By Deb Borfitz
March 15, 2010 | Pharmaceutical companies are beginning to embrace meaningful development of “companion diagnostics” in response to both the realities of applied genomics and the market disruption posed by personalized medicine. Companion diagnostics are tests done to determine if patients’ genetics indicate they’ll respond to a particular treatment or dosing level before the drug script is fulfilled.
So says Patrick Terry, CEO of strategic business consultancy Technic Solutions. For the pharmaceutical industry, personalized medicine represents both risk and opportunity. If a diagnostics company comes up with a test to identify probable non-responders to a blockbuster compound, sales of the drug could take an enormous hit. Developing those diagnostics internally or in partnership with test developers, on the other hand, could help offset the inevitable losses.
Perhaps no one knows better than Terry how to succeed in the business of personalized medicine diagnostics. He’s co-founder of the wildly successful and now publicly traded Genomic Health, which was the first to molecularly dissect archival tissue of patients in cancer trials seeking reasons for differential response to treatment and improved outcomes. Formerly in the facilities building side of the life sciences, Terry catapulted into the genetics arena about 15 years ago when his two children were newly diagnosed with an advanced aging disease known as PXE. Working in a Harvard lab by night, he discovered and then patented the causative gene.
This eureka became his segue into “precision medicine” that re-classifies disease on the molecular level. In 2000, after creating a genetic test for PXE, Terry teamed up with biotech entrepreneur Randy Scott to form Genomic Health. In the space of four years, the company developed the test for genetically stratifying breast cancer that is now standard-of-care. More recently, Genomic Health released a diagnostic for colon cancer.
Designing robust clinical trials for disease representing potentially dozens of molecular subtypes is no small task, says Terry. From a purely sales perspective, industry sponsors are also in a quandary about how personalized they really want their medicines to be. “But there’s no avoiding science…and a lot of capital is flowing into this type of research.” Cancer, rheumatoid arthritis, and a host of other diseases are now widely recognized as heterogeneous conditions of the genome.
Narrow targets can in fact make a lot of financial sense for conditions like neovascularization (blood vessel development), which has a key chemical signal (VGEF) for which dozens of therapeutics are in development. “If you’re the fifth or even the third one out of the gate with a VGEF compound, you’re probably not going to displace the first movers or be commercially successful,” Terry says. Thus the more practical option may be to look for new markers that could be used as a companion diagnostic. Genentech is already working on diagnostic tests specific to its drug development program, Terry notes, trying to stay ahead of external diagnostic and biotechnology companies working to molecularly stratify Avastin and Lucentis.
On-label use of drugs like Avastin could well expand to new molecular signatures of disease rather than affected organ. The National Institutes of Health will spend “billions of dollars” over the next few years to molecularly characterize each of the 20 or so major cancers, Terry says. In clinical trials, high priority will be put on any genes implicated in multiple cancers.
For sponsors, the question of the moment is not if but how and when to embrace personalized medicine, says Terry. “I will be one of those who push the envelope on this…in collaboration with pharma or in competition with them.” Technic Solutions has expertise in the “disruptive paradigms” that Terry predicts will collapse clinical trial timelines for personalized, stratified medicine to under five years and “put adaptive clinical trial design concepts on its head.”
Quintiles and Parexel are among the “early movers” in this arena, says Terry, and diagnostics companies will be increasingly turning to them for help. Eli Lilly, GlaxoSmithKline, and Novartis have also “completely embraced” personalized medicine. “The large multi-nationals all have risk venture divisions and they’re all investing in diagnostics companies or developing companion diagnostics through partnerships.”