Tech & Health

July 18, 2023

Alliance for Genomic Discovery FAQs

Here are frequently asked questions about Vanderbilt University Medical Center’s Alliance for Genomic Discovery.

Alliance for Genomic Discovery (AGD) FAQs

– July 2023 –

  1. What is Nashville Biosciences?

Nashville Biosciences (“NashBio”) is a wholly owned for-profit subsidiary of VUMC, launched in 2018 (http://www.nashville.bio/).

 

Read the news: The Alliance for Genomic Discovery announces founding biopharma members: AbbVie, Amgen, AstraZeneca, Bayer and Merck

  1. Why was NashBio formed?

NashBio was formed to extend the utility of BioVU/Synthetic Derivative (“SD”) into the commercial field for research to improve human health, maintaining strict ethical, social, and legal protections and principles.

  1. What is NashBio doing with Illumina?

Last year, NashBio and Illumina announced a collaboration agreement to sequence the whole genomes of approximately 250,000 DNA samples from BioVU under a program named the Alliance for Genomic Discovery (“AGD”). This past January, they announced that Amgen would be the first company to join AGD, and that Amgen’s genomics subsidiary deCODE genetics would begin sequencing the first 35,000 genomes and ultimately sequence all 250,000 samples planned. This week NashBio and Illumina are announcing the addition of four more companies to the AGD, with a goal of reaching eight participant companies.

  1. What companies are involved in the AGD?

Illumina is the leading manufacturer and provider of next-generation sequencing and genotyping tools and reagents, making them a natural convenor of the AGD with NashBio. Amgen is a top-20 innovative pharmaceutical company, and its subsidiary deCODE genetics pioneered more than 20 years ago many of the genotype-phenotype analyses now common in this domain using health records and biospecimens collected from the Icelandic population. Now, four other top-20 innovative pharmaceutical companies with an interest in applying genomics to drug R&D have agreed to join the AGD – AbbVie, AstraZeneca, Bayer and Merck. As additional companies agree to participate, further announcements will be made.

  1. What are these companies paying to NashBio & VUMC?

Illumina and NashBio are collaborating to establish the structure for AGD; no money will be exchanged between them. AGD participants will pay the full cost to access the BioVU® DNA samples and whole genome sequence them. As with other NashBio activities, any proceeds after all costs have been paid will ultimately be used to support/improve BioVU®/SD in other ways to enrich and expand its utility for research.

  1. What are AGD participants gaining access to, and what can they do with it?

Illumina and AGD participants will have access to the whole genome sequence data generated as well as structured phenotype data (e.g., ICD coding, lab values, vitals, medications) extracted from BioVU®/SD for these samples only. These datasets will be made available to all AGD participants through Illumina’s cloud-based informatics platform (Illumina Connected Analytics) or a similar Trusted Research Environment (“TRE”) that has been accredited and approved by NashBio & VUMC. Consistent with current practice, AGD participants will be able to work with NashBio to use and analyze other data from BioVU®/SD that is not in the Illumina platform as needed, on a project-by-project basis. Illumina and all AGD participants are limited to use the data for their own internal R&D and product development promoting health and health care.

  1. What data do we get back in exchange?

All whole genome sequencing data generated will be made available to VUMC/VU researchers on the same timeline that they are made available to AGD participants.

  1. How will this impact BioVU®/SD and research at Vanderbilt?

All existing data currently available in BioVU®/SD will remain available to all researchers following current practice and policy. Per above, the whole genome sequencing data will be available for BioVU® researchers as it is generated.

  1. How and when will investigators be able to access this data?

Details on the exact mechanism, vehicle and cost structure for gaining access to these new data are still being determined collaboratively with the various governance bodies that oversee BioVU® and VUMC leadership. In the short term, VUMC/VU researchers will have access to the same ICA informatics platform that AGD participants have. In the long term, VUMC leadership and the BioVU® governance bodies will determine the best platform to access and analyze these data.

  1. When will this start, and how long will it take?

Sample retrieval and sequencing began this past January for the first 35,000 samples. Following this week’s announcement, it is expected to take until March 2025 to sequence all 250,000 samples currently planned.

  1. Why are we doing this, and why now?

VUMC has been developing BioVU®/SD as a research resource for more than 15 years and has continued to grow the resource as scientific need evolves. As our scientific understanding of the genome continues to expand, the need for and utility of deeper and more detailed data about the genome continues to expand and will eventually become essential to maintaining a leading-edge position in the field. Several recent developments (e.g., two industry consortia sequencing the UK Biobank, the FinnGen consortium, Our Future Health, etc.) established a precedent for this type of activity and have shown that both academic and commercial research can benefit from these collaborations while still protecting the underlying data resources and individual patients that contributed to them. VUMC leadership decided to pursue a similar model to these other consortia to accelerate BioVU®/SD’s utility for understanding and treating human disease and to continue improving Vanderbilt researchers’ competitiveness.

  1. Who can I refer to if I have further questions about NashBio or this sequencing alliance?

For questions about VUMC and AGD, please contact Peter Embí, MD – SVP for Research & Innovation, VUMC (peter.embi@vumc.org). For questions about NashBio and AGD, please contact Elizabeth Ann Stringer, PhD – Chief Scientific Officer, Nashville Biosciences (elizabethann@nashvillebiosciences.com). We also intend to host an open town hall shortly to provide more information about NashBio and the AGD.