Paul Beresford, vice president of business development and strategic marketing at Biodesix, spoke to FierceBiomarkers ahead of his appearance on the BIO2012 panel "Commercialization of Personalized Medicine: Stakeholders' Recipe For Success." So what is Biodesix's own recipe for success? Keeping it collaborative and seeking validation, he explains.
Biodesix's business model is based on two strands--clinical diagnostics and companion diagnostics, tests used to streamline drug development by selecting patients who are expected to respond based on the presence or absence of a biomarker. However, the company hasn't gone down a simple "fee for service" route as its business model for these.
"Traditionally, in the development of companion diagnostics, the biopharma company developing the drug pays for the development of the assay and owns the intellectual property, which does validate the biomarker company's technology. However, we wanted to use a more collaborative model, ending with us owning or sharing the IP," says Beresford. This gives Biodesix more flexibility once the diagnostic moves from something simply supporting a trial to a potential product on the market.
Tests for personalized medicine start with biomarkers, and Biodesix sets off by comparing mass spectrometry spectra from a range of clinical samples. However, this is just the beginning, as Beresford explains: "We can discover biomarkers, but the biggest challenge is the validation."
As an example of this, Biodesix's serum proteomic test, VeriStrat, is available to predict the outcomes of patients with advanced non-small cell lung cancer treated with epidermal growth factor receptor inhibitors (EGFRIs), but is still being assessed in prospective clinical trials, which will provide the data that the company needs to fully validate the technique and drive full clinical adoption. This test also has potential in other tumor types, including breast, head and neck and colorectal cancer, according to Beresford, but each of these will need retrospective and prospective clinical trials.
"Personalized medicine is a very exciting area. It's got a buzz around it--all we need to do now is get the tests into practice and prove that they work," concludes Beresford.