NIH Drug Discovery and Development Process Chemistry Consulting Services

This is a Small Business Sources Sought (SBSS) 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 and type of qualified Small Business companies technically capable of meeting this potential 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. The notice is strictly for market research and information purposes only. The information requested will assist the Government in determining the appropriate acquisition method including small business socio-economic set-aside possibilities and to determine the availability of qualified Small Business companies technically capable of meeting the Government's potential requirement. All Small Business companies with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice. Background. The Office of Translational Research at the National Institute on Neurological Disorder and Stroke (NINDS) has a potential requirement for process chemistry consulting services on projects involved in the NIH Blueprint Neurotherapeutics (BPN) Network and other drug discovery programs at NIH helping to advance the scientific context of the NINDS mission. In 2010, the NIH Blueprint for Neuroscience Research, a consortium of 15 NIH Institutes and Centers that support neuroscience research, announced a Grand Challenge for Neurotherapeutics to address the paucity of effective drugs for disorders of the nervous system. As a result, the Neurotherapeutics Network (BPN) was established as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry development. The BPN provides funding and access to a full range of industry-style drug development services and expertise for neuroscience researchers who have a compelling therapeutic rationale and starting materials for a drug discovery project (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm). The NIH is seeking senior-level, industry-experienced drug discovery consultants to provide leadership and technical guidance on drug discovery projects in the Blueprint Neurotherapeutics Network and possibly other NIH neuroscience-focused drug discovery programs. Purpose and Objectives. The purpose of the BPN network is to provide leadership and technical guidance on advancing discovery projects into development, making significant contributions to promising drug discovery projects selected through a rigorous peer-review process, and shaping a program that may serve as a model for future NIH drug discovery efforts. NINDS requires feedback and guidance on projects from the process chemistry consultant through conference calls and by email. The consultant will support the process chemistry efforts of preclinical and clinical programs of the small molecules of development, and may recommend assays to be incorporated into a testing funnel or development plan, interpret data delivered by research service contractors, and provide guidance on process endpoints. Project requirements. The focus of the deliverables, reports, and/or data generated by the contractor from any resultant contract will be highlighted by the following areas of particular importance: Advise, strategically plan, and manage process chemistry to support the development of efficient and scalable manufacturing processes, and innovative technologies Identify development challenges and suggest strategies to address these challenges on realistic timelines Manage the process developement technology transfer of projects at manufacturing sites Lead chemical development activities Oversee the writing of writing of protocols Lead the process chemistry activities for compounds in developement Evaluate manufacturing processes and changes, assess regulatory implications, and support their implementation Anticipated effort and period of performance Any solicitation resulting from this notice will have an average requirement of 10-20 hours per week over a five year performance period. Capability Statements Sought Respondents must provide a Capability Statement as part of their response that includes information on: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work (c) prior completed contractor support roles of similar nature, including any government contracts and/or contracts with commercial entities; and (d) experience and management capability as it relates to the functions described in this notice. Responses must include the respondents' DUNS number, company name, address, point of contact, and size and type of business pursuant to the NAICS code identified in this announcement. Other related information in the Capability Statement may include: Respondent's opinion as to the perceived difficulty and/or feasibility of this requirement or proposed acquisition; possible solutions and approaches that may currently exist in the marketplace; and information regarding innovative ideas or concepts as they relate to the development of a potential solicitation. Capability Statements shall be limited to 10 pages and submitted in response to this notice no later than the closing date specified in this announcement as an attached Adobe PDF or Microsoft Office file via email to NIDASSSAPurchaseRequ@mail.nih.gov and with a copy to jeffrey.williams@nih.gov. Please include "Responses to Sources Sought Notice HHS-NIH(SSSA)-SBSS-14-NINDSBPNPC" in the subject line of the email. Respondents should include their technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. CONCLUDING STATEMENTS 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 pre-solicitation 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).