SOURCES SOUGHT NOTICE

1.Solicitation Number: 75N95024SS001892.Title: Assay Development Consultant Support Services3.Classification Code: R499 – Support - Professional: Other4.NAICS Code: 541690 - Other Scientific and Technical Consulting Services5.Size Standard: $19M6.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, to determine the method of acquisition, and availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. 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. Small businesses are encouraged to respond.For equipment/supply requirements, responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule).

Background: The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives.

The National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.

More than 25 million Americans suffer from chronic pain, a highly debilitating medical condition that is complex and lacks effective treatments. In recent decades, there has been an overreliance on opioids for chronic pain despite their poor ability to improve function. This contributed to a significant and alarming epidemic of opioid overdose deaths and addictions. Innovative scientific solutions to develop alternative treatment options for pain are thus critically needed. As part of the mission of the Helping to End Addiction Long-term [HEAL] Initiative, NINDS is working with other NIH Institutes and Centers to encourage the translation of basic research into new non-addictive pain treatments. This program announcement is intended to create a foundation to initiate the optimization and development of pain therapeutics and catalyze the development of partnerships between the academic and industrial sectors so that translational research in pain can flourish as a cooperative, iterative process leading to safe, effective, and non-addictive treatments for

Launched in April 2018, the NIH HEAL Initiative is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. The Initiative will advance research to reduce the risks of opioid use and misuse and improve pain management, thereby reducing reliance on opioids. NINDS is the lead Institute for pain research at NIH and leads the Executive Committee of the NIH Pain Consortium, which includes 23 Institutes and Centers.

The NIH Pain Consortium’s mission includes improving the treatment of a variety of pain conditions. NINDS will focus efforts in the NIH HEAL Initiative in developing non-addictive pain treatments that may displace the need for opioids, and importantly, serve as effective treatments for acute and chronic pain conditions for which opioids are not effective. This work will be informed by partners from the government, industry, academia, and patients suffering from pain.

The HEAL program will support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate promising small molecule and biologic hits/leads towards clinical trials. The HEAL program will provide neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through Phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team

maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services can be provided without cost to the PI through NIH contracts.

The NIH Blueprint for Neuroscience Research, a consortium of 8 NIH Institutes and Centers that support neuroscience research, established the Blueprint Neurotherapeutics Network (BPN) as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through Phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services can be provided without cost to the PI through NIH contracts.

Purpose and Objectives: The NIH is seeking senior-level, industry-experienced drug discovery and development consultants with expertise in Assay Development to provide technical guidance to the following programs:

• Assay Development consulting to support the NIH Helping to End Addiction Long-term [HEAL] Initiative HEAL initiative aims to optimize non-addictive Therapies [Small Molecules and Biologics] to treat Pain.

• Assay Development consulting to support The Blueprint Neurotherapeutics Program [BPN] drug development programs.

• Other NIH neuroscience-focused drug discovery and development programs.

Project requirements:

The Contractor shall provide consulting support services to the NIH Blueprint Neurotherapeutics Network as follows:

Assay Development

Assay Development consultants will be expected to provide senior-level Assay Development expertise and contribute feedback and guidance on projects to the NIH and to LDT members through conference calls and by email. The role of the Assay Development consultant may include but is not limited to the following responsibilities and tasks:

• Consultants may be required to evaluate bioactivity assays and recommend strategies and experiments to optimize and/or validate the assays for use in a

medicinal chemistry campaign. •Assay development consultants may be asked to assist in the establishment ofmilestones related to assay optimization or validation.

•Consultant may be required provide guidance on the design and interpretation ofcommonly used in vivo assays, such as cognitive and behavioral tests.

•Serve as the assay development expert in order to identify potentialdevelopmental challenges and suggest strategies to address these challengeson realistic timelines.

•In partnership with other consultants, contractors, and the NIH staff, advise,strategically plan, and manage programs to facilitate lead optimization, INDenabling, and clinical studies.

•Serve as a resource to lead development team members for assay requirements,and logistics to conduct drug development activities for small moleculecompounds from the preclinical stage through to the initial clinical stage.

•In partnership with other consultants, contractors, and the NIH staff, advise,strategically plan, and manage programs to facilitate lead optimization, INDenabling, and clinical studies.

•Serve as a resource to lead development team members for assay requirements,and logistics to conduct drug development activities for small moleculecompounds from the preclinical stage through to the initial clinical stage.

•Accompany NIH staff or visit, at NIH program staff request, Contract ResearchOrganizations [CRO] under contract to the NIH (e.g. NIH BlueprintNeurotherapeutics Network (BPN) or the NIH Helping to End Addiction LongTerm (HEAL)). Assist NIH staff in inspecting facilities and discussappropriateness of CRO proposed methodology. Submit trip reports to BPN andHEAL program staff.

•Collaborate on the design of investigative studies in support of developmentcompounds.

Anticipated period of performance: The required period of performance is a one-year base period from September 30, 2024 through September 29, 2025 and two (2) subsequent one-year option periods

Capability statement /information sought.

Companies that believe they possess the capabilities to provide the required product should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID

from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) 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. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and 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. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Shivani Patel, Contracts Specialist at e-mail address Shivani.patel@nih.gov The response must be received on or before 3/21/2024, 9:00 am Eastern Time. “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 presolicitation synopsis and solicitation may be published in www.sam.gov. 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).