In the article Immuno-Oncology Drug Rivalries Highlight Biomarkers Opportunities, Challenges published in The MedTech Strategist (March 2017), the rivalries between big pharma and their biomarkers are highlighted. The battle between Merck and BMS around their Keytruda and Opdivo therapies in particular could mark “a potential turning point for the molecular diagnostics industry, which has since seen unprecedented recognition of the importance of its under-appreciated role in personalized medicine.”
We know that precision medicine is going to be the dominant force in healthcare but some companies are taking their time catching up with this idea. So if you’re thinking of taking advantage of the situation and maybe sprinting ahead while others are still warming up, here are some ideas on how to secure that lead.
Explore the world outside oncology
Oncology has always been the front runner in precision medicine (PM) so this is where targeted therapies and diagnostics have, for the most part, been focused. However, there is new and exciting activity outside this area where biomarker and targeted approaches are proving successful. These include biomarker-driven therapies for diabetes and inflammatory diseases (such as asthma and rheumatoid arthritis) and neurological diseases (such as Alzheimer’s, Parkinson’s and multiple sclerosis).
The total number of targeted drugs in this space doubled in five years1 and while oncology still dominates as the single most important therapy area, development in other disease areas has increased exponentially.
Precision medicine outside oncology is more complex and potentially more expensive and risky, but get it right and there are significant access, market and patient share benefits. It may not demand the high prices of PM in oncology but there is a much larger population for new targeted therapies, so is it worth exploring your options here?
Another area where you could get ahead is in the use of diagnostics at opportune points 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. By incorporating existing and novel biomarkers into the treatment pathway, the right patients could get earlier treatment that also benefits cost-management. It’s certainly something that would interest payers.
Diaceutics’ Pharma Readiness for Diagnostic Integration 2017 reveals which of the leading pharma companies are working in diagnostics outside oncology2.
Figure 1. Dx-enabled late stage pipeline – indications (Diaceutics’ Pharma Readiness for Diagnostic Integration 2017)
Get creative with partnering
Pharma is already gearing up for a non-oncology future, as demonstrated by a sharp increase in PM deals in other disease areas since 2011, and Diaceutics anticipates that non-oncology could be as active as oncology, possibly even more so. But there could be a change in the volume and nature of the agreements that pharma have with external partners in this space. The focus of such agreements is changing towards multi-partnering and collaborations built on technology. If pharma is forging alliances with relevant stakeholders in areas where technology evolution is evident, the future diagnostic landscape could change.
Partnerships now aren’t always between a pharma and a diagnostic company – collaborations with biotech companies, labs, platform developers and academia could speed the development of new targeted therapies via more effective diagnostic lifecycle planning and management. Investigate how technology collaborations can advance your reach or help you utilize a developing technology field, such as NGS.
Use your competitive intelligence
Competitive intelligence (CI) is all about filtering knowledge and insight from data and information, allowing a company to keep an eye on the landscape and disseminate relevant information among teams. Perhaps most importantly, it can provide reassurance that there are no big surprises coming along from your competitors. For some pharma companies this collection of information involves dedicated CI teams, whereas others outsource to external vendors.
Whichever way it is gathered, good intelligence can offer huge benefits to pharma companies, especially in PM, where market trends are continually shifting (and are absent in traditional therapies). CI and its relevant tools and dashboards, when effectively employed, can enable manipulation of myriad sources of information, driving key insights and leading a company to ask, “What should we do to maintain a position of strength?”
Pharma companies with a strong awareness in PM are adjusting their focus from oncology towards non-oncology disease areas such as autoimmune and CNS. They can use CI to gain insight into clinical trials, new biomarkers, key partnerships and how to improve regulatory and clinical success for certain assets.
Try wearables for size
Precision medicine is not only shifting its focus to newer disease areas but also to the billion dollar mobile health and wearables market, so this is an option for broadening diagnostic scope.
When it comes to diagnostics, those for oncology tend to be linked to specific therapies based on single analyte detection (by PCR, FISH, IHC, etc.) from tumor or blood samples. Outside oncology, however, there will be multiple entry points for biomarkers along the treatment pathway that are not necessarily blood-based. Depending on the disease area, potential new diagnostic tools such as motion sensors, imaging, breath or urine biomarkers, can be employed singly or in combination. These make the non-oncology space a more complicated but competitive landscape. Tools like this may ultimately be employed to differentiate certain brands, drive faster regulatory approval and/or improve the value proposition presented to payers and patients.
In every day disease management, wearable devices and health apps can improve patient monitoring and increase patient and physician satisfaction with a therapy. For instance, in MS, an activity tracker can help establish a fitness routine, guide treatment or assess quality of movement, and an app has helped MS patients to better engage and communicate information to their physicians. If an app can monitor or prevent flare-ups, pharma can really focus its efforts on delving deeper into the benefits for a particular patient population.
- Diaceutics’ Pharma Readiness for Personalized Medicine Summary Report 2016
- Diaceutics’ Pharma Readiness for Diagnostic Integration 2017