Comments on: Repairing the Engine of Drug Innovation

By: GabeGurman

GabeGurman — Fri, 06 Nov 2009 18:11:03 +0000

Patricia,
John Lechleiter brings up some very valid arguments. For as long as the FDA has existed, companies have complained that its regulations and directives have hindered innovation and, subsequently, business growth – and new regulations continue to be introduced.

So the question becomes how can companies work within this framework to continue innovating despite intense regulatory scrutiny? By finding ways to streamline processes and improve compliance to the point where regulations become less of a burden and consumers can develop trust in the safety of their medicines.

The answers for biopharma innovation and drug safety can be simple. Better processes. More efficient regulatory reporting. Streamlined management of quality initiatives to mitigate risk. FDA reform may take the chains off innovation in the short term, it won’t be long before more regulations arise that are deemed a hindrance – it’s just inevitable. By addressing these issues at a process level, companies can be prepared to confront them and continue their innovation regardless.

By: cliffintokyo

cliffintokyo — Fri, 06 Nov 2009 08:37:58 +0000

Ron: enjoyed reading your good, thought-provoking comments.
“Big pharma does not understand what its smart people are buying into externally” looks a bit like the beginning of an admission that business admin people do not really understand new technology R & D management. Does this mean that ’science-managers’ might become more responsible for the in-licensing of R & D projects? This is something that this group of people would seem to be very well qualified for but have historically not always handled well, in my experience. To all smart R & D managers out there – be aware of that ‘increased accountability’ rubrik which goes along with empowerment; ‘naturally’ a COO might say!

By: Ron

Ron — Thu, 05 Nov 2009 17:53:02 +0000

Intuitively, post-merger size and the resultant diversification should reduce risk, even if productivity is not increased. But to maintain returns, diversity has to mean including some higher risk ventures that can pay off big. Just getting big without taking intelligent risks won’t work.

Collaboration with small companies, academia and government is a tricky area. Just as Wall Street foundered by overestimating the smartness of its smart people when it got involved with derivatives, Big Pharma often doesn’t understand what its ’smart people’ are buying into on the outside.

By: cliffintokyo

cliffintokyo — Wed, 04 Nov 2009 08:38:59 +0000

Good blog.
Big pharma is populated by intelligent people who will certainly come up with organizational strategies designed to overcome the issue of internal innovative R&D being smothered by the monsters created by critical-mass building mega-mergers.
Many people suspect that increased patient focus and increased accountability will inevitably mean concentrating R&D on lower risk projects with higher chances of success. What insider would say it should be otherwise in the present embattled climate? Larger pharma companies in Japan have also recently been acquiring bioventures with products in development. For the forseeable future there will be relatively little room in big pharma for research scientists who have a personal ambition to work on breakthrough therapies for unmet needs.
Biopharma ventures will (we hope) seize the opportunity to fill the gap, and this is where visionary and inspired research champions will have to look for exciting future employment. If the ventures don’t rise to the challenge, it is difficult to be optimistic about the prospects for innovative biopharma R&D in 15-20 years time…..