G
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 the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) conducts translational research in 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 Investigational New Drug (IND) is filed with the US Food and Drug Administration (FDA). 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 research and development (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 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 scientific 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 identifying preclinical drug candidates with improved efficacy, optimized ADME properties, and minimal predicted toxicity.
Project Requirements
Written capability statements should demonstrate your organization's in-house ability and related experience in all of the following Technical Areas: (1) Medicinal Chemistry Support; (2) In Vitro Testing; (3) Assays and Assay Panels; (4) Pharmacokinetic and Metabolism Evaluation; and (5) Toxicology.
I. Technical Area 1: Medicinal Chemistry Support
The NCATS project team will design lead compounds to be synthesized and provide that information to the Contractor. The Contractor will be responsible for synthesizing, storing, tracking, and providing the analogs to the project team. The task order may require ADME (absorption, distribution, metabolism, and exretion) and toxicology testing of the analog. The task order may require pharmacokinetic evaluation of compounds in multiple species.
II. Technical Area 2: In Vitro Testing
During lead optimization, it may be necessary to address a specific pharmacological or toxicological liability. In these cases, the Contractor will be responsible for providing appropriate in vitro testing for this purpose. In such cases where the in vitro testing system has been developed by one of the partners on the project team, the system will be provided to the Contractor for testing.
III. Technical Area 3: Assays and Assay Panels
The Contractor shall provide a full range of in vitro assays and assay panels to investigate the Structure-Activity Relationships (SAR) around pharmacological, ADME, and toxicological properties. Assay panels and individual assays proposed must be in routine use and currently operational at the Contractor's site. The Contractor must also provide the necessary analytical method development and perform analyses to support these assays.
Proposed assay panels should encompass a sufficient range to predict the span of known pharmacological, toxicological, and ADME activities. Pharmacological profiling is required to evaluate the activity of compounds against a broad array of cellular targets. Assays should include, but are not limited to, receptors, ion channels, transporters, enzymes, and secondary messengers. ADME profiling is required to predict potential in vivo ADME qualities. Assays should include, but are not limited to, in vitro measures of permeability, solubility, intestinal and hepatic metabolism, and protein binding. Toxicological profiling is required to predict potential in vivo toxicities. Available assays should evaluate activities that include, but are not limited to cytochrome P450 (CYP) enzyme induction, metabolic activation, CYP inhibition, and the potential for cardiotoxicity, lipidosis, endocrine interactions, and other toxicities.
IV. Technical Area 4: Pharmacokinetic and Metabolism Evaluation
Understanding of pharmacokinetic (PK) and metabolism characteristic of the compounds is essential during Lead Optimization. The Contractor shall provide PK evaluation of compounds in multiple species such as mouse, rat, and dog.
V. Technical Area 5: Toxicology
Early in vivo toxicity testing plays an important role in late stage lead optimization. The Contractor shall provide various non-Good Laboratory Practice (non-GLP) toxicology studies in multiple species such as mouse, rat, and dog.
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 multiple 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 first quarter of FY2019.
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 11:59 A.M. EASTERN STANDARD TIME (EST), TUESDAY, JANUARY 30, 2018, to Jeffrey Schmidt, Contracting Officer at [email protected] with Mark McNally, Contract Specialist cc'd at [email protected].
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).
Points of Contact
Primary Point of Contact:
Jeffrey Schmidt
Contracting Officer
[email protected]
Phone: (301) 402-1488
Secondary Point of Contact:
Mark McNally
Contracting Specialist
[email protected]
Phone: (301) 827-5869