From Hype to Reality: Data Science Enabling Personalized Medicine
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Integrative Analysis of Exogenous, Endogenous, Tumour and Immune
Gut Online First, published on February 6, 2018 as 10.1136/gutjnl-2017-315537 Recent advances in basic science Integrative analysis of exogenous, endogenous, Gut: first published as 10.1136/gutjnl-2017-315537 on 6 February 2018. Downloaded from tumour and immune factors for precision medicine Shuji Ogino,1,2,3,4 Jonathan A Nowak,1 Tsuyoshi Hamada,2 Amanda I Phipps,5,6 Ulrike Peters,5,6 Danny A Milner Jr,7 Edward L Giovannucci,3,8,9 Reiko Nishihara,1,3,4,8,10 Marios Giannakis,4,11,12 Wendy S Garrett,4,11,13 Mingyang Song8,14,15 For numbered affiliations see ABSTRACT including inflammatory and immune cells. A fraction end of article. Immunotherapy strategies targeting immune checkpoints of somatic mutations may result in the generation of such as the CTLA4 and CD274 (programmed cell death new antigens (neoantigens) that can be recognised as Correspondence to 1 ligand 1, PD-L1)/PDCD1 (programmed cell death 1, non-self by the immune system. During an individu- Dr Shuji Ogino, Program in MPE Molecular Pathological PD-1) T-cell coreceptor pathways are revolutionising al's life-course, cells may acquire somatic molecular Epidemiology, Brigham and oncology. The approval of pembrolizumab use for alterations, and some of these cells undergo clonal Women’s Hospital, Boston, MA solid tumours with high-level microsatellite instability expansion, displaying hallmarks of early neoplasia. 02215, USA; shuji_ ogino@ dfci. or mismatch repair deficiency by the US Food and Many of these cells are likely kept in check or killed harvard. edu Drug Administration highlights promise of precision by the host immune system before they can develop Received 24 October 2017 immuno-oncology. -
Preparing Pathology for Personalized Medicine: Possibilities for Improvement of the Pre-Analytical Phase
Preparing pathology for personalized medicine: possibilities for improvement of the pre-analytical phase. Patricia Jta Groenen, Willeke A Blokx, Coos Diepenbroek, Lambert Burgers, Franco Visinoni, Pieter Wesseling, Han van Krieken To cite this version: Patricia Jta Groenen, Willeke A Blokx, Coos Diepenbroek, Lambert Burgers, Franco Visinoni, et al.. Preparing pathology for personalized medicine: possibilities for improvement of the pre-analytical phase.. Histopathology, Wiley, 2011, 59 (1), pp.1. 10.1111/j.1365-2559.2010.03711.x. hal-00630795 HAL Id: hal-00630795 https://hal.archives-ouvertes.fr/hal-00630795 Submitted on 11 Oct 2011 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. Histopathology Preparing pathology for personalized medicine: possibilities for improvement of the pre-analytical phase. For Peer Review Journal: Histopathology Manuscript ID: HISTOP-08-10-0429 Wiley - Manuscript type: Review Date Submitted by the 06-Aug-2010 Author: Complete List of Authors: Groenen, Patricia; Radboud University Nijmegen Medical Centre, Pathology Blokx, -
Personalized Medicine: Definitions, History, and Implications for the OT Profession
The Open Journal of Occupational Therapy Volume 3 Issue 4 Fall 2015 Article 1 October 2015 Personalized medicine: Definitions, history, and implications for the OT profession Diane Powers Dirette Western Michigan University - USA, [email protected] Follow this and additional works at: https://scholarworks.wmich.edu/ojot Part of the Occupational Therapy Commons Recommended Citation Dirette, D. P. (2015) "Personalized medicine: Definitions, history, and implications for the OT profession," The Open Journal of Occupational Therapy: Vol. 3: Iss. 4, Article 1. Available at: https://doi.org/10.15453/ 2168-6408.1213 This document has been accepted for inclusion in The Open Journal of Occupational Therapy by the editors. Free, open access is provided by ScholarWorks at WMU. For more information, please contact wmu- [email protected]. Personalized medicine: Definitions, history, and implications for the OT profession Keywords individualized medicine, personalized medicine, precision medicine, stratified medicine, paradigm shifts Credentials Display Diane Powers Dirette, Ph.D., OTL Copyright transfer agreements are not obtained by The Open Journal of Occupational Therapy (OJOT). Reprint permission for this Letter from the Editor should be obtained from the corresponding author(s). Click here to view our open access statement regarding user rights and distribution of this Letter from the Editor. DOI: 10.15453/2168-6408.1213 This letter from the editor is available in The Open Journal of Occupational Therapy: https://scholarworks.wmich.edu/ ojot/vol3/iss4/1 Dirette: Personalized medicine in OT That dreaded phone call comes from your treatment of leukemia, cystic fibrosis, liver cancer physician in the middle of the day informing you of (Kaiser, 2015), lung cancer (Eisenstein, 2014), the results of your biopsy that was ordered amyotrophic lateral sclerosis (Cashman & Ospri, following an abnormal mammogram. -
Personalized Medicine: the Impact of Molecular Testing on Patient Care
Personalized Medicine: The Impact of Molecular Testing on Patient Care Mini-Elective Spring 2020 University Course Dates: January 17, 24, 31, February 7, 14 Fridays, 2:30-4:30 PM of Pittsburgh Maximum Students: 5 School of Class Year: MS1 and MS2 Medicine Course Directors: Simion Chiosea, MD Professor of Pathology Somak Roy, MD Assistant Professor of Pathology Contact Information: Lynn Wolkenstein 412-647-7065 [email protected] Jessica Tebbets 412-802-6797 [email protected] Registration: Betsy Nero, Office of Medical Education [email protected] Description: Personalized medicine applies knowledge of molecular data for early disease detection, targeted treatment, and detection of person’s predisposition to a particular disease. It improves diagnosis and treatment of a disease and advances effectiveness of healthcare. This mini-elective is based in the Department of Pathology and will introduce students to principles and current applications of personalized medicine. During mini-elective students will be able to observe and discuss the principles of molecular testing, become familiar with the clinical interpretation of molecular results in all areas of medicine, including oncology, neuro-oncology, endocrinology, and gastroenterology. The training will be conducted in the clinical Molecular and Genomic Pathology (MGP) laboratory, Department of Pathology, University of Pittsburgh. MGP laboratory is one of the largest laboratories in the US focused on molecular diagnostics of solid tumors. It processes over 22,000 samples each year using high-throughput technologies, such as Next Generation Sequencing (NGS) and a variety of the conventional molecular biology techniques. It performs molecular testing for all hospitals of the UPMC system and serves as reference laboratory for other medical centers across the United States. -
Assessment of Pharmacist's Knowledge and Perception Toward
pharmacy Article Assessment of Pharmacist’s Knowledge and Perception toward 3D Printing Technology as a Dispensing Method for Personalized Medicine and the Readiness for Implementation Mohammed S. Algahtani Department of Pharmaceutics, College of Pharmacy, Najran University, Najran 1988, Saudi Arabia; [email protected]; Tel.: +966-17-458-7200 Abstract: The main user of three dimensional (3D) printing for drug dispensing will be the hospital pharmacist. Yet despite the tremendous amount of research and industrial initiatives, there is no evaluation of the pharmacist’s knowledge and opinion of this technology. The present study aimed to assess knowledge and attitude among pharmacists about 3D printing technology as an innovative dispensing method for personalized medicine and the barriers to implementation in Saudi Arabia. We found that 53% of participants were aware of 3D printing technology in general, but only 14–16% of pharmacists were aware of the specific application of 3D printing in drug dispensing. Participants showed a positive perception regarding the concept of personalized medicine and that 3D printing could provide a promising solution to formulate and dispense personalized medicine in the pharmacy. It was also found that 67% of pharmacists were encouraged to adopt this new technology for drug dispensing, reflecting their willingness to learn new innovations. However, the technology cost, regulation, and the shortage of practicing pharmacists were also reported as the top barriers for Citation: Algahtani, M.S. Assessment of Pharmacist’s implementation. Facilitating the implementation of this technology in the pharmacy practice will Knowledge and Perception toward require a strategic plan in which pharmacists collaborate with regulatory bodies and 3D printing 3D Printing Technology as a engineers to overcome challenges and barriers to implement such promising technology. -
The Future of Precision Medicine : Potential Impacts for Health Technology Assessment
This is a repository copy of The Future of Precision Medicine : Potential Impacts for Health Technology Assessment. White Rose Research Online URL for this paper: https://eprints.whiterose.ac.uk/133069/ Version: Accepted Version Article: Love-Koh, James orcid.org/0000-0001-9009-5346, Peel, Alison, Rejon-Parilla, Juan Carlos et al. (6 more authors) (2018) The Future of Precision Medicine : Potential Impacts for Health Technology Assessment. Pharmacoeconomics. pp. 1439-1451. ISSN 1179-2027 https://doi.org/10.1007/s40273-018-0686-6 Reuse This article is distributed under the terms of the Creative Commons Attribution-NonCommercial (CC BY-NC) licence. This licence allows you to remix, tweak, and build upon this work non-commercially, and any new works must also acknowledge the authors and be non-commercial. You don’t have to license any derivative works on the same terms. More information and the full terms of the licence here: https://creativecommons.org/licenses/ Takedown If you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing [email protected] including the URL of the record and the reason for the withdrawal request. [email protected] https://eprints.whiterose.ac.uk/ The Future of Precision Medicine: Potential Impacts for Health Technology Assessment Title: The Future of Precision Medicine: Potential Impacts for Health Technology Assessment Authors: James Love-Koh1,2, Alison Peel1, Juan Carlos Rejon-Parilla3, Kate Ennis1,4, Rosemary Lovett3, Andrea Manca2,5, Anastasia Chalkidou6, Hannah Wood1, Matthew Taylor1 1 YorK Health Economics Consortium 2 Centre for Health Economics, University of YorK 3 National Institute for Health and Care Excellence 4 Institute of Infection and Global Health, University of Liverpool 5 Luxembourg Institute of Health 6 Kings Technology Evaluation Centre Corresponding Author Details: Name: James Love-Koh Address: Centre for Health Economics, Alcuin A Block, University of York, Heslington, York, YO10 5DD, UK. -
Paving the Way for Personalized Medicine
OCTOBER 2013 Paving the Way for Personalized Medicine FDA’s Role in a New Era of Medical Product Development U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S. FOOD AND DRUG ADMINISTRATION Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development COMMISSIONER’S MESSAGE 2 I. INTRODUCTION 3 II. PERSONALIZED MEDICINE FROM A REGULATORY PERSPECTIVE 5 1. DEFINING PERSONALIZED MEDICINE 5 2. FDA’S UNIQUE ROLE AND RESPONSIBILITIES IN PERSONALIZED MEDICINE 11 III. DRIVING TOWARD AND RESPONDING TO SCIENTIFIC ADVANCES 14 1. BUILDING THE INFRASTRUCTURE TO SUPPORT PERSONALIZED MEDICINE 16 2. RECENT ORGANIZATIONAL EFFORTS 20 IV. DEFINING AND CLARIFYING REGULATORY PATHWAYS AND POLICIES 23 1. ENSURING THE AVAILABILITY OF SAFE AND EFFECTIVE DIAGNOSTICS 29 2. PRODUCT INTERDEPENDENCY 32 3. PRODUCT LABELING 36 4. POST-MARKET SURVEILLANCE 40 V. ADVANCING REGULATORY SCIENCE IN SUPPORT OF PERSONALIZED MEDICINE 42 1. DEVELOPING REGULATORY STANDARDS, RESEARCH METHODS, AND TOOLS 42 2. CONDUCTING AND COLLABORATING IN RESEARCH 47 VI. A NEW ERA OF MEDICAL PRODUCT DEVELOPMENT: OPPORTUNITIES AND CHALLENGES AHEAD 54 GLOSSARY OF TERMS 58 ENDNOTES 60 ver the past few years, a number of products that signal a new era of medical product development have entered the market or come on the horizon. In just the last two years, the FDA approved four cancer drugs for use in patients whose tumors have specific genetic characteristics that Oare identified by a companion diagnostic test. Last year, FDA approved a new therapy for use in certain cystic fibrosis patients with a specific genetic mutation. Earlier this year, three-dimensional (3D) printing was used to create a bioresorbable tracheal splint for treating a critically-ill infant. -
Introduction to Genomic Medicine
Introduction to Genomic Medicine What is genomic medicine? There are more than 7 billion people on our planet, each a massive collection of about 100 trillion cells. How do these cells know what to do? What tells them to work together to keep your brain thinking, heart pumping, and hair growing? The answer lies in a long, winding molecule called deoxyribonucleic acid, or DNA. DNA could be referred to as an instruction manual on how cells work as it contains genes that carry instructions needed to build and maintain the many different types of cells that make us unique. Researchers call this complete set of DNA instructions a “genome.” Our health is determined by our inherited or acquired genetic differences combined with our lifestyles and other environmental factors. Although greater than 99.9% of a DNA sequence is identical from person to person, the last 0.1% helps to explain these differences. Different people may have small variations in specific genes, and some people may have genes that others do not. These may increase susceptibility to a specific disease or provide protection from that illness. By combining and analysing information about our genome, with clinical and diagnostic information and then comparing that with data from others, patterns can be identified. Together this information can help to determine our individual risk of developing disease, detect illness earlier, provide accurate diagnosis, support disease monitoring and determine the most effective interventions to help improve our health, either by the use of medication or lifestyle choices. Genomic medicine describes these efforts. Genomic medicine sometimes also known as personalized medicine is a move away from a ‘one size fits all’ approach to the treatment and care of patients with a particular condition, to one which uses new approaches to better manage patients’ health and target therapies to achieve the best outcomes in the management of a patient’s disease or predisposition to disease. -
Definition of Personalized Medicine and Targeted Therapies
Journal of Personalized Medicine Article Definition of Personalized Medicine and Targeted Therapies: Does Medical Familiarity Matter? Valentyn Fournier 1,* , Thomas Prebet 2, Alexandra Dormal 2, Maïté Brunel 1, Robin Cremer 3 and Loris Schiaratura 1 1 University of Lille, ULR 4072—PSITEC—Psychologie: Interactions, Temps, Emotions, Cognition, F-59000 Lille, France; [email protected] (M.B.); [email protected] (L.S.) 2 Yale Cancer Center, Yale University, 333 Cedar Street, New Haven, CT 06520, USA; [email protected] (T.P.); [email protected] (A.D.) 3 Espace éthique régional des Hauts-de-France, Centre Hospitalier Universitaire de Lille, F-59037 Lille, France; [email protected] * Correspondence: [email protected] Abstract: Personalized medicine (PM) is increasingly becoming a topic of discussion in public health policies and media. However, there is no consensus among definitions of PM in the scientific literature and the terms used to designate it, with some definitions emphasizing patient-centered aspects and others emphasizing biomedical aspects. Furthermore, terms used to refer to PM (e.g., “pharmacogenomics” or, more often, “targeted therapies”) are diverse and differently used. To our knowledge, no study has apprehended the differences of definition and attitudes toward personalized medicine and targeted therapies according to level of familiarity with the medical field. Our cohort included 349 French students from three different academic fields, which modulated their familiarity level with the medical field. They were asked to associate words either to “personalized medicine” or “target therapies”. Then, they were asked to give an emotional valence to their associations. -
What Are Precision Medicine and Personalized Medicine?
What Are Precision Medicine and Personalized Medicine? Precision medicine, also known as personalized medicine, is a new frontier for healthcare combining genomics, big data analytics, and population health. Source: Thinkstock Since the beginning of recorded history, healthcare practitioners have striven to make their actions more effective for their patients by experimenting with different treatments, observing and sharing their results, and improving upon the efforts of previous generations. Becoming more accurate, precise, proactive, and impactful for each individual that comes under their care has always been the goal of all clinicians, no matter how basic the tools at their disposal. But now, modern physicians and scientists are now able to take this mission far, far beyond the reach of their ancestors with the help of electronic health records, genetic testing, big data analytics, and supercomputing – all the ingredients required to engage in what is quickly becoming truly precise and personalized medicine. Precision medicine, also commonly referred to as personalized medicine, is one of the most promising approaches to tackling diseases that have thus far eluded effective treatments or cures. Cancer, neurodegenerative diseases, and rare genetic conditions take an enormous toll on individuals, families and societies as a whole. Approximately 1.7 million new cancer cases were diagnosed in the United States in 2017. Around 600,000 deaths were expected during that year, according to the American Cancer Society. The Agency for Healthcare Research and Quality adds that the direct economic impact of cancer is around $80 billion per year – loss of productivity, wages, and caregiver needs sap billions more from the economy. -
Advancing Standards for Precision Medicine
Advancing Standards for Precision Medicine FINAL REPORT Prepared by: Audacious Inquiry on behalf of the Office of the National Coordinator for Health Information Technology under Contract No. HHSM-500-2017-000101 Task Order No. HHSP23320100013U January 2021 ONC Advancing Standards for Precision Medicine Table of Contents Executive Summary ...................................................................................................................................... 5 Standards Development and Demonstration Projects ............................................................................ 5 Mobile Health, Sensors, and Wearables ........................................................................................... 5 Social Determinants of Health (SDOH) ............................................................................................. 5 Findings and Lessons Learned .......................................................................................................... 6 Recommendations ........................................................................................................................................ 6 Introduction ................................................................................................................................................... 7 Background ................................................................................................................................................... 7 Project Purpose, Goals, and Objectives .................................................................................................. -
Molecular Pathological Epidemiology Gives Clues to Paradoxical Findings
Molecular Pathological Epidemiology Gives Clues to Paradoxical Findings The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters Citation Nishihara, Reiko, Tyler J. VanderWeele, Kenji Shibuya, Murray A. Mittleman, Molin Wang, Alison E. Field, Edward Giovannucci, Paul Lochhead, and Shuji Ogino. 2015. “Molecular Pathological Epidemiology Gives Clues to Paradoxical Findings.” European Journal of Epidemiology 30 (10): 1129–35. https://doi.org/10.1007/ s10654-015-0088-4. Citable link http://nrs.harvard.edu/urn-3:HUL.InstRepos:41392032 Terms of Use This article was downloaded from Harvard University’s DASH repository, and is made available under the terms and conditions applicable to Open Access Policy Articles, as set forth at http:// nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of- use#OAP HHS Public Access Author manuscript Author Manuscript Author ManuscriptEur J Epidemiol Author Manuscript. Author Author Manuscript manuscript; available in PMC 2016 October 07. Published in final edited form as: Eur J Epidemiol. 2015 October ; 30(10): 1129–1135. doi:10.1007/s10654-015-0088-4. Molecular Pathological Epidemiology Gives Clues to Paradoxical Findings Reiko Nishiharaa,b,c, Tyler J. VanderWeeled,e, Kenji Shibuyac, Murray A. Mittlemand,f, Molin Wangd,e,g, Alison E. Fieldd,g,h,i, Edward Giovannuccia,d,g, Paul Lochheadi,j, and Shuji Oginob,d,k aDepartment of Nutrition, Harvard T.H. Chan School of Public Health, 655 Huntington Ave., Boston, Massachusetts 02115 USA bDepartment of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, 450 Brookline Ave., Boston, Massachusetts 02215 USA cDepartment of Global Health Policy, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan dDepartment of Epidemiology, Harvard T.H.