Pharmacology Consulting Support Services for Pharmaceutical Development

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.However, should the Government issue a solicitation or ultimately award a contract, offerors and quoters are required to be registered in the SAM (System for Award Management) via https://www.sam.gov at the time an offer or quotation is submitted in order to comply with the annual representations and certifications requirements [FAR Subpart 4.11 - System for Award Management].Background: The NIH Blueprint for Neuroscience Research, a consortium of 15 NIH Institutes and Centers that support neuroscience research, established the NIH 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 discovery and development services and expertise.The BPN program is intended for projects requiring medicinal chemistry optimization and CRO support through phase I clinical testing. Each project is directed by a Lead Development Team composed of the principal investigator, industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by contract research providers. Bioactivity and efficacy studies are funded through an award to the principal investigator; other research services are provided without cost to the PI through NIH contracts.The BPN External Oversight Committee (EOC) was instituted in late 2011 and will continue through, at least 2027. The NIH National Institute of Neurological Disorders and Stroke (NINDS) oversees the EOC. The EOC typically convenes monthly via web-enabled virtual meetings and teleconference calls. Additionally, the EOC meets once per year at NIH for a day long face to face meeting and on an ad hoc basis to evaluate BPN project specific issues. These additional meetings of the EOC are scheduled around EOC member availability and full participation in such scheduled events is expected.Purpose and Objectives: The purpose of this requirement is to procure pharmacology consulting services in support of NIH Blueprint Neurotherapeutics Network drug discovery and development programs and the associated BPN External Oversight Committee. The NIH is seeking to procure a highly experienced executive-level, drug discovery and development subject matter expert with experience in the area of Pharmacology to provide feedback to the NIH program leadership and technical guidance on drug discovery and development projects within the BPN portfolio. The Contractor will serve as a member of the BPN External Oversight Committee, which provides strategic guidance on BPN projects and on occasion other NIH drug discovery and development programs.Specific Requirements: The Contractor shall provide consulting support services to the BPN EOC and NIH Leadership in relation to drug discovery and development programs as follows:• Review operations and processes of BPN programs and provide recommendations regarding advancing pharmacology related trials, directing collaborative research among multiple institutions or teams, and leading teams in small molecule drug discovery for nervous system conditions.• Advise regarding suitability and relevance of proposed BPN program pharmacology milestones, recommend revised pharmacology milestones for BPN programs as needed, and evaluate project progress relative to established milestones.• Analyze potential pharmacology opportunities and concerns for future BPN program projects under consideration.• Recommend potential solutions and assist in implementation of selected strategies to resolve programmatic challenges related to pharmacology for drug discovery and development as they arise.• Mentor BPN executive team and project leaders in scientific entrepreneurship, including but not limited to managing drug discovery and development projects, directing collaborative research among multiple institutions or teams, leading teams in small molecule drug discovery, and global regulatory regulations and guidelines, for continued development and improvement of the BPN programs• Provide feedback to assist in successful work towards scientific and business goals and aspirations of program projects• Participate in web-enabled virtual meetings and teleconference calls with BPN staff on both a monthly and an ad-hoc-as-required basis.Capability statement /information sought: The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.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.The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.All responses to this notice must be submitted electronically to the Contract Specialist.Facsimile responses are NOT accepted.The response must be submitted to the Contract Specialist at rieka.plugge@nih.gov.The response must be received on or before November 15, 2019 at 5:00 P.M., Eastern Standard 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 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)."