Companion diagnostics are evolving quickly as novel technologies emerge and new drug targets appear. Dr. Mark Roberts, Director of Diagnostics Development, recently shared his thoughts on the industry trends ahead of the World CDx Boston 2015.
How much progress has been made in the area of companion diagnostics?
Companion diagnostics have come a long way, but there is much farther to go. Over the past five years there has been a change in the industry mind-set and people are now fully embracing companion diagnostic strategies even earlier in their drug development programs. This is especially true in the case of oncology, where most of the compounds progressing through clinical development are targeted biologics that by definition will have an accompanying diagnostic.
With that in mind, a CDx strategy may have to be considered earlier in the development process than what has been the historical norm. I also believe people are starting to appreciate CDx as a real differentiator for their compound, whether it’s in oncology or emerging areas such as CNS, inflammation and infectious disease. Companion diagnostics are clearly viewed as essential to the future of healthcare.
What is the biggest unmet need that the industry is currently facing?
I think that the biggest unmet need in the industry needs to be looked at slightly differently in the sense that the models of the drug and diagnostic development are in some ways similar, but in some ways very different. Right now, the economics of the model between the diagnostic sale and the drug sale do not align.
We need to start thinking about the health economics in the market and how these help encourage diagnostic companies to get more involved with this knowing that their investment is going to be relatively weak. There is a need for governments–and especially in the US–the regulatory agencies to think more around the diagnostic and the drug being a team. Coming full circle, I think the single biggest problem right now is market adoption of the diagnostic and we still need to work on a better way to drive this uptake and availability.
How do we improve companion diagnostic adoption for practicing physicians?
There still is an education gap – but with all the talk around personalized medicine it’s narrowing. From an industry perspective, the perception that you develop a diagnostic and it would be widely adopted is far from the reality. Like the drug, regulatory approval is only the first step in having health authorities approve the diagnostic’s use and insurers and government agencies agreeing to cover or reimburse the cost.
Drug developers are not used to commercializing diagnostics and diagnostic companies are not used to selling tests with such narrow scope of use, which is tied to the adoption of the drug. Health economics/valueased studies will be increasingly important in supporting the value proposition of the drug/companion diagnostic pairing and in educating the physician.
From your CRO perspective, what is the most significant challenge when working with drug and diagnostic developers to align co-development?
I see two main challenges. Despite my comments around earlier consideration for CDx timelines, one challenge that we continue to see is Pharma companies don’t want to invest in the development of the diagnostic until they are absolutely sure it is required for approval of the drug. Unfortunately, once that decision is made all parties are scrambling to make sure that availability of the diagnostic doesn’t delay the start of the pivotal drug trial, because no one wants to incur the cost and delay of a diagnostic bridging study.
As a CRO, often we are supporting drug programs that appear not to require a CDx when something is unveiled at the very last minute and everything changes. Earlier engagement is absolutely necessary for long-term success so the industry needs to develop a more de-risked or risk-sharing model so that investment can take place much earlier.
The second most significant challenge is communication. The diagnostic and pharma companies operate in different worlds and different timelines so their needs are often not aligned; this can add tremendous complexity to the drug/CDx co-development model. With the benefit of hindsight, we are now much more proactive at engaging the pharma companies early to understand their thinking around targeted therapies to ensure that the expectations of the pharma and the diagnostic companies are in sync.
In the future, will companion diagnostics change the face of patient care and the healthcare system as we currently know it?
For the foreseeable future, the companion diagnostic strategy is going to be central to both drug development and patient management. It will be essential from a drug development point of view in allowing us to quickly identify the target patient population, drive trial enrollment, and drive the compound quicker to a decision on whether to proceed to full clinical development. It will allow drug companies to re-evaluate compounds that have previously failed in the clinic (but did show promise in a subset of patients) as they are now able to identify, early on, who those patients are.
As the ultimate beneficiary of the advances in personalized medicine, we, as patients, would love nothing more than the opportunity to be pre-screened to determine the optimal choice of drug. As a health care provider, it would provide tremendous reward knowing that you don’t have to follow a prescribe/reevaluate model but can get it right first time.
From a health economics point of view, a lot of these new biological therapies are very expensive and need to be restricted to only those patients that will see benefit; the option to spend maybe a couple of hundred dollars on a test to determine whether a patient should receive a therapy that costs many tens of thousands of dollars annually is compelling.
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About Mark Roberts, Ph.D.
Mark J. Roberts, received his PhD in Pharmaceutical Sciences from the University of Nottingham (UK) and has worked in the clinical diagnostics arena for over 20 years, holding senior positions in both the in vitro diagnostic and reference laboratory industries. He joined Covance in 2012 to spearhead our Companion Diagnostics initiative, designed to assist pharmaceutical and diagnostic companies in drug/ companion diagnostic co-development.