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.
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.
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.
Background: 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.
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.
Purpose and Objectives: The NIH is seeking executive (senior scientific)-level, industry-experienced drug discovery and development consultants with expertise in Pharmaceutics / Formulation/CMC to provide technical guidance to the following programs:
- Pharmaceutics / Formulation / CMC consulting to support the NIH Blueprint Neurotherapeutics [BPN] program
- Pharmaceutics / Formulation / CMC consulting to support the NIH Help End Addiction Longterm [HEAL] program
- Pharmaceutics / Formulation / CMC consulting to support the NIH Biologics program
- Other NIH neuroscience-focused drug discovery and development programs
Project requirements:
General Requirements:
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.
The Contractor shall provide this support while serving on NIH BPN Lead Development Teams. Lead Development Teams (LDT) meet for approximately two hours every one to two weeks via teleconference and each LDT project may require between three and ten hours weekly, inclusive of meeting and preparation time.
The Contractor is expected to provide support services in a collaborative way. Lead Development Teams the Contractor is assigned to may work on a number of projects in the exploratory through preclinical safety stages. Some projects may proceed to investigational new drug (IND) and clinical trial stages.
Specific Requirements:
The Contractor shall provide consulting support services to NIH as follows:
Pharmaceutics / Formulation / CMC
Pharmaceutics / Formulation/ CMC consultants will be expected to provide executive (senior scientific)-level Pharmaceutics / Formulation/ CMC expertise and contribute feedback and guidance on projects to the NIH and to LDT members through video/teleconference calls and by email. The role of the Pharmaceutics / Formulation/CMC consultant may include but is not limited to the following responsibilities and tasks:
- Evaluate Pharmaceutics / Formulation / CMC activities for BPN compounds under development in accordance with US regulatory and International Council of Harmonization for Registration of Pharmaceuticals for Human Use [ICH] guidelines.
- Identify and assess regulatory risks for compounds under development and provide CMC guidance to BPN program and LDTs. Develop Pharmaceutics / Formulation / CMC strategies which accord with US and international guidelines.
- Provide recommendations for drug substance manufacturing, analytical method development, and process development for small molecules.
- Provide pharmaceutical sciences expertise in chemical manufacturing, formulation, and product development for small molecules.
- Assist in ensuring timely preparation, review, and submission of chemical manufacturing and controls documents to regulatory authorities including FDA, European Medicines Agency [EMA] and other national authorities, to support the conduct of clinical trials and marketing applications.
- Provide expertise in activities related to API development.
- Recommend dose form selection and API development strategies for BPN efforts.
- Develop plans to assist BPN staff in strategically managing chemical manufacturing and controls pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies.
- Accompany NIH staff or visit, at BPN staff request, Contract Research Organizations [CRO] under contract. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to BPN staff.
- Assist BPN staff to design investigative chemical manufacturing and controls pharmacokinetics studies, including study strategy and experimental design. Provide advice regarding recommended study milestones and prepare milestone reports as needed.
- Facilitate Lead Development Team discussions via telephone and email regarding assigned formulation / CMC efforts.
Level of Effort:
The estimated level of effort for this requirement is one (1) contractor employee on a part-time basis.
The required level of effort varies depending on the quantity and complexity of BPN projects at any given time. It is anticipated that a minimum of 20 hours of support is required annually. A Not to Exceed (NTE) amount of 800 Optional Hours shall be exercised if needed, using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.
Capability statement /information sought.
Companies that believe they possess the capabilities to provide the required services 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 Evan Feely, Contracting Officer, at the following e-mail address: evan.feely@nih.gov.
The response must be received on or before July 30, 2024, 5 pm 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).”
