Precision Medicine and Artificial Intelligence : The Perfect Fit for Autoimmunity

__Precision Medicine and Artificial Intelligence: The Perfect Fit for Autoimmunity__ covers background on AI, its link to PM, and examples of AI in healthcare, especially autoimmunity. The book highlights future perspectives and potential directions as artificial intelligence (AI) has gained significant attention in the past decade. Autoimmune diseases are complex and heterogeneous conditions, but exciting new developments and implementation tactics surrounding automated systems has enabled the generation of large amounts of data, making autoimmunity an ideal target for AI in the field of Precision Medicine (PM). More and more diagnostic products utilize AI, which is also starting to be supported by regulatory agencies such as the Food and Drug Administration (FDA). Knowledge generation by leveraging large data sets including demographic, environmental, clinical and biomarker data has the potential to not only impact the diagnosis of patients, but also disease prediction, prognosis and treatment options. Front-Matter_2021_Precision-Medicine-and-Artificial-Intelligence Front Matter Copyright_2021_Precision-Medicine-and-Artificial-Intelligence Copyright Contributors_2021_Precision-Medicine-and-Artificial-Intelligence Contributors Preface_2021_Precision-Medicine-and-Artificial-Intelligence Preface Chapter-1---History--current-status--and-futur_2021_Precision-Medicine-and-A History, current status, and future directions of artificial intelligence Introduction: History of artificial intelligence Artificial intelligence success in games and competitions Ever expanding use of artificial intelligence Commercial aspects Setting and managing proper expectations Ethic and privacy consideration Enabling technologies Computing power Sensors Electronic health record systems Blockchain technologies Internet of things Frameworks and libraries Introduction of artificial intelligence in life science and healthcare Three-tiered application approach of artificial intelligence in healthcare Business intelligence in healthcare AI-based clinical decision support Artificial intelligence and insight into the data/focus on business decisions Medical areas Electronic health record TeleHealth and remote patient monitoring Radiology Pathology Infectious diseases Autoimmunity Future artificial intelligence development Competing interests References Chapter-2---Precision-medicine-as-an-appro_2021_Precision-Medicine-and-Artif Precision medicine as an approach to autoimmune diseases Introduction From individualized to precision medicine Trends that promote precision medicine Challenges for therapeutics, medical interventions and clinical trials Heterogeneity of autoimmune diseases Improved standard of care increases threshold for outcome measures Prevention of disease morbidity and mortality Modifiable and non-modifiable risk factors Prediction tools Education of populations at risk for autoimmune diseases Prevention of autoimmunity: Simple, safe and potentially beneficial approaches Clinical trials for the prevention of autoimmune diseases Mobile devices and web-based software applications and the future of medicine Symptom checker Wearable technologies Future of rheumatology? Importance of biomarkers Health economics Conclusion Competing interests References Chapter-3---Biomarker-and-data-science-as-in_2021_Precision-Medicine-and-Art Biomarker and data science as integral part of precision medicine Introduction Definitions of biomarkers Diagnostic biomarkers Disease monitoring biomarkers Pharmacodynamic/response biomarkers Risk markers/factors Predictive biomarkers Prognostic biomarkers Digital biomarkers Pre-analytical aspects of biomarkers Benefits and pitfalls of biomarkers Biomarker discovery Gene-expression profiling Mass-spectrometry-based proteomic profiling Peptidomics Biomarker family approach Secreted protein approach Protein arrays Epitope mapping as discovery strategy Different phases of biomarker discovery Platform switch Biomarker verification and validation Statistical approaches and big data Visualization and relevance assessment Multi-variate analysis/large datasets The statistical trap and correction methods Methods to measure and describe clinical performance characteristics Machine learning models From bench to bedside Conclusions References Chapter-4---Companion-and-complementary-diagn_2021_Precision-Medicine-and-Ar Companion and complementary diagnostics: A key to precision medicine Introduction Companion and complementary diagnostics Drug-diagnostic codevelopment Regulatory requirements US FDA The European Union and other countries Concluding remark References Chapter-5---Checkpoint-inhibitors--Interface-of-can_2021_Precision-Medicine- Checkpoint inhibitors: Interface of cancer and autoimmunity: Opportunity for second level precision medicine Introduction History of immune checkpoint inhibitors Mechanisms of immune checkpoint inhibitors PD-1 or PD-L1 inhibitors CTLA-4 inhibitors The interface between cancer and autoimmunity Immune-related adverse events Patients with pre-existing autoimmunity Opportunities for precision medicine Management of immune-related adverse events Autoantibodies and immune-related adverse events Conclusions Acknowledgments Competing interests References Chapter-6---The-evolving-potential-of-precision-m_2021_Precision-Medicine-an The evolving potential of precision medicine in the management of autoimmune liver disease Introduction History of autoimmune liver disease Spectrum of autoimmune liver disease Autoimmune hepatitis Primary biliary cholangitis Primary sclerosing cholangitis Overlap syndromes Laboratory biomarkers of autoimmune liver disease Serological markers for autoimmune hepatitis Serological markers of primary biliary cholangitis Serological markers of primary sclerosing cholangitis Challenges in differential diagnosis of autoimmune liver disease Development of precision medicine in autoimmune liver disease Conclusions Competing interests References Chapter-7---Precision-medicine-in-auto_2021_Precision-Medicine-and-Artificia Precision medicine in autoimmune disease Introduction Precision medicine in the diagnosis and prognosis of autoimmune disease Precision medicine and the identification of co-morbidities in autoimmune disease Precision medicine in the treatment of autoimmune diseases Precision medicine in the evaluation of outcomes in autoimmune disease Precision medicine and prediction and prevention of autoimmune disease Autoantibodies and other factors are highly predictive of future rheumatoid arthritis (and other autoimmune diseases) Identification of meaningful biologic targets for prevention “Personalized medicine”—What should (and will) a person do to treat a current autoimmune disease, or prevent a future a ... Conclusions Disclosures References Chapter-8---Development-of-multi-omics-appr_2021_Precision-Medicine-and-Arti Development of multi-omics approach in autoimmune diseases Introduction Translation of multi-omics into clinical application Types of omics technologies Epigenomics Transcriptomics Proteomics Metabolomics Immunogenomics Microbiomics Glycomics Other-omics fields Progress and success in autoimmunity Competing interests References Chapter-9---N-of-1-trials--Implications-for-cli_2021_Precision-Medicine-and- N-of-1 trials: Implications for clinical practice and personalized clinical trials Introduction Lessons learned from case reports and case series Complementary medicine approach Study designs Statistical considerations Ethics and insurance Regulatory aspects Conclusions References Chapter-10---Health-risk-assessment-and-famil_2021_Precision-Medicine-and-Ar Health risk assessment and family history: Toward disease prevention Background Genetic and environmental risk factors for autoimmune diseases Pathogenesis of autoimmune diseases Family history as a construct for prevention Assessing family history Scenarios for prevention based on family history Increased awareness and earlier diagnosis Relative and absolute risk Prevention strategies Primordial and primary prevention Cigarette smoking Low quality diet Excess weight Dental health management PRE-RA family study Pharmacologic prevention Drugs for primary prevention of RA Family history of RA and perception of pharmacologic interventions Drugs for secondary and tertiary prevention of RA Conclusions Financial support and sponsorship Conflict of interest References Chapter-11---Regulatory-aspects-of-artificial-intel_2021_Precision-Medicine- Regulatory aspects of artificial intelligence and machine learning-enabled software as medical devices (SaMD) Introduction The Food and Drug Administration (FDA)’s perspective Regulatory aspects on artificial intelligence (AI)-enabled clinical decision support software Inadequacy of traditional 510(k) process for clearing AI/ML-enabled SaMD De-novo pathway for AI/ML SaMD The Pre-Certification (Pre-Cert) Program Status of those proposed program Examples of FDA cleared products using AI in healthcare CE mark and in-vitro diagnostic regulation Software qualification and classification under medical device regulation (MDR) In-vitro diagnostic regulation (IVDR) National Medical Products Administration—China Data privacy considerations around AI/ML-enabled software Health Insurance Portability and Accountability Act European Union’s General Data Protection Regulation Challenges to the manufacturers when AI/ML SaMD evolve Summary References Chapter-12---Precision-medicine-from-the-patient-s_2021_Precision-Medicine-a Precision medicine from the patient's perspective: More opportunities and increasing responsibilities Introduction Challenges of autoimmunity Technology and telemedicine Direct to consumer information and marketing The role of the general practitioner/primary care Education and communication Patient consulting organizations References Index_2021_Precision-Medicine-and-Artificial-Intelligence Index A B C D E F G H I L M N O P Q R S T U V W X Precision Medicine and Artificial Intelligence: The Perfect Fit for Autoimmunity covers background on artificial intelligence (AI), its link to precision medicine (PM), and examples of AI in healthcare, especially autoimmunity. The book highlights future perspectives and potential directions as AI has gained significant attention during the past decade. Autoimmune diseases are complex and heterogeneous conditions, but exciting new developments and implementation tactics surrounding automated systems have enabled the generation of large datasets, making autoimmunity an ideal target for AI and precision medicine. More and more diagnostic products utilize AI, which is also starting to be supported by regulatory agencies such as the Food and Drug Administration (FDA). Knowledge generation by leveraging large datasets including demographic, environmental, clinical and biomarker data has the potential to not only impact the diagnosis of patients, but also disease prediction, prognosis and treatment options. Allows the readers to gain an overview on precision medicine for autoimmune diseases leveraging AI solutions Provides background, milestone and examples of precision medicine Outlines the paradigm shift towards precision medicine driven by value-based systems Discusses future applications of precision medicine research using AI Other aspects covered in the book include regulatory insights, data analytics and visualization, types of biomarkers as well as the role of the patient in precision medicine