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.
Author(s): Michael Mahler
Publisher: Academic Press
Year: 2021
Language: English
Pages: 300
City: London
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
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