|Trends & Perspectives|
Among the American IVD manufacturers working to make personalized medicine a day-to-day reality in healthcare, none appears busier than Ventana Medical Systems in Tucson, Arizona.
The INFORM HER2 Dual ISH DNA Probe cocktail assay was approved as an aid in the assessment of patients considered for treatment with Herceptin (trastuzumab).
Among the American IVD manufacturers working to make personalized medicine a day-to-day reality in healthcare, none appears busier than Ventana Medical Systems in Tucson, Arizona. Since the beginning of 2012, Ventana, a Roche company, has made six announcements (at last count) of collaborations with external pharmaceutical companies on drug-diagnostic development. Plus, one of its partners, Clovis Oncology, made an announcement in late March that it had completed enrollment in its pivotal LEAP trial of CO-101 versus gemcitabine in metastatic pancreatic cancer.
Preceding all of this partnering activity, Ventana announced in June of last year that it had earned FDA approval for the first fully automated diagnostic assay for HER2 gene status determination in breast cancer patients, the INFORM HER2 Dual ISH DNA Probe cocktail assay (HER2 Dual ISH), for commercialization in the United States. (The assay was approved as an aid in the assessment of patients considered for treatment with Herceptin [trastuzumab].)
What’s driving these pharma-IVD partnerships is personalized healthcare, says Doug Ward, vice president of Translational Diagnostics at Ventana Medical Systems. “Right now what you see,” he says, “is that the pharma industry is evolving relative to its development of cancer therapies. More and more you see pharma companies driving their innovation and differentiation, which is part of the Roche pharma mission and strategy, as well.” Pharma is accomplishing this innovation and differentiation via targeted therapies. “For them to get their targeted therapies onto market,” Ward says, “they need to utilize a biomarker to identify those segments of the population that will best respond in a safe and effective manner to their drug.”
Ward, who heads up Ventana’s 10-year-old Translational Diagnostics division, says that partnering with pharma companies on the development of targeted therapies has always been at the center of Ventana’s strategy. “We have always seen this as core: to identify biomarkers to help pharmas be more targeted and therefore more safe and effective. We have led this charge from a diagnostics perspective. And certainly now you see pharmas also driving this,” he says.
How It’s Done. The logistics of bringing a targeted drug and its companion diagnostic test to market are not overly daunting to Ventana. “There is complexity to it,” Ward admits, “which is probably why the evolution has taken a bit more time than we all would like.” But the challenges can be overcome and return on investment realized, he says.
“More and more you see pharma and biotech companies who have a targeted therapy from day one,” he explains. “They may then do a Phase-One expansion, where they enrich their enrollment, but they will use the actual biomarker for enrollment of that expansion. They may take all comers in Phase One, but they’ll do a biomarker eval on that. In Ventana’s case, in my organization specifically, we partner at that stage to develop what we call a ‘robust prototype assay.’ That is developed by our assay development team and transferred into our CAP/CLIA lab. We will perform the analysis on those patient samples, then they’ll go to a Phase One expansion-they may start to enroll patients to enrich their Phase One, and the enrollment will be based on that biomarker.” A key element to all of this, Ward says, is that at a very early stage, prior to the registration study, pharmas need to evaluate their scoring approach and also have a cutoff for selection. “And then you’d utilize that scoring criteria as well as that cutoff in your enrollment studies,” he says.
Good ROI For All. Despite the complexity of developing a targeted therapy with a companion diagnostic, the return on investment is worth it, Ward says. The pharma company can enroll fewer patients in trials, and the costs of managing those clinical trials are thereby minimized. For the IVD company, Ward explains, “The investment that we put into this is going to be returned in terms of the collaboration with the pharma partner; but also, in the end, these companion IVDs are reimbursed and fit into the typical diagnostics business model of selling instruments and reagents to hospitals and labs.” Furthermore, payers are not paying for patients to receive therapy that isn’t appropriate for the correct targeted patient population. “The ROI can be seen across the healthcare continuum,” he asserts.
Forward-Thinking Leadership. Ventana Medical Systems has a relatively new leader in Mara Aspinall, who was appointed president in September 2011. Aspinall is a champion of personalized healthcare and is “a perfect leader at this time for Ventana,” Ward says. She has led various intiatives to educate the healthcare community on diagnostics, genomics, and personalized medicine, and she has a strong background in both personalized healthcare and science and technology. “That is very powerful to help lead this organization,” Ward says, “because we consider ourselves very innovative and high-tech, yet we also take a personalized approach to diagnostics.”