Att 1 - SOW 2027_HEAL Senior Advisor 2 - 10499.doc

STATEMENT OF WORK (SOW) SERVICES

Senior Advisor 2 Services for the NINDS Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative for the Pain Therapeutics Development Program (PTDP) External Oversight Committee (EOC) Subject Matter Expert (SME) Services

GENERAL INFORMATION

Title of Project:

Senior Advisor 2 for the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative to act as Subject Matter Expert (SME) with Pharmaceutical Development and Pain Expertise.

This solicitation to acquire executive level Senior Advisor 2-Subject Matter Experts [SME] is directly related to human safety as pain pharmacological SMEs support NINDS funded projects to develop drugs for neurological conditions and non-opioid drugs for pain. This contract action is to implement NINDS Directive to reduce the burden of neurological diseases and pain for all people through development of appropriate drugs.

Statement of Need, Purpose, and/or Objective:

NINDS is seeking to procure a highly experienced executive-level, drug discovery and development Senior Advisor 2 with extensive expertise in drug discovery and development, in support of the NIH HEAL Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. The NIH is seeking to procure a highly experienced executive-level Senior Advisor 2, drug discovery and development subject matter expert with experience in the area of Pharmacology and Pain to provide feedback to the NIH program leadership and technical guidance on drug discovery and development projects within the NINDS HEAL portfolio. The Contractor will serve as a member of the HEAL External Oversight Committee, which will provide strategic guidance on HEAL projects and on occasion other NIH drug discovery and development programs.

Background Information:

The NINDS HEAL-Small Molecules & Biologic program is part of the suite of the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative. This program is designed to identify novel non-addictive analgesic drug targets and therapeutics with the goal of advancing at least 2 novel therapeutics into the clinic within 5 years. The purpose of the NINDS HEAL program is to support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain and ready them for advancement towards Phase II clinical studies.

Since HEAL's goal for enhancing understanding, managing, and treating pain is to support the development of novel drug targets and mechanisms, the program plans to support early translational discoveries and will mitigate the risk through the use of the milestone phased funding mechanism as well as providing NIH contracted drug discovery and development subject matter experts. In addition, access to NIH contracted CRO's will provide rigor and expertise not found in most academic institutions and small businesses. To further mitigate the risk, each project is directed by a Lead Development Team (LDT) composed of the principal investigator, industry contractors hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by contract research providers. Bioactivity and efficacy studies are funded through an award to the principal investigator; other research services are provided without cost to the PI through NIH contracts. Milestones will be reviewed at least annually, and projects will be stopped if they reach scientific roadblocks at go/no-go decision points.

The HEAL External Oversight Committee (EOC) was instituted in late FY 2021. The NIH National Institute of Neurological Disorders and Stroke (NINDS) oversees the EOC. The EOC typically convenes monthly via web-enabled virtual meetings and teleconference calls. Additionally, the EOC will meet once per year at NIH for a day long face to face meeting and on an ad hoc basis to evaluate HEAL project specific issues. These additional meetings of the EOC are scheduled around EOC member availability and full participation in such scheduled events is expected.

Period of Performance:

The required period of performance is a one-year base period approximately from September 15, 2026 through September 14, 2027 and 2 subsequent Option years [9/15/2027 – 9/14/2028 and 9/15/2028 to 9/14/2029]. Options to extend the term and labor hours may be requested if continued services are needed.

Place of Performance:

The primary place of performance shall be Contractor site. Conference calls and email shall be the primary mode of communication; however, the Contractor may be required to work at Government facilities in the continental United States, primarily Bethesda, MD, on an as needed basis.

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 businesses.

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 HEAL Executive Oversight Committee (EOC). Executive Oversight Committee (EOC) meet both monthly for approximately one hour and on an ad-hoc basis for milestone/introductory calls of HEAL projects via teleconference. EOC members are also requested to attend one on site visit to the NIH campus yearly for EOC meetings.

Specific Requirements:

The Contractor shall provide drug discovery and development Senior Advisor 2 support services as members of the HEAL PTDP EOC and NIH Leadership in relation to drug discovery and development programs as follows:

· Review operations and processes of HEAL programs and provide recommendations regarding advancing pharmacology related trials, directing collaborative research among multiple institutions or teams, and leading teams in small molecule drug discovery for nervous system conditions.

· Advise regarding suitability and relevance of proposed HEAL program pharmacology milestones, recommend revised pharmacology milestones for HEAL programs as needed, and evaluate project progress relative to established milestones.

· Analyze potential pharmacology opportunities and concerns for future HEAL program projects under consideration.

· Recommend potential solutions and assist in implementation of selected strategies to resolve programmatic challenges related to pharmacology for drug discovery and development as they arise.

· Mentor HEAL executive team and project leaders in scientific entrepreneurship, including but not limited to managing drug discovery and development projects, directing collaborative research among multiple institutions or teams, leading teams in small molecule drug discovery, and global regulatory regulations and guidelines, for continued development and improvement of the HEAL programs

· Provide feedback to assist in successful work towards scientific and business goals and aspirations of program projects

· Participate in web-enabled virtual meetings and teleconference calls with HEAL staff on both a monthly and an ad-hoc-as-required basis.

LEVEL OF EFFORT

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 HEAL projects at any given time. It is anticipated that a minimum of 20 hours of support and a maximum of 50 hours is required annually.

GOVERNMENT RESPONSIBILITIES

No Government furnished property shall be provided. Project related data will be provided to the Contractor for performance of work efforts. All data provided to the Contractor must be treated as confidential and not be disclosed to any third party. The Contractor must not store, process, or transmit project related data on non-Government equipment.

Project data will be collected and stored by HEAL. HEAL will provide data as needed to the Contractor each time it requests service.

OTHER CONSIDERATIONS

Travel:

The contractor employee working under this contract will be required to attend at least one in-person meeting at the NIH to discuss HEAL project issues. Under this and other circumstances as needed, the contractor will be required to travel within the continuous United States to provide the services described in this statement of work. Travel reimbursement will be provided for such required travel. All travel arrangements must be made in accordance with Federal Travel Regulations and must be approved by the Contracting Officer’s Representative prior to being finalized or invoiced. Contracting Officer’s Representative-authorized travel shall not exceed $2,000.00 annually. Please note that travel time may not be billed to the Government, in accordance with the Federal Travel Regulation.

Key Personnel:

The Contractor employee providing services for this effort shall be considered key personnel. Key Personnel requirements are as follows:

· A PhD in a Pharmacology and Drug Development-related discipline with expertise in Pain.

· Managing drug discovery and development projects in biopharmaceutical industry or academia at senior director level or executive level experience.

· At least 15 years of executive-level experience providing Pharmacology guidance in pain research and related to biopharmaceutical endeavors to government agencies, academic institutions, and/or start-up companies at the executive level. Experience must include responsibility for operations and budgets.

· At least 10 years of experience directing collaborative research efforts that involves multiple institutions/teams

· Knowledge and understanding of global regulatory regulations and guidelines.

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.

Information Systems Security:

The following definitions and clauses are required for Information Systems Security:

1. FAR clause 52.239-1, Privacy or Security Safeguards (Section 2.A.2.b.)

2. HHSAR Clause 352.224-71 (Section 2.A.2.e.)

3. FAR 7.105(b)(5) (Section 2.A.7.)

4. FAR 11.002(g) (Section 2.A.7.)

5. FAR 52.239-1(c) (Section 2.D.3.b.)

6. FAR Subpart 4.13 (Section 2.F)

7. FAR Subpart 52.204-9 (Section 2.F)

The Contractor must ensure that any computer system used in the course of this contract shall include the following features:

1. Any computer used in relation to this contract must be patched with most updated IT Security Patches.

2. Any Contractor computer used in relation this contract must have virus protection loaded and running with definition files that are updated on at least a daily basis.

3. Hard drives and portable media used for this contract must be encrypted using the FIPS 140-2 standard.

4. Contractors are required to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/

5. Contractor are required to sign the NIH non-disclosure agreement http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf

6. Contractors are required to report any lost or stolen NIH data to the NINDS ISSO within one hour of knowing of the lost or theft even if the data is on a Contractor furnished computer.

7. Contractors are required to adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx

8. Any computers used in reference to this contract must be assessed for vulnerabilities.

9. Any computers used in reference to this contract must be backed up on an external hard drive which is password protected.

10. Any computers used in reference to this contract must have auditing enabled such that if an incident occurred then that event could be reconstructed.

11. Any computers that are used in reference to this contract must employ at a minimum user name and password authentication or if possible two factor authentication.

12. Any computer used in relation to this contract must be password protected. All Password must meet the NIH standard such that users must choose passwords that have at least eight characters and at least three of the following types of characters:

a. capital letters

b. lower case letters

c. numeric characters

d. special characters (!@#$%^&*()_+|~-=\`{}[]:";'<>?,./) Data Rights:

The National Institute of Neurological Disorders and Stroke (NINDS) 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.

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. Unless it is an “undue burden” or compliant products or services do not exist, the products must conform to Section 508. 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 discuss with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

Collaboration Requirements:

It is required that all contractors involved with the NIH community work collaboratively with federal staff and other contractors towards the NIH mission and other affected organizations and follow the direction of the Contracting Officer’s Representative (COR), and/or the designated Federal 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

Contract employee performing 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).

FAR Part 11—Describing Agency Needs