Attachment 1 - Statement of Work_Final.pdf

STATEMENT OF WORK (SOW) SERVICES

Medical Writing Consultant Support Services

GENERAL INFORMATION

Title of Project:

Medical Writing 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 Medical Writing and Drug Dossier Development to provide leadership and technical guidance to the following programs:

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

• NIH Helping to End Addiction Long-term (HEAL) Initiative

• The Early Phase Pain Investigation Clinical Network (EPPIC-Net) Network – Drug

Dossier development

• 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 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.

The Early Phase Pain Investigation Clinical Network (EPPIC-Net) is a part of the NIH Helping to End Addiction Long-termSM (HEAL) Initiative. The HEAL Initiative is an aggressive, trans-NIH effort to speed scientific solutions to the current opioid crisis by improving prevention and treatment strategies for opioid misuse and addiction and to enhance pain management, via the development of effective, non-addictive treatments. EPPIC-Net is a sophisticated clinical trial network established to design and execute early phase (focused on Phase 2) clinical trials of promising non-addictive pain therapies in well-characterized patient cohorts with pain conditions of high unmet need.

EPPIC-Net accepts applications from academic and industry investigators with promising pain therapeutic assets, including drugs, biologics, and devices; proof-of-concept testing and validation of potential biomarkers may also be considered. Assets are reviewed in a three-stage application process: Stage 1: preliminary application, Stage 2: dossier application and Stage 3:

protocol application. The preliminary application stage is open to all applicants; stages 2 and 3 are by invitation only. For selected assets, EPPIC-Net designs and conducts the clinical trial at no cost to the asset owner. Funding for selected protocols is provided to the EPPIC-Net infrastructure for conduct of the trial; ownership and intellectual property rights remain with the asset owner. The NINDS intends to issue a solicitation for Medical Writing Consultant Support Services seeking three, part-time consultants with expertise in Medical Writing to assist in these efforts.

Period of Performance:

The required period of performance is a one-year base period, which is estimated to be from September 14, 2023 through September 13, 2024, and two (2) subsequent one-year option periods.

Place of Performance:

The primary place of performance shall be Contractor site. Video calls, conference call, 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 for short duration such as site visit or in-person meeting.

Type of Contract Contemplated:

A Labor Hour Purchase Order, with Options to Extend the Term of the Contract and Options for Increased Quantity – Separately Priced Line Item, 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.

1. Support to BPN Programs [small molecules and HEAL]

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.

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 candidates. 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.

2. Support EPPIC-Net

For EPPIC-Net, the Contractor shall work with invited applicants at the second stage of the application process to prepare a dossier document based on a template provided by NIH. The dossier shall include detailed information on the asset, such as that on drug pharmacology, device specifications, and preclinical and clinical safety/efficacy data, as applicable, based on information provided by the asset holder and, as needed, gathered by the Contractor independently. The Contractor shall participate in a one-hour introductory call and other calls, as needed, with the asset holder and/or EPPIC-Net staff to work on the dossier. The completed dossier, as approved by the applicant, should be provided to the applicant for submission to NIH within three weeks of the Contractor receiving the assignment from NIH.

Specific Requirements:

The Contractor shall provide consulting support services to the NIH Blueprint Neurotherapeutics Network as follows:

1. Medical Writing

Medical Writing consultants shall be responsible for the preparation and submission of high-quality regulatory and other supporting documents for NIH projects. The consultants shall coordinate with LDTs to prepare, edit, review, and submit documents to regulatory agencies (e.g., FDA) within project timelines. Documents may include but are not limited to clinical protocols, Investigational New Drug applications (INDs), Investigator Brochures (IBs), IND Amendments, Drug Master Files, and Statement of Investigators (Form FDA 1572) and drug dossiers. The role of the Medical Writing consultant may include but is not limited to the following responsibilities and tasks:

• Work independently or as part of a team to gather, compile, write, and edit regulatory documents for submission to regulatory agencies.

• Ensure that submissions meet format and content requirements applicable to FDA requirements in compliance with ICH guidelines.

• Manage timelines for regulatory submissions.

• Work independently to complete assigned projects.

• Maintain familiarity with current best industry practices and regulatory requirements that affect medical writing.

• Review and perform quality control (QC) on other documents as part of the overall clinical research process.

2. Drug Dossier Development

Drug Dossier Development consultants shall be responsible for the preparation and submission of high-quality Drug Dossiers for EPPIC_net. The Consultants shall coordinate dossier development with the Asset holder. The role of the Drug Dossier development Consultant may include but is not limited to the following responsibilities and tasks:

• Work independently or as part of a team to gather, compile, write, and edit drug dossiers for submission to Asset Holder for onward submission to EPPIC-Net.

• Manage timelines for dossier submissions.

• Work independently to complete assigned projects.

• Maintain familiarity with current best industry practices and regulatory requirements that affect drug dossier development.

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, EPPIC-net and HEAL projects at any given time. It is anticipated but not guaranteed that a minimum of 20 hours of support is required annually under the basic requirement. In addition, a Not to Exceed (NTE) amount of 780 Optional Hours will be exercised, if needed, using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item, up to maximum of 800 hours under the contract, per year.

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 $1,500 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 requirements

• Consultants must have extensive experience in managing or being a senior leader in drug discovery projects in the biopharmaceutical industry. Experience with drug discovery for nervous system conditions is preferred.

• Broad experience across the entire drug discovery and development process is especially desired.

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

• 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 knowledge and understanding if global regulatory regulations and guidelines.

• 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.

• Must participate actively in LDT discussions.

• Must collaborate with EPPIC-Net applicants chosen by NINDS.

Education and work experience requirements

Medical Writers should demonstrate high-level expertise as follows:

• An advanced degree (Master’s or PhD) in a scientific discipline is required.

• A minimum of 10 years of direct regulatory and medical writing experience.

• Experience with writing, editing, reviewing, and oversight of regulatory submissions, including but not limited to INDs, IBs, clinical protocols, FDA response letters and drug dossiers.

• Excellent interpersonal, written, and verbal communication skills including the ability to effectively communicate with project teams and to lead virtual meetings to discuss documents.

• Ability to effectively work in a virtual team environment.

• Familiarity with Electronic Common Technical Document (eCTD) format

• Familiarity with FDA regulations, ICH guidelines, and the drug development process

• Experience with the oversight of regulatory document preparation for outside organizations is preferred.

• Experience in the pharmaceutical/biotech industry or CRO environment preferred.

The proposed Key Personnel shall 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 and are incorporated by reference:

• 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.

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.

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

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.

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

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 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