Tips on developing oncology biomarkers and companion diagnostics – Transcript of interview with Dr. John Reddington

The increased demand for targeted therapeutics has prompted oncology drug developers to uncover innovative solutions to new challenges. Fueled by an explosion of information about the biological underpinnings of cancer, now is a time of unprecedented opportunity in cancer drug development.

In this interview with Dr. John Reddington, COO at Cambridge Biomedical, I get answers to questions about how biomarkers and companion diagnostics are developed and the role they are playing in targeted oncology drug development. He also discusses some of the regulatory issues and commercialization challenges associated with biomarker development and offers advice on how to deal with them.

What is Cambridge Biomedical?

Cambridge Biomedical is a specialty laboratory founded in 1997 with two divisions. The first is the CAP/CLIA laboratory that performs highly complex esoteric testing for large US reference labs. The other part of the business is a contract laboratory division that provides bioanalytical method validation and sample testing to the pharma, biotech and medical device industries.

What challenges are oncology drug developers facing right now with the increased demand for targeted therapeutics?

I think the biggest challenge is the move away from the one pill fits all approach to a more individualized approach to treating a patient’s cancer. This means being able to predict which patients are most likely to respond to a given therapy, as well as those that might potentially be harmed by a given treatment.

What role are biomarkers and companion diagnostics playing in oncology drug development and targeted therapy?

The first issue that has to be addressed in personalizing a therapeutic approach, is to find a biomarker that can be objectively measured and associated with a disease and a potential treatment.  A companion diagnostic is a test method utilizing the biomarker, which is specifically used to either select patients, measure their response to treatment and/or monitor for adverse reactions to the drug.

How are biomarkers and companion diagnostics being developed?

Post-discovery companion diagnostic methods must be optimized and put through an extensive validation procedure that’s tailored to the appropriate regulatory standards. The tricky bit here is that companies that develop therapeutics seldom have the expertise and experience in-house to effectively develop and then clinically test the companion diagnostics.

What are some of the regulatory issues associated with biomarker and companion diagnostic development?

First of all, the companion diagnostic must be in its final form at the beginning of a clinical testing period and cannot be altered or optimized further over the course of a phased clinical trial. The diagnostic should be co-developed during the same clinical trial period, utilizing the same patient population on which the therapeutic is being tested.

Another challenge is the fact that diagnostic regulations vary considerably throughout the world. There is also the fact that advances in technology make it difficult for the regulatory guidance to keep up with these current changes.

Finally there is a bit of a turf war being fought in the US, between the FDA and CMS (Centers for Medicare Services), as to who is best suited to regulate, approve and monitor companion diagnostic tests. Unfortunately, it is unlikely that this issue will be resolved completely in the near future.

What are some of the commercialization challenges?

At the top of the list are the financial challenges associated with takes about five years and between five and 15 million dollars, so not a trivial amount. The next challenge is trying to coordinate the approval for the drug with the approval of the companion diagnostic, so that they will hit the market at the same time. As with drug commercialization, the diagnostic company must obtain a reimbursement code, convince third-party payers of its value and then work to integrate the diagnostic into normal clinical practice.

What advice can you give small and midsized oncology developers to help them  optimize their clinical research efforts?

My recommendation to small or midsized oncology companies is that if you do not have in-house expertise and/or the bandwidth to develop the diagnostic yourself, you should partner up very early on with a diagnostic company that can take on the responsibility of parallel development of the diagnostic while you focus on getting regulatory approval for the therapeutic. This way you can leverage each others’ expertise and infrastructure to cost-effectively develop the companion products.

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