Is Co-development the Best Method for Companion Diagnostics?

Paul de Koning, Vice President, Head Global Clinical Pharmacology & Exploratory Development, Astellas Pharma Global Development, joins Pharma IQ to discuss targeted treatment and diagnostics.

Pharma IQ: How do you assess the value of targeted treatment and diagnostics?

P de Koning: Of increasing importance, actually.  I think the sort of standstill that we’ve seen in the development of novel innovative medicines, has been contributed by the fact that we were still trying to develop compounds using a one-size-fits-all approach. In todays environment there is much more emphasis on showing added value and optimal risk-benefit ratios. Targeting treatments to the most responsive patients and / or targeting away from those most prone to experience adverse effects is critical in achieving the above. Diagnostics are an integral part of that strategy. So I think that a diagnostics enabled targeted treatment hopefully will allow us to bring more innovative compounds to market than we’ve been seeing over the past ten to fifteen years. 

Pharma IQ: And in what ways do you feel the current economic climate has affected exploratory development in their early phase pipeline?

P de Koning: I think that because the economic climate nowadays requires you to prove added value, the exploratory development phase is used much more to really explore in more depth the best indication for a compound. So, it’s no longer that we just rush compounds through into late stages of development with the risk of failures in the expensive phase three.  We try to fail earlier, because we can’t afford anymore to have those late attritions. 

Pharma IQ:. Can you briefly outline some recent trends in companion diagnostics?

P de Koning: Yes, I think what we’re seeing is that there is a move from more retrospective application of companion diagnostics to co-development of diagnostics as an integral part of the development of a novel drug. That way we assure availability at the time of registration. 

Pharma IQ: Paul, where do you believe the main opportunities in companion diagnostics lie at the moment?

P de Koning: I think they’re in the areas where we understand the target well. In other words, where we are able to measure the target and the effect of a new compound on that target in the diseased population. We have seen most examples of this in oncology.  In oncology we develop compounds against very specific targets and where we’re often able to assess whether a patient with cancer actually has that particular target, yes or no, and therefore should yes or no potentially benefit from that novel compound.  The least we understand the role a novel target has in the disease, the less likely it is we’ll be able to successfully develop companion diagnostics.

Pharma IQ: Which technologies do you think will drive the revolution in medicine?

P de Koning: I think, at the moment, it’s mainly accurate, fast analytical techniques that allow you to turn around analytical results on short notice. Also of importance are those technologies that allow evaluation of gene or proteomic signatures to stratify patients into potential responder groups quickly.

Pharma IQ: Ten years from now, will we see a really dramatic transformation in the way that healthcare is delivered?  Do you think it will be far more personalised, or do you think the process will take longer than ten years?

P de Koning: I think I’m realistic, and it will take longer than ten years.  We’ll see a gradual uptake of more targeted treatments, again, most probably led by oncology treatments. Also we will see more metabolic profiling to screen how patients are likely handling drugs: how they metabolize and excrete them, Overall I think we still have too little understanding of many diseases to see a very significant shift towards very specialised targeted treatments.  I think we’ll see for some time that we still use more the common generic treatments as the first shot, and only thereafter start to look at more targeted treatments, which will inevitably be more expensive.  So it all depends on the success – the relative success – of the targeted treatments.  If they show fantastic result, fantastic efficacy, the uptake will be faster.  If they show a stepwise increase in efficacy, it’s going to take longer.

Pharma IQ: I understand you’re going to be speaking at the Global Companion Diagnostics Forum, taking place in London on the 16^th and 17^th March, so I might see you there.  For anyone interested in attending the event, what would be your key take-out message?

P de Koning: I think that at the conference you’ll hear practical examples, but particularly also, you’ll learn how to successfully plan for the development of the companion diagnostic.