Terminology for personalized medicine

Similar documents
Reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug development

PAREXEL GENOMIC MEDICINE SERVICES. Applying genomics to enhance your drug development journey

Centre for Personalised Medicine in Tübingen - developing tailor-made treatments for patients

ICH Topic E16 Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions. Step 3

Personalised Healthcare Solutions (PHCS) Excellence for your Biomarker-driven Strategies

Roche, Roche Molecular Diagnostics and more

ICH Topic E15 Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories.

Personalized. Health in Canada

Genomics And Pharmacogenomics In Anticancer Drug Development And Clinical Response (Cancer Drug Discovery And Development)

Personalized Medicine

GUIDANCE ON THE EVALUATION OF NON ACCREDITED QUALIFICATIONS

NHS ENGLAND BOARD PAPER

Reimbursement Strategy for Companion Diagnostics:

Integrating Genomics in Family Medicine

Introduction to Pharmacogenetics Competency

Comments from the FDA Working Group on SUBGROUP ANALYSES. Estelle Russek-Cohen, Ph.D. U.S. Food and Drug Administration Center for Biologics

Maximizing opportunities towards achieving clinical success D R U G D I S C O V E R Y. Report Price Publication date

Genomic Medicine in France

Overview of Health Informatics. ITI BMI-Dept

SSPPS STRATEGIC PLAN. Pharmacy Education, Pharmaceutical Sciences Research, Clinical Pharmacy Practice. April 30, Overview

FINAL DOCUMENT. Global Harmonization Task Force. Title: Clinical Evidence for IVD medical devices Key Definitions and Concepts

BIOCRATES Life Sciences AG Short Company Presentation

E2ES to Accelerate Next-Generation Genome Analysis in Clinical Research

The Five Key Elements of a Successful Metabolomics Study

Introduction to Bioinformatics

Farmacogenomics: meerwaarde en plaats in de Klinische Biologie

MOSAIQUES DIAGNOSTICS

Cytomics in Action: Cytokine Network Cytometry

Leveraging an Academic-Industry Partnership for Commercial Success

Developing an Accurate and Precise Companion Diagnostic Assay for Targeted Therapies in DLBCL

Background Paper 7.4 Pharmacogenetics and Stratified Medicine

Pharmacogenomics and Health Policy

WELCOME RECEPTION. Metabolomics applied to novel cardiometabolic disease mechanisms and therapeutic targets Christopher B. Newgard, Houston, USA

The Integrated Biomedical Sciences Graduate Program

Learning Objectives. Introduction

Presentation to the Committee on Accelerating Rare Disease Research and Orphan Product Development

Controversy In Pharmacogenomics

Molecular Pathology: The Molecular Basis of Human Disease William B. Coleman, Gregory J. Tsongalis

Gene expression connectivity mapping and its application to Cat-App

PHYSICIAN RESOURCES MAPPED TO GENOMICS COMPETENCIES AND GAPS IDENTIFIED WITH CURRENT EDUCATIONAL RESOURCES AVAILABLE 06/04/14

CRO partner in Rx/CDx Co-Development

Neue Technologien für die patientennahe personalisierte Diagnostik

REIMAGINING DRUG DEVELOPMENT:

Research Strategy Delivering internationally excellent research for a healthy, safe and sustainable society

Goals of pharmacogenomics

Integrating Pharmacogenomics into Decision Making

Towards unbiased biomarker discovery

The 100,000 Genomes Project Genomics Collaboration Event Finnish Residence

Life SCIENCE GR ADUATE SCHOOL OF

TECHNOLOGIES & SERVICES FOR THERAPEUTIC ANTIBODY DEVELOPMENT

SESSION I DESIGNING FOR IMPLEMENTATION

2017 Precision Medicine Study

Exam MOL3007 Functional Genomics

Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development A Workshop

Shivom, the global Genomics-Blockchain Ecosystem The Next Era of Genomics and Healthcare

Future of Molecular Diagnostics: Innovative Technologies Driving Market Opportunities

Pharmacogenomics in Pain Management

IRDiRC: International Rare Diseases Research Consortium

FDA Perspectives on Biomarkers. Steven Kozlowski, M.D. Office of Biotechnology Products OPS/CDER/FDA

Multiple Myeloma Research Foundation 2014 Research Fellow Award Program Guidelines

BACKGROUNDER. Results of Genomics Technology Platforms 2016 Competition for Operations Support and Technology Development Funds

China National Grid --- BioNode. Jun Wang Beijing Genomics Institute

TRANSFORMING GLOBAL GENETIC DATA INTO MEDICAL DECISIONS

TOTAL CANCER CARE: CREATING PARTNERSHIPS TO ADDRESS PATIENT NEEDS

University of Bristol - Explore Bristol Research. Peer reviewed version. Link to published version (if available): /

Bridging the Genomics-Health IT Gap for Precision Medicine

State of the Art in Data Management for Precision Medicine & Genomics. March 8, pm 3 pm ET

Proteomics And Cancer Biomarker Discovery. Dr. Zahid Khan Institute of chemical Sciences (ICS) University of Peshawar. Overview. Cancer.

Response, quality and variation: what drug development may be missing

Konica Minolta to Acquire Invicro (US)

Biomarkers: Physiological & Laboratory Markers of Drug Effect

March 18 th, Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852

The MRC Framework for the Development, Design and Analysis of Stratified Medicine Research

First Annual Biomarker Symposium Quest Diagnostics Clinical Trials

Opportunities for industry/smes in EU-funded health research

Comments on Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants

Use of Big Data to Support Regulatory Decision Making

PLTW Biomedical Science Medical Interventions Course Outline

Integrated Radiology & Pathology Diagnostic Services: The Time is Now at UCLA

Molecular Diagnostics. Castle Medical LLC.

THE PATH TO PRECISION MEDICINE IN MULTIPLE MYELOMA. themmrf.org

GENOMICS WORLD MARKETS (SAMPLE COPY, NOT FOR RESALE)

The In Vitro Diagnostic CRO

APPLICATIONS OF GENETICS, GENOMICS AND BIOINFORMATICS IN DRUG DISCOVERY

A Framework for Decision Making for Tests in the Scottish Molecular Pathology service. Date of issue: April 2015

MICROARRAYS+SEQUENCING

MARCH 15-16, 2018 PARIS PALAIS BRONGNIART. An event of PROGRAM

Perspectives in Clinical Research

Implementing an e-validation Solution at Myriad Genetics

Ninth Annual Metabolic Biomarkers Second Annual Biomarker Data Analysis

BSc BIOMEDICAL SCIENCE

Examples of founding and evolving leading LifeScience companies. November 2016

Genomics for Precision Medicine Strategy

GENE EXPRESSION REAGENTS MARKETS (SAMPLE COPY, NOT FOR RESALE)

PERSONALISED MEDICINE FOR THE BENEFIT OF PATIENTS

Transcription:

Terminology for personalized medicine Sarah Ali-Khan 1 PhD, Stephanie Kowal 2, Westerly Luth 2, Richard Gold 1 SJD, and Tania Bubela 2 PhD JD 1. Centre for Intellectual Property Policy (CIPP), Faculty of Law, McGill University 2. School of Public Health, University of Alberta Contents 1. Keywords and synonyms for personalized medicine (p.3) 2. Keywords and synonyms for personal genomics (p.6) 3. Keywords and synonyms for diagnostics, biomarkers and testing (p.7) Introduction Below we list keywords and synonyms for personalized medicine (PM) identified through systematic searches of academic, policy, popular news media and websites of regulatory agencies, funders, and national health and biomedical organizations in Australia, Canada, the European Union, the United Kingdom and the United States. The details of our search approaches are described in detail in the document: Terminology for PM: a systematic collection, available: http://paceomics.org/index.php/outputs/tools-and-resources/ We also list terms for personal genomics and associated diagnostics and testing terms found in our search, though identifying these was not the primary goal of this work. These searches were carried out from June to September 2013. Note that we recorded the terminology listed below as it appeared in the sources we did not add plurals and other variations of the keywords. We anticipate that researchers who may use these vocabulary lists including PACEOMICS teams and others will incorporate such variations during the development of customized search strings (e.g. target/targets/targeted, profiles/profile/profiling; personalized/ personalization/personalizing/personalised etc.). PACEOMICS 1

These lists are also available as excel sheets with sources/references listed for each keyword. See also PACEOMICS policy brief #10: Changing terminology for Personalized Medicine. Available: PACEOMICS 2

Keywords and synonyms for personalized medicine biologically personalized therapeutics (BPTs) biomarker guided treatment clinical proteomics co-dependent technologies customized drug products customized treatment drug-diagnostic pairings drug target pharmacogenomics genetic medicine genetically-guided therapy genomic analysis genomic medicine genomics-enabled medicine genomics-guided medicine genotype-guided therapy hybrid technology individualised medicine individualized dosing Individualized drug testing individualized drug therapy individualized genotyping individualized medications Individualized medicine individualized medicines individualized pharmacotherapy individualized targeted therapy individualized therapy individualized therapies individualized treatment integrated diagnostics and therapeutics integrated personal omics testing (ipop) molecular medicine molecular stratification molecular 3harmaco agents PACEOMICS 3

molecular targeted therapies molecular therapies molecular therapeutics molecular-targetted agents molecularly targeted therapies omic strategies P4 medicine (personalized, predictive, preventative, participatory) participatory medicine patient-specific therapy patient-centered care personalized diagnostic medicine personalised medicine personalised medicines personalised treatment personalize medical care personalized genetic medicine personalized genomic medicine personalized medicine personalized medicines personalized molecular cancer therapeutics personalized molecular medicine personalized nanomedicine personalized therapy personalized therapies 4pharmaco agents 4pharmaco molecular therapeutics 4pharmaco therapeutics 4pharmaco therapy pharmogenomics pharmacometabolomics pharmacoproteomic pharmacotherapy precision medicine predictive health predictive medicine predictive, preventive, pre-emptive approach P4 medicine (personalized, predictive, preventive, participatory) proactive, pre-emptive and preventive healthcare PACEOMICS 4

preventive medicine participatory medicine prospective medicine Rx-cDx stratified medicine stratified pharmacotherapy stratified therapy tailored drug tailored medicine tailored therapy tailored therapeutics tailored treatments targeted drug targeted healthcare interventions targeted therapeutics targeted therapies targeted therapy targeted treatment theragnostics theranostics PACEOMICS 5

Keywords and synonyms for personal genomics personal genetics personal genetic profiling personal genome personal genome information personal genomics personalized genomics direct-to-consumer genetic information services direct-to-consumer genomics PACEOMICS 6

Keywords and synonyms for companion diagnostics, biomarker and testing-related terms biological markers biomarker biomarker approaches biomolecular analysis biomolecular diagnostics cdx clinical biomarkers companion diagnostic test companion diagnostics companion test diagnostic biomarkers diagnostic risk assessment diagnostic-therapeutic linkage disease segmentation tools drug-diagnostic co-development drug-diagnostic combination esoteric diagnostics gene detection technique gene signatures gene expression signatures genetic biomarker genetic profiling genetic signature genetic test genetic testing genetically-guided therapy genomics-based diagnostic test genomics-based molecular diagnostics genomics-based tests genomic profile genomic-profiling marker-assisted diagnosis PACEOMICS 7

metabolomics molecular biological molecular-based diagnostics molecular-based testing molecular classification molecular detection molecular diagnosis molecular diagnostic molecular diagnostic methods molecular genetic screening molecular genetic screening tools molecular genetic tests molecular biomarkers molecular markers molecular monitoring molecular phenotype molecular profiling molecular signatures molecular screening molecular stratification molecular testing monitoring markers multi-analyte tests multiparameter analysis multiparameter profiling nanotheranostics oncogenomics personal phenotyping personalised diagnostic test personalized diagnostics pharmacodiagnostic testing pharmacodiagnostics 8pharmacogenomics markers pharmacogenetic algorithm pharmacogenetic guidance pharmacogenetic-based algorithms pharmacogenetics-based tests pharmacogenetic testing 8harmacogenomics marker 8harmacogenomics markers PACEOMICS 8

pharmacogenomics diagnostics pharmacogenomics testing personalized risk profile pharmacogenetic testing phenotypic screening pre-treatment genotyping predictive assays predictive gene signatures predictive toxicogenomic screening prognostic assays prospective genotyping proteomic analysis protein-based markers protein biomarkers proteimic biomarker proteomic pattern diagnostics proteomic profile proteomic profiling proteomic screening single molecule biomarkers theragnostic tissue-based biomarkers toxicogenomic markers toxgnostics transcript profiling transcriptomics transcriptomic screening ***** PACEOMICS 9