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 National Institutes of Health (NIH) requires a senior-level, industry-experienced drug discovery and development consultant 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.

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

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

Background Information:

The 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 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.

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 advance scientific solutions to the current opioid crisis by improving prevention and treatment strategies for opioid misuse and addiction and enhancing 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 conducting the trial; ownership and intellectual property rights remain with the asset owner.

Period of Performance:

The anticipated period of performance is a one-year base period from the effective date of award and two (2) subsequent one-year option periods as follows:

Base Period: September 14, 2020 – September 13, 2021 Option Period One: September 14, 2021 – September 13, 2022 Option Period Two: September 14, 2022 – September 13, 2023

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 or the facilities of selected PIs on an as-needed basis.

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 Items 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 that are needed to perform the requirements outlined in this SOW.

The Contractor shall provide consultant support services to NIH neuroscience-focused research project teams that require the Contractor’s specific areas of expertise.

Support to BPN Program:

The Contractor shall provide this support while serving on NIH BPN LDTs. LDTs meet for approximately two hours via teleconference every one to two weeks; each LDT project may require between three and ten hours weekly, inclusive of meeting and preparation time. The Contractor may also be called upon outside the LDT on an ad-hoc basis.

Since members of the LDT may lack drug discovery and development experience, it is essential that the Contractor provide the required consulting services in a manner that is, informative, collegial, and collaborative. LDTs that the Contractor is assigned to may work on several projects in the exploratory through preclinical safety stages. Some of these projects may proceed to investigational new drug (IND) and clinical trial stages.

Support EPPIC-Net:

For EPPIC-Net, the Contractor will 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 will include detailed information on the asset, such as drug pharmacology, device specifications, and preclinical and clinical safety/efficacy data, as applicable, based on information provided by the asset holder and gathered by the Contractor independently as needed. The Contractor is expected to 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 as follows:

1. Medical Writing:

Medical Writing consultants will be responsible for the preparation and submission of high-quality regulatory and other supporting documents for NIH projects. The consultants will 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, IND applications, Investigator Brochures (IBs), IND Amendments, Drug Master Files, 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 and comply 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 will be responsible for the preparation and submission of high-quality Drug Dossiers for EPPIC_net and will 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 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 1,080 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 disclosed to any third party.

Project data will be collected and stored by the National Institute of Neurological Disorders and Stroke (NINDS). The NINDS will provide data as needed to the Contractor by request.

OTHER CONSIDERATIONS

Travel:

The Contractor may be required to travel to provide the services described in this SOW, for which they will be reimbursed.

All travel arrangements must be made in accordance with the Federal Travel Regulation (FTR), approved by the Contracting Officer (CO), and authorized by the Contracting Officer’s Representative (COR) prior to being finalized or invoiced.

An annual NTE amount of $1,200.00 shall be exercised for travel, if needed, using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.

Annually, approximately eight (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 FTR.

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

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

• Consultants must have knowledge and understanding of 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 NIH teams chosen by NINDS.

Education and work experience requirements:

Key Personnel must demonstrate high-level expertise in medical writing through satisfying the following minimum requirements:

• An advanced degree (Master’s or PhD in appropriate scientific discipline

• 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, and FDA response letters

• 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 will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause 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 into any resulting contract by reference:

• FAR clause 52.204-9 (JAN 2011) (Section 2.F) https://acquisition.gov/content/52204-9-personal-identity-verification-contractor-personnel

• FAR clause 52.239-1, Privacy or Security Safeguards (AUG 1996) (Sections 2.A.2.b.)

and 2.D.3.b.)

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

• HHSAR Clause 352.224-71 (DEC 2015) (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 Subpart 4.13 (Section 2.F) https://acquisition.gov/content/41300-scope-subpart

• 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

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.

https://acquisition.gov/content/52204-9-personal-identity-verification-contractor-personnel https://acquisition.gov/content/52204-9-personal-identity-verification-contractor-personnel 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://acquisition.gov/content/41300-scope-subpart https://www.acquisition.gov/content/part-7-acquisition-planning#i1118935 https://www.acquisition.gov/content/11002-policy

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. Contractors 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 Information Systems Security Officer (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 relation to this contract must be assessed for vulnerabilities.

9. Any computers used in relation to this contract must be backed up on an external hard drive, which is password protected.

10. Any computers used in relation to this contract must have auditing enabled so that if an incident occurred, it could be reconstructed.

11. Any computers used in relation 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 passwords must meet the NIH standard, which requires that users 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 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 FAR 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General,” (MAY 2014) is incorporated into any resulting contract 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 PI’s institution regarding assignment of rights and royalties distribution prior to advising on any activities. The Contractor 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 FAR Final Rule for Section 508 (EIT Accessibility) can be found at www.section508.gov and at the Access Board’s http://irtsectraining.nih.gov/ http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx https://www.section508.gov/

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 CO. 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 CO 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 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.

https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards

SCOPE OF WORK