Attachment_11_-_Pre-sol-notice_1.doc

Pre-Solicitation Notice for RFP No. 75N92025R00003 Title: National Gene Vector Biorepository (NGVB) The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Contractor to provide support to translational gene therapy research by providing resources and services, including those that allow investigators to meet the unique U.S. Food & Drug Administration (FDA) requirements associated with gene therapy under a National Gene Vector Biorepository (NGVB) program for a five year (5) year period. The purpose of this announcement is to provide a Pre-Solicitation Notice for the release of Solicitation No. 75N92025R00003. The Sources Sought Notice and Pre-solicitation Non-competitive (Notice of Intent) Synopsis were posted under Solicitation No. 75N92024R0279. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION.

Background:

The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Contractor with the ability to continue the National Gene Vector Biorepository (NGVB).

The NGVB has its origins in the relatively early days of gene therapy, when in 1995, the then National Institutes of Health (NIH), National Center for Research Resources (NCRR) launched the Native Gene Vector Laboratories (NGVL) Program for gene therapy researchers in the extramural community. The NGVL produced clinical-grade gene therapy vectors for researchers to use in human gene therapy trials. The NGVL ran through the end of 2006, but as other vector production programs became available, the NCRR transitioned it into the National Gene Vector Biorepository (NGVB) and Coordinating Center at Indiana University in 2008. The emphasis now was no longer on vector production, but on the types of important translational resources that the NGVB currently offers. When the NIH established the National Center for Advancing Translational Sciences (NCATS), the NCRR was phased out and the NGVB was transferred to NHLBI. The NGVB was transferred to NHLBI as a P40 grant in April 2012. The NGVB was converted from a grant mechanism to a contract and has been operating under an Indefinite Delivery, Indefinite Quantity (IDIQ) contract since December 2018.

The NGVB provides gene therapy investigators with a variety of services that can enhance their research. The services currently offered by the NGVB, which are to continue under the next contract, are focused in four main areas: 1) reagent repository, 2) pharmacology and toxicology resources, 3) insertional site analysis on clinical trial specimens, and 4) archiving services. The NGVB also performs some research related to the services they provide, particularly with respect to the testing and development required to perform analyses on clinical trial specimens. Not only do these services and resources enhance an individual investigator’s research, but some of these services are required by the FDA for agents under an Investigational New Drug (IND).

The NGVB is a unique resource that not only serves as a biologic specimen and data repository, but it also develops assays and performs testing on clinical specimens, as required by the FDA for long-term follow-up.

The NGVB has the capability to store clinical specimens under the specialized requirements of Good Laboratory Practices (GLP) standards needed for Investigational New Drug (IND)-enabling work. Currently, there are over 20,000 irreplaceable tissue and blood specimens held under GLP conditions and the NGVB contractor will need to have the capability to archive these current specimens, as well as future specimens. Additionally, the NGVB performs assay development and testing for the clinical specimens under College of American Pathologists (CAP) and Clinical Laboratory Improvement Act (CLIA) certifications and/or Good Manufacturing Practices (GMP) standards, as the case requires. The NGVB contractor must also possess these capabilities.

Purpose and Objectives:

The NHLBI requires the NGVB support translational gene therapy research by providing resources and services, including those that allow investigators to meet the unique FDA requirements associated with gene therapy. The work is focused in the following four main areas: 1) Reagent Repository, 2) Pharmacology and Toxicology Resources, 3) Clinical trial and pharmacology study specimen archiving under Good Laboratory Practices (GLP) conditions, and 4) Research and Development of qualified assays for Insertional Site Analysis. The NGVB will also maintain an up-to-date website that describes the resources available to researchers and has interactive tools similar to those available at the current website: https://ngvbcc.org.

Project Requirements

1. Serve as a biologic specimen and data archiving service for animal and human studies/clinical gene therapy trials performed to support or under an IND. Specimens may be required to be held as long as 15 years.

2. Develop assays and perform testing on clinical specimens, as required by the FDA for long-term follow-up of certain gene therapy clinical trials. This includes testing for replication competent virus (RCV) and insertional site analyses to look for potential malignant transformation of the transduced cells on clinical specimens from gene therapy clinical trials supported by the NIH, as required by the FDA.

3. Develop assays for clinical specimen testing as necessary and perform testing under College of American Pathologists (CAP) and Clinical Laboratory Improvement Act (CLIA) certifications and/or Good Manufacturing Practices (GMP) standards, as the case requires.

4. Transfer archived specimens (over 20,000 specimens to date) from the current NGVB to the new contractor and store under GLP conditions without loss or compromise of the specimens.

5. Establish and maintain a gene therapy reagent repository and sharing service with a web-based catalogue of gene therapy reagents, including plasmids, cell lines, and vectors. Also, supply certified and research-grade cell lines for vector production, key adeno-associated virus (AAV), and adenoviral, retroviral, lentiviral, DNA, and herpes simplex virus (HSV) vector reagents.

6. Provide archiving services for Good Laboratory Practice (GLP) samples and establish and maintain a web-based database of completed gene therapy biodistribution and toxicity studies (pharmacology/toxicology database).

7. Develop and maintain databases for the testing and archiving services performed in support of gene therapy clinical trials.

8. Provide online tutorials or educational materials on the resources and services offered by the NGVB.

This is not a Request for Proposal (RFP) and the Government is not committed to award a contract pursuant to this announcement. This advertisement does not commit the Government to award a contract.

The RFP will be available in the System for Award Management (SAM) at https://sam.gov/content/home. Prospective offerors are responsible for downloading the RFP and all attachments. The offeror is responsible for monitoring SAM for the release of the solicitation and any amendments. The RFP will be available from SAM on or about November 22, 2024.

Attachment 11