The long-term perspective at Roche allows us to be courageous
At Roche we have the possibility for the long-term perspective, which allows and also requires us to be courageous.
In the development of a medicinal product there can also be setbacks. Which highs and lows have you already experienced in your role as Medical Director?
Roughly ten years ago the doubters were especially predominant. At that time Roche was undertaking research together with Genentech on a new active substance for the treatment of patients with advanced cancer. When I took over the lead of the Roche project team there were already seven negative Phase-II studies for different cancer types. Seven! Our US development partner Genentech, at that time not yet a part of Roche, preferred to discontinue the development of the molecule originating from the own laboratory, and also at Roche there was indecisiveness whether it was worthwhile to continue working on it.
How did you handle the situation at that time?
In the final instance the faith in the preparation was greater than the fear of failing again. We took another detailed look at the available new preclinical data, which was quite promising with a specific form of breast cancer (HER2 positive). So as project team we decided to research further at a lower level - in spite of the no from our partner and in spite of all prejudices. Thanks to a clear rationale and specific success and discontinuation criteria we fortunately received a last chance for a clinical study intentionally planned with a lower number of patients. Because the initial study results were impressive and convincing. The team resources grew again, the number of the study participants was extended to address further scientific questions. Finally on the basis of the generated data we were able to design a large Phase-III marketing authorisation study. Today the treatment is an inherent component in the treatment of women with (HER2+) breast cancer.
Can such a success be transferred to other areas at will?
Naturally not - in research one must also be able to give up at some point and yield to a negative data situation. It is good to believe in one’s own strength, but it is better to substantiate it with facts. Scientific data sets the boundaries for us that are necessary so that courage does not turn into overconfidence. In the case of the breast cancer medicinal product, when reviewing the understanding from the preclinical phase we did not anticipate that we would hit rock bottom with our final small study.
Does one need to balance innovation and security?
Our aspiration is to work at the forefront of science and to show new paths. Therefore we want to approach a possible innovation completely openly. At Roche we have a high number of so-called early clinical projects, of which it is expected that roughly 90% will never make it to routine clinical application. For Roche this is not a large problem because our innovation aspiration with world-class researchers definitely rates higher than unconditional economic efficiency, however Roche naturally also aspires to increase the success quota. In short: at Roche we have the possibility for the long-term perspective, which allows and also requires us to be courageous.
Have you also already failed?
Some years ago we wanted to develop an already established medicinal product for additional indications, which means an application to minimise the relapse risk of already presumably healed cancer patients. After numerous Phase III studies and investments of more than one billion Euros we had to admit a complete failure. And this really hurt – not only us, but it was also a disappointment for the patients who had participated in the very long studies and had raised hopes.
How is the topic of "failing" handled at Roche?
After this failure I was initially very intensively engaged in the processing, communication, safety and regulatory measures. There was hardly any air left to breathe. It is reassuring that Roche is not a company where a rude awakening follows later for the employees. I have never heard negative voices and reproaches - this is also due to the fact that investment decisions are carried widely and are based on clear scientific hypotheses, which unfortunately in retrospect are not rarely proven to be wrong. So researchers at Roche do not hit rock bottom nor do they lose the ground beneath their feet when they risk innovations. This they can be certain of.
Read more about opportunities in Medical Affairs in Germany