Medicinal Chemistry Support Program for Therapeutic Development (MCSP)

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: (1) the availability and capability of qualified business sources; (2) determine whether they are small businesses (e.g., 8(a), Veteran-owned small businesses, service-disabled Veteran-owned small businesses, HUBZone small businesses, small disadvantaged businesses, and women-owned small businesses); (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; and (4) the availability of domestically manufactured and commercial services. Your response 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 considered a small business under the applicable NAICS code should indicate its small business status in its response. 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). Statement of Need and Purpose: The National Institute on Neurological Disorders and Stroke (NINDS) and the NIH Blueprint Neurotherapeutics Network (BPN) [https://www.nih.gov/neuroscience-blueprint], with participation from the Helping to End Addiction Long-term® Pain Therapeutics Development Program (HEAL-PTDP) [https://www.ninds.nih.gov/current-research/trans-agency-activities/ninds-role-heal-initiative/pain-therapeutics-development-program-ptdp], have established a ‘virtual pharma' network of contract service providers and consultants with extensive industry experience to enable therapeutic (e.g., small molecule, peptide, biologic) development in the NIH research community. This network offers researchers access to a range of industry-style therapeutic development services and expertise, including medicinal chemistry, IND-enabling studies, and Phase 1 clinical trial infrastructure, with the goal of supporting efforts to advance compounds successfully through Phase 1 clinical testing. The Medicinal Chemistry Support Program for Therapeutic Development (MCSP) component has the need to recompete its medicinal chemistry services to support a range of medicinal chemistry activities (exploratory, hit-to-lead and lead optimization phases) including project management and reporting, compound logistics, shipping, synthesis, computational chemistry/Computer Aided Drug Discovery (CADD) and in vitro absorption, distribution, metabolism, excretion and toxicology (ADMET) studies in support of preclinical drug discovery efforts supported by NIH, NINDS and its contributors. The ultimate goal of the NIH served by this program and of individual projects is to bring new drugs to market. To this end, the NIH has been granted a Determination of Exceptional Circumstances (DEC) to the Federal Acquisition Regulation (FAR) for this contract. The DEC enables the Contributors, Institutes that apply for a Grant, to retain control of the intellectual property for compounds created through the Medicinal Chemistry Support Program for Therapeutic Development (MCSP). Program Requirement: The scope of this MCSP program shall be medicinal chemistry services including project management and reporting, compound logistics, synthesis, computational chemistry and in vitro ADMET studies in support of preclinical drug discovery efforts supported by NIH, NINDS and its Contributors. NINDS requires a full service, turn-key medicinal che...