By Peter Keeling, CEO, and Steve Vitale, managing director, Diaceutics Group
Oncology has always been the front runner in personalized medicine, so this is where targeted therapies and diagnostics have, for the most part, been focused. However, there is new activity outside this area where biomarker and targeted approaches are proving successful.
There are now biomarker-driven therapies for diabetes and inflammatory diseases and neurological diseases. The number of targeted drugs in this space has doubled in five years, and while oncology still dominates as the single most important therapy area, development in other disease areas has increased exponentially.
Outside of oncology, there will be multiple entry points for biomarkers that are not necessarily bloodbased. Depending on the disease area, new diagnostic tools such as wearables can be employed singly or in combination, making the non-oncology space a more complicated but competitive landscape. These tools may ultimately be employed to differentiate certain brands, drive faster regulatory approval, and/ or improve the value proposition presented to payers and patients.
IS THE FUTURE ALREADY HERE?
Pharma is already gearing up for a non-oncology future, as demonstrated by a sharp increase in personalized medicine deals outside of oncology since 2011. Deals between pharma and diagnostic or lab partners have started to converge in both spaces. As such, non-oncology could be equally, if not more, active as oncology. But there could be a change in the volume and nature of the agreements that pharma has with external partners in this space. Additionally, the focus of such agreements, which is towards technology partnering, may change, as shown by Novartis and Microsoft teaming up to further develop Kinect for MS assessment.
A DIVERSE TESTING LANDSCAPE OUTSIDE ONCOLOGY
In MS, the gold standard for diagnosis is imaging, but there is significant work being done on biomarkers to identify patients, or measure therapeutic response to pharmaceutical interventions. Stratify JCV was developed to address a significant safety issue for a specific therapy, but many companies are trying to identify a prognosis biomarker to identify and track disease progression. In addition, sensitive wearable technologies can gather data on daily movement and motion to inform the clinical perspective. Clinical trials reveal substantial activity in this area, while health apps and devices are expanding from the consumer field into the diagnostic world.
We also can expect to see a rise in the use of diagnostics at opportune points early on the treatment pathway. In rheumatoid arthritis, for example, big issues restrict biologics to a small patient pool in the very late stages of the disease, when damage to the joints has already been done. But research shows that earlier identification and treatment can reduce joint damage and improve quality of life. By identifying inflection points on the pathway, and incorporating existing and novel biomarkers, is it possible to create a perfect storm of diagnostic, education, and novel therapy to get earlier treatment to the right patients that also benefits cost-management? Collaboration with payers on this last point could provide the incentive to make sure tests are used as early as possible and have rapid uptake.
NON-ONCOLOGY PERSONALIZED MEDICINE
The non-oncology space may be complex and risky, but it offers significant benefits. It is likely pharma companies will create diagnostic entries into treatment pathways where they hold valuable assets. This could impact product uptake, peak sales, access, and pricing discussions, because there is a strong correlation between the choice of test, particularly early in the treatment pathway, and the potential to avoid costly outcomes later.
Competitors in key disease areas are lining up some interesting multitest strategies. As a result, “one-size-fits-all” therapies will increasingly be competing with test-enabled therapies, and 2017 will be a key tipping point.