DDD consultants-SOW (Final).doc

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Drug Discovery and Development consultants for the National Institute on Drug Abuse (NIDA) Step Up for Substance Use Disorder (SUD): Drug target initiative for scientists Engaged in Fundamental Research Statement of Need and Purpose:

The purpose of this requirement is to procure services of small molecules and biologics drug discovery and development consultants to provide technical development recommendations to the NIDA Step Up for Substance Use Disorder (SUD) program.

Background Information and Objective:

NIDA has published a notice of intent to publish a Funding Opportunity Announcement (FOA), “Step Up for Substance Use Disorder (SUD): A Drug Target Initiative for Scientists Engaged in Fundamental Research.” The new program will provide up to 50 short-term awards to conduct experiments aiming to expand the range of drug targets and mechanisms for SUD therapies. In addition, NIDA will provide in-kind access to drug discovery and development expertise, business strategy and commercialization support, and assistance in the company/startup formation, as needed. For each project funded under this FOA, the NIDA will assemble an NIH expert panel called a Project Development Team (PDT) comprising of Program Official (PO), Science Officer (SO), the Principal Investigator/Project Director (PI/PD) and appropriate NIH expert consultants. Together, the team will create a credible thesis for how the PI/PD will address an important SUD issue in a transformative way, differentiate from other approaches, and create a path for progressively de-risking that opportunity. The PDT will help the PD/PI establish an overall strategy for the project, including identifying the critical value inflection point to determine what needs to be done in the preceding stage to make the technology attractive to the potential partners.

The objective of this requirement is to provide the in-kind access to biomedical product development expertise, business strategy and commercialization support, and assistance in the company/startup formation that will be critical to the success of the program.

Period of Performance (PoP). Option Period(s) and Option Quantities:

The anticipated PoP for this contract is 1 year with two additional 1 year option periods, to extend services for up to 3 years if all options are exercised.

1. Option Period (Contract Years 2 and 3): This option shall extend the period of performance of the contract for 12 months. No work shall be performed during this period unless the Government exercises its option. If the option is exercised, the work will be the same as performed for Year 1 (Base Year). An Option Period may be exercised by the Government up to two times.

2. Option Quantity 1 (Level of Effort for Small molecules and biologics drug discovery and development consultant): The Contractor shall devote up to 800 additional person hours in performance of the Statement of Work. The government may exercise Option Quantity 1 up to four (4) times during each year of the contract.

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 NIDA Project Development Teams (PDT). PDT meetings are scheduled by the Program Officer (PO) on an as needed basis for each of the projects in the Step Up for Substance Use Disorder program.

For proposal purposes, up to fifty (50) projects in the exploratory through preclinical stages are anticipated in this program and the consultation hours are estimated up to 800 hours inclusive of meeting and preparation time for the small molecules and biologics drug discovery and development consultant services. Further, Small molecules and biologics drug discovery and development consultant hours may be exercised as an option quantity of up to 800 hours X 4 per year on an as needed basis under Option Quantity 1 (if exercised).

The Contractor shall provide small molecules and biologics drug discovery and development consulting support services to the NIDA Step Up for Substance Use Disorder (SUD): Drug target initiative for scientists Engaged in Fundamental Research program for small molecules and biologics drug discovery and development. Consultants will be expected to provide senior-level expertise and contribute feedback and guidance on projects to the NIH and to PDT members through conference calls and by email.

Specific Requirements For Small Molecules and Biologics Drug Discovery and Development Consultants:

The role of the drug discovery and development consultants may include but is not limited to the following responsibilities and tasks:

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

• Review of study protocols and reports for scientific merit.

• Advise on early-stage development planning, nonclinical pharmacology for biologics and/or small molecules.

• Provide feedback on research strategy proposed by the investigator.

• Provide guidance on the design and interpretation of proposed in vivo assays, such as cognitive and behavioral tests.

• Evaluate Structure Activity Relationship (SAR) data.

• Evaluate bioactivity assays and recommend strategies and experiments to optimize and/or validate the assays.

• Assist in the establishment of milestones related to assay optimization or validation.

• Identify potential developmental challenges and suggest strategies to address these challenges on realistic timelines.

• Evaluate the potential tractability (including surrounding IP space) of a chemical structure for medicinal chemistry.

• In partnership with the NIH staff, advise, and strategically plan to facilitate exploratory chemistry, hit-to-lead, and lead optimization.

• Serve as the expert in order to identify potential drug discovery and development challenges and suggest strategies to address these challenges.

• Collaborate on design of studies in support of NIDA drug discovery projects.

• Participate in Project Development Team discussions via telephone and email regarding assigned projects.

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 small molecules and biologics drug discovery projects for the SUD or/and nervous system conditions in the biopharmaceutical industry. Experience with drug discovery for substance use disorder conditions is preferred.

• Consultants must be able to work in a 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 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.

Education and work experience requirements:

• An advanced degree in biological sciences or translational sciences is required.

• Minimum of 15 years of small molecules and biologics drug discovery and development experience in the area of substance use disorder research or/and nervous system conditions.

• Experience in executing and managing drug development tasks, particularly for substance use disorder and/or 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 drug discovery and development performed by contract research organizations, and managing drug project portfolios.

ESTIMATE OF EFFORT:

The estimated level of effort for this requirement is contractor employees on a part-time basis for up to fifty (50) anticipated projects and the consultation hours are estimated up to 800 hours per year. If Option Quantity 1 is exercised, The Contractor shall devote up to 800 additional person hours in performance of the Statement of Work. The government may exercise Option Quantity 1 up to four (4) times during each year of the contract.

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.

The key personnel specified in this contract is essential to work performance. At least 30 days prior to the contractor voluntarily diverting the specified individual 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.

DELIVERY OR DELIVERABLES

Monthly Report – The Contractor shall provide the Contracting Officer’s Representative (COR) and Contracting Officer (CO) a report of all tasks and subtasks completed during the month.

Final Report - The Contractor shall provide the Contracting Officer’s Representative (COR) and Contracting Officer (CO) a final report of all tasks and subtasks completed, outcomes of each, timelines within which they were accomplished, any challenges encountered and how they were resolved, lessons learned, and a summary of customer feedback, where applicable. The final report may be a compilation or summary of those details.

The Contractor shall prepare and submit a final report that includes all tasks/activities for the duration of the Contract. The Contractor shall submit a draft final report within four (4) weeks prior to the contract end period, in a format approved by the COR. The COR will have ten (10) business days to provide the Contractor any comments/edits. The contractor shall revise and submit the final document within three (3) business days of receipt of comments.

REPORTING REQUIREMENTS

Same as in the above deliverables section.

OTHER CONSIDERATIONS

Travel:

N/A Key Personnel:

The Contractor employee providing services for this effort shall be considered Key personnel.

Information System Security Plan:

Data Rights:

In accordance with FAR clause 52.227-14, "Rights in Data-General,” The National Institute on Drug Abuse shall have unlimited rights to deliverables provided under this procurement including reports, analyses, recommendations and all other deliverables. In addition, it includes any additional deliverables required by contract change. FAR clause 52.227-14, "Rights in Data-General," shall be incorporated into any resulting award by reference.

Intellectual property: As an exception to the data rights clause above, should a consultant contribute to the creation of new intellectual property, he or she can’t be named as an inventor according to U.S. or prevailing patent law. In such cases, the consultant must complete negotiations with the pertinent principal investigator's institution regarding assignment of rights and royalty's disfribution prior to advising on any activities. The consultant must provide copies of any and all intellectual property agreements made related to this effort for this requirement to the NIDA COR.

Electronic and Information Technology Standards:

The Contractor must ensure that any computer system used in the course of this contract shall include the following features:

Any computer used in relation to this contract must be patched with most updated Information Technology (IT) Security Patches.

Any Contractor computer used in relation to this contract must have virus protection loaded and running with definition files that are updated on at least a daily basis.

Hard drives and portable media used for this contract must be encrypted using the Federal Information Processing Standards (FIPS) 140-2 standard.

Contractor is required to take NIH Security and Privacy Training annually at http://irtsectraining.nih.gov/

Contractor is required to sign the NIH non-disclosure agreement https://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf Contractor is required to report any lost or stolen NIH data to the NIDA Informatioin Sytstem Security Officer (ISSO) within one hour of knowing of the lost or theft even if the data is on a Contractor furnished computer.

Contractor is required to adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/aboutus/publicinfosecurity/securitytraining/Pages/NIH_IT_GeneralRu lesofBehavior.aspx

Any computers used in reference to this contract must be assessed for vulnerabilities.

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

Any computers used in reference to this contract must have auditing enabled such that if an incident occurred then that event could be reconstructed.

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.

Any computer used in relation to this contract must be password protected. All Passwords 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:

o capital letters o lower case letters o numeric characters o special characters (!@#$%A&*()_+ I~-=\'{}[]:";'<>?,./) Publications and Publicity:

Confidentiality of Information:

Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH Non-Disclosure Agreement (NDA) https://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf as applicable. A copy of each signed and witnessed NDA shall be submitted to the CO and/or COR prior to performing any work under this acquisition.