate the symptoms or delay the onset requires that every effort be made to facilitate the development and testing of new compounds. The need to develop therapeutics for other aging-related diseases is also apparent. Additionally, the advent of Positron Emission=2 0Tomography (PET) imaging agents for assessing brain beta-amyloid and other pathophysiological features of AD requires toxicological testing of these agents prior to human studies. The contract provides toxicology resources to academic and small business investigators who believe they have promising compounds for the treatment or prevention of Alzheimer's disease or other aging-related diseases or have PET imaging agents but who do not have the resources to perform the required toxicology studies. This contact provides investigators access to toxicological evaluations that are required by the Food and Drug Administration (FDA) when requesting an Investigational New Drug (IND) designation for clinical studies. This preclinical drug-development program expands the potential range of drug therapies and imaging agents for Alzheimer's disease and other aging-related diseases by making these resources available to a larger and more diverse group of investigators. This contract complements NIA's support of studies in preclinical drug discovery and development through a variety of grant and contract mechanisms for drugs to prevent and treat Alzheimer's disease and other aging-related diseases and for imaging agents. It provides NIA with the capability to translate basic science research into clinical trials by providing the resources needed by individual investigators and small companies to generate the toxicology data required to obtain an IND from the FDA to do initial human studies. Thus, the continuing availability of this contract is an important part of NIA's efforts to facilitate drug discovery, development, and testing for Alzheimer's disease and other diseases of aging. Capability statements from qualified small businesses should address their experience and capabilities in the following seven (7) areas: (1) analytical chemistry; (2) pharmacokinetics and bioavailability; (3) preliminary toxicity screens; (4) IND-directed toxicology studies; (5) safety pharmacology; (6) GLP and AAALAC accreditations; and (7) experience performing contracts of similar size and scope to this requirement. Capability statements should not exceed 10 single-sided pages (minimum 12 pt. font), excluding attachments. Work assignment procedures may be utilized to control costs and effort. Over the 5 year base period it is estimated that approximately 30,000 total labor hours would be required. Of these, approximately 7% would be professional staff hours and 93% support staff hours. Your establishment must be in compliance with FDA Good Laboratory Practice (GLP) regulations and animal facilities must be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). For contract award you must have an Animal handling Certificate. Submit responses to the attention of either Bruce E. Anderson or Drake G. Russell at: Attention: Drake Russell/Bruce E. Anderson NIDA Office of Acquisitions, Neurosciences NIMH R&D Contracts Management Branch 6001 Executive Blvd., Rm 8154 (MSC 9661) Bethesda, MD 20892-9661 (For hand delivered commercial overnight services, use Rockville, MD 20852)