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Abstract ObjectivePhase II of MVP-CHAMPION, a federal collaboration between the Veterans Affairs Healthcare System (VA) and the Department of Energy (DoE), leveraged large-scale clinical, geo-spatial, and genetic data with state-of-the-art artificial intelligence (AI), and high-performance computing (HPC) to improve value in healthcare. Materials and MethodsEight clinical priority projects for which AI was a critical missing capability were initiated to address: lung cancer screening (MVP 061), suicide risk screening (MVP 062), cardiovascular risk in obstructive sleep apnea (MVP 063), checkpoint inhibitor toxicity (MVP 064), heart failure (MVP 065), renal complications in diabetes (MVP 066), post COVID-19 sequelae (MVP 067), and antipsychotic medication toxicity (MVP 068). ResultsBuilding on a strong regulatory and administrative foundation, we developed multimorbidity-aware analytic frameworks, reusable computational tools, and analytic pipelines. These greatly facilitated identification of novel risk factors including genetic variants and specification of more discriminating prediction models. Novel genetic risk factors are informing development and repurposing of medications and discriminating prediction models promise to improve healthcare value. DiscussionThe research foundation developed in Phase I and extended in Phase II of MVP CHAMPION has supported an unprecedented federal collaboration and yielded significant scientific advances. Our clinical findings are poised for near-term application, while advances in machine learning and high-performance computing may accelerate the broader adoption of artificial intelligence in healthcare. ConclusionThis maturing VA-DoE federal collaboration is poised to transform the future of Veterans’ healthcare and the broader national landscape of precision health.
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Unleashing the Power of Biologics: Exploring the Governance and Regulation of Membrane-Based Virus Purification (MVP) Technologies
Background: Biologics is an exciting and growing area of medicine. Within the larger field of biologics, the use of viral vectors and virus-like particles (VLPs) is increasingly common, making it crucial to develop innovative and practical unit operations for the related purification process. Objective: Some scientists and engineers propose that membrane-based downstream virus purification (MVP) platforms would allow for more scalable and cost-effective production of these critical particles. However, the so-cial, political, and ethical implications of these advancements remain largely unex-plored. This paper aims to explore various pivotal facets of MVP technology govern-ance and regulations within the U.S. context, including (1) government policy ar-rangements related to the implementation of the technologies, (2) stakeholder atti-tudes, policy preferences, and behaviors, and (3) the fundamental factors that shape these attitudes, policy preferences, and behaviors. Methods: In doing so, we analyze publicly available federal and state government documents pertaining to biomanu-facturing, healthcare, and legislative attempts. Additionally, we will perform a stake-holder analysis on relevant industries, healthcare service providers, and recipients. Conclusions: Our goal is to outline the socio-political, ethical, and regulatory factors pertaining to the regulation and governance of these technologies.
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- Award ID(s):
- 2218054
- PAR ID:
- 10594077
- Publisher / Repository:
- MPDI
- Date Published:
- Journal Name:
- Biologics
- Volume:
- 5
- Issue:
- 2
- ISSN:
- 2673-8449
- Page Range / eLocation ID:
- 9
- Format(s):
- Medium: X
- Sponsoring Org:
- National Science Foundation
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- Free Publicly Accessible Full Text
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Accepted Manuscript
- Journal Article:
- https://doi.org/10.3390/biologics5020009
