Attachment 1 - SOW.v.2.pdf

FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SOW) SERVICES

Pharmacology Consulting Services in relation to Pharmaceutical Development

GENERAL INFORMATION

Title of Project:

Pharmacology Consulting Services in relation to Pharmaceutical Development

Statement of Need, Purpose, and/or Objective:

The purpose of this requirement is to procure pharmacology consulting services in support of NIH Blueprint Neurotherapeutics Network drug discovery and development programs and the associated BPN External Oversight Committee. The NIH is seeking to procure a highly experienced executive-level, drug discovery and development subject matter expert with experience in the area of Pharmacology to provide feedback to the NIH program leadership and technical guidance on drug discovery and development projects within the BPN portfolio. The Contractor will serve as a member of the BPN External Oversight Committee, which provides strategic guidance on BPN projects and on occasion other NIH drug discovery and development programs.

Background Information:

The NIH Blueprint for Neuroscience Research, a consortium of 15 NIH Institutes and Centers that support neuroscience research, established the NIH 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 discovery and development services and expertise.

The BPN program is intended for projects requiring medicinal chemistry optimization and CRO support through phase I clinical testing. Each project is directed by a Lead Development Team composed of the principal investigator, industry consultants 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.

The BPN External Oversight Committee (EOC) was instituted in late 2011 and will continue through, at least 2027. 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 meets once per year at NIH for a day long face to face meeting and on an ad hoc basis to evaluate BPN 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 estimated period of performance is a one-year base period from January 14, 2022 through January 13, 2023 and two subsequent one-year optional periods.

Place of Performance:

The primary place of performance shall be the 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 Increase the Quantity—Separately Priced Line Item and Options to Extend the Term of the Contract is contemplated.

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

Specific Requirements:

The Contractor shall provide consulting support services to the BPN EOC and NIH Leadership in relation to drug discovery and development programs as follows:

• Review operations and processes of BPN 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 BPN program pharmacology milestones, recommend revised pharmacology milestones for BPN programs as needed, and evaluate project progress relative to established milestones.

• Analyze potential pharmacology opportunities and concerns for future BPN 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 BPN 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 BPN 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 BPN staff on both a monthly and an ad-hoc-as-required basis.

LEVEL OF EFFORT

The required level of effort varies depending on the quantity and complexity of BPN projects at any given time. It is anticipated that a minimum of approximately 50 hours of support is required annually. An additional Not to Exceed (NTE) amount of 60 Optional Hours/annually shall be exercised if needed, using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.

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 BPN. BPN 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 BPN project issues. Under this and other circumstances as needed, the consultant 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 $1,500.00 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 Pharmacology, MD, Organic Chemistry and/or Drug Development-related discipline

• 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 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 the 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 username 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 consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

Collaboration Requirements:

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

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).