Attachment 1 - Statement of Work.pdf

STATEMENT OF WORK (SOW) SERVICES

Bioactivity Assay Development Consultant Support Services

GENERAL INFORMATION

Title of Project:

Bioactivity Assay Development Consultant Support Services

Statement of Need, Purpose, and/or Objective:

The NIH is seeking senior-level, industry-experienced drug discovery and development consultants with expertise in Bioactivity Assay Development to provide leadership and technical guidance to the following programs:

• The Blueprint Neurotherapeutics Program [BPN] – Assay Development to support neuroscience-focused drug development programs.

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

Background Information:

The National Institutes of Health (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 National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.

The NIH Blueprint for Neuroscience Research, a consortium of 15 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. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services can be provided without cost to the PI through NIH contracts.

Period of Performance:

The required period of performance is a one-year base period from September 27, 2021 through September 26, 2022 and two (2) subsequent one-year option periods.

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 or facilities of selected principal investigators 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 BPN 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. Consultants may serve on an ad hoc basis or as members of LDTs. Consultants will be expected to offer input on project milestones, development strategy, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects and programs.

A consultant serving as an LDT co-chair shall facilitate LDT discussions, work with an NIH project manager by email and telephone to maintain and communicate the overall project strategy to other LDT members, and advise the PI on the preparation of milestone reports. Co-chairs for LDTs are selected based on breadth of expertise and previous experience serving in a comparable role.

Since members of the LDT may lack drug discovery and development experience it is essential the consulting services be provided in a manner that is both informative and collegial. The Contractor is expected to provide support services in a collaborative way. BPN Program Director or staff might want to discuss the program with offerors. The Contractor may be assigned to work on a number of projects 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 Assay Development consulting support services to the NIH Blueprint Neurotherapeutics Network as follows.

Bioactivity Assay

Bioactivity Assay consultants may be required to evaluate bioactivity assays and recommend strategies and experiments to optimize and/or validate the assays for use in a medicinal chemistry campaign. Bioactivity Assay consultants may be asked to assist in the establishment of milestones related to assay optimization or validation. The NIH may seek guidance from consultants on the design and interpretation of commonly used in vitro assays, such as biochemical and cell-based assays. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. Assay-related consultation services may be required on an ad hoc basis or on LDTs.

The role of the Bioactivity Assay consultant may include but is not limited to the following responsibilities and tasks:

• In partnership with other consultants, contractors, and NIH staff, advise, strategically plan, and manage programs to facilitate lead optimization, IND-enabling studies, and clinical studies.

• Serve as a resource to LDT for assay requirements and logistics to conduct drug development activities for small molecule compounds from the preclinical stage through to the initial clinical stage

• Serve as the assay expert in order to identify potential developmental challenges and suggest strategies to address these challenges.

• Collaborate on design of investigative studies in support of development compounds.

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 BPN projects at any given time. It is anticipated that a minimum of 20 hours of support is required annually. A

Not to Exceed (NTE) amount of 800 Optional Hours 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.

Project data will be collected and stored by NINDS. NINDS will provide data as needed to the consultant each time it requests service. The consultant may store data up to 12 months after initially receiving it, after that time the consultant should either delete the data files and sanitize the computer using NIST SP 800-88 (current revision) or if information is still needed contact the COR for permission to store data longer.

OTHER CONSIDERATIONS

Travel:

The consultant may be required to travel within the contiguous 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 and authorized by the Contracting Officer’s Representative prior to being finalized or invoiced.

A Not to Exceed (NTE) amount of $1,200 annually for travel shall be exercised if needed, using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.

Approximately 8 hours of travel time are anticipated for this requirement. 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:

General Experience

• Consultants must have extensive experience in managing or being a senior leader in drug discovery and development projects in the biopharmaceutical industry. Experience with drug discovery and development for nervous system conditions is required. Broad experience across the entire drug discovery and development process is especially desired.

• Consultants must be able to work in a virtual, cross-functional team environment and manage competing priorities.

• Consultants must have strong interpersonal skills, an attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy.

• Consultants must have 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.

• Experiences in team leadership, consulting, or service on strategic and advisory boards will be considered.

Specific Discipline Experience

The following educational and experience requirements are the minimum acceptable requirements.

Bioactivity Assay consultants should demonstrate high-level expertise as follows:

• An advanced degree in a appropriate scientific discipline is required

• A minimum of 20 years of experience in assay development

• Demonstrated expertise and experience in developing, implementing, and optimizing cell-based and biochemical assays for high throughput screening and safety screening

• Demonstrated hands-on experience in the application of assays in industrial pharmaceutical discovery and development; application of automated technologies and robotics relevant to pharmaceutical assays; and application of a diverse range of molecular and cellular techniques in pharmaceutical assays

• Experience working with multi-disciplinary drug development teams at a senior level in the pharmaceutical industry.

• Experience with drug discovery and development of small molecules for nervous system conditions is required.

• Experience serving in a leadership role in a virtual team environment is highly preferred.

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 System Security:

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

https://www.acquisition.gov/content/52239-1-privacy-or-security-safeguards

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

https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.224-71

• FAR 7.105(b)(5) (Section 2.A.7.) https://www.acquisition.gov/content/part-7-acquisition-planning#i1118935

• FAR 11.002(g) (Section 2.A.7.) https://www.acquisition.gov/content/11002-policy

• FAR 52.239-1(c) (Section 2.D.3.b.) https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1049272

• FAR Subpart 4.13 (Section 2.F) https://acquisition.gov/content/41300-scope-subpart

• FAR Subpart 52.204-9 (Section 2.F) https://acquisition.gov/content/52204-9-personal-identity-verification-contractor-personnel

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.

https://www.acquisition.gov/content/52239-1-privacy-or-security-safeguards https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.224-71 https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.224-71 https://www.acquisition.gov/content/part-7-acquisition-planning#i1118935 https://www.acquisition.gov/content/part-7-acquisition-planning#i1118935 https://www.acquisition.gov/content/11002-policy https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1049272 https://www.acquisition.gov/content/part-52-solicitation-provisions-and-contract-clauses#i1049272 https://acquisition.gov/content/41300-scope-subpart https://acquisition.gov/content/52204-9-personal-identity-verification-contractor-personnel https://acquisition.gov/content/52204-9-personal-identity-verification-contractor-personnel

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 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.

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 consultant may store data up to 12 months after initially receiving it, after that time the consultant should either delete the data files and sanitize the computer using NIST SP 800-88 (current revision) or if information is still needed contact the COR for permission to store data longer.

Intellectual Property:

Consultants who contribute to the creation of new intellectual property will be named as inventors according to US or prevailing patent law. Accordingly, consultants 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 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 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 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).

SCOPE OF WORK