I have just read an excellent article by David B. Jackson, and felt obliged to comment, its in this months edition of Drug Discovery Today , and its entitled Clinical and economic impact of the non-responder phenomenon – implications for systems based discovery. It makes a number of very good points and uses them as a justification for more computer modeling and data mining of diseases and therapies, however what struck me is the economic impact and the opportunity impact of this phenomenon and how it can impact on strategic decision making and as a pharmaceutical development consultant I am always looking out for such things.
Molecular diversity is part of life and as you know this impact in drug effectiveness considerable especially in the area of cancer, we all know that many oncology drugs will just not work in many patients but in those where they do work the effects are profound. David makes the argument that these present a huge opportunity for insilico drug development projects, as the reasons for a drug not working in some patients are often investigated and there tends to be lots of data available both genetic and molecular, it all means that there is a huge well understood group of patients just waiting to have their disease tackled. Just to give us an idea of the economic attractiveness of this data he runs a few interesting calculations.

The economics of non response:

While the non responder problem afflicts all therapeutic areas, it is particularly pronounced in clinical oncology, in 2006 for example the top 15 selling onco-therapeuics generated sales of approximately US$26.43billion. Within this group of drugs the average un-weighted overall response rate is 35%, the economic implications of this are massive. Estimates are that 65% of cancer patients do not response to conventional therapeutic options. so new drugs tend to grow the market rather than replace other existing therapies.
All of this means that there is a massive opportunity in many cancer indications and the level of data, both molecular and genetic should be making the job of designing new therapies an attractive option to in silico  development experts.

In summary the story is – Drug = non responder = opportunity + data

If David is to be believed we should all be reaching for our silver platters, I for one am not completely convinced that its as simple as that but I am sure all this is creating huge opportunities with the skills and backing to take advantage of it, combined with the psuh to publish unsucessful studies its all looking good.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug  evelopment target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.