SOURCES SOUGHT
A -- CRO Support for NCATS Animal Model Development and In Vivo Pharmacology Studies and Related Services
- Notice Date
- 10/3/2017
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except 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, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- HHS-NIH-NCATS-SBSS-18-001
- Archive Date
- 11/8/2017
- Point of Contact
- Jeffrey Schmidt, Phone: (301) 402-1488
- E-Mail Address
-
schmidtjr@mail.nih.gov
(schmidtjr@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Please note that to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the cost of contract performance incurred for personnel must be expended for employees of the small business awardee (see FAR 52.219-14 Limitations on Subcontracting). Background The Division of Preclinical Innovation (DPI) at National Center for Advancing Translational Science (NCATS) conducts translational research in the area of human therapeutics development and aims to move small molecule and biologic drug candidates forward in the drug development pipeline to predetermined milestones, at which point, DPI will hand off the drug candidate to external partner(s) to bring the novel therapy to patients. In addition to developing new candidate drugs, DPI seeks to advance the entire field of drug discovery and development by encouraging scientific and technological innovations aimed at improving success rates in the crucial pre-clinical stage of drug development. DPI's model is to operate as a full range small molecule and biologics drug development organization, moving drug candidates through each phase of the pre-clinical drug development process until an IND is filed with the US Food and Drug Administration (FDA). For certain drug development programs, DPI will support its candidate's development up to human Phase IIB studies if and when determined by DPI management team as necessary to achieve DPI's mission. DPI conducts drug development as collaborations through programs such as the Therapeutics for Rare and Neglected Diseases (TRND) and the Bridging Interventional Development Gaps (BrIDGs) programs. DPI drug development programs originate from academia, industry, non-profit foundations, or internally from NCATS and other NIH institutes, and its R&D operational strategy is to combine the capabilities of DPI in-house staff and DPI partners, who may be the drug originators. Each drug program operates in a multi-disciplinary, multi-partnership matrix team environment, and a DPI program officer (PO) is responsible for the overall planning, execution, and reporting of the program. Contract research organizations (CROs) and contract manufacturing organizations (CMOs) provide DPI with manufacturing, pharmacology, toxicology, regulatory, and clinical operations services to assist with drug development. Planning and execution of each individual drug development program includes identification of technical areas best suited for utilization of CROs and CMOs to conduct some or all parts of a given drug development program. The objective of this contract is to support the DPI drug development programs by providing services related to the development of animal models and the execution of in vivo pharmacology and related studies, including the use of relevant supporting services needed to accomplish requested tasks. The DPI program requires confirmation and verification of the efficacy of development compounds in an acceptable animal model of the disease. To accomplish this endeavor, DPI has a need for novel, re-developed, optimized, or use of existing, validated animal models to conduct in vivo pharmacology studies for rare disorders and neglected diseases. These models are not able to be pre-determined as needs change depending on the disease; as such, access to both small (e.g., mice, rat) and large (e.g., dog, cat, monkey, pig) models are needed. In addition, therapies can cover a wide range of modalities, small molecules, and biologics (e.g. antibody, proteins, and cell and gene therapy). Project Requirements Written capability statements should demonstrate your organization's ability and related experience in all of the following Technical Areas: (1) In Vivo Pharmacology Services in Small Animal Models; (2) In Vivo Pharmacology Services in Large, Non-Traditional Animal Models Including Non-Human Primates; (3) Small Animal Models-Acquisition, Optimization/Refinement, and Development; (4) Large, Non-Traditional Animal Models-Acquisition, Optimization/Refinement, and Development; (5) In Vitro Pharmacology Studies in Ex-Vivo or Cell- Based Models or Other Relevant Animal Replacement Models-Acquisition, Optimization/Refinement, or Development; (6) Pharmacology Consulting and Animal Model Development Expertise. I. Technical Area 1: In Vivo Pharmacology Services in Small Animal Models Provide services related to the conduct of in vivo studies with therapeutics under development. The studies under this technical area will be conducted using acquired small animal models and will be in support of support the initial programmatic requirement of efficacy verification and further product development. Anticipated activities under this technical area include, but are not limited to: - Defining pharmacokinetic/pharmacodynamic (PK/PD) relationships. - Evaluating a range of endpoints and biomarkers in response to therapeutic candidates. - Determining correct route of administration (e.g. SC, IV, PO, IT, or ICV). - Determining appropriate dosing parameters. - Determining appropriate formulation(s) for administration. - Examination of preliminary toxicity and safety parameters. II. Technical Area 2: In Vivo Pharmacology Services in Large, Non-Traditional Animal Models Including Non-Human Primates Provide services related to the conduct of in vivo studies with therapeutics under development. The studies under this technical area will be conducted using acquired large, non-traditional animal models and will be in support of support the initial programmatic requirement of efficacy verification and further product development. Anticipated activities under this technical area include, but are not limited to: - Defining pharmacokinetic/pharmacodynamic (PK/PD) relationships. - Evaluating a range of endpoints and biomarkers in response to therapeutic candidates. - Determining correct route of administration (e.g. SC, IV, PO, IT, or ICV). - Determining appropriate dosing parameters. - Determining appropriate formulation(s) for administration. - Examination of preliminary toxicity and safety parameters. III. Technical Area 3: Small Animal Models-Acquisition, Optimization/Refinement, and Development Provide services related to the acquisition, optimization, refinement, and development of small animal models. Characterize and validate the model for the therapeutic area that is under evaluation. IV. Technical Area 4: Large, Non-Traditional Animal Models-Acquisition, Optimization/Refinement, and Development Provide services related to the acquisition, optimization, refinement, and development of large, non-traditional animal models. Characterize and validate the model for the therapeutic area that is under evaluation. V. Technical Area 5: In Vitro Pharmacology Studies in Ex-Vivo or Cell- Based Models or Other Relevant Animal Replacement Models-Acquisition, Optimization/Refinement, or Development Conduct in vitro pharmacology studies to test therapeutics in existing, refined, or newly developed ex-vivo or cell-based models of disease or other relevant animal replacement models. VI. Technical Area 6: Pharmacology Consulting and Animal Model Development Expertise Provide pharmacology consultants and animal model expertise as required by the studies being conducted under this program. Provide services in support of report writing, including IND-enabling reports. Note the pharmacology consultants may not be required to have animal model expertise. Additional Information Specify whether your organization uses any proprietary technology for any of the activities described for all Technical Areas. If so, clarify whether NCATS and NCATS collaborators will have freedom to use the technology at a third-party facility in case the project is later transferred to a third party. In addition, your organization's capability statement should: (1)Indicate how many staff members the small business would be able to dedicate to the program, and which of those would be available in-house; (2)Identify which requirements would be performed in-house versus those that would be performed outside your organization; and (3)Describe your organization's ability to rapidly scale staff capacity up or down to support the anticipated workload. Contract Type and Anticipated Period of Performance The Government anticipates making single Indefinite Delivery/Indefinite Quantity (ID/IQ) type contract awards under the future solicitation-with the eventual contract being administered and funded via Task Orders (TO). The Government anticipates awards will be made in the fourth quarter of FY2018. each study must be approved by the Government prior to initiation of any work under this contract. Other Important Considerations To enable Collaborators to retain control of the intellectual property for compounds created through this program, the Government has sought a Declaration of Exceptional Circumstances (DEC) to the Federal Acquisition Regulations (FAR) for this program. Required Information All capability statements must provide the following: (1) DUNS number; (2) organization name; (3) organization address; (4) point of contact; (5) point of contact title, address, telephone, and email address; and (6) size and type of business (e.g., 8(a), HUBZone, etc.) pursuant the applicable NAICS code. Submission Instructions and Due Date Written capability statements must be SUBMITTED ELECTRONICALLY NO LATER THAN TUESDAY, October 24, 2017 to Jeffrey Schmidt, Contracting Officer at jeffrey.schmidt@nih.gov with Jessica Adams, Contract Specialist cc'd at jessica.adams@nih.gov. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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