NIH Drug Discovery and Development Consulting Services

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. 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. 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 are provided without cost to the PI through NIH contracts. The BPN currently has projects in the exploratory through preclinical safety stages. Some projects will proceed to the Investigational New Drug (IND) and clinical trial stages. Project continuation will depend on the achievement of project-specific milestones and portfolio management. New projects are reviewed twice per year and the highest scoring projects may be incorporated into the program. Purpose and Objectives: The NIH is seeking senior-level, industry-experienced drug discovery and development consultants with expertise in the following specific discipline to provide leadership and technical guidance on drug discovery and development projects in the BPN and possibly other NIH drug discovery and development projects and programs: - Chemical Manufacturing and Controls / Pharmaceuticals Project 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 consultant may serve on BPN LDTs, which require a regular time commitment of 3-10 hours per week, including meeting and preparation time. Each LDT meets for approximately 2 hours every 1-2 weeks by teleconference. The consultant may be asked to serve as a co-chair of LDTs. Serving as an LDT co-chair shall require the consultant to facilitate LDT discussions, work with an NIH project manager by email and telephone to maintain and communicate the overall project strategy to other LDT members, and advise the PI on the preparation of milestone reports. Co-chairs for LDTs are selected based on breadth of expertise and previous experience serving in a comparable role. A teleconference call with all consultants is held once or twice per month to discuss programmatic issues of broad interest. The consultant will serve as a resource to LDT members for the regulatory requirements, processes, and logistics to conduct drug development activities for small molecule compounds from the preclinical stage through to the initial clinical stage. The consultant may be asked to provide strategic guidance for CMC regulatory activities necessary to enable preclinical drug product manufacturing, IND enabling studies, and clinical trials. The role of the CMC/Pharmaceutics consultant may include but is not limited to the following responsibilities and tasks: - Lead CMC activities for compounds in development, in accordance with the US regulatory and the ICH guidelines. - Provide expertise in drug substance manufacturing, analytical method development, and process development for small molecules. - Provide pharmaceutical sciences leadership in chemical manufacturing, formulation, and product development for small molecules. - Provide CMC guidance and strategy to LDTs, including identifying and assessing regulatory risks. - Ensure the timely preparation, review and submission of CMC documents to regulatory authorities including FDA, EMA and other national authorities, to support the conduct of clinical trials and marketing applications. - Ensure the compliance of CMC activities with applicable regulatory requirements. - Evaluate manufacturing processes and changes, assess regulatory implications and support process implementation. - Assist NIH with inspections and onsite visits with contract organizations. - Maintain current knowledge of the relevant guidelines and regulations and determine applicability to activities. - Provide expertise in dose form selection. - Provide expertise in API development and related activities. 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. Accordingly, a minimum and maximum level of effort is anticipated. A minimum of 200 hours and a maximum of 800 hours of support is required annually. Hours above the annual minimum shall be exercised in increments of 20 hours, if needed, using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item Anticipated period of performance: The anticipated period of performance is a base period of 12 months with four (4) 12 month option periods. Other important considerations: Cite any other information that is necessary for potential respondents to understand the nature of the potential requirement or proposed acquisition. Capability statement /information sought. 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. The capability statement should include 1) the total number of employees, 2) documentation of ability to provide the required services, 3) any contractor GSA Schedule contracts by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Contractors must also provide their Company Name, DUNS number, Physical Address, and Point of Contact Information. 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 nonresponsive.When submitting this information, please reference the solicitation notice number. 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 Mr. Brian Lind, at e-mail address lindbj@nida.nih.gov.. The response must be received on or before December 22, 2016 at 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 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)."