Synthesis of pharmaceutically active small molecules

Federal Business Opportunities (FBO)

SOURCES SOUGHT NOTICE

1. Solicitation Number: HHS-NIH-NIDA-SSSA-SS-17-601

2. Title: Synthesis of pharmaceutically active small molecules

3. Classification Code: 68 - Chemicals and chemical products

4. NAICS Code: 325998 - All Other Miscellaneous Chemical Product and Preparation Manufacturing

Description:
This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement.

This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.

Background:
The NCATS Pharmaceutical Collection (NPC) is a comprehensive, publicly-accessible collection of approved and investigational drugs for high-throughput screening that provides a valuable resource for both validating new models of disease and better understanding the molecular basis of disease pathology and intervention. The NPC has already generated several useful probes for studying a diverse cross section of biology, including novel targets and pathways. NCATS provides access to its set of approved drugs and bioactives through the Therapeutics for Rare and Neglected Diseases (TRND) program and as part of the compound collection for the Tox21 initiative, a collaborative effort for toxicity screening among several government agencies including the US Environmental Protection Agency (EPA), the National Toxicology Program (NTP), the US Food and Drugs Administration (FDA), and the NCGC. Of the nearly 2750 small molecular entities (MEs) that have been approved for clinical use by US (FDA), EU (EMA), Japanese (NHI), and Canadian (HC) authorities and that are amenable to HTS screening, we currently possess 2,400 as part of our screening collection. Since the NPC was first established, several new drugs have been approved, that are not part of NPC. The objective of this purchase is to add up to 340 of these new compounds into this collection such that it can be used in mission critical scientific research at NCATS.

Purpose and Objectives:
The purpose of this contract is to expand the NCATS Pharmaceutical Collection for use in mission critical chemical library screening campaigns.

Project requirements:
Generic Name of Product: Synthesis of pharmaceutically active small molecules.

Purchase Description:

Item Type Manufacturer Total Amount
100-340 Compounds; total depending upon the feasibility of chemical synthesis as determined by Pharmaron Pharmaron 25-100 mg as determined by NCATS

Salient characteristics:
The National Center for Advancing Translational Sciences (NCATS) requires as many of 340 compounds defined in structure produced as possible.
REQUIRED DELIVERABLES:
1. Analytical data with purity, LC/MS (>95% area)
2. LC/MS data conforms to structure of the compound
3. NMR data conforms to structure of the compound
4. Complete report of synthetic procedures to create the compound with all associated:
i. Analytical data
ii. Reaction schemes
iii. Reagents list used during the creation
iv. Work up procedures
v. Final yield (in mg) and purity values

Quantity:
100 - 340 compounds between 25-100mg in total mass provided each depending upon the compound in question.

Delivery Date:
Monthly for the duration of a year.

Period of Performance: 1 year

Anticipated Contract Type:
A firm fixed price purchase order is anticipated.

Capability Statement:
Contractors that believe that they possess the ability to fulfill this requirement should submit documentation on their ability to meet each of the project requirements to the Contract Specialist. Interested organizations must demonstrate and document in any response submitted, to this market survey extensive experience with and the ability to perform all of the specialized requirements elsewhere described.

The information submitted must be in an outline format that addresses each of the elements of the project requirement and in the capability statement/information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required.

The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested.

Interested organizations are required to identify their organization name, address, DUNS Number type of business (e.g. 8(a), HubZone, etc), applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government request 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 to Jermaine Duncan, Contract Specialist, via email at jermaine.duncan@nih.gov 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 in Federal Business Opportunities. 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 purchase order.

Contracting Office Address:
31 Center Drive
Room 1B59
Bethesda, Maryland 20892
United States

Primary Point of Contact:
Jermaine Duncan, Contract Specialist
Jermaine.duncan@nih.gov
Phone: 301-827-7515