SOURCES SOUGHT
A -- PHARMACOLOGY AND TOXICOLOGY FOR THERAPEUTICS PROGRAM (PTTP)
- Notice Date
- 9/25/2015
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- SBSS-NIH-NINDS-16-01
- Archive Date
- 10/19/2015
- Point of Contact
- Donna Morris, Phone: (301) 496-1813, Kirkland L. Davis, Phone: (301) 496-1813
- E-Mail Address
-
donna.morris@nih.gov, kd17c@nih.gov
(donna.morris@nih.gov, kd17c@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SMALL BUSINESS SOURCES SOUGHT (SBSS) NOTICE NIH-NINDS-16-01 TITLE: PHARMACOLOGY AND TOXICOLOGY FOR THERAPEUTICS PROGRAM (PTTP) The National Institute of Neurological Disorders and Stroke (NINDS) and the NIH Blueprint Neurotherapeutics Network (BPN) (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm) have established a ‘virtual pharma' network of contract service providers and consultants with extensive industry experience to enable therapeutic (e.g., small molecule, peptide, biologic) development in the NIH research community. This network offers researchers access to a range of industry-style therapeutic development services and expertise, including medicinal chemistry, IND-enabling studies, and Phase 1 clinical trial infrastructure, with the goal of supporting efforts to advance compounds successfully through Phase 1 clinical testing. Projects may utilize some or all of the BPN infrastructure. The Pharmacology and Toxicology for Therapeutics Program (PTTP) component will support all preclinical pharmacology and toxicology testing needed to inform lead discovery and the selection of a clinical candidate, and comprehensive studies needed for regulatory filings such as an Investigational New Drug (IND) application for the FDA to allow for clinical evaluation of the candidates. PURPOSE OF NOTICE The NINDS is interested in identifying small business concerns with the requisite capabilities and qualifications that could provide a full range of in-vitro and in-vivo preclinical pharmacokinetic, toxicology, and safety studies for the purposes of developing new therapeutics. The applicable NAICS code for this requirement is 541711. Therefore, the small business size standard for this requirement is 500 or fewer employees. Small businesses that meet the applicable size standard above and who believe that they have the capabilities, capacity, experience and qualifications to provide the full range of in-vitro and in-vivo preclinical pharmacokinetic, toxicology, and safety studies are asked to address each of the areas described in the Program Requirement section below and to submit a response. Please ensure that your response is complete and sufficiently detailed to assist in our evaluation as to whether or not this requirement could be set-aside for small business participation only. If your business concern is NOT a small business, there is no need to respond to this announcement. If responses indicate a reasonable expectation of obtaining competitive offers from two or more responsible and capable small business concerns, the anticipated subsequent Request for Proposals may be set-aside for small business participation only and a future Pre-Solicitation Notice for this requirement would indicate this determination. PROGRAM REQUIREMENT The NINDS anticipates requiring non-GLP services (e.g., in vitro ADMET, rodent and non-rodent pharmacokinetics, dose range finding toxicology) for up to 20 lead optimization-stage projects per year and GLP IND-directed services (e.g., GLP toxicology, safety pharmacology, and genotoxicity evaluation) for up to 10 development-stage projects per year. An organization must have the capacity to conduct multiple projects simultaneously (e.g., concurrent studies for 2-3 lead optimization stage projects and 2-3 IND-stage projects). The NINDS is seeking sources that can provide a full range of in vivo and in vitro pharmacokinetic, toxicology, and safety studies including, but not limited to, the following: • In vitro ADMET (e.g., metabolic stability, permeability, plasma protein binding, cytotoxicity, hERG, etc.) • Rodent and non-rodent single and multiple dose pharmacokinetic evaluation • Rodent and non-rodent dose-range finding toxicity assessment • Rodent and non-rodent acute toxicity (GLP) • Rodent and non-rodent chronic toxicity (GLP) • Safety Pharmacology Studies in rodent and non-rodent species (e.g., cardiovascular, pulmonary, CNS) • Genotoxicity assessments (e.g., Ames, mouse lymphoma assay, chromosomal aberration assay) • Carcinogenesis studies in rodents In addition to the above, sources must also meet the following certification/compliance criteria: (1) A laboratory facility fully compliant with the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) Regulations. (2) Facilities accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International as indicated by providing your organization's latest accreditation report. Information about AAALAC accreditation is available at www.aaalac.org. (3) Organization must have 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 at http://grants.nih.gov/grants/olaw/olaw.htm. (4) The organization is expected to be able to conduct in vivo studies in the following species: rodents (rats and mice), dogs (purpose bred Beagle dogs), rabbits, non-human primates (Cynomolgus, Rhesus), and other animal models (as appropriate), obtained from an AAALAC-accredited registered breeder (Association for Assessment, Accreditation, and Laboratory Animal Care, U. S. Department of Agriculture (USDA). Responses to this notice must address/provide (1) Information regarding your organization's: (a) staffing and personnel qualifications, e.g., numbers, availability and type of staff that would be assigned to such a program; their expertise, experience and education, including citation of any formal training; (b) current in-house capability and capacity to perform the work, including ability to conduct the full range of required pharmacology and toxicology studies and sufficient capacity to provide services for up to 20 lead optimization stage and 10 development/IND stage projects annually; (c) a discussion of the requirements to be performed in-house versus those performed outside the responding organization; (d) status of or ability to obtain/meet the certification/compliance criteria specified above; and (e) description of current (active) and prior (completed) projects of the same and/or similar nature. In addition, responses must provide: The respondents' DUNS number; organization name; organization address; point of contact, including title, address, telephone, and email address; and your current small business size status (e.g., small, small disadvantaged business, HUBZone small business, women-owned small business, 8(a), etc.) pursuant to the applicable NAICS code specified above. Generic marketing brochures/capability statements will not be evaluated. Please submit one (1) electronic copy of your response via e-mail to Ms. Donna Morris, Contract Specialist, at donna.morris@nih.gov and one copy to Mr. Kirkland L. Davis, Contracting Officer, at kd17c@nih.gov in MS Word (.doc, docx) or Adobe Portable Document Format (PDF). The e-mail subject line must specify SBSS-NIH-NINDS-16-01. You are encouraged to limit your response to fewer than 15 pages. ALL RESPONSES ARE DUE BY 4:00 PM EASTERN STANDARD TIME ON October 16, 2015. This Small Business Sources Sought 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. Responses will be held in a confidential manner. Any proprietary information should be so marked.
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- Record
- SN03904510-W 20150927/150925235737-fa8cce8ecb494efb2fdde6fcd3cd443e (fbodaily.com)
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