Is there a global need for breakthrough drugs? Tick.
Is there the industry and political will to develop such drugs? Tick. And what about the pipeline infrastructure to make this happen? Very large tick.
So why does Ted Torphy, Vice President and Head of External Innovation for Research Capabilities at Johnson & Johnson, believe that a lack of alignment between stakeholders in the pharmaceutical industry could be severely hampering the progress of the discovery and development of new drugs?
“Right now, many of the stakeholders within this ecosystem – the payers and the regulators and the drug companies like us – are not necessarily aligned to the extent that we could be to discover, develop and launch drugs that really make a difference, the breakthrough drugs where there's a lot of risk associated with them,” says Torphy.
“I'm not pointing a finger at any of the constituencies, but it seems like there should be an expedited pathway for lifesaving or life-changing drugs where there is an incentive for the innovators of those drugs to focus more of their resources there, rather than focusing many of their resources on incremental changes for well-understood therapeutic care.”
One example Torphy points to is the integrated EMR-enabled databases. “With these, you can essentially follow what's happening with patients who are receiving therapy in real time. But after a robust phase II programme, if it's truly a lifesaving or a life-changing drug and you're a pioneer in that field, how can we set things up so that we could launch it in a contained way, that we launch it after a robust phase II but only within this system where there's essentially daily monitoring? If we could do that, the regulators would get much more information before a drug is launched more widely, and much more information about the safety and efficacy of the drug in real patients. Not just well-controlled clinical trials but in real life, in real patients.”
Which ultimately adds up to a win-win for all involved, concludes Torphy. “The patients win because they're getting therapy for debilitating or life threatening disease. We win because we understand much more about our drug and who the drug works in and who the drug does not work in before it's finally launched. So it just seems to me that the financial incentives are not necessarily aligned right now to deliver truly innovative drugs. But that's a challenge we all need to work towards.”
The pathways to meet that challenge will no doubt be one of the issues on the agenda at the Next Generation Drug Discovery Summit 2011, which takes place from 5-7 April 2011 at the Park Hotel, Bremen, Germany.
This closed-door summit, hosted by GDS International, features some of the leading voices in the European pharma drug development sector, including Phillipe Van Der Auwere, Global Head of Safety Risk Management at Roche; Kalpana Merchant, CSO.