presol_ips-biorepository_noi.pdf

Pre-solicitation Non-competitive (Notice of Intent) Synopsis

Type: Pre-Solicitation Notice Number: 75N92019R0052 - NOI Title: Biorepository of Lung Disease-Specific Human Induced Pluripotent Stem Cells Classification Code: A – Research and Development NAICS Code: 541715 Is this a Recovery and Reinvestment Act Action: No Response Date: January 09, 2020 Primary Point of Contact: Cornelius Moore / Rick Gomes

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A

CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-

NAME).

This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR subpart 6.302-1.

The National Heart, Lung, and Blood Institute (NHLBI) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to Boston University for the Biorepository of Lung Disease-Specific Human Induced Pluripotent Stem Cells. It is anticipated that one award will be made around May 2020 for a period of five (5) years. THIS IS

A SYNOPSIS. THIS IS NOT A SOLICITATION.

BACKGROUND AND PROGRAM OBJECTIVES

The National Heart, Lung, and Blood Institute (NHLBI) seeks to continue to provide investigators a biorepository of human-induced pluripotent stem cells (BhiPSC-Lung) to support lung health and disease research. The BhiPSC-Lung will focus on the development, characterization, and distribution of lung iPSC lines and associated progeny for the research community to facilitate the understanding of both healthy human lung development and disease pathobiology.

The purpose of this resource to facilitate basic, translational, and population science research, the NHLBI expects BhiPSC-Lung to generate and maintain a large iPSC biorepository from healthy populations and patients with lung diseases. The primary goals are to 1) maintain and distribute the current iPSC lines; 2) maintain the training modules and hands-on training courses; 3) complete the collection of iPSC lines derived explicitly from all known monogenic lung diseases; 4) differentiate the iPSC lines with knock-in reporters into organoids and distribute to the community; 5) generate iPSCs from blood samples collected in the Framingham Heart Study; 6) characterize the transcriptome of the iPSC lines with RNA seq; and

7) provide NHLBI investigators with the necessary expertise, services, and resources to enhance lung health and disease research.

The objective of BhiPSC-Lung is to build and support a critical national biorepository of normal and lung disease-specific induced pluripotent stem cells (iPSCs), as well as their differentiated progeny, to serve the lung research community. BhiPSC-Lung will focus on the development, characterization, and distribution of lung iPSC lines and associated progeny to facilitate the understanding of both healthy human lung development and disease pathobiology.

It is anticipated that one contract award will be made. The award will comprise a twelve (12) month base with four (4) consecutive twelve (12) month options.

Options Anticipated Dates Base Period May 1, 2020 – April 30, 2021

Option Period 1 May 1, 2021 – April 30, 2022 Option Period 2 May 1, 2022 – April 30, 2023 Option Period 3 May 1, 2023 – April 30, 2024 Option Period 4 May 1, 2024 – April 30, 2025

PROJECT REQUIREMENTS

Throughout the period of performance, the Contractor shall work cooperatively with the NHLBI Contracting Officer’s Representative (COR) in all relevant aspects of study development and execution. The Contractor shall appoint key personnel, including a principal investigator, to lead and manage the study. This task area aims to provide administrative and infrastructure support required to establish and maintain the resource.

The services to be delivered are:

Task Area A - Core Administrative Task

1. In collaboration with NHLBI, create and maintain a Manual of Procedures (MOP) throughout the contract period describing BhiPSC-Lung operations and achieving program objectives, including: i) timeline; ii) key milestones, such as IRB (Institutional Review Board) approval, core site and partner site establishment, development of an electronic platform for tracking services, and recruitment goals; iii) workflow for processing and fulfilling RSAs; iv) protocols for iPSC development, characterization, validation, and distribution; v) database management incorporating data transfer and security; and listing of key personnel, responsibilities, and replacement plan; vi) deliverables, such as dedicated personnel to coordinate scientific project requests, status reports, the number of iPSC lines generated, the number of iPSC lines/vials shipped, and the number of NHLBI investigators served; and vii) communication plan.

2. In collaboration with the NHLBI, develop and manage a Request for Service Application (RSA) process for NHLBI-supported investigators to apply for services with only nominal shipping and handling costs. Information in the RSA shall include: i) project title; ii) aims; iii) needs for iPSC and differentiated progeny; iv) intent to prepare, package, and ship investigator-provided, de-identified patient blood samples, as applicable, for biorepository processing; v) NIH/NHLBI funding support; and vi) agreement to acknowledge the biorepository services contributing to project progress, applications for funding support, and future manuscripts. The RSA receipt and review process shall include: i) continuous electronic form submission; ii) data checks for completeness; iii) application tracking and processing; iv) application review criteria; and v) evaluation of selected RSAs, such as those submitted by investigators providing patient blood samples, by an External Advisory Committee (EAC) and the NHLBI.

3. In collaboration with the NHLBI, establish, manage, and coordinate logistics for an EAC to review the BhiPSC-Lung services and selected RSAs to recommend to the NHLBI. The EAC should have approximately 3-4 members with an expertise in lung iPSC biology, public data repositories, population genetics, RNA-seq, and/or other scientific areas relevant to the scope of BhiPSC-Lung. The BhiPSC-Lung proposal should not include any names of potential EAC members, and the Offeror should not contact potential members until after an award is made.

4. Submit the results of EAC review to the NHLBI iPSC Program Committee (NIPC) for secondary analysis and determination of which RSAs should be fulfilled by the BhiPSC- Lung. The NIPC will be comprised of NHLBI representatives.

5. The Principal Investigator (PI) may be asked to participate in EAC and NIPC meetings on an ad hoc basis.

6. House a public repository of iPSC line characterization data, de-identified donor clinical records, and RNA-seq information for investigators to find, use, and analyze curated results. Once validated for reproducibility, RNA-seq data will be submitted to the NCBI Gene Expression Omnibus (GEO) and any applicable NHLBI data platforms.

7. In collaboration with the NHLBI, disseminate information to raise awareness of the BhiPSC-Lung services to the research community. Develop informational materials for relevant scientific meetings.

8. Develop and maintain a public website to communicate information about the BhiPSC- Lung, including, but is not limited to the program mission, the application process for services, and related iPSC protocols. The code for the website shall be open source and compliant with Section 508, as well as all NIH/HHS/Federal security policies.

Section 508 Accessibility Standards

• 1194.21 Software applications and operating systems

• 1194.22 Web-based intranet and internet information and applications

• 1194.24 Video and multimedia products

• 1194.31 Functional performance criteria

• 1194.41 Information, documentation, and support

9. Develop and maintain an internal website for cataloging iPSCs and managing RSA workflow that is accessible to EAC members and relevant Government staff. The website should adhere to the same requirements stated for the public website.

10. Develop and maintain a secure, confidential electronic database of all RSAs received, including the name of the requesting investigator, NIH/NHLBI funding support, project title, lung disease studied, and information on quality control and quality assurance methods, as well as any other pertinent data for the requested iPSC. These records shall be submitted to the EAC and the NHLBI as defined in the MOP and upon request.

11. Provide expertise in the iPSC workflow process including but limited to: blood sample processing and shipment; iPSC thawing and culture; and iPSC differentiation.

12. Ship vials of iPSCs and differentiated progeny with sequencing information, patient medical history, and other relevant data to the requesting investigator, who is only to be responsible for nominal shipping and handling costs.

13. Ensure that reports, supporting documents (e.g., current certifications, inspections, and assurances), and data are available for review by the NHLBI or Federal oversight representatives if a site visit or audit is requested. Participate in any planned site visits by the NHLBI, other Federal staff, and outside experts to the contractor’s facilities.

14. Participate in teleconferences (monthly) and meetings (1 in-person meeting per year) with the NHLBI and other Federal agency staff members, as applicable.

15. Prepare and submit status reports regularly (monthly, quarterly, semi-annually, and annually).

16. Maintain a listing of publications, presentations, or other achievements that were supported by the work performed by the BhiPSC-Lung and make this available to the NHLBI upon request.

17. Adhere to IRB, local, state, and federal guidelines in the handling of patient information and samples.

18. Develop contract startup and closeout plans.

• Contract Initiation

The Contractor is expected to execute an efficient transition from the current grant-supported program Boston University CReM iPSC Biobank to the contract award.

For the grant-contract transfer, the Contractor shall develop a Startup Plan that includes: i) a description of any operational changes; ii) a timeline to implement the grant-to-contract conversion; and iii) updates to the MOP, service request process, website handling, and billing procedures. A draft Startup Plan should be submitted to the NHLBI within the first 45 calendar days of the contract award and finalized within 90 days of the contract award.

• Contract Expiration

In collaboration with NHLBI, develop a Closeout Business Plan with timelines and milestones for sustainable independence of the biorepository after NHLBI support ends at least three (3) months before the expiration date of the contract, or earlier if requested by the COR. The Closeout Business Plan should identify a delivery schedule for transferring materials developed through this contract to the Successor.

The Contractor shall execute the following activities beginning at least two (2) months prior to contract expiration or earlier if requested by the COR:

1. Cooperate with the Successor.

2. Participate in meetings and teleconferences with the COR and Successor for updates on current activities.

3. Supply a detailed list of current in-progress task orders.

4. Deliver clearly labeled stored materials; Government-furnished property;

electronic versions of documents; Web-related files; software programs; and mailing lists developed under this contract to the Successor.

5. Secure all items and equipment safely and appropriately to ensure that equipment is not damaged, and adherence to warranty conditions and service agreements is maintained.

19. The Contractor shall be responsible for transportation of equipment and materials and other costs required for the closeout.

Task Area B - Scientific Projects

Task Area B aims to provide support for projects that fall outside the scope of activities described in Task Area A. Task Area B services are only to be performed upon the award of a task order. The specific actions to be performed will vary depending on the nature of the project and the services needed. The exact number of task orders to be conducted per year will depend upon a range of factors such as scientific merit, alignment to program objectives, project cost, available funds, and duration. For planning purposes, Offerors should assume between 2 – 5 projects per year may be conducted and sample task orders are listed in the RFP that Offerors can respond to in their proposal.

The services to be provided may include, but are not limited to the following:

1. Recruit lung disease and healthy patients from diverse racial and ethnic backgrounds.

Explore options to enhance diversity, such as community outreach, partnering with other clinical sites that primarily care for a diverse population, and leveraging NHLBI cohorts.

2. Generate iPSC lines from blood samples taken from recruited lung disease and healthy patients, followed by validation for stem cell-specific markers, pluripotency assessment, and RNA-seq.

3. Develop iPSC clones from each patient for expansion, banking, and backups in case of genetic aberrations.

4. Differentiate iPSCs into iPSC derived lung cells and organoids and confirm by staining for lung-specific markers or the activation of reporters.

5. Differentiate iPSCs with reporters into alveolospheres and bronchospheres and distribute them to the research community.

6. Carry out transcriptomic studies in a subset of the collected iPSCs with both single-cell RNA sequencing and RNAseq after they have been differentiated into bronchospheres, alveolospheres, and air-liquid interface cultures.

7. Continue the annual hands-on one-week long training course.

8. Support collaborations with other NHLBI-supported iPSC programs, such as the NHLBI Progenitor Cell Translational Consortium (PCTC), the NHLBI Production Assistance for Cellular Therapies (PACT) Program, and the 21st Century Cures Act Regenerative Medicine Innovation Project (RMIP), whenever feasible.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bonafide capabilities for fulfilling the requirement, addressing each project requirement separately. The response should also include: 1) the total number of employees; 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above-outlined requirements; 3) a description of general and specific facilities and equipment available, including computer equipment and software, 4) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated, and 5) any other information considered relevant to this program. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will typically be considered exclusively to determine whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by the closing date on this notice and must reference the solicitation number. Responses may be submitted electronically following the instructions below.

“All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.”

Submission Instructions:

Interested parties shall submit capability statements via the FedConnect web portal (www.fedconnect.net) and reference the FedConnect Pre-solicitation Number 75N92019R0052.

The due date for receipt of statements is 3:00 p.m. Eastern Time on January 09, 2020. Vendors can register with FedConnect at https://www.fedconnect.net/FedConnect/default.htm.

Please note that multiple federal agencies use FedConnect and therefore, FedConnect assistance will be provided by Compusearch Software Systems, not the NHLBI OA. More information about registration requirements can be found by downloading the FedConnect Ready, Set, Go! Guide at https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.p df.

For assistance in registering or for other FedConnect technical questions, please call the FedConnect Help Desk at (800 )899-6665 or email at support@fedconnect.net. Please use the Contracting Officer/ Contract Specialist contact information provided, should you require a waiver not to use FedConnect for submitting.

75N92019R0052 https://www.fedconnect.net/FedConnect/default.htm https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf mailto:support@fedconnect.net

Pre-solicitation Non-competitive (Notice of Intent) Synopsis