In-vivo ADMETTesting Services for Neurotherapeutics Development

Sources Sought Notice HHS-NIH-NIMH-RDSS-2010-023 In-vivo ADMET testing services for Neurotherapeutics Development: Sources Sought PURPOSE: The NIMH is interested in identifying all sources with the requisite capabilities and qualifications to provide a full range of in vitro and in vivo preclinical pharmacology and safety (ADMET) studies for the purposes of developing new drugs for nervous system disorders. The NIMH anticipates requiring non-GLP ADMET services for up to 20 projects in the lead optimization stage per year and GLP IND-directed ADMET services for 5-10 projects per year, over a five-year period. BACKGROUND: High-throughput screens and basic research studies have led to the discovery of many small molecule compounds with activity in models of nervous system diseases. Some of these compounds might be transformed into drugs, with chemical modifications to improve their potency and pharmacological properties. However, biotechnology and pharmaceutical companies are hesitant to invest in the early development of compounds for rare diseases or new targets, given concerns about profitability and risk, and academic researchers who have identified a promising compound rarely have access to the necessary drug development resources, including ADMET services. The NIMH will require in vitro and in vivo ADMET services over the course of medicinal chemistry lead optimization and to prepare projects for IND applications. The NIMH anticipates requiring non-GLP ADMET services for up to 20 projects per year at the lead optimization stage and IND-directed GLP studies for 5-10 projects per year. The ADMET contractor must have the capacity to conduct multiple projects simultaneously. Medicinal chemistry, scale-up synthesis and GMP manufacture, and the preparation of the IND paperwork will be conducted under separate contracts. This contract will serve as part of the NIH Blueprint for Neurotherapeutics Network (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm) and be utilized for individual drug development projects outside of the Blueprint Network. The NIMH is seeking sources that can provide a full range of in vivo and in vitro ADMET services including but not limited to the following: - Rodent acute toxicity/dose tolerance trial - Dose ranging/toxicology study in rodent - Dose ranging/toxicology study in dog or monkey - Assays to assess blood-brain barrier penetration and bioavailability - GLP Toxicity Study in rodent (typically 28 day) - GLP Toxicity Study in dog or monkey (typically 28 day) - Safety and Pharmacology Studies in rodent - Safety and Pharmacology Studies in dog or monkey - ADME study in rodent - ADME Study in dog or monkey Sources must meet the following criteria at the time of submission of original proposals: (1). The laboratory facility must be in compliance with the Food and Drug Administration's (FDA) Good Laboratory Practice Regulations (GLP) as published in the December 22, 1978 Federal Register (Volume 43, No. 247, pp. 59986 60025). GLP Regulations are available on the World Wide Web (WWW) at www.fda.gov/ora/compliance_ref/bimo/glp/87finalrule.htm and GLP Regulations Questions and Answers are available at www.fda.gov/cder/guidance/old004fn.pdf. A copy of the most recent FDA GLP inspection report must be included in the proposal. (2). The Contractor's animal facilities must be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International as indicated by providing the latest accreditation report. Information about AAALAC accreditation is available on the WWW at www.aaalac.org. The Contractor must also provide an animal welfare assurance indicating compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, information for which is available on the WWW at http://ohrp.osophs.dhhs.gov/index.htm and http://grants.nih.gov/grants/olaw/olaw.htm. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS. Once a determination is made regarding the suitability of this future requirement for a small business set-aside or an open competition to include both large and small business, a separate Pre-Solicitation Announcement will be issued in advance of the release of a Request for Proposals. The applicable North American Industry Classification System (NAICS) code for this requirement is 541711. Therefore, the small business size standard for this announcement is 500 or fewer employees. Please note that in order to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the direct labor cost must be in-house. Specifically, FAR 52-219-14 - Limitations on Subcontracting states that at least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern. Submitted Capability Statements must address how the business meets the applicable size standard designated for this project. INFORMATION REQUESTED: Your response should demonstrate: 1) your ability, experience, and resources to design and carry out the range of in vitro and in vivo ADMET studies described above, and 2) your capacity to provide ADMET services for up to 20 projects at the lead optimization stage and IND-directed ADMET studies for up to 8 projects per year. In describing your capacity, please indicate how many projects you are capable of supporting, even if it is fewer than the maximum required, and how many projects you can support at any given time. Please also indicate the staff that you would be able to dedicate to this contract. Please submit 3 copies of your response to the attention of Phil Hastings-Tickerhoff, Contracting Officer, at the address provided by 3:00 PM Local Time on October 1, 2010. Electronic submittal will also be accepted at phastings@nida.nih.gov (please format for printing). You are encouraged to limit you response to fewer than 15 pages and must specifically address each of the requirement specific items stated above. Generic marketing brochures will not be considered further. This Announcement is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or the Government's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the Government's evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this announcement or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Responses will be held in a confidential manner. Any proprietary information should be so marked. All respondents are asked to indicate the type and size of your business organization, e.g., Large Business, 0. Small Business, Veteran-Owned Small Business, Service-Disabled Veteran-Owned Small Business, HUBZone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a). Phil Hastings-Tickerhoff, Contracting Officer, National Institutes of Health, NIMH R&D CMB, 6001 Executive Blvd., Room 8154, MSC 9661, Bethesda, MD 20892-9661 or via overnight delivery to Rockville, MD 20852. The use of e-mail or overnight delivery is encouraged to avoid potential shipment delays.