What Are IDEAs Made Of: The Clinical-Commercial Nexus

Mike Rea

IDEA Pharma

There is no Development that is not commercial, no Commercial that is not Clinical. This is the pharma industry. We develop drugs that launch and that return their investment, so any sense that there is another way is erroneous.

The clinical teams set out to prove the idea that is to be taken to market, meeting all the hurdles that are put in place to stop it getting there. Moving a product between two hurdles that doesn't make it over the final hurdle is of no value to anyone. Doing a Proof of Concept study means having a concept to prove.

In any other industry, the disciplines that end up producing a marketable product may well regard each other with healthy cynicism, skepticism and disrespect, but they recognise the interrelationship between their disciplines, and see the separation with clarity too. In pharma, it is essential to recognise that a 'product' is not the same as in most other industries - the product that ends up launching is a combination of the molecule and the evidence that it has collected. Those two things are interdependent, of course, but the evidence that was not collected is also important - it may be because it doesn't work in other areas, or that it was never given the chance to work.

"In pharma, it is essential to recognise that a 'product' is not the same as in most other industries..."

For too long in pharma, however, marketing has allowed itself to be the one that receives the ball tossed over the wall, and tries to run with it / sell it. Unfortunately, they have also behaved as though that was all they had to bring to the process. In one classic meeting with a (now-departed) Head of Development, we heard the line ‘Marketing get involved too early as it is. All they ever do is to come in and say "could we make it once a day instead?"’ His comment said more about the quality of input to the early evaluation process (and his own company's marketing, perhaps) than about the correct place of Commercial in decisions about where to put a product in a market.

There remains too much 'obviousness' about the early phase development of a molecule - 'if we have a pain drug, we should do the normal pain trials, and go looking for a signal that looks interesting.' That approach would be fine if the process could run in two ways, if the tape could be re-run and a different outcome be taken to market. However, limited patent life will always mean that the process is one-way, and the risk of underpowering a study to produce a claim that can be used on market while the teams were waiting for an indication of difference to emerge is significant.

All of this places a significant challenge on the Commercial teams to prove their value. Understanding how the market will value whatever the product has shown is an important feedback loop to Clinical / Development. Too often it is a black hole, however. We heard one Clinical group suggest that sending clinical development plans into Commercial be like 'throwing stones into a jellyfish – they go in, but nothing of value comes back.' Of course, any healthy system needs a feedback loop, needs its 'I wonder if…' and 'here's why’ moments. The role of the commercial members of a team is to be that feedback loop, to say 'if you do this, here is what will happen commercially,' whereas too often they end up discussing clinical trial design, and try to understand the molecular pathways.

"There is no development that does not have a commercial consequence, and the presence of that feedback loop is critical to make the system healthier."

Here's why that's a problem. If you think an answer is obvious, and that your task is to find a way to deliver that answer, you will work diligently towards its solution. If, as part of that diligent work, you have to produce clinical development plans, there is a presumption that you're good at that. If you then send that plan around and the only commentary you get is on the plan itself, there comes a time when sending it around becomes less and less productive, and more and more annoying.

Marketing in pharma needs to recognise and embrace its proper role with clarity - to provide the commercial 'so whats' from the development plans, and to suggest other destinations. There is no development that does not have a commercial consequence, and the presence of that feedback loop is critical to make the system healthier. Continuing to suggest that it can sell whatever is served up does no-one any favours.

About the author:

Mike Rea is a Principal with IDEA Pharma, who enjoys taking a look outside the industry to learn how it can think differently. For direct enquiries he can be contacted on mike.rea@ideapharma.com and for more information on IDEA Pharma please see http://www.ideapharma.com/what/default.htm.

How can Commercial better feedback to Clinical?