Medicinal Chemistry Support for Therapeutic Development

5.101 — PRESOLICITATION NOTICE, THIS IS A NOTICE OF A PROPOSED CONTRACT ACTION. THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE MODIFICATION UNDER CONTRACT NO. HHSN271201800001I WITH CURIA GLOBAL, INC. The National Institute on Neurological Disorders and Stroke (NINDS) and the NIH Blueprint Neurotherapeutics Network (BPN) at the National Institutes of Health (NIH) intends to modify the Single Award Indefinite Delivery, Indefinite Quantity (IDIQ) Contract No. HHSN271201800001I “Medicinal Chemistry Support Program for Therapeutic Development” to increase the Single Award IDIQ maximum by $30,145,159 from $39,500,000 to $69,645,159 during the ten (10) year ordering period from March 16, 2018 to March 15, 2028; there are no other changes. The increase to the IDIQ maximum will allow for the continuation of work begun under the Medicinal Chemistry Support Program for Therapeutic Development contract and prevent any delays or disruption of support services for scientific research working for the development of therapeutics essential for ongoing and upcoming pre-clinical and clinical trials while a new contract is properly planned and competed. The results of the efforts of this contract are the basis to advance preclinical candidate compounds for further development i.e., advanced PK and toxicological evaluation in preparation of IND filings. The ultimate goal of the NIH programs served by this contract and of individual projects is to bring new drugs to market. The increase in the IDIQ maximum will, therefore, allow for the continuation of work initiated under this contract. NORTH AMERICAN INDUSTRY SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541715 with a small business size standard of 1,000 employees REGULATORY AUTHORITY The resultant modification will include all applicable provisions and clauses of the Revolutionary FAR Overhaul (RFO) Initiative, in accordance with Executive Order 14275 and OMB Memorandum M-25-26. STATUTORY AUTHORITY This modification is conducted under the authority of 41 U.S.C. 3304(a)(1) and in accordance with RFO 6.103-1 Only one responsible source and no other supplies or services will satisfy agency

requirements.. DESCRIPTION

Background Since 2011, The National Institute on Neurological Disorders and Stroke (NINDS) and the NIH Blueprint Neurotherapeutics Network (BPN) https://www.ninds.nih.gov/current-research/trans-agency-activities/nih-blueprint-neuroscience-research/bpn-small-molecules has established a virtual pharma network of contract service providers and consultants with extensive industry experience to enable small molecule, peptide and biologic therapeutics discovery and development in the NIH community. The contract is primary

objective is for the development of therapeutics within the mission of NINDS, BPN and other NIH Institutes. This full-service facility and staff supports a range of medicinal chemistry services including SAR analysis and design, synthesis, in vitro ADMET, computational chemistry/Computer Aided Drug Discovery (CADD) and compound logistics of storage and shipping. The Network, similar NINDS and NIH programs offer researchers access to a range of industry-standard services and expertise including full service medicinal chemistry services, Pharmacokinetics/toxicology, drug manufacturing and formulation and Phase I clinical testing. The term neurotherapeutics includes therapies targeted to indications due to disorders of the central and/or peripheral nervous system, and shall include novel agents developed by the National Institutes of Health (NIH) and its grantees (henceforth known as the “Contributor(s)”) and provided to the NINDS for collaborative development as well as investigational agents supported through the NINDS including the Blueprint Neurotherapeutics Network (BPN) and other Institutes or Centers (ICs). Although the NINDS focus is on neurotherapeutics, it is envisioned the other ICs may on occasion access this contract for small molecule therapeutics other than neurotherapeutics. The data generated from this contract will be used by NINDS, contributors or sponsored investigators in support of IND directed preclinical activities. The results of the efforts of this contract will be the basis to advance preclinical candidate compounds for further development i.e., advanced PK and toxicological evaluation in preparation of IND filings. Goals and

Objectives The scope of this contract is for 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, NINOS and its contributors. The work may include any individual service or combinations of services described (e.g. Synthesis, CADD, ADMET individually or in combination). The Contractor must have the capacity to continue its work on existing and ongoing projects simultaneously in the three chemistry stages as outlined below (exploratory, hit-to-lead, lead optimization). The Contractor must also be able to rapidly scale up or down the number of staff dedicated to the contract, depending on the number of projects underway at any given time. The contract includes two performance areas: Performance Area 1: Tech Transfer, Storage Handling and Distribution, Access Training and IT Security Relevant to Existing Compound Repository. Under this Performance Area, the Contractor shall perform all activities related to the overall administration and implementation of the medicinal chemistry support services including but not limited to the setup for project management, overall contract management, technical preparedness and support, communications and submission of

deliverables under the contract and the ongoing delivery of project reports and compound management logistics. Performance Area 2: Medicinal Chemistry Support. Under this Performance Area 2, 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 for Medicinal Chemistry Planning, Synthesis, Isolation, Characterization which may include: Project planning Project management Design, procurement, and milligram-scale synthesis of chemical analogs Multi-gram and scale-up synthesis for testing in animal models In vitro ADME and toxicology testing for lead optimization Compound registration and data entry Communication (teleconferences, minutes, written updates)