- “Summary of International Strategies for Personalized Medicine” (July 2013) – Summary of main themes and recommendations of three recent reports from the U.S., the U.K. and the EU.
- “Call for an Ontario Health Data Ecosystem” (2015)
OPMN Subcommittee Reports
The OPMN struck three subcommittees to tackle some of the pressing issues impacting the realization of personalized medicine in Ontario. Each of three OPMN subcommittees has prepared a summary document outlining the specific challenges and opportunities relative to their respective mandates:
- Subcommittee 1: “Adapting Electronic Medical Records for Personalized Medicine”
Personalized medicine is driven by “big data” – the collection, storage and interpretation of large data sets that includes personal, clinical, research and environmental information. This report details why electronic medical records (EMRs) need access to these data sets and describes the tools necessary to interpret them in order to enable personalized medicine.
- Subcommittee 2: “Evaluating Our Current Health Technology Assessment Capabilities in Light of Personalized Medicine Technologies”
Ontario has well-established processes for assessing new health technologies for incorporation into our health care system. This report discusses the particular challenges that personalized medicine presents to these processes.
- Subcommittee 3: “Evaluating our Current Pre-Market Development Process for Personalized Medicine Technologies”
The success of market-approved technologies can be improved by a better pre-market development process (as championed by MaRS EXCITE) that includes an integrated evaluation approach that develops both the evidence required for product licensing and for payer and market adoption. This report begins to develop a framework for adapting such a process to personalized medicine technologies.
Introduction to Personalized Medicine
- The Personalized Medicine Coalition (USA): “Personalized Medicine in Brief“, “The Personalized Medicine Report: Opportunity, Challenges, and the Future” and “Personalized Medicine by the Numbers” – These three articles are a selection of informative publications provided by the Personalized Medicine Coalition, a USA-based advocacy group for personalized medicine.
- PricewaterhouseCoopers “Breakthroughs: The Impact of Personalized Medicine Today” (April, 2011) – Introductory report including insights from several leading US medical centers
- U.S. Food and Drug Administration Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development. Report on how the US FDA has changed its regulatory infrastructure to facilitate personalized medicine.
- PHG Foundation (U.K.) Clinical Whole Genome Analysis: Delivering the Right Diagnosis. Report on the essential steps and issues in using whole genome analysis for clinical diagnosis.
- U.S. Presidential Commission for the Study of Bioethical Issues Anticipate and Communicate. Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. Report with recommendations on how to handle incidental findings from a broad range of medical disciplines including genomics, imaging or any other form of biomedical testing.
- PHG Foundation (U.K.) Genomics of Obesity. Report on the importance of the genetic determinants of obesity and recommendations on how to integrate genetic testing into obesity treatment.
- “Global Alliance to Enable Responsible Sharing of Genomic and Clinical Data” (2013) – White paper outlining the need for a global alliance to create and maintain the inter-operability of technical standards for managing and sharing sequence data in clinical samples, developing guidelines and harmonizing procedures for privacy and ethics, and engaging stakeholders to encourage responsible and voluntary sharing of data and of methods.
- National Research Council (USA) “Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease” (2011) – Report on impact of personalized medicine, how it will change the classification of disease and how to implement changes in the USA to enable better diagnosis and treatment
- PHG Foundation (UK) Next Steps In The Sequence (2011) – Comprehensive report on use of whole genome sequencing in clinical practice
- PHG Foundation (UK) Genomics in Medicine: Delivering Genomics through Clinical Practice (2012) – Report on the implementation of genetic testing across the spectrum of medical specialties
- Institute of Medicine (USA) Evolution of Translational ‘Omics: Lessons Learned and the Path Forward (March, 2012) – A discussion of best practices in the implementation of “omics”-based test development and implementation
- Cancer Quality Council of Ontario (CA) Signature Event Report on Personalized Medicine (2010) – Summary of a 2010 conference on implementation of personalized medicine in Ontario’s cancer system
- American Clinical Laboratory Association (USA) The Economic and Functional Impacts of Genetic and Genomic Clinical Laboratory Testing in the United States (January 2012) – Batelle Technology Practice report prepared on behalf of the ACLA;
- Nuffield Council on Bioethics (UK) Medical Profiling and Online Medicine: the Ethics of “Personalized Healthcare” in a Consumer Age (October 2010) – Analysis of the benefits and harms of some aspects of personalized medicine including online medicine, and recommendations to groups in charge of health care policy and delivery
- UnitedHealth (USA) Personalized Medicine: Trends and Prospects for the New Science of Genetic Testing and Molecular Diagnostics (March 2012) – Working Paper from health insurance company UnitedHealth, including hard data on current patterns of use of genetic testing and molecular diagnostics
- Presidential Commission for the Study of Bioethical Issues (USA) Privacy and Progress in Whole Genome Sequencing (October 2012) – Comprehensive report on ethical issues raised by whole genome sequencing with input from extensive group of experts and federal agencies, with recommendations for policy to protect privacy while enabling data sharing for scientific and medical progress
Personalized Medicine Websites, Groups
- Personalized Medicine Coalition– US advocacy group to advance “the understanding and adoption of personalized medicine concepts and products for the benefit of patients”
- PHG Foundation– International not-for-profit foundation to enable the translation of discoveries in biomedicine and personalized medicine in the UK; source of many excellent white papers
- Public Population Project in Genomics and Society– “P3G” is an international consortium with a focus on biobanking, data harmonization and legal and social issues pertaining to these activities
- Canadian Coalition for Genetic Fairness– Consortium of patient advocacy groups and organizations for diseases with a genetic basis)
- HumGen International– Resource centre for ethical, legal and social issues in human genetics based at McGill University, Montreal