The Massachusetts Biotechnology Council meeting on The Business of Science concluded March 27, as it began: lots of discussion of the technology, interspersed with programs about the business and financial aspects of bio which all had the same themes: bio is the great wave of the future, Massachusetts is at the forefront, but other geographic bio clusters are hot on our heels and there are many ways we in Massachusetts can be overtaken and surpassed.
One interesting counterpoint came from an Indian panelist who noted that the suppositions that FDA was too slow and too conservative to the detriment of US bio in general, are simply inaccurate. Notwithstanding the oft-recited tales of horrible delay in FDA, the timing of drug approval overseas in not faster and will not become faster because other countries rely on FDA to set the tone and the standard of review. This assertion was not directly challenged but was, alas, simply ignored; the final speaker, who was from FDA, was asked in several ways why the FDA moved so slowly.
The FDA position, by the way, articulated by Dr. Eric Perakslis (Informatics chief), is that they DO hurry when there is a clear unmet medical need; the FDA will be willing to incur risk if the benefit seems to balance it. The biggest problem the FDA has these days, he noted, was in their newly established regulatory function over tobacco, where he wondered how to measure benefits against risks for a product having no benefits at all. (My best guess is that Eric is not a big smoker.)
What is impeding Mass bio? The state gifts ban (which kills interaction that leads to innovation); the unique Massachusetts ban on co-payment assistance which thereby imperils the payment stream; the failure of schools from elementary to Community colleges to train workers in requisite skill sets; anti-immigration laws that now overly restrict special visas; a lack of language skills among our workforce members; lack of government funded apprenticeships in private industry thereby impeding hiring of skilled and experienced workers; the growth of viable bio clusters elsewhere with governmental support superior to that afforded in Massachusetts (citing particularly Germany and Singapore).
The attendees are all “bio people” and it is hard to separate their valid but survivable complaints from the truly existential threats to Massachusetts biotech companies; every industry has its burdens to bear, and bio is not the only industry that fairly can say that it is over-regulated, under-served by government, not supported by the educational system and, these days, denied essential capital.
The one extremely positive message that came out of the meeting, however, and one message shared by attendees from within and outside Massachusetts, is that everyone today believes that Massachusetts has innate advantages in Higher Education and entrepreneurship and that therefore, given appropriate nurturing, bio will be an economic and social engine for the region for a very long time.