Attachment 1 - Statement of Work.pdf

STATEMENT OF WORK (SOW)

GENERAL INFORMATION

Biological Therapeutics Bioassay Subject Matter Expert Consulting Services to Support the Development of Therapeutic Biotechnology Products (Biologics)

General

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 apply that knowledge to enhance health, lengthen life, reduce illness and disability, and conduct, support, and make medical discoveries that improve people’s health and save lives. The National Institute of Neurological Disorders and Stroke (NINDS) is an institute within the NIH that conducts 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 use that knowledge to reduce the burden of neurological disease.

The NINDS has a need for biological therapeutics assay development subject matter expert (SME) consultants to provide technical recommendations and advice that will support the translational development of novel therapeutics (Biologics) for NIH drug discovery and development programs. The support included in this contract will cover bioassay development and/or qualification/validation for a variety of biologics including but not limited to: monoclonal antibodies, peptide therapeutics, viral vector therapeutics (e.g., AAV, lentiviruses, etc.), nucleic acid and cell-based therapeutics, proteins, or other biological therapeutic modalities. Preferably, consultants should have significant expertise supporting assay development for more than one biological therapeutic modality (e.g., monoclonals, peptides, ASOs and viral vectors).

NIH Drug Development Programs Involving Biologics

This requirement supports the NIH Biologics development projects under the NIH Blueprint Neurotherapeutics Network Biologics (BPN-Biologics) program, the NINDS Ultra-Rare Gene Therapy (URGenT) program, the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP), and other extramural or intramural NIH drug discovery and development programs.

The NIH Blueprint Neurotherapeutics (BPN) network (https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-neurotherapeutics-bpn-network) is a consortium comprised of the NIH Office of the Director and 10 NIH Institutes and Centers (ICs) that support neuroscience research. BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise.

The program, originally focused on small molecules, was launched for projects requiring medicinal chemistry optimization, pharmacokinetics (PK), pharmacodynamics (PD), drug manufacturing and formulation, investigational new drug (IND)-enabling toxicological studies support through Phase I clinical testing and it is now being expanded to include the

Title of Project:

Background Information and Objective:

https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-neurotherapeutics-bpn-network https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-neurotherapeutics-bpn-network development of biological therapeutics for neurological diseases (BPN-Biologics).

(https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-biologics).

The URGenT program (https://www.ninds.nih.gov/Current-Research/Research-Funded- NINDS/Translational-Research/urgent-network) has been established by the NINDS to support the development and clinical evaluation of therapeutics to address ultra-rare genetically based neurological disorders. The network will provide neuroscience researchers with funding and access to a full range of industry-style biologics development services and expertise and in the future may expand to include other NIH institutes. The program is intended to rapidly advance patient-customized therapeutics through manufacturing, preclinical toxicology testing, and evaluation in Phase 1 clinical studies.

The HEAL-PTDP program (https://heal.nih.gov/) is a multi-IC initiative that has been established by the NIH to support preclinical optimization and development of safe, effective, and non-addictive biologic therapeutics to treat pain. The goal of the program is to accelerate the optimization and development of promising small molecule and biologic hits/leads to Phase I clinical trials and readiness for the Early Phase Pain Investigation Clinical Network (EPPIC-Net) or other Phase II clinical studies. Applicants must have a promising biologic hit/lead, robust biological rationale for the intended approach, and identified assays for optimization of the agent. The scope of this program includes optimization and early development activities, IND-enabling studies, development of a PD/ target engagement biomarker, assembly and filing of an IND application and Phase I clinical testing. This is a milestone-driven phased cooperative agreement program involving participation of NIH program staff in the development of the project plan and monitoring of research progress.

The total period of performance (PoP) includes a one-year base period and two (2) subsequent one-year option periods. The anticipated PoP dates are as follows:

Base Period: September 30, 2022 – September 29, 2023 Option Period One: September 30, 2023 – September 29, 2024 Option Period Two: September 30, 2024 – September 29, 2025

The primary place of performance will be the Contractor site. Conference calls and email will be the primary mode of communication; however, the Contractor may be required to work at Government facilities or the facilities of selected principal investigators on an as needed basis.

SCOPE OF WORK

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

Period of Performance:

Place of Performance:

General Requirements:

https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-biologics https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Translational-Research/urgent-network https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Translational-Research/urgent-network https://heal.nih.gov/ provided by the Government that are needed to support NIH biologics programs, including NIH BPN-Biologics, URGenT, and HEAL PTDP.

The Contractor shall provide this support on an ad hoc basis or while serving on NIH Biologics Lead Development Teams (LDTs), which include both SME consultants and NIH staff. These teams will map out a product development and clinical evaluation research strategy, including milestones, and oversee manufacturing and nonclinical study services by Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs).

SME consultants will be expected to provide feedback and guidance on project milestones, development strategy, study design, and data interpretation through in-person meetings, conference calls, and email. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual biologics projects and programs.

Consultants may be involved in multiple projects.

SMEs will be required on a part-time basis; hours will vary depending on the needs of the projects they are assigned to. The NIH estimates that the required level-of-effort will be 20- 800 hours per year.

The contractor shall provide consulting services in the following Performance Area.

Performance Area 1: Bioassay Development, Qualification/Validation SME

Bioassay development consultants will be required to evaluate or develop bioassay development plans and recommend strategies and experiments to optimize assays and/or qualify/validate the assays, for use in a clinical and nonclinical studies. Bioassay consultants may be asked to assist in the establishment of milestones related to assay optimization or validation. Bioassays may be used to measure drug product in manufacturing studies, and/or in serum or tissue samples obtained from clinical and/or nonclinical studies. The NIH may seek guidance from consultants on the design and interpretation of commonly used in vitro assays, such as biochemical and/or cell-based assays. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. Bioassay-related consultation services may be required on an ad hoc basis or on LDTs.

Bioassay SME Consultants should have:

1) High-level expertise and experience in developing, implementing, and optimizing biochemical and cell-based assays for biologics

2) Demonstrated hands-on experience in the application of bioassays in industrial biopharmaceutical discovery and development programs; application of a diverse range of molecular and cellular techniques in biologics product assays

3) Preferably, consultants should have significant expertise supporting assay development for more than one biological therapeutic modality (e.g., monoclonals, peptides, ASOs and/or viral vectors).

4) Experience working with multi-disciplinary biologics product development teams at a senior level in industry

Specific Requirements:

5) Experience with biologics development, preferably for neurological conditions, is required

6) Extensive understanding of FDA regulatory requirements for IND submissions and clinical trial execution (and where applicable for ultra-rare diseases) is preferred

Bioassay SME Consultants will:

1) Provide expertise in developing, qualifying/validating assays required to support

PK/PD, toxicology, and clinical safety studies, and manufacturing/release testing of the biologic

2) Assist in the establishment of milestones related to assay optimization or validation

3) Serve as the assay development expert in order to identify potential developmental challenges and suggest strategies to address these challenges on realistic timelines

4) In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage programs to facilitate lead optimization, IND enabling, and clinical studies execution

5) Serve as a resource to lead development team members for assay requirements, and logistics to conduct biologics development activities from the preclinical stage through to the initial clinical stage

6) Collaborate on the design of investigative studies in support of biologics development.

7) Serve as a resource to LDT for assay requirements and logistics to conduct biologics development activities from the preclinical stage through to the initial clinical stage

The role of the Bioassay SME consultant may include, but is not limited to, the following responsibilities and tasks:

a) Review and comment on the adequacy of bioassay approaches proposed by Principal Investigators (PIs) and/or CMOs/CORs

b) Evaluate bioassay development and/or qualification/validation studies on a weekly or biweekly basis

c) Serve as the team bioassay expert in order to identify potential product development challenges and suggest strategies to address these challenges

d) Collaborate on design of studies in support of therapeutics development projects

e) In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage bioassay studies to facilitate preclinical evaluation and safety testing, Investigational New Drug (IND) submissions, and clinical studies

f) Facilitate LDT discussions via telephone and email regarding assigned bioassay efforts

The Contractor employee working under this award may be considered key personnel. Key Personnel requirements are as follows:

General Requirements:

a) Demonstrated senior-level oversight of research and development efforts for biological therapeutics products

b) A track-record of successfully building and leading biologics development teams

c) A significant track-record of scientific accomplishment as evidenced by publications and/or contributions to the development of marketed products

d) Experiences in team leadership, consulting, or service on strategic and advisory boards are desired

e) Must be able to work in a virtual, cross-functional team environment and manage competing priorities

f) Must participate actively in project team discussions

g) Must have strong interpersonal skills, an attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy

h) Broad experience across the entire biologics discovery and development process is especially desired

i) Must have experience working with multi-disciplinary teams at a senior level preferably in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels

Education and Specific Work Experience Requirements:

a) A MS, PhD, or MD in a relevant scientific discipline is required

b) Must have at least 10 years of relevant professional experience

c) Must have at least 10 years demonstrated experience in biologics product development

d) Must have at least 10 years of experience in managing or being a senior leader in biologics development projects in the biopharmaceutical industry

e) SME consultants supporting the URGenT program must also have at least 5 years of experience in supporting rare and/or ultra-rare biologics product development programs

f) SME consultants supporting BPN-Biologics must have at least 10 years of experience across broad biological therapeutics product development programs

g) Experience with biologics development for nervous system conditions is preferred but not required

h) Experience interacting with the FDA or other regulatory authorities preferred

i) Extensive understanding of FDA or other regulatory agency requirements for IND submissions and clinical trial execution (and when applicable for ultra-rare diseases) is preferred

j) High-level expertise and experience in developing, implementing, and optimizing cell-based and/or biochemical assays

Key Personnel:

k) Demonstrated hands-on experience in the application of assays in industrial biopharmaceutical discovery and development; application of a diverse range of molecular and cellular techniques in biopharmaceutical assays

The required level of effort to support BPN-Biologics, URGenT, and Heal PTDP may vary depending on the quantity and complexity and the number of projects at any given time.

The NINDS anticipates a Labor Hour contract type and that a minimum of 20 hours of support will be required annually. A Not to Exceed (NTE) amount of 780 Optional Hours may also be exercised, if needed, using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.

SME consultants shall be responsible for providing subject matter expertise in the following areas:

1) Needs and/or gap assessment of bioassays required for biologics therapeutic product development processes

2) Estimation of time, cost, and effort involved in each stage of the development process

3) Review and comment on the adequacy of bioassay approaches proposed by Principal

Investigators (PIs) and/or CMOs/CORs

4) Evaluate ongoing bioassay development and/or qualification/validation studies on a weekly or biweekly basis

Consultants shall also be responsible for submitting ad hoc summary reports of their analyses as needed.

OTHER CONSIDERATIONS

The Government does not anticipate providing Government-furnished property. Project related data (i.e., Government furnished information) will be provided to the Contractor for performance of work efforts. All data provided to the Contractor must be treated as confidential and shall not be disclosed to any third party.

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

Level of Effort:

Deliverables and Reporting Requirements:

Government Responsibilities:

The Contractor may be required to travel within the contiguous United States to provide the services described in this SOW. The Contractor shall make its own travel arrangements; the Government shall reimburse all reasonable travel costs up to the Government approved limits.

All travel arrangements must be made in accordance with Federal Travel Regulations in effect at the time of travel and must be approved by the Contracting Officer’s Representative and authorized by the Contracting Officer prior to being finalized or invoiced.

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

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

Information System Security Plan:

Travel:

http://irtsectraining.nih.gov/ http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx

The NIH shall have unlimited rights to, and ownership of, all deliverables provided under this contract, including reports, analyses, recommendations and all other deliverables. This also 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 General,” shall be incorporated by reference into any resulting award.

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 shall not be disclosed to any third party.

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.

Consultant(s) shall guarantee strict confidentiality of the information/data that is provided by the NINDS or by any other participant on a project to which the consultant is assigned. The NINDS has determined that the information/data that the consultant will be provided during the performance of the consulting contract is of a sensitive nature.

Consultant(s) may only disclose the information/data generated for a particular project to other participants on that same project. These specific individuals will be identified when the consultant is assigned to a project.

Disclosure of the information/data, in whole or in part, by the consultant to anyone else can only be made after the consultant receives prior written approval from the Contracting Officer.

Whenever the consultant is uncertain with regard to the proper handling of information/data under the contract, the consultant shall obtain a written determination from the Contracting Officer.

Contractor agrees that it will not use the Confidential Information for any purpose except as set forth within this SOW, unless such time as such Confidential Information becomes public information.

Not applicable. The Contractor will not write or publish articles of data produced as a result of the SOW requirements.

Section 508—Electronic and Information Technology Standards:

Data Rights:

Confidentiality of Information:

Publications and Publicity:

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

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).

Non-Personal Service Statement: