Attachment_A_-_Revised_Statement_of_Work.pdf

ATTACHMENT A

REVISED STATEMENT OF WORK

Dated 02/18/2016

CENTRALIZED INFORMATION TECHNOLOGY SYSTEM FOR THE NIH BLUEPRINT

NEUROTHERAPEUTICS NETWORK

BACKGROUND

The National Institutes of Health (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 that can enter either at the Discovery stage, to optimize well-validated hit compounds through medicinal chemistry, 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: http://grants.nih.gov/grants/guide/pa-files/PAR-14-293.html#sthash.jHGg7T0i.dpuf ). These projects may require 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) 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 BPN anticipates reaching a steady state of 5-10 projects at a given time with 3-5 users per project. A contractor is required to provide software 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 provide the BPN with 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 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, http://grants.nih.gov/grants/guide/pa-files/PAR-14-293.html#sthash.jHGg7T0i.dpuf http://grants.nih.gov/grants/guide/pa-files/PAR-14-293.html#sthash.jHGg7T0i.dpuf searching, downloading/exporting, and visualizing chemical 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 analogs produced by NIH-funded contractors and PIs (including chemical 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.

The database shall come with thirty five (35) user licenses and be a customizable software product which meets the following specific requirements:

1. 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 at http://www.access-board.gov/sec508/standards.htm . 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.

g) 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.

http://csrc.nist.gov/publications/PubsFIPS.html http://www.access-board.gov/sec508/standards.htm http://www.access-board.gov/sec508/standards.htm http://www.section508.gov/

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

i) 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 ).

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

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

l) 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.

m) 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).

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

o) 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).

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

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

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

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

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 steroselective features of chemical structures, such as chiral centers and stereoisomers.

http://csrc.nist.gov/groups/SNS/piv/index.html

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 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 Imax/Emax and/or fold change values (for example ratio Imax/Emax using reference standard), and show concentration/dose-response curves. Outlier exclusion shall be performed manually at the data entry stage of database use.

b) 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.

c) The database must have the ability to blind compound identification for biological testing. Compound blinding shall constitute hiding the compound structure and providing a different code number and correlation table.

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

e) 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 Specifications

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 over the 5 year period.

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 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 8-10 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 5-10 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 most successful projects may require regular access to the IT system for up to five years. 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 (5-10 for each project), consultants (3- 6 for the entire BPN program), BPN chemistry contractor staff (2-4 for the entire BPN program), and NIH staff (5-15 for the entire BPN program). The anticipated number of system users will be a base of 10-25 individuals (consultants, chemistry contractors, and NIH staff) plus 5-15 additional individuals (Contributors) for each project.

6. Optional License Requirements (Options for Increased Quantity)

The Contractor shall provide five (5) options for increased quantity annually. Each option shall include five (5) additional system licenses.

7. Transition-In/Implementation

A one month transition-in/implementation period shall be a part of the base period of the award resulting from this solicitation. Transition-In/Implementation shall provide time for set-up of the database system and also for user training.

At the initiation of the award resulting from this solicitation, the BPN will provide the successful offeror with a list of existing projects, data in a standard format from those projects, and a list of users and their roles. Data to be imported into the database may be different for each project, however the database shall have a standard format for all projects that may be customized to remove unnecessary fields.

The Contractor shall customize its database system per the requirements of this Statement of Work, set up appropriate user security levels, and import BPN data into the system within one month of contract award. The informatics database system must be fully live and fully operational thereafter.

Within one week of contract award, the Contractor shall offer training for the informatics database system. The training shall familiarize users with the system so that users can successfully navigate it without further training when the system is fully operational. The training shall be available for use at end-user discretion from within one week of contract award until the system is fully live within one month.

The training shall be on a productions system of a “sandbox” variety that simulates the environment users will encounter when the system is fully operational following data from previous projects being uploaded. It is not expected that BPN data will have been uploaded into the system at the time of training; however the format of the system is expected to be the same as it will be at time of full operating capacity.

Note: Transition-In/Implementation is applicable to the base period only. Transition- In/Implementation is not anticipated for the incumbent. Therefore, it shall not be proposed by the incumbent. All other offerors shall price transition-in/implementation separately from the total price of the base period.

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 within one (1) week of 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. Offerors shall price transition out as a separately priced option period. Transition-Out shall be exercised within the final contract period.

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. Quarterly Reports shall be submitted for Quarters 1, 2, and 3. Reports shall be submitted in electronic format to the Contracting Officer’s Representative. In addition, one hardcopy of each report shall be submitted to both the Contracting Officer and the Contracting Officer’s Representative.

b) Annual/Final Report

Upon final completion of the 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 and shall cover Quarter 4 as well as an Annual Review.

The Annual/Final Report shall cover the same content as the Quarterly Reports.

Reports shall be submitted in electronic format to the Contracting Officer’s Representative. In addition, one hardcopy of each report shall be submitted 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 http://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508 _annual_report.doc Reports shall be submitted in electronic format to the Contracting Officer’s Representative. In addition, one hardcopy of each report shall be submitted to both the Contracting Officer and the Contracting Officer’s Representative.

d) Information Technology (IT) Security Plan

In accordance with HHSAR Clause 352.239-72, Security Requirements for Federal Information Technology Resources, the successful offeror shall submit an IT Security Plan within thirty (30) days following contract award. The IT Security Plan shall be consistent with, and further detail, the approach to, IT security contained in the Contractor’s bid or proposal that resulted in the award of this contract. The IT Security Plan shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT Security Plan only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT Security Plan applies.

The Contractor shall review and update the IT-SP in accordance with NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations, on an annual basis.

CONTRACT TYPE

http://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc http://www.hhs.gov/sites/default/files/web/508/contracting/technology/section_508_annual_report.doc

A firm fixed price contract is contemplated. Each contract period shall include options for increased quantity.

PERIOD OF PERFORMANCE

The period of performance shall be 06/01/2016 through 05/31/2017 with four (4) one year option periods.

PLACE OF PERFORMANCE

The system and support required shall be provided remotely.

EVALUATION CRITERIA

The Government will award a contact resulting from this solicitation on the basis of best value in consideration of trade-off between technical factors and price/cost. Technical factors together shall be considered more important than price. The technical evaluation factors are as follows, in order of importance:

Factor 1: Confirmation of Compliance with Federal Security and Disability Requirements (Mandatory Criterion - PASS/FAIL)

The contractor shall confirm in writing that all support required in this RFQ will be provided in accordance with FISMA and Section 508 Requirements.

Factor 2: Technical Approach (75 Points)

The proposed technical approach and associated information technology system shall be evaluated on the following:

1. The extent to which the approach and system meet each of the requirements specified in this solicitation. Specifically, the proposal shall detail database features and processes in relation to the Statement of Work requirements. In particular, the proposal will be evaluated for demonstrated ability to meet the following requirements:

a. System Requirements (Pages 2, 3, and 4 of SOW) -- (25 points).

b. Chemistry-related requirements (Page 4 of SOW) -- (25 points).

c. Biology-related requirements (Pages 4 and 5 of SOW) -- (25 points).

Factor 3: Staffing & Customer Service (20 Points)

The offeror shall propose a combined staffing and customer service plan for the implementation and maintenance of the proposed IT system which will be evaluated for the following:

1. Response for Technical Support: (10 points)

The plan shall be evaluated for the response time for technical support and the efficiency and effectiveness of proposed methods for quality technical support and addressing of overall project requirements.

2. Contract Management (10 Points)

The plan shall be evaluated for efficiency and effectiveness of proposed methods for communicating with the Government, problem resolution, and completing invoicing in accordance with the Government provided instructions.

Factor 4: Live System Demonstration (5 Points).

Offerors shall provide a live demonstration of the proposed system using a video conferencing and screen sharing online meeting arranged by the Government via a system such as Webex. The live only system demonstration shall reflect the Offeror’s technical proposal content and shall include the following topics:

1. Database Login Process and Features (Page 3 SOW sections1i, 1j, 1k,1p)

2. Compound Registration Process and Features (Pages 3 and 4 SOW sections 1q, 2b, 2c, 2e, 2f, 2g)

3. Bioactivity Processes and Features (Pages 3 and 4 SOW sections 1m, 1q, 1s, 3a, 3b, 3c)

4. Data/Compound Search Processes and Features (Pages 3 and 4 sections 1n, 1o, 2d)

5. Data Visualization Processes and Features (Page 4 SOW section 1r)

6. Report Generation Processes and Features (Pages 3, 4 and 5 SOW sections 1l, 3a, 3d, 3e)

The demonstration shall be approximately one hour followed by half an hour to allow for questions from NIH personnel. The total time allotted for the live system demonstration shall not exceed 90 minutes per Offeror.

CONTRACTING OFFICER’S REPRESENTATIVE

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

Dr. Enrique Michelotti 6001 Executive Boulevard, Room 7179 Rockville, MD 20852 301-443-5415 michelottiel@mail.nih.gov

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change the COR designation for this contract.