Attachment 1 SOW.pdf

STATEMENT OF WORK

CENTRALIZED INFORMATION TECHNOLOGY SYSTEM FOR THE NIH BLUEPRINT

NEUROTHERAPEUTICS NETWORK

BACKGROUND

The National Institutes of Health (NIH) Blueprint for Neuroscience Research, a consortium of 9 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 that can enter either at the Discovery stage, to optimize well-validated hit compounds through medicinal chemistry, biomanufacturing, or biologic modification, or at the Development stage, to advance development candidates through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing (See more at: https://grants.nih.gov/grants/guide/pa-files/PAR-20-122.html and https://grants.nih.gov/grants/guide/pa-files/PAR-20-111.html). These projects may require medicinal chemistry or biomanufacturing 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) and PI collaborators, 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 are provided without cost to the PI through NIH contracts.

The BPN currently has 8 ongoing projects but it is expected that additional projects will be added, and some will be discontinued each year. The projects under this contract are anticipated to reach a steady state of 5-16 projects at a given time with 3-5 users per project.

A contractor is required to provide Commercial Off the Shelf (COTS) software and services for each BPN and NIH-funded project utilizing its centralized web-based IT system until each project has been discontinued and the contractor has facilitated the transfer of all data to the relevant PI according to instructions from the NIH Contracting Officer’s Representative (COR).

PURPOSE

The purpose of this acquisition is to procure COTS software suite and related consulting and software support. The vendor shall provide software to for a centralized, web-based information technology (IT) system to collect and maintain data from BPN and other NIH-funded projects that will allow users to upload/import, review, download/export, analyze, and visualize chemical and molecular structures and bioactivity, pharmacology, and toxicology data.

PROJECT REQUIREMENTS

The Contractor shall provide a centralized, web-based, information technology (IT) database that will provide user-friendly interfaces for entering, uploading/importing, searching, downloading/exporting, and visualizing chemical and molecular structures and bioactivity, pharmacology, and toxicology data, as well as software technical support. The centralized data system will collect and maintain data which includes, but is not limited to, information on the chemical and molecular analogs or biosimilars produced by NIH-funded contractors and PIs (including chemical and molecular structures) and data from bioactivity, pharmacology, and toxicology assays. The data will be reviewed and analyzed by members of an LDT, PIs, CROs, NIH-hired consultants, and NIH staff. Some of these users will require access to all projects, while other users must only have access to individual projects.

Attachment 1

SOW

https://grants.nih.gov/grants/guide/pa-files/PAR-20-122.html https://grants.nih.gov/grants/guide/pa-files/PAR-20-111.html

1. COTS Software and System Requirements

a) The database must be hosted on the contractor’s server.

b) The database must be compatible with PC and Mac standard operating systems.

c) The database system must be accessible via the internet and must operate on the most current versions of Internet Explorer, Firefox, Chrome, and Safari. It is expected the database will support teamwork between geographically dispersed collaborators.

d) The database must be compliant with Federal Information Security Management Act (FISMA; see http://csrc.nist.gov/publications/PubsFIPS.html for FIPS 199 form, which defines the security level, and Certification and Accreditation Requirements for NINDS Contracts, for specific requirements).

e) The database must be compliant with Section 508 of the Rehabilitation Act of 1973 (29 U.S.C.

794d), which requires that all electronic and information technology products and services developed, acquired, maintained, or used by any Federal department or agency are accessible to individuals with disabilities. The Section 508 provisions applicable to this solicitation are detailed in subparts 1194.21, 1194.22, 1194.23, and 1194.41, which can be viewed athttps://www.section508.gov/content/requiring-business-partners-provide-accessible-documents.

General information about Section 508 is available at http://www.section508.gov/.

f) The contractor must provide complete database back up as well as system recovery as needed.

Any data lost to system failure must be restored within 24 hours. The contractor must ensure the informatics system and database are available continuously twenty-four (24) hours a day, seven

(7) days per week. Availability may be interrupted for scheduled maintenance. Such interruptions shall be no longer than twelve (12) hours in duration and the scheduled maintenance shall ideally be performed overnight or on the weekends. In the event of an availability outage with no advanced warning, the outage shall not exceed two (2) hours.

g) The contractor must provide at least 48 hours of notification for scheduled down time for server or database upgrade or maintenance.

h) The database system must have a "Dual-Factor" authentication method for all users who access the system and must be compatible with NIST FIPS 201 Standards (Personal Identity Verification of Federal Employees and Contractors, http://csrc.nist.gov/groups/SNS/piv/index.html ).

i) The database must offer role-level security features.

j) The database must offer restriction of writing and viewing privileges by project.

k) The database must offer the ability to build and modify user-specified reporting templates for project management, portfolio analysis, structure activity relationship (SAR) analysis, and decision prioritization.

l) The database must support different methods of data input (e.g., text, tables, graphs, numeric data, text) as well as different file formats (e.g. Microsoft Office, XML).

m) The database must allow searches by field, either independently or in combination with other fields.

n) The database must be capable of linking tabular data and structural data via a common field, such as an identification number (i.e., a relational database).

o) The database must offer a user-friendly interface (i.e., accessible to scientists without informatics expertise) for data upload and database querying.

p) The database must allow upload and association of chemical or biological data from external sources and databases.

q) The database must offer easy and flexible visualization of biological and chemical data from multiple perspectives.

r) The database must date and time stamp uploaded/imported data

Attachment 1

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https://www.section508.gov/content/requiring-business-partners-provide-accessible-documents

2. Chemistry-related Requirements

a) The database must be capable to upload and store chemical structures and other identifying information for up to 500,000 compounds.

b) The database must be able to register compounds with unique ID numbers and assign sub ID batch numbers to different samples of the same compound. The system must also be able to register salts, acid compounds, and basic compounds.

c) The database must be able to upload and represent chemical structures from various data types including but not limited to SMILES strings, InChI strings, SD files, and Mol files, among others.

The software must display stereoselective features of chemical structures, such as chiral centers and stereoisomers.

d) The database must offer structure-based searching capacity, including the ability to search and easily sort by substructure and structural similarities.

e) The database must have the ability to enter, store, and download physicochemical and analytic purity information that is linked to fields including compound ID number, chemical structure, lot number, and plate number.

f) The database must offer tools for calculation of chemical formula, molecular weight, and other chemical properties such as logP, solubility, and polar surface area

g) The database must offer the ability for individual users to register and draw unique structures

3. Biology-related Requirements

a) The database must be capable of uploading and storing molecular structures, sequences, domain structures, and function of biologic macromolecules and other identifying information for up to 500,000 molecules.

b) The database must be capable of uploading biologic macromolecule products and expression patterns, molecular interactions, complexes and pathways.

c) The database must offer molecular interaction-based as well as complex formation searching capacity

d) The database must be able to perform four parameter curve fits of titration response data based on the variable slope sigmoidal equation and using outlier exclusion. It must have the ability to calculate IC50/EC50 and max-fold values and show concentration/dose-response curves.

e) The database must be able to upload, store, and download data from bioactivity, pharmacokinetic, and toxicity assays that are linked to ID number, chemical structure, lot number, and, when applicable, plate and well number.

f) The database must have the ability to blind compound identification for biological testing.

g) The database must generate reports and download/export structural, chemical, and biological data in tabular (e.g., Excel) format.

h) The database must be able to combine tables of different kinds of data (e.g., structural and activity data) in an easy-to-read format

4. Technical Support and Training

Attachment 1

The Contractor shall provide technical support for installation, maintenance, troubleshooting, and upgrading of the database and software. Technical support staff shall be available to respond to requests and resolve technical issues within 24 hours of a request for support.

The Contractor shall provide the following user training online:

a) General training sufficient to orient general users to perform all basic tasks, including importing assay and chemical structure data. General training will be repeated as directed by the COR with the option of multiple sessions.

b) Advanced training for analysis of structure activity relationships and other chemistry features as well as compound registration will be provided online as needed.

The Contractor shall provide documentation (user manual) to describe the use of all aspects of the application’s functionality. This documentation must be made available electronically and user support contact information (contractor email and phone number) must be provided.

As each project is completed, the Contractor shall assist the Contributor PI in downloading or transferring the data in a universal format (e.g., CSV, Excel, SDF) that can be easily recognized for import and use by another informatics system or database, as instructed by the NIH COR.

5. Anticipated Usage

The BPN anticipates initiating the award with approximately 8-16 projects that have existing data, which will need to be imported into the Contractor’s system. Additional projects will be added and dropped out of the BPN program throughout each year, and it is anticipated that 5-16 NIH projects per year will require access to the system at any given time. The duration of these projects will depend on their achievement of milestones, which will be evaluated approximately every 6 months. The NIH might also initiate projects outside of the BPN.

Each project will involve a team of geographically separated individuals of which the composition may change over time. Each project team will be composed of the following personnel who will need access to the IT system (estimates of numbers in parentheses):

• Contributor's lab members and their collaborators (3-4 for each project)

• Consultants (3-6 for the entire BPN program)

• BPN chemistry contractor staff (10-18 for the entire BPN program)

• NIH staff (5-15 for the entire BPN program).

The anticipated number of system users will be a base of 10-50 individuals (consultants, chemistry contractors, and NIH staff) plus 5-15 additional individuals (Contributors) for each project.

6. License Requirements

The database shall come with fifty (50) user licenses.

Within each contract period, up to ten (10) options for Increased Quantity may be purchased at the discretion of the Government. Each option for Increased Quantity includes five (5) additional system licenses, for a total possible amount of fifty (50) additional system licenses per contract period. Options for Increased Quantity may be purchased all together within a contract period or purchased individually within a contract period.

7. Transition-In/Implementation

The informatics system must be ready for data deposition and analysis within one month of contract award. The system must be fully operational and available thereafter. At the initiation of the award resulting from this solicitation, in the event that a new Contractor other than the incumbent (“Incumbent Contractor”) is awarded this follow-on contract, the COR will provide the successful offeror with a list of existing projects, data in a standard format from those projects (e.g., CSV, Excel, SDF), and a list of users and their roles. The contractor shall import the existing data into the database system per project, provide users with the appropriate security levels, and train users on the system within one month of contract award. The data shall be seamlessly transferred to the new system without any loss of data and with minimum impact and service disruption to users of the system.

In the event that a new Contractor other than the Incumbent Contractor is awarded this follow-on contract, the new Contractor shall ensure the system is fully implemented and functional during the remaining 11 months of the Base Period and all months of any exercised option periods,

8. Transition-Out

At the conclusion of the contract (base period or option period, as applicable), the Contractor shall place all BPN data into a universal format (e.g., CSV, Excel, SDF) that may be easily recognized for import and use by another informatics system or database according to the instructions of the NIH COR. This data shall be provided to the Government 30 days prior to the conclusion of the contract. Please note that the contract may be concluded after any contract period, depending on whether option periods are or are not exercised.

9. Reporting Requirements

a) Quarterly Report

The contractor shall provide a quarterly report about system performance metrics for each week of the reporting period, including: number of sessions logged, number of compounds and assay data points in the database, average structure search time, number of help desk inquiries, time spent by contractor assisting users or modifying templates, number of scheduled and unscheduled system outages, amount of time the system was unavailable to users. Reports shall be submitted in electronic format both the Contracting Officer and the Contracting Officer’s Representative.

b) Annual/Final Report

Prior to the completion of each contract period, the contractor shall submit an annual/final report. The final report for the final contract period will take the place of the last quarterly report. Reports shall be submitted in electronic format to both the Contracting Officer and the Contracting Officer’s Representative.

c) Section 508 Annual Report

The contractor shall provide an annual Section 508 report in accordance with the Health and Human Services Section 508 Annual Report for Vendors template which is available for review at https://www.hhs.gov/web/section-508/contracting/technology-products/product-accessibility-template/index.html. Reports shall be submitted in electronic format to both the Contracting Officer and the Contracting Officer’s Representative.

CONTRACT TYPE

A fixed price contract with option items and option periods is contemplated.

ESTIMATED PERIOD OF PERFORMANCE

Base Period: 05/01/2021 - 04/30/2022 Option Period 1: 05/01/2022 – 04/30/2023 Option Period 2: 05/01/2023 – 04/30/2024 Option Period 3: 05/01/2024 – 04/30/2025 Option Period 4: 05/01/2025 – 04/30/2026

PLACE OF PERFORMANCE

The system and support required shall be provided remotely.