Att 1_SOW.doc

STATEMENT OF WORK (SOW) SERVICES

Small Molecules and / or Biologics Pharmaceutics / Formulation / Chemistry Manufacturing Control [CMC] Consultant Support Services

GENERAL INFORMATION

Title of Project:

Subject Matter Expert Consultant for Pharmaceutics / Formulation / Chemistry Manufacturing Control [CMC].

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 Pharmaceutics / Formulation/CMC to provide technical guidance to the following programs:

· Pharmaceutics / Formulation / CMC consulting to support the NIH Blueprint Neurotherapeutics [BPN] program.

· Pharmaceutics / Formulation / CMC consulting to support the NIH Help End Addiction Longterm [HEAL] program.

· Pharmaceutics / Formulation / CMC consulting to support the NIH Biologics program.

· 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.

More than 25 million Americans suffer from chronic pain, a highly debilitating medical condition that is complex and lacks effective treatments. In recent decades, there has been an overreliance on opioids for chronic pain despite their poor ability to improve function. This contributed to a significant and alarming epidemic of opioid overdose deaths and addictions. Innovative scientific solutions to develop alternative treatment options for pain are thus critically needed. As part of the mission of the Helping to End Addiction Long-term [HEAL] Initiative, NINDS is working with other NIH Institutes and Centers to encourage the translation of basic research into new non-addictive pain treatments. This program announcement is intended to create a foundation to initiate the optimization and development of pain therapeutics and catalyze the development of partnerships between the academic and industrial sectors so that translational research in pain can flourish as a cooperative, iterative process leading to safe, effective, and non-addictive treatments for

Launched in April 2018, the NIH HEAL Initiative 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 will focus efforts in the NIH HEAL Initiative in developing non-addictive pain treatments that may displace the need for opioids, and importantly, serve as effective treatments for acute and chronic pain conditions for which opioids are not effective. This work will be informed by partners from the government, industry, academia, and patients suffering from pain.

The HEAL program will support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate promising small molecule and biologic hits/leads towards clinical trials. The HEAL program will provide 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.

Place of Performance:

The primary place of performance shall be Contractor site. Video conference 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 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 the Contractor is assigned to 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:

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

1. Evaluate Pharmaceutics / Formulation / CMC 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.

2. Identify and assess regulatory risks for compounds under development and provide CMC guidance to BPN program and LDTs. Develop Pharmaceutics / Formulation / CMC strategies which accord with US and international guidelines.

3. Provide recommendations for drug substance manufacturing, analytical method development, and process development for small molecules.

4. Provide pharmaceutical sciences expertise in chemical manufacturing, formulation, and product development for small molecules.

5. Assist in ensuring timely preparation, review, and submission of chemical manufacturing and controls documents to regulatory authorities including FDA, European Medicines Agency [EMA] and other national authorities, to support the conduct of clinical trials and marketing applications.

6. Provide expertise in activities related to API development.

7. Recommend dose form selection and API development strategies for BPN efforts.

8. Develop plans to assist BPN staff in strategically managing chemical manufacturing and controls pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies.

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

10. Assist BPN staff to design investigative chemical manufacturing and controls pharmacokinetics studies, including study strategy and experimental design. Provide advice regarding recommended study milestones and prepare milestone reports as needed.

11. Facilitate Lead Development Team discussions via telephone and email regarding assigned formulation / CMC efforts.

LEVEL OF EFFORT

The estimated level of effort for this requirement is contractor employee(s) 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.

Contracting Officer approved and Contracting Officer’s Representative.

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 1 clinical) CMC 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

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

2. Minimum 15 years of experience in pharmaceutics / formulation / CMC activities.

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

4. A track record of advancing projects into drug development. Measures of success include 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 as signs of a strong track record in drug development.

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

7. Experience in small molecules and biologic 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).