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 OGI Update - July 20, 2010.

On June 22, 2010, the Ontario Genomics Institute (OGI) Science with Industry workshop program and MaRS Future of Medicine series joined forces to present a one-day workshop on molecular diagnostics.  Dx2010 Markers to Market brought together leading international researchers, regulatory representatives and entrepreneurs from the diagnostics sector to examine regulatory hurdles and commercialization challenges on the path from biomarker discovery to market for molecular diagnostics and prognostics.

Speakers at the event included:

• Greg Hines, CEO of ArcticDx Inc. (Canada), drew on his experience with the commercialization of Macula Risk^®, a molecular diagnostic test for age-related macular degeneration, as well as his experience in the molecular diagnostic and pharmaceutical industries, to highlight three important commercialization principles: a strong intellectual property position; a proven regulatory strategy; and proof of commercial viability. 

• Elizabeth Mansfield, Director of Personalized Medicine, FDA (USA), talked about the FDA’s current approach to regulation of in vitro diagnostic tests.  Particular challenges and issues around diagnostic Lab Developed Tests and also direct-to-consumer tests include a current lack of overall regulation, with no pre-market review or requirement for clinical validation, as well as the creation of an unlevel playing field for traditional diagnostic companies that take on the higher regulatory hurdles of FDA approval of their products. The FDA is working to address these issues going forward. 

• Thomas Metcalfe, Head, Science and Technology Incubator, Translational Research Sciences (TRS), Roche (Switzerland, SIX:ROG, OTCQX:RHHBY), highlighted drivers moving the pharmaceutical industry towards personalized healthcare, including: increasing healthcare and R&D costs, creating a desire for improved benefit-cost ratios; and the rapid development of new technologies, increasing both capabilities and levels of efficiency and value.   Current challenges in realizing the promise of personalized healthcare include: the ongoing need for a deeper understanding of the molecular basis of a targeted disease; the need for clinical samples for validation; and, looking forward, a need for innovative regulatory approaches.

• Allen Roses, Director of Deane Drug Discovery Institute, Duke University (USA), presented recent findings from a clinical trial related to Alzheimer’s disease and the prediction of risk of developing symptoms based on a specific genotype.  He stressed the value and importance, in developing predictive tests, of identifying prospective cohorts and early communication with the FDA on trial design.

• Patrice Sarrazin, Senior Scientific Evaluator, Health Canada, provided an overview of regulations for genetic testing in Canada including the types – based on risk level -- of in vitro diagnostic tests classified as devices and regulated as such by Health Canada, and discussed the steps manufacturers need to take to meet Health Canada regulations.  He focused particularly on the benefits of engaging with Health Canada early in the product development process.

• Lisette Stork-Sloots, Senior Program Director at Agendia (Netherlands), a genomics cancer diagnostics company, talked about MammaPrint^® – the first and only FDA-cleared In Vitro Diagnostic Multivariate Index Assay (IVDMIA) breast cancer recurrence assay.  She discussed the development of their diagnostic test from bench to bedside, citing the pivotal importance of test validation, regulatory accreditation and reimbursement.

The 70 workshop participants represented academic, investment and commercial institutions active in the diagnostic discovery and product development sector of life sciences, and included researchers, entrepreneurs, intellectual property experts, and venture capital investors.

Several of the speakers’ presentations are available to view online at:  http://www.OntarioGenomics.ca/event/2010-7-05/539

As part of the event, OGI Science with Industry and MaRS Future of Medicine interviewed the speakers on a range of topics related to diagnostics and the topics covered during the symposium.  You can watch the interviews at:  http://www.OntarioGenomics.ca/event/2010-7-05/539

MORE INFORAMATION:

For more information on OGI’s Science with Industry workshops click here or contact Rhonda Tannenbaum, Director, Business Development at +1 416-673-6586 or rtannenbaum@OntarioGenomics.ca 

For more information on MaRS Future of Medicine series click here or contact:  John McCulloch, Advisor, Life Sciences and Health Care at +1 416-673-8127 or jmcculloch@marsdd.com

About OGI
The Ontario Genomics Institute (OGI) is a private, not-for-profit corporation focused on using world-class research to create strategic genomics resources and accelerate Ontario’s development of a globally-competitive life sciences sector.  Through its relationship with Genome Canada, the Ontario Ministry of Research and Innovation (MRI), and other private and public sector partners, OGI works to: identify, attract and support investment in Ontario-led genomics research; catalyze access to and the impact of genomics resources; and, raise the visibility of genomics as well as its impact and associated issues.  

For more information about OGI:  www.OntarioGenomics.ca

OGI media enquiries:
Alastair Harris-Cartwright
Corporate Communications Manager
T: +1 (416) 673-6582. 
E: aharriscartwright@OntarioGenomics.ca

About MaRS
MaRS Discovery District (www.marsdd.com) is a large scale, mission driven innovation centre located in Toronto and networked across Ontario, focused on building Canada’s next generation of technology companies.  MaRS works closely with entrepreneurs to grow and scale their ventures into global market leaders in life sciences and health care, information, communications and digital media technologies, clean tech, advanced materials and engineering, as well as innovative social purpose business.