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2 - US Integration of Government, Academia, and Industry

A Catalyst for Science-Technology Revolutions

Published online by Cambridge University Press:  30 August 2023

Michael J. Malinowski
Affiliation:
Louisiana State University
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Summary

In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

Keywords

Jennifer Anne DoudnaCRISPRsickle cell diseaseMendelian traitsMendelian diseasesoff-label useWalter Isaacsongenomicsgenomic revolutionbiotech revolutionHuman Genome Project (HGP)genome sequencingbioinformaticspersonalized medicinepersonal genome medicineinformation-technology eraOperation Warp SpeedCOVID-19 vaccinesManhattan ProjectReagan Administrationmessenger ribonucleic acidmRNAFood and Drug Administration (FDA)clinical trialsvaccine research and developmentcoronavirusModernaBioNTechemergency use authorization (EUA)Biomedical Advanced Research and Development Authority (BARDA)Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)Rapid Acceleration of Diagnostics (RADx)Vaccine Research CenterDefense Production ActFederal Food, Drug, and Cosmetic ActNational Academies of Sciences, Engineering, and Medicine (NASEM)COMIRNATY vaccineSpikevax vaccineMcKesson CorporationWar Productions BoardWorld War IICold Warmilitary-industrial complexDwight D. EisenhowerUS automotive industryOrganization of Arab Petroleum Exporting Countries (OPEC) Pentagon PapersReagan AdministrationBayh–Dole ActStevenson–Wydler ActFederal Technology Transfer Act of 1986cooperative research and development agreement (CRADA)Small Business Innovation Research Program (SBIR)Small Business Technology Transfer Program (STTR)recombinant DNAGenentechAmgenEpogenOrphan Drug ActCoordinated Framework for Regulation of Biotechnologyhigh-throughput DNA sequencingBiotechnology Innovation Organization (BIO)Safe Genes ProgramAll of Us Research ProgramCenters for Mendelian GenomicsFrancis CollinsFDA Office of Orphan Productsgene therapyimmunotherapyJesse Gelsingerhuman embryonic stem cell researchCoronavirus Aid, Relief, and Economic Security Act (CARES)Government Accountability Office (GAO)COVAXanti-vaccination movementvaccine hesitancyreal-world dataThe 21st Century Cures Act,Randomized controlled trialsRCT Duplicatecurrent good manufacturing practiceCeredaseLeroy Hood
Type
Chapter
Information
Personal Genome Medicine
The Legal and Regulatory Transformation of US Medicine
, pp. 73 - 123
Publisher: Cambridge University Press
Print publication year: 2023

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