Saturday, February 15, 2014

Generic Genes, Generic Drugs: The Biggest Unmet Need in Personalized Medicine?

This month in San Francisco, at the 21st annual TriCon meeting - an international congress for diagnostics and personalized medicine - Mark Trusheim of MIT and CoBioConsulting led a full day symposium on precision medicine.  In the afternoon, there was an expert panel on an important area, the creation of genomic tests for "legacy drugs," especially generic drugs.   Panelists included Trusheim, Mara Aspinall, President of Ventana Systems (a division of Roche), and Mark Curran, Vice President, Immunology Biomarkers, Janssen.  Each had given a talk earlier in the day.

Precision Medicine Opportunities with Legacy Drugs 

I had the privilege of moderating the panel, and opened by remarking that the causes of slow progress should be sufficient in that with generic genes, and generic drugs, there is no incentive for targeted and potentially substantial investment, as payers will generally seek to pay for the new tests at more or less there marginal cost.  However, that said, the public health benefits of better use of generic drugs was potentially colossal.   One start-up in this field with a roster of publications is AssureX Health, which has developed a bioinformatics-based panel of pharmacogenetic genes that helps predict responders and nonresponders from some 40 psychopharmacologic drugs.

Earlier in the day, Dr. Curran had discussed the emerging role of new approaches to biomarkers for drug development and clinical management in rheumatology.   He noted that the Crescendo Vectra DA test was being explored in clinical development by Janssen.   Mara Aspinall discussed diagnostics as the "silent partner" in nearly all of medical care.  For example, improved glucose tests supported the original discovery of insulin, while widespread use was impeded until home test strips, and later home glucometers were practical, several decades later.  Mark Trusheim spoke about several recent publications from him and his collaborators (here and here), and a new project, JANUS, that will produce a multilateral view of diagnostic and drug economics from multiple stakeholders viewpoints (pharma, diagnostic company, payer, patient, public health).  (I gave a two-part talk, speaking about recent changes in federal health policy impacting diagnostics reimbursement, and offering some thoughts on better ways for stakeholders to compete when assessing clinical utility.  Email me via my Foley Hoag webpage for a copy of the deck, or click here.)