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Fertility and Sterility Jun 2018There is a great deal of hype surrounding the concept of personalized medicine. Personalized medicine is rooted in the belief that since individuals possess nuanced and... (Review)
Review
There is a great deal of hype surrounding the concept of personalized medicine. Personalized medicine is rooted in the belief that since individuals possess nuanced and unique characteristics at the molecular, physiological, environmental exposure, and behavioral levels, they may need to have interventions provided to them for diseases they possess that are tailored to these nuanced and unique characteristics. This belief has been verified to some degree through the application of emerging technologies such as DNA sequencing, proteomics, imaging protocols, and wireless health monitoring devices, which have revealed great inter-individual variation in disease processes. In this review, we consider the motivation for personalized medicine, its historical precedents, the emerging technologies that are enabling it, some recent experiences including successes and setbacks, ways of vetting and deploying personalized medicines, and future directions, including potential ways of treating individuals with fertility and sterility issues. We also consider current limitations of personalized medicine. We ultimately argue that since aspects of personalized medicine are rooted in biological realities, personalized medicine practices in certain contexts are likely to be inevitable, especially as relevant assays and deployment strategies become more efficient and cost-effective.
Topics: Cost-Benefit Analysis; Humans; Motivation; Precision Medicine; Reproductive Techniques, Assisted; Research Design
PubMed: 29935653
DOI: 10.1016/j.fertnstert.2018.05.006 -
Preventive Medicine May 2020The structure of preventive medicine residency training in the U.S. warrants serious examination. U.S. public health and general preventive medicine residencies have...
The structure of preventive medicine residency training in the U.S. warrants serious examination. U.S. public health and general preventive medicine residencies have suffered a 17% decline in the number of residency programs since 2000, and current residency programs are, on average, half-empty. The required clinical year is not unique to preventive medicine, a basic, undifferentiated MPH for preventive medicine doesn't distinguish the preventive medicine specialist, and practicum year requirements are overly broad and not necessarily specific to the specialty, leaving the specialty vulnerable to equivalence by most other specialties. Strategies including creation of an additional preventive medicine-specific clinical year, developing a new public health degree for the specialty, and more specific practicum rotations, as well as potentially changing the specialty's name and altering the annual structure of training, are proposed along with an equivalence test.
Topics: Clinical Competence; Education, Medical, Graduate; Humans; Internship and Residency; Medicine; Physicians; Preventive Medicine; Public Health
PubMed: 32184116
DOI: 10.1016/j.ypmed.2020.106060 -
Genome Apr 2021Precision medicine is an emerging approach to clinical research and patient care that focuses on understanding and treating disease by integrating multi-modal or... (Review)
Review
Precision medicine is an emerging approach to clinical research and patient care that focuses on understanding and treating disease by integrating multi-modal or multi-omics data from an individual to make patient-tailored decisions. With the large and complex datasets generated using precision medicine diagnostic approaches, novel techniques to process and understand these complex data were needed. At the same time, computer science has progressed rapidly to develop techniques that enable the storage, processing, and analysis of these complex datasets, a feat that traditional statistics and early computing technologies could not accomplish. Machine learning, a branch of artificial intelligence, is a computer science methodology that aims to identify complex patterns in data that can be used to make predictions or classifications on new unseen data or for advanced exploratory data analysis. Machine learning analysis of precision medicine's multi-modal data allows for broad analysis of large datasets and ultimately a greater understanding of human health and disease. This review focuses on machine learning utilization for precision medicine's "big data", in the context of genetics, genomics, and beyond.
Topics: Artificial Intelligence; Genomics; Humans; Machine Learning; Precision Medicine
PubMed: 33091314
DOI: 10.1139/gen-2020-0131 -
Archives of Medical Research Jan 2021Human Mesenchymal Stem Cells (hMSCs) are multipotent stem cells capable of renewing themselves and differentiation in vitro into different kinds of tissues. In vivo...
INTRODUCTION
Human Mesenchymal Stem Cells (hMSCs) are multipotent stem cells capable of renewing themselves and differentiation in vitro into different kinds of tissues. In vivo hMSCs are sources of trophic factors modulating the immune system and inducing intrinsic stem cells to repair damaged tissues. Currently, there are multiple clinical trials (CT) using hMSCs for therapeutic purposes in a large number of clinical settings.
MATERIAL AND METHODS
The search strategy on clinicaltrials.gov has focused on the key term "Mesenchymal Stem Cells", and the inclusion and exclusion criteria were separated into two stages. Stage 1, CT on phases 1-4: location, the field of application, phase, and status. For stage 2, CT that have published outcome results: field of application, treatment, intervention model, source, preparation methods, and results.
RESULTS
By July 2020, there were a total of 1,138 registered CT. Most studies belong to either phase 2 (61.0%) or phase 1 (30.8%); most of them focused in the fields of traumatology, neurology, cardiology, and immunology. Only 18 clinical trials had published results: the most common source of isolation was bone marrow; the treatment varied from 1-200 M hMSCs; all of them have similar preparation methods; all of them have positive results with no serious adverse effects.
CONCLUSIONS
There appears to be a broad potential for the clinical use of hMSCs with no reported serious adverse events. There are many trials in progress, their future results will help to explore the therapeutic potential of these promising cellular sources of medicinal signals.
Topics: Cell Differentiation; Clinical Trials as Topic; Humans; Medicine; Mesenchymal Stem Cell Transplantation; Mesenchymal Stem Cells; Regenerative Medicine
PubMed: 32977984
DOI: 10.1016/j.arcmed.2020.08.006 -
Clinical Pharmacology and Therapeutics Jan 2023Real-world data/evidence (RWD/RWE) may provide insightful information on medicines' clinical effects to guide regulatory decisions. While its contribution has been...
Real-world data/evidence (RWD/RWE) may provide insightful information on medicines' clinical effects to guide regulatory decisions. While its contribution has been recognized for safety monitoring and disease epidemiology across medicines' life cycles, using RWD/RWE to demonstrate efficacy requires further evaluation. This study aimed to (i) characterize RWD/RWE presented by applicants to support claims on medicines' efficacy within initial marketing authorization applications (MAAs) and extension of indication applications (EoIs), and (ii) analyze the contribution of RWD/RWE to regulatory decisions on medicines' benefit-risk profile. RWD/RWE was included to support efficacy in 32 MAAs and 14 EoIs submitted 2018-2019. Of these, RWD/RWE was part of the preauthorization package of 16 MAAs and 10 EoIs, and was (i) considered supporting the regulatory decision in 10 applications (five MAAs, five EoIs), (ii) considered not supporting the regulatory decision in 11 (seven MAAs, four EoIs), and (iii) not addressed at all in the evaluation of 5 applications (four MAAs, one EoI). Common limitations of submitted RWD/RWE included missing data, lack of representativeness of populations, small sample size, absence of an adequate or prespecified analysis plan, and risk of several types of bias. The suitability of RWD/RWE in a given application still requires a case-by-case analysis considering its purpose of use, implying reflection on the data source, together with its assets and limitations, study objectives and designs, and the overall data package issued. Early interactions and continuous dialogues with regulators and relevant stakeholders is key to optimize fit-for-purpose RWE generation, enabling its broader use in medicines development.
Topics: Humans; Decision Making; Europe; Government Regulation; Medicine
PubMed: 36254408
DOI: 10.1002/cpt.2766 -
Journal International de Bioethique Et... 2023Cell therapy is becoming established in many fields, including oncology with CAR-Ts or in regenerative medicine for cardiovascular diseases, diabetes or musculoskeletal...
Cell therapy is becoming established in many fields, including oncology with CAR-Ts or in regenerative medicine for cardiovascular diseases, diabetes or musculoskeletal disorders with mesenchymal stromal cells. These therapeutic cells are called advanced therapy medicinal products (ATMPs) and include all processes including cells manipulated to obtain reprogramming (iPS), to induce gene expression or by genome editing to modify the expression of a gene. The development of new biomaterial supports that can be 3D printed and take the desired shape of the target tissue before being colonised by the cellular elements necessary for their biological functions and replace the failing organ. All of these new technologies are driving innovation and the development of tomorrow’s bio-medicines. These new biotherapies will profoundly modify patient care in all areas, changing medical practices but with a considerable societal impact. Thus, the development and clinical research on cellular biotherapies are essential health issues but with a major ethical, societal and economic impact.
Topics: Humans; Cell- and Tissue-Based Therapy; Regenerative Medicine; Biotechnology; Medical Oncology
PubMed: 37684204
DOI: 10.3917/jibes.342.0165 -
Acta Medica Iranica Mar 2017Personalized medicine as a novel field of medicine refers to the prescription of specific therapeutics procedure for an individual. This approach has established based... (Review)
Review
Personalized medicine as a novel field of medicine refers to the prescription of specific therapeutics procedure for an individual. This approach has established based on pharmacogenetic and pharmacogenomic information and data. The terms precision and personalized medicines are sometimes applied interchangeably. However, there has been a shift from "personalized medicine" towards "precision medicine". Although personalized medicine emerged from pharmacogenetics, nowadays it covers many fields of healthcare. Accordingly, regenerative medicine and cellular therapy as the new fields of medicine use cell-based products in order to develop personalized treatments. Different sources of stem cells including mesenchymal stem cells, embryonic stem cells and induced pluripotent stem cells (iPSCs) have been considered in targeted therapies which could give many advantages. iPSCs as the novel and individual pluripotent stem cells have been introduced as the appropriate candidates for personalized cell therapies. Cellular therapies can provide a personalized approach. Because of person-to-person and population differences in the result of stem cell therapy, individualized cellular therapy must be adjusted according to the patient specific profile, in order to achieve best therapeutic results and outcomes. Several factors should be considered to achieve personalized stem cells therapy such as, recipient factors, donor factors, and the overall body environment in which the stem cells could be active and functional. In addition to these factors, the source of stem cells must be carefully chosen based on functional and physical criteria that lead to optimal outcomes.
Topics: Cell- and Tissue-Based Therapy; Embryonic Stem Cells; Humans; Induced Pluripotent Stem Cells; Mesenchymal Stem Cells; Precision Medicine; Regenerative Medicine; Stem Cell Transplantation
PubMed: 28282715
DOI: No ID Found -
International Journal of Molecular... Jul 2022In recent decades, tremendous progress has been made in the medicinal field in understanding the molecular mechanisms underlying human pathologies, due to the...
In recent decades, tremendous progress has been made in the medicinal field in understanding the molecular mechanisms underlying human pathologies, due to the significant development of advanced laboratory techniques and technologies [...].
Topics: Gastroenterology; Gastrointestinal Tract; Humans; Precision Medicine; Protein Processing, Post-Translational; Proteomics
PubMed: 35897777
DOI: 10.3390/ijms23158201 -
International Journal of Molecular... Aug 2023Our understanding of the molecular mechanisms underlying cancer development and evolution have evolved rapidly over recent years, and the variation from one patient to... (Review)
Review
Our understanding of the molecular mechanisms underlying cancer development and evolution have evolved rapidly over recent years, and the variation from one patient to another is now widely recognized. Consequently, one-size-fits-all approaches to the treatment of cancer have been superseded by precision medicines that target specific disease characteristics, promising maximum clinical efficacy, minimal safety concerns, and reduced economic burden. While precision oncology has been very successful in the treatment of some tumors with specific characteristics, a large number of patients do not yet have access to precision medicines for their disease. The success of next-generation precision oncology depends on the discovery of new actionable disease characteristics, rapid, accurate, and comprehensive diagnosis of complex phenotypes within each patient, novel clinical trial designs with improved response rates, and worldwide access to novel targeted anticancer therapies for all patients. This review outlines some of the current technological trends, and highlights some of the complex multidisciplinary efforts that are underway to ensure that many more patients with cancer will be able to benefit from precision oncology in the near future.
Topics: Humans; Neoplasms; Precision Medicine; Medical Oncology; Interdisciplinary Studies; Phenotype
PubMed: 37628794
DOI: 10.3390/ijms241612613 -
Lakartidningen Sep 2022Healthcare professionals play a central role in health promotion and supporting patients to healthy lifestyles. The handbook FYSS (Physical Activity in the Prevention...
Healthcare professionals play a central role in health promotion and supporting patients to healthy lifestyles. The handbook FYSS (Physical Activity in the Prevention and Treatment of Disease), produced by Swedish Professional Associations for Physical Activity (YFA), can facilitate this work by providing evidence-based recommendations on how to prevent and treat common diseases and conditions using physical activity in a systematic way. This thematic issue presents a sample of the chapters included in the new FYSS 2021.
Topics: Exercise; Health Personnel; Health Promotion; Healthy Lifestyle; Humans; Precision Medicine
PubMed: 36106735
DOI: No ID Found