Receptor Binding and Predictive Toxicology

Purpose and Objectives:

The purpose of this contract is to provide the NIDA Division of Therapeutics and Medical Consequences with reports in which the Contractor assesses the pharmacological specificity and potential toxicity of lead compounds by screening at a large number of biological targets. This contract will also support studies to determine the affinity (IC50, Ki) and/or function (EC50, IC50) of test compounds for receptors at specified biological targets indicated by compound profiling or other sources. This contract will provide a way to screen additional compounds, possibly large compound libraries, at one or more receptors or transporters in order to determine biological activity, with the objective of discovering specific receptor or transporter ligands with novel chemical structures. This contract will provide assays to assess predictive toxicology in key areas that could indicate a candidate compound would have difficulties in the drug development process.

This contract will allow development of in vitro assays at targets that may be of importance in the development of compounds for the treatment of drug abuse and its consequences. This contract will allow for the purchase of test compounds on an “as needed” basis.

Project Requirements:

MANDATORY REQUIREMENTS:

Due to the nature of the compounds which will be evaluated under this contract, it is mandatory that offerors possess a Drug Enforcement Administration (DEA) Research Registration for Schedules II to V in order to handle substances under the Controlled Substances Act of 1970 at the time of submission of the proposal. In addition, the successful offeror must either possess, or demonstrate the ability to obtain a DEA registration for Schedule 1 controlled substances prior to awarding the contract.

Many of the compounds that will be tested will come from private sources (e.g., the pharmaceutical industry) that wish to keep information and data confidential (e.g. until patents are filed). In most cases, NIDA will have signed a confidentiality agreement with the provider indicating that the data obtained will not be released without the provider’s written permission. For this reason, the Contractor may not publish, present, or otherwise disclose the results of studies on test compounds unless the NIDA COR grants written permission to publish or otherwise disclose this information. Tasks to be performed: Task 1: Receptor Profile Screening (screening a compound at approximately 100 sites) Task 2: Receptor Binding Affinity and/or Functional Activity, (IC50, Ki, and Hill slope values by using six (6) or more test ligand concentrations and generate inhibition curves); Task 3: Predictive Toxicology and Pharmacokinetic Testing (Cyp450, hERG channel, genotoxicity (Ames test). Task 4: Compound Library Screening (prepare reports of biological activity describing compound activity as a percent of inhibition at each concentration, or as stated in the Task Order). Task 5: Assay Development (interested organizations may be asked from time to time to submit a proposal to perform an assay not in their current catalog). Task 6: Compound Purchase (interested organizations may be asked from time to time to purchase a compound for testing if it is commercially available in the event that the compound cannot be purchased or otherwise obtained by the Government by other means and shipped to the Contractor in a reasonable time frame).

Interested organizations must demonstrate and document, in the capability statement submitted, extensive experience in the technical area under consideration. Send information relevant and specific, on each of the following qualifications:

1) expertise in evaluation and personnel with the knowledge of, and experience in conducting receptor and enzyme binding and/or functional assays as well as in vitro predictive toxicology including cardiovascular (e.g. hERG Channel) and genetic predictive assays (e.g. Ames test); b) state-of-the-art assay methodologies; 2) equipment, instrumentation, facility, and personnel to perform the Tasks 3) DEA Research Registration for Schedules II to V with the potential to apply for Schedule I if required.

Capability Statement:

Contractors that believe they possess the ability to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contract Specialist.

THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for the preparation of any information sent for the Government's use. Any proprietary information should be so marked. All capability statements should provide the following: 1) company name and address; 2) point of contract, 3) phone/fax/email; 4) NAICS Code(s), 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) types(s) of business, if any (e.g.,: small, Veteran-owned, service-disabled Veteran-owned, women-owned, 8(a), Small Disadvantaged Business (SDB), and Historically Underutilized Business Zone (HUBZone).

Interested organizations are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non­ responsive. When submitting this information, please reference the solicitation notice number.

All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Alexander Beraud, Contract Specialist, at [email protected] before the closing date and time of this announcement. All responses must be received by the specified due date and time in order to be considered.

Note:

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published on https://beta.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government anticipates negotiation of a firm fixed price contract.

PLEASE SEE ATTACHED SOURCES SOUGHT NOTICE FOR ALL RELEVANT DETAILS