Attachment 1. Statement of Work.pdf

STATEMENT OF WORK (SOW) SERVICES

Process Chemistry Consulting Services

GENERAL INFORMATION

Title of Project:

Process Chemistry Consulting Services

Statement of Need, Purpose, and/or Objective:

The National Institute on Neurological Disorders and Stroke (NINDS) is seeking executive (senior scientific)-level, industry-experienced drug discovery and development consultants with subject matter expertise in Process Chemistry Development to provide technical guidance to 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 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 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. 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 contract research organizations

(CRO).

Launched in April 2018, the NIH Helping to End Addiction Long-term™ (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 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://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 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 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 required period of performance is a one-year base period from September 1, 2022 through August 31, 2023, followed by two (2) one-year option periods: Option Period 1 - September 1, 2023 through August 31, 2024; Option Period 2 - September 1, 2024 – August 31, 2025.

Place of Performance:

The primary place of performance shall be Contractor’s site. Video and teleconference 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:

A Labor Hour type Purchase Order with Options to Extend the Term of the Contract and Option to add additional consulting hours is contemplated. This acquisition shall be 100% set aside for small business vendors.

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 services described below.

The Contractor shall provide this support while serving on NIH BPN Lead Development Teams (LDT). LDTs 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 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 consulting support services to the NIH BPN, HEAL Initiative, and/or other neuroscience-focused drug discovery and development programs as follows:

PROCESS CHEMISTRY

Process Chemistry consultants will be expected to provide executive (senior scientific)-level Process Chemistry expertise and contribute feedback and guidance on projects to the NIH and to LDT members through video and/or teleconference calls and by email. The role of the Process Chemistry consultant may include but is not limited to the following responsibilities and tasks:

1. Support process chemistry efforts of preclinical and clinical programs of the small molecules under development. Consultants may be tasked with providing guidance on process endpoints, recommending assays and milestones to be incorporated into a testing funnel or development plan, and interpreting data delivered by research service contractors.

2. In partnership with other Consultants, Contractors and NIH staff, advise, strategically plan, and manage process chemistry to support development of efficient and scalable manufacturing processes.

3. Provide expertise in process, scale up and implementation of innovative technologies, in support of IND-enabling and clinical studies.

4. Serve as the process chemistry expert in identifying potential developmental challenges and suggesting strategies to address these challenges on realistic timelines.

5. Lead the chemical development activities including scale-up and process development from pilot-scale to commercial scale and technology transfer to commercial plants.

6. Manage the process development technology transfer of projects at contractors’ manufacturing sites.

7. Oversee the writing of protocols for manufacturing scale-up batches and writing of associated process development reports.

8. Lead the process chemistry activities for compounds in development in accordance with guidelines of the Federal Drug Administration and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

9. Evaluate manufacturing processes and changes, and provide assessment of regulatory implications.

10. Accompany NIH staff on visits or independently visit CROs under contract to NINDS. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to BPN and/or HEAL program staff.

11. Maintain current knowledge of the relevant guidelines and regulations.

Level of Effort

The estimated level of effort for this requirement is two (2) consultants providing services on a part-time basis.

The required level of effort varies depending on the quantity and complexity of NINDS 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 780 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. Project related data will be provided to the Contractor as needed for the performance of work efforts. Project data created by the Contractor shall be collected and stored by NINDS.

All data provided to the Contractor must be treated as confidential and not be disclosed to any third party.

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. Reimbursement of travel costs will be provided for 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 $1,500 per year for travel shall be exercised if needed using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.

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

Key Personnel:

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

General requirements:

1. Consultants must have extensive experience in managing drug discovery and early development (e.g., Phase 1 clinical) process development efforts as evidenced by employment as an executive (senior scientific)-leader in drug discovery projects in the biopharmaceutical industry or as an experienced consultant providing the same services. Experience with drug discovery for nervous system conditions is preferred.

Biologics experience is a plus.

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

3. 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.

4. Consultants must demonstrate ability to educate and build trust with LDT members of many disciplines to build consensus and maintain focus of team on milestone achievement.

5. 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.

6. Must participate actively in LDT discussions.

Education and work experience requirements:

1. An advanced degree in chemistry or medicinal chemistry.

2. Minimum of 15 years of medicinal chemistry experience

3. Experience in executing and managing drug development tasks, preferably with experience in developing drugs for nervous system conditions. Experience in Pain therapeutics is a plus.

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.

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 indicators of a strong track record in drug development.

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

7. Previous experience in the preparation and submission of the CMC components of IND [Investigational New Drug], CTA [Clinical Trial Authorization], NDA [New Drug Application], and MAAs [Marketing Authorization Application].

8. Biologics experience 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.

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 consultant will access project related files in a NINDS Sharepoint and Contractor maintained sites through secure login. The consultant will access email related to meeting planning through secure login.

The Contractor must ensure that any computer system used in the course of this contract shall conform to all of the following:

1. Must be patched with most updated IT Security Patches.

2. Must have virus protection loaded and running with definition files that are updated on at least a daily basis.

3. Use only hard drives and portable media that are encrypted using the FIPS 140-2 standard.

4. Must be assessed for vulnerabilities.

5. Must be backed up on an external hard drive which is password protected.

6. Must have auditing enabled such that if an incident occurs, then that event could be reconstructed.

7. Must employ at a minimum user name and password authentication, and two factor authentication if possible.

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

9. Contractor and consultants that will perform the work described herein must:

a. Take NIH Security and Privacy Training annually. It can be accessed at http://irtsectraining.nih.gov/

b. Must sign the NIH non-disclosure agreement accessible at http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf 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 http://irtsectraining.nih.gov/ http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf

c. Must report any lost or stolen NIH data to the NINDS Information Systems Security Officer, Mike Gyorda, within one hour of knowing of the loss or theft, even if the data is on a Contractor-furnished computer.

d. Must adhere to the NIH IT Rules of Behavior which are published at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx

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:

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 performing any services or advising on any activities.

The consultant shall provide copies of all intellectual property agreements to the assigned Contracting Officer’s Representative (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:

https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx 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 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 FAR.

SCOPE OF WORK