Attachment 1_SOW.doc

STATEMENT OF WORK (SOW) SERVICES

Small Molecules and / or Biologics Drug Metabolism and Pharmacokinetics Consultant Support Services

GENERAL INFORMATION

Title of Project:

Subject Matter Expert Consultant for Drug Metabolism Pharmacokinetics [DMPK].

Statement of Need, Purpose, and/or Objective:

The NIH is seeking executive (senior scientific)-level, industry-experienced drug discovery and development consultants with expertise in Drug Metabolism and Pharmacokinetics [DMPK] to provide technical guidance to the following programs:

· DMPK consulting to support the NIH Blueprint Neurotherapeutics program [BPN].

· 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 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 the effective date of award Place of Performance:

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

Type of Contract Contemplated:

A Labor Hour Purchase Order 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 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.

The Contractor is expected to provide support services in a collaborative way. Lead Development Teams to which the Contractor is assigned may 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 program as follows:

DMPK

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

1. Offer input on project milestones, target product profiles, and testing funnels

2. Evaluate pharmacokinetics study protocols and data to identify potential drug discovery and development challenges. Recommend strategies to address these challenges.

3. In partnership with other consultants and contractors, develop plans to assist NIH staff in strategically managing pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies.

4. Assist BPN staff to design investigative pharmacokinetics studies, including study strategy and experimental design bearing budget constraints in mind. Provide advice regarding recommended study milestones and prepare milestone reports are needed.

5. Evaluate DMPK activities for BPN compounds under development in accordance with US regulatory and International Council of Harmonization for Registration of Pharmaceuticals for Human Use [ICH] guidelines.

6. Identify and assess regulatory risks for compounds under development and provide DMPK guidance to BPN and LDTs. Develop DMPK strategies which accord with US and international guidelines.

7. Assist NIH staff and LDT in ensuring timely preparation, review, and submission of DMPK documents to regulatory authorities including FDA, European Medicines Agency [EMA] and other national authorities, to support the conduct of clinical trials and marketing applications

8. Analyze and interpret data for pharmacokinetics drug discovery, development, and translational projects.

9. Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts.

10. Accompany NIH staff or visit, at BPN program staff request, Contract Research Organizations [CRO] under contract to the BPN program. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to BPN program staff.

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.

Project data will be collected and stored by NINDS. NINDS will provide data as needed to the consultant each time it requests service.

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

1. Consultants must have extensive experience in managing drug discovery and early development (e.g. Phase I clinical) DMPK 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.

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 maintaining 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

· An advanced degree in a life or physical science discipline is required.

· Minimum 15 years of experience in pharmacokinetics and drug metabolism of small molecules.

· Experience in executing and managing drug development tasks, preferably with experience in developing drugs for nervous system conditions.

· 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.

· 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 as signs of a strong track record in drug development.

· Expertise leading DMPK chemistry efforts performed by contract research organizations and managing drug project portfolios.

· Experience in small molecule and biologics therapeutics 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 Contractor will access project related files in a NINDS Sharepoint and NINDS Contractor maintained sites through secure login. Consultants 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 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.

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.

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 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).