资源描述
?2022?2?3?4?9?16?22?23?24?25?26?27?28?29 2022?(?)?1?2022?2023?2026?2024?2032?2024?2023?5.0?2023?2028?2025?AI/ML?2026?2022?2025?2022?2022?2026?2023?2023?IAM?IT?(OT)?(BCM)/?2022?(?)?2?1?2020?2?2021?3?70?AI?5.0?4?(in silico)?4D?(mis-feeding)?(GDPR)?5?Thomas Hillek?EMA?Marko Vogel?Dr.Klara Gieler?3 2022?(?)?4 2022?(?)?1|?2001?1?1000?genome.gov/sequencingcosts14?15,16?(NGS)?17,18,19?IKTOS?20?Insitro,Inc.?21?22?Recursion Pharmaceuticals Inc.?(Roche Holding AG)?(Genentech,Inc.)?(ML)?23?MELLODY?MachineLearningLedgerOrchestration for Drug Discovery?10?10?TB?24?DARWIN EU?Data Analysis and Real WorldInterrogation Network?(EMA)?DARWINEU?2023?1?2022?1?(DTC-GT)?6?LunaPBC,Inc.?7NebulaGenomics,Inc8?Zenome.io Ltd.9?DNA?Genelink,S.L.10?MyHeritage Ltd.11?Ancestry Ireland UnlimitedCompany12?3?23andMe,Inc?2022?13?2?2023?10?20022006200420082010201420122016202020181,0001,000,000100,00010,0000,000,00010,000,000USD?5 2022?(?)?3?2024?RWD?RWE?(RWD)?FDA?RWD?RWD?(RWE)?25?RWE?26,27?Pear Therapeutics Inc.?RWE?28?(Merck KGaA)?RWD?MAVENCLAD?(RMS)?29?2021?FDA?COVID-19?(COVID-19 Evidence Accelerator)?COVID-19?30?(Pfizer Inc.)?RWE?COVID-19?31?OPTIMA?13?36?RWD?32?2026?33,34?COVID-19?Dassault Systmes UKLimited?FDA?(Living Heart Project)?35,36?Neurotwin?37?AI?Unlearn.AI,Inc.?38GNS Healthcare?PatientTM?39?40?4D?11?pH?41?42?3D?43?Bionaut Labs?(Bionauts?)?BionautLabs?CandelTherapeutics,Inc.?44?5?2032?4?6 2022?(?)?RWD?RWDRWE?RWDRWE?RWDRWE?AI?AI?/?Internet?(DoS)?(IoT)?,?RWDRWE?RWDRWE?(HCP)?/?DevSecOps?GDPR?FDA?7 2022?(?)?Thomas Hillek?EMA?4D?RWD?mRNA?COVID-19?(ESG)?8 2022?(?)?9 2022?(?)?73%36%43%58%58%66%67%15%16%?4.0+?+?/?+?43%15%17%29%39%41%?5.0?2|?4.0?5.0?(A)?4.0?(B)?4.0?AI?552?Bitkom Industry?55?4.0?5.0?C?5.0?AI?IoT)?RPA?(Merck KGaA)?(Evonik Industries AG)?(Siemens AG)?CO2?50,51?2021?(BoehringerIngelheim Pharma GmbH&Co.KG)?52?53,54?5.0?5.0?AI?RPA?4.0?2?A?B?45,46,47,48?5.0?2?C?49?6?5.0?2023?4.0?AB?10 2022?(?)?Roger van den Heuvel?EMA?1?1?=?-?-?x?%?11 2022?(?)?7?2023?(C>)?56?C>?-80?-196?57?CharlesRiver Laboratories58?ThermoFisherScientificInc59?AdvancedBioScience Laboratories Inc60?Viralgen61?(CDMO)?(CMO)?COVID-19?Catalent,Inc62?63?8?2023?9?2025?(CM)?CM?68,69?(MIT)?ContinuusPharmaceuticals?(ICM)?6930?70?FDA?HR+HER2-?Verzenio?CM?71?(ICH)?FDA?(EC)?CM?2022?72,73?122022?10?2028?3D?BioNTech SE?mRNA?BioNTainer?2022?BioNTainers?COVID-19?mRNA?64?MedMagLabs?RoyalWolfAustralia(United Rentals Inc.)?C-Lab”?65WALDNER Holding SE&Co.KG66?Global Life Sciences Solutions USA LLC67?3D?74,75?3D?76?(Henkel AG&Co.KGaA)?Nexa3D?77?AMCM GmbH?3D?78?79,80?3D?81,82?83,84?3D?4D?Stratasys Ltd,Autodesk Inc.?MIT?Self-Assembly Lab?4D?85?86?12 2022?(?)?15?9?8?7?5.0?10?3D?6?5.03D?CDMO/CMO?3D?3D?3D?(IP)?RPA?(BCM)?3D?3D?3D?DevSecOps?GDPR?3D?13 2022?(?)?Caroline Rivett?Jayne Goble?Caroline?Jayne?Caroline?Jayne?/?Caroline?Schrems II?14 2022?(?)?Jayne?2020?7?DevSecOps?Caroline?1?2?3?Jayne?MIoT?15 2022?(?)?16 2022?(?)?11?2022?25%?87?88?3?89?Enlace Health,Inc.90?Lyfegen HealthTech AG91?2021?8?Lyfegen HealthTech AG?92?CAR-T?93?95,96,97,98?Lady Technologies Inc.99?Ovy GmbH100?EIT-kit”?3D?3D?101,102?Lingo?103?3|?X?Y?SoC?94?2022?12?SoC?00050021510353250000000000000000000?17 2022?(?)?13?2022?(DTx)?104,105?106?DTx?107,108?109,110?(DiGA)?111?DTx?112?(Novo Nordisk Pharma GmbH)?Cornerstones4Care113?myDose Coach114?(RocheDiabetes Care GmbH)?mySugr GmbH?115?BioNTech SE?116?2021?117?KoninklijkePhilips N.V.?118?DTx?Amblyotech LLC119?(Roche Diabetes CareGmbH)?mySugrGmbH120?15?2023?(NLP)?121,122?Sophia123?NorgineGmbH?(Plenvu)AVA124,125?Fabi?Maibo126?AMI?127?16?2023?(Roche Holding AG)?(Sandoz International GmbH)?(MerckSharp&Dohme Corp.)?(GrnenthalGmbH)?(NovoNordisk Pharma GmbH)?AI?ML?128,129,130?131?14?2022?18 2022?(?)?17?2024?”132?BioNTech SE?(Genentech,Inc.)?(iNeST)?133?(Moderna,Inc.)?(Merck Sharp&Dohme Corp)?mRNA-4157?134,135?WIN136?ICPerMed137?PMC?138?2025?(Zimmer Biomet Holdings,Inc.)?CanaryMedical Inc.?Knee?PersonaIQ?139?(FDA)?SmartFuse?140?141?MojoVision Inc.?LED?(AR)?142?143?144?145?19?AI/ML?2026?X?CT?MRI?X?146?90?147?AI/ML?Meta AI?10?148?149,150?HealthyNetworks O?151?2026?AR?(VR)?5G?152,153,154?VR/AR?HoloLens?MetaPlatforms Ireland Limited?Oculus?155?3D?156?Lume VR Ltd.?vLume?157,158?20?18?19 2022?(?)?222022?12?13?11?16?17?18?19?AI/ML?14?15?20?AI/ML?AI?/?/?AI?/?/?GDPR?FDA?DevSecOps?DevSecOps?20 2022?(?)?Marko Vogel?IT?IT?/?B2B?IT?21 2022?(?)?,OT?,CBEST,TBEST?SOC,SIEM?(CMA)?/?TOM?(IAM)?GRC?Powered SecOps?Powered delivery Powered IAM?(DLP)?KPMG Digital Responder?|?|?|?|?|?|?222022?1?2?IT?3?FDA?NIST?(IGA)?B2B?/?/?IT?IT?IBM?(FDA)?(DSCSA)?IBM?(DSCSA)?FDA blockchainpilotsuccessfullycompleted(kpmg.us)?22 2022?(?)?23 2022?(?)?2030?2030?24 2022?(?)?Thomas Hillek?EMA?Marko Vogel?Dr.Klara Gieler?Caroline Rivett?Jayne Goble?Roger van den Heuvel?EMA?Ashish Madan?Prof.Dirk Loomans?Dr.Stefan Schneider?Uwe Meyer?Prof.Dr.Heiko von der Gracht?Maximilian A.Woidich?26 2022?(?)?2021?6?26?2021?11?23?/?117?2020?2021?/?18?7?8?=1?;?=2?;?=3?2020?2021?27 2022?(?)?/?/?23andMe,Inc.1?2,3,6,?1210,14?3?16,17Advanced BioScience Laboratories Inc7Meta AI19Amblyotech,LLC14Meta Platforms Ireland Limited20AMCM GmbH10?14,20Ancestry Ireland Unlimited Company1?12Atos SE6?17Autodesk,Inc.10Mojo Vision Inc.18?2,3,14,15MyHeritage Ltd.1Bionaut Labs5mySugr GmbH13,14BioNTech SE8,14,17?1(figure)Bitkom e.V.6(figure)Nebula Genomics,Inc.1?2,6Nexa3D10?2Norgine GmbH15Canary Medical Inc.18?2,11,14Candel Therapeutics,Inc.5?13,15,16Catalent,Inc.7?19Charles River Laboratories7Ovy GmbH12?10Pear Therapeutics,Inc.3Continuus Pharmaceuticals9?(PMC)17Dassault Systmes UK Limited4?2,3,14?915Enlace Health,Inc.11Recursion Pharmaceuticals Inc.2?9?13,14?2?2,16?6?18Genelink,S.L.1?16?2,17?6,13,14,?1316?11Self-Assembly Laboratory10?1,2?6Global Life Sciences Solutions USA LLC8Stratasys Ltd.10GNS Healthcare4?7?8?(FDA)Introduction?163,4,9,18?19United Rentals Australia Pty Limited8?10?5,10ICPerMed International Consortium17Unlearn.AI,Inc.4IKTOS2Viralgen7Insitro,Inc.2WALDNER Holding SE&Co.KG8?(ICH)9WIN Consortium17?11Zenome.io Ltd1Koninklijke Philips N.V.16?18Lady Technologies Inc.12Lume VR Ltd.20?7LunaPBC,Inc.1Lyfegen HealthTech AG11?12?(MIT)9,10?5?/?28 2022?(?)?1 Future Opportunities Report,The Global 50,Dubai Future Foundation,20222 Trends in the Life Sciences Industry,Winter Edition 2020,KPMG,20203 Trends in the Life Sciences Industry,Summer Edition 2021,KPMG,20214Kerkmann C,Nagel L-M,Todesfall nach Hackerangriff auf Uni-Klinik Dsseldorf,?,20225 Connected medical device cybersecurity,The competitive advantage of regulatory compliance,KPMG,20226 https:/ 7https:/ https:/ 11 https:/www.myheritage.de/12 https:/ https:/ el-medicines/14 Wetterstrand KA.DNA Sequencing Costs:Data from the NHGRI Genome Sequencing Program(GSP)Available at:www.genome.gov/sequencingcostsdata15 Dirnbacher-Krug S,Reinhard R,Blitzlicht Gesundheit?Sanofi Aventis sterreich GmbH.03/202016 Brown N,Cambruzzi J,Cox PJ,Davies M,Dunbar J,Plumbley D,Sellwood MA,Sim A,Williams-Jones BI,Zwierzyna M,Sheppard DW.Big Data in Drug Discovery.Prog Med Chem.2018;57(1):277-356.17 Pop L,Zanoaga O,Chiroi P,Nutu A,Korban S,Stefan C,Irimie A,Berindan-Neagoe I.Microarrays and NGS for Drug Discovery.Drug Design-Novel Advances in the Omics Field and Applications.IntechOpen.2021.https:/doi.org/10.5772/intechopen.9665718 Evolving Data-Driven Regulation,HMA-EMA Joint Big Data Taskforce,Phase II report,HMA,EMA,201919 https:/www.bpb.de/nachschlagen/lexika/lexikon-in-einfacher-sprache/301100/big-data 20 https:/ 21 https:/ Savage N,Tapping into the drug discovery potential of AI,202123 https:/ https:/www.imi.europa.eu/projects-results/project-factsheets/melloddy 25 https:/www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence 26 McGrail S,3 Use Cases for Real World Evidence in Pharma Drug Development,202127 https:/real-world-evidence- Maricich YA,Xiong X,Gerwien R,Kuo A,Velez F,Imbert B,Boyer K,Luderer HF,Braun S,Williams K.Real-world evidence for a prescription digital therapeutic to treat opioid use disorder.Curr Med Res Opin.2021 Feb;37(2):175-183.29 https:/ 30 https:/www.fda.gov/science-research/fda-science-forum/generating-actionable-insights-real-world-data-covid-19-evidence-accelerator31 Bar-On YM,Goldberg Y,Mandel M,Bodenheimer O,Freedman L,Alroy-Preis S,Ash N,Huppert A,Milo R.Protection against Covid-19 by BNT162b2 Booster across Age Groups.?.2021 Dec 23;385(26):2421-2430.32 https:/www.pfizer.de/presse/meldungen/forschungsprojekt-optima-kuenstliche-intelligenz-krebs 33 https:/ https:/www.twi- 35 https:/ Vinluan F,Life sciences use of digital twins mirrors its application in other industries,MedCity News,202137 Marr B,The five biggest healthcare tech trends in 2022,?,2022 38 https:/www.unlearn.ai/solutions#intelligent 39 https:/ The AI-enabled digital twin for life sciences,KPMG,2021?29 2022?(?)?41 Xin C,Jin D,Hu Y,Yang L,Li R,Wang L,Ren Z,Wang D,Ji S,Hu K,Pan D,Wu H,Zhu W,Shen Z,Wang Y,Li J,Zhang L,Wu D,Chu J.Environmentally Adaptive Shape-Morphing Microrobots for Localized Cancer Cell Treatment.ACS Nano.2021 Oct 19.42 Zhang J,Ren Z,Hu W,Soon RH,Yasa IC,Liu Z,Sitti M.Voxelated three-dimensional miniature magnetic soft machines via multimaterial heterogeneous assembly.Sci Robot.2021 Apr 28.43 Hanaphy P,Zurich scientists develop 3D printed microbots for drug delivery inside the human body,3D Printing Industry,2020 44 https:/ ral-immunotherapies/45 Oluyisola O.E,Bhalla S,Sgarbossa F et al.Designing and developing smart production planning and control systems in the industry 4.0 era:a methodology and case study.?,33,311332.2022.https:/doi.org/10.1007/s10845-021-01808-w46 https:/ https:/home.kpmg/de/de/home/themen/2018/02/digitalisierung/sanofi.html48 https:/ European Commission,Directorate-General for Research and Innovation,Breque,M.,De Nul,L.,Petridis,A.,Industry 5.0:towards a sustainable,human-centric and resilient European industry,Publications Office,2021,https:/data.europa.eu/doi/10.2777/30840750 https:/ 51 https:/ https:/www.boehringer-ingelheim.de/pressemitteilung/eroeffnung-solids-launch-fabrik53 https:/ https:/ 55 Berg A,Industrie 4.0 so digital sind Deutschlands Fabriken,bitkom,202056 https:/ le&referrer-analytics=157 https:/ https:/ 59 https:/ https:/ https:/ https:/ Lonza baut Produktion fr Corona-Impfstoff von Moderna weiter aus,?64 https:/investors.biontech.de/news-releases/news-release-details/biontech-introduces-first-modular-mrna-manufacturing-facility65 https:/.au/a-shipping-container-with-the-potential-to-save-lives 66 https:/www.waldner.de/en/products/laboratory-furniture/mobile-lab-solutions/67 https:/ ing-facility68 https:/ 69 https:/www.dcatvci.org/features/continuous-manufacturing-and-pharma-where-does-it-stand/70 https:/ cines-in-the-u-s/71 https:/ https:/www.ema.europa.eu/en/ich-guideline-q13-continuous-manufacturing-drug-substances-drug-products 73 https:/www.ich.org/74 https:/ 75 Bandyopadhyay A,Heer B,Addtitive manufacturing of multi-material structures,Materials Science and Engineering,201876 Chavoin JP,Taizou M,Moreno B,Leyx P,Grolleau JL,Chaput B.Correcting Poland Syndrome with a Custom-Made Silicone Implant:Contribu tion of Three-Dimensional Computer-Aided Design Reconstruction.Plast Reconstr Surg.2018 Aug;142(2):109e-119e.77 https:/ https:/ 79 https:/ https:/ 2022?(?)?81 Guzzi EA,Bovone G,Tibbitt MW.Universal Nanocarrier Ink Platform for Biomaterials Additive Manufacturing.Small.2019 Dec.82 Regg P,3D-printed bioresorbable airway stent,?,202183 Paunovi N,Bao Y,Coulter FB,Masania K,Geks AK,Klein K,Rafsanjani A,Cadalbert J,Kronen PW,Kleger N,Karol A,Luo Z,Rber F,Brambilla D,von Rechenberg B,Franzen D,Studart AR,Leroux JC.Digital light 3D printing of customized bioresorbable airway stents with elastomeric properties.Sci Adv.2021 Feb 384 https:/ https:/selfassemblylab.mit.edu/4d-printing86 https:/ Shrank WH,Rogstad TL,Parekh N.Waste in the US Health Care System:Estimated Costs and Potential for Savings.?.2019 Oct 15;322(15):1501-1509.88 https:/www.jwatch.org/na52991/2021/01/05/tallying-waste-american-healthcare 89 https:/catalyst.nejm.org/doi/full/10.1056/CAT.17.055890 https:/ https:/92 https:/ Jrgensen J,Hanna E,Kefalas P.Outcomes-based reimbursement for gene therapies in practice:the experience of recently launched CAR-T cell therapies in major European countries.?,2020.94 Pathway to success in outcome-based contracting,KPMG Switzerland,2020.95 https:/www.siren.care/96 https:/samueli.ucla.edu/smartwatch-tracks-medication-levels-to-personalize-treatments/97 https:/www.escardio.org/The-ESC/Press-Office/Press-releases/Novel-necklace-detects-abnormal-heart-rhythm 98 https:/ 99 https:/kegg.tech/100 https:/ https:/news.mit.edu/2021/making-health-motion-sensing-devices-more-personal-eit-kit-0922102 Zhu J,Snowden JC,Verdejo J,Chen E,Zhang P,Ghaednia H,Schwab JH,Mueller S.An Electrical Impedance Tomography Toolkit for Health and Motion Sensing.In The 34th Annual ACM Symposium on User Interface Software and Technology(UIST 21).?.2021.400413.https:/doi.org/10.1145/3472749.3474758103 https:/ Dang A,Arora D,Rane P.Role of digital therapeutics and the changing future of healthcare.J Family Med Prim Care.2020 May31;9(5):2207-2213.105 https:/ https:/dtxalliance.org/understanding-dtx107 https:/108 https:/www.lifebio.org/our-news/lifebio-news/new-app-uses-artificial-intelligence-ai-voice-and-visual-prompts-coupled-with-reminiscence-thera py-to-enhance-quality-care-and-quality-of-life-for-older-adults109 https:/momentone.carrd.co110 https:/www.myleon.co/111 https:/diga.bfarm.de/de/verzeichnis112 https:/ https:/ https:/diabetes.sanofi.de/produkte-uebersicht/mydosecoach/allgemeine_produktinformationen115 https:/www.roche.de/aktuelles/news/roche-diabetes-care-gewinnt-mit-mysugr-app-ausschreibung-zur-zukunftsregion-digitale-gesundheit/116 https:/www.pharmaceutical- https:/ https:/ https:/ https:/ 2022?(?)?121 https:/ https:/mobidev.biz/blog/technology-trends-healthcare-digital-transformation123 https:/ 124 https:/ 125 https:/www.plenvu.de/plenvu/patient/einnahme 126 https:/ 127 https:/ https:/ https:/ 130 https:/ 131 https:/ https:/eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52015XG1217(01)&from=FR133 https:/biontech.de/de/science/platforms134 https:/clinicaltrials.gov/ct2/show/NCT03313778135 https:/ 136 http:/www.winconsortium.org/137 https:/www.icpermed.eu/138 https:/www.personalizedmedicinecoalition.org/139 https:/ 140 https:/ https:/www.wernersiemens-stiftung.ch/en/projects/smart-implants/142 https:/www.mojo.vision/mojo-lens143 https:/penntoday.upenn.edu/news/smart-dental-implants144 https:/pharmacy.ucsf.edu/news/2021/09/kidney-project-successfully-tests-prototype-bioartificial-kidney145 Yang K,OCearbhaill ED,Liu SS,Zhou A,Chitnis GD,Hamilos AE,Xu J,Verma MKS,Giraldo JA,Kudo Y,Lee EA,Lee Y,Pop R,Langer R,Melton DA,Greiner DL,Karp JM.A therapeutic convection-enhanced macroencapsulation device for enhancing cell viability and insulin secretion.?.2021 Sep 14.146 TschuchnigM.E.,Gadermayr M,Anomaly Detection in Medical Imaging-A Mini Review,2021147 https:/www.nhs.uk/conditions/mri-
展开阅读全文