Attachment 1 - Statement of Work.pdf

STATEMENT OF WORK (SOW) SERVICES

“Medicinal Chemistry Consulting Services”

GENERAL INFORMATION

Medicinal Chemistry Consulting Services

Statement of Need, Purpose, and/or Objective:

The NINDS is seeking to acquire consulting services from executive (senior scientific)-level, industry-experienced drug discovery and development Consultants with expertise in small molecule medicinal chemistry to provide technical guidance to one or more of the following programs:

• National Institutes of Health (NIH) Blueprint Neurotherapeutics Network (BPN)

• NIH Helping to End Addiction Long-termSM (HEAL) Initiative

• Other NIH neuroscience-focused drug discovery and development programs.

Background Information:

The 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 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.

Launched in April 2018, the NIH HEAL Initiative SM is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. The Initiative will advance research to reduce the risks of opioid use and misuse and improve pain management, thereby reducing reliance on opioids. NINDS is the lead Institute for pain research at NIH and leads the Executive Committee of the NIH Pain Consortium, which includes 23 Institutes and Centers. The NIH Pain Consortium’s mission includes improving the treatment of a variety of pain conditions. NINDS, in collaboration with other participating NIH Institutes, will focus efforts in the NIH HEAL Initiative on developing non-addictive pain treatments that may displace the need for opioids, and importantly, serve as effective treatments for acute and chronic pain conditions.

Each project for BPN and HEAL programs is directed by a Lead Development Team (LDT) composed of the principal investigator (PI) and industry Consultants contracted by NIH, and NIH staff. The LDT maps out a research strategy, including milestones, and oversees

Title of Project:

https://www.nih.gov/heal-initiative https://www.ninds.nih.gov/glossary?title=NINDS https://www.ninds.nih.gov/glossary?title=NIH https://painconsortium.nih.gov/ https://www.ninds.nih.gov/glossary?title=NIH https://www.ninds.nih.gov/glossary?title=NINDS https://www.nih.gov/heal-initiative implementation of a proposed methodology. Bioactivity and efficacy studies are funded through an award to the PI; other research services are provided to the PI through NIH-funded contracts.

Period of Performance:

The anticipated period of performance is a one-year base period of July 1, 2022 to June 31, 2023, followed by two (2) one-year options periods of July 1, 2023 to June 30, 2024 and July 1, 2024 to June 30, 2025.

Place of Performance:

The primary place of performance shall be the Consultant’s/Contractor’s site. Video conferencing and email shall be the primary mode of communication. The Contractor will be expected to attend a kick-off meeting at the start of a project once he/she is assigned to the project. Kick-off meeting are anticipated to be 6 to 8 hours. Kick-off meetings may be held at a principal investigator’s (PI) facility or conducted remotely. If held at a PI’s facility, the Government will pay for the Contractor’s travel expenses to attend the kick-off meeting, in accordance with FAR Part 31.205-46 Travel costs.

Type of Contract Contemplated:

A Labor Hour Purchase Order with Options to Extend the Term of the Contract is contemplated.

The order shall be 100% set aside for small business vendors.

Small business vendors must be actively registered in the System for Award Management when submitting a quotation in response to this solicitation.

SCOPE OF WORK

General 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 Contractor shall provide this support while serving on NIH Lead Development Teams. Lead Development Teams (LDT) meet for approximately two hours every one to two weeks via teleconference and each LDT project may require between three and ten hours weekly, inclusive of meeting and preparation time.

The Contractor is expected to provide support services in a collaborative way. The Contractor may be assigned to a number of Lead Development Teams in the exploratory through preclinical safety stages. Some projects may proceed to investigational new drug (IND) and clinical trial stages.

Specific Requirements:

The Contractor shall provide consulting support services to the NIH BPN, HEAL Initiative, and/or other NIH neuroscience-focused drug discovery and development programs as follows:

Medicinal Chemistry https://www.acquisition.gov/far/31.205-46#FAR_31_205_46

The medicinal chemistry Consultant will be expected to provide executive (senior scientific)-level Medicinal Chemistry expertise and contribute feedback and guidance on projects to the NIH and to LDT members through video/tele conference and by email. The role of the medicinal chemistry Consultant may include but is not limited to the following responsibilities and tasks:

1. Offer input on project milestones, target product profiles, and testing funnels.

2. Provide feedback on chemical structures and processes proposed by a chemistry service Contractor for each round of SAR.

3. Evaluate SAR data on a weekly or biweekly basis.

4. Evaluate the potential tractability (including surrounding IP space) of a chemical structure for medicinal chemistry. Specific consulting responsibilities will depend on the expertise of the individual Consultant and the needs of individual projects.

5. In partnership with other Consultants, Contractors, and the NIH staff, advise, strategically plan, and manage medicinal chemistry programs to facilitate exploratory chemistry, hit-to-lead, lead optimization, IND enabling, and clinical studies.

6. Serve as the medicinal chemistry expert in order to identify potential drug discovery and development challenges and suggest strategies to address these challenges.

7. Collaborate on design of investigative studies in support of NIH drug discovery and development projects.

8. Review Medicinal Chemistry sections of regulatory filings provided by CROs (Contract Research Organizations) or PIs (Principal Investigators).

9. Collaborate on the design of investigative studies in support of development compounds.

10. At the request of program manager, accompany NIH staff on visits to CRO facilities that provide research services to NIH programs including the NIH Helping to End Addiction Long-term (HEAL) and NIH Blueprint Neurotherapeutics Network. Assist NIH staff in inspecting CRO facilities, and prepare and submit trip reports to BPN and/or HEAL program managers if requested.

11. Discuss appropriateness of CRO’s proposed methodology.

12. Facilitate Lead Development Team discussions via telephone and email regarding assigned medicinal chemistry efforts.

LEVEL OF EFFORT

The estimated level of effort for this requirement is three (3) part-time Consultants. The required level of effort will depend on the quantity and complexity of NINDS projects at any given time. It is anticipated that a minimum of 20 hours of consulting services will be required annually. In addition, up to 780 optional hours per year may be available and exercised by NINDS, as needed, pursuant to FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.

GOVERNMENT RESPONSIBILITIES

No Government furnished property shall be provided. Project data will be collected and stored by NINDS. NINDS will provide data to the Contractor/Consultant as needed to perform work on assigned projects.

OTHER CONSIDERATIONS

Travel:

The Government shall reimburse the Consultant allowable travel costs for any travel necessary to perform the work on an assigned project, and in accordance with FAR Part 31.205-46 Travel costs.

Prior to being finalized, all travel arrangements must be first authorized by the Contracting Officer’s Representative, approved by the Contracting Officer, and be in accordance with the Federal Travel Regulation.

A Not to Exceed (NTE) annual amount of $1,500 for travel shall be exercised if needed, pursuant to FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.

Approximately eight (8) hours of travel time is anticipated for this requirement. Please note that, pursuant to the Federal Travel Regulation, travel time may not be billed to the Government.

Key Personnel:

The Contractor Consultant providing services for this effort shall be considered Key personnel.

Key Personnel requirements are as follows:

General requirements:

1. Extensive experience in managing drug discovery and early development (e.g. Phase 1 clinical) medicinal chemistry efforts as evidenced by employment as an executive (senior scientific)-leader in the biopharmaceutical industry or as an experienced Consultant providing the same services. Experience with drug discovery for nervous system conditions is preferred.

2. Experience with antibody conjugate chemistry, peptides, siRNA synthesis is a plus.

3. Able to work in a cross-functional team environment and manage competing priorities.

4. Strong interpersonal skills, an attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy.

5. A demonstrated ability to educate and build trust with Lead Discovery Team (LDT) members of many disciplines to build consensus and maintaining focus of team on milestone achievement.

6. Experience working with multi-disciplinary teams at a senior level in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels.

7. Able to actively participate actively in LDT discussions.

Education and work experience requirements:

1. A PhD degree in chemistry or medicinal chemistry is required.

2. Minimum of 15 years of medicinal chemistry experience in the biopharmaceutical industry or a combination of experience in the biopharmaceutical industry, formal academic drug discovery organizations and professional consulting in this area.

3. Experience in executing and managing drug development tasks, with experience in developing drugs for nervous system conditions preferred but not required.

4. A track record of advancing projects into drug development. Measures of success include patents, Investigational New Drug (IND) applications, publications, and drugs brought to market.

https://www.acquisition.gov/far/31.205-46#FAR_31_205_46

5. Previous experiences in identifying and anticipating problems early in a project, overcoming technical difficulties, and making strategic decisions that make wise use of limited resources (including terminating projects that appear unlikely to succeed) will be considered as signs of a strong track record in drug development.

6. Expertise leading chemistry efforts performed by contract research organizations and managing drug project portfolios.

7. Experience in therapeutics for CNS and pain relief will be considered a plus.

The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows:

The key personnel specified in this contract are considered to be essential to work performance.

At least 30 days prior to the Contractor voluntarily diverting any of the specified individuals to other programs or contracts, the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the Contractor is terminated for cause or separates from the Contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

NINDS Information Systems Security:

The Consultant will access project related files through a NINDS Sharepoint and/or Contractor-maintained websites through secure login. The Consultant will access email related to meeting planning through secure login.

The information and information systems security requirements for this requirement are provided in Attachment 5 – Information and Physical Access Security.

Data Rights:

The National Institute of Neurological Disorders and Stroke shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data- General,” shall be incorporated into any resulting award by reference.

Intellectual Property:

A Consultant who contributes to the creation of new intellectual property will be named as inventors according to US or prevailing patent law. Accordingly, the Consultant must complete negotiations with the principal investigator’s institution regarding assignment of rights and royalties distribution prior to advising on any activities.

The Consultant shall provide copies of all intellectual property agreements to the NIH COR, for documentation purposes.

Section 508—Electronic and Information Technology Standards:

Section 508 of the Rehabilitation Act of 1973 requires that Federal agencies’ electronic and information technology (EIT) is accessible to people with disabilities. The Federal Acquisition Regulations (FAR) Final Rule for Section 508 (EIT Accessibility) can be found at www.section508.gov and at the Access Board’s Web site at https://www.access-board.gov/508.htm. The Contractor must state that they will comply with the requirements of Section 508 or cite a justifiable reason for an exception.

Confidentiality of Information:

Confidential Information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

Confidential Information or records shall not be disclosed by the Contractor without written authorization from the Contracting Officer. Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

Collaboration Requirements:

It is required that all Contractors, including Consultants, involved with the NIH community work collaboratively with Government staff and follow the direction of the Contracting Officer’s Representative (COR), and/or the designated Government Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required.

Non-Personal Service Statement

The Contractor providing the required services will be controlled, directed and supervised at all times by management personnel of the Contractor. Actions of Contractor employees may not be interpreted or implemented in any manner that results in any Contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulations (FAR).

https://www.section508.gov/ https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards

SCOPE OF WORK