To the tune of “It’s a Small World“…
It’s a world of swag
A world of beers
It’s a world of sessions
And a world of careers
There’s so much that we share
That the Fail Whale’s not rare
It’s a small world after all
There is just one room
Where the keynote’s done
Though the press corp’s outside
Twitter can’t be denied
It’s a small world after all… [Chorus]
Speakers Daniel Todd, from EMD Serono, and Steve LaPierre, from Boston Scientific, were led by Foley Hoag lawyer Jayson Slotnik in a discussion of the final CER legislation and predictions about implementation. The overall tone was skeptical — the panel noted the potential for CER data to ultimately contribute to CMS coverage decisions, and worried about the cost of prospective randomized trials and about potential impacts on the FDA approval process.
They were, however, optimistic about the role of personalized medicine in the CER implementation. Steve LaPierre expects it to be helpful, and Daniel Todd advocates using the reference to molecular and genetic subtypes in the legislation to push for personalized analysis if a product is selected for a CER study. He calls personalized medicine a silver lining.
The panel also noted positive structural aspects, including helpful governance provisions in the CER legislation. Specifically, they were impressed with the public reporting and audit provisions and the availability of comment periods to allow private sector input.
In looking at how CER will shake out, the panel expected progressive adaptation of the program over the next 3-7 years.
Daniel Todd emphasized the importance of picking a first recommendation to establish credibility. The controversy this year about breast cancer screening recommendations shows the loss of credibility that can come from a debatable result, so they expect CER to ramp up over time.
He also predicted that dissemination of CER results through social media may drive bottom-up adoption of findings, and that defensive medicine may also contribute to adoption.
As noted in the lead up to BIO, several of the conference sessions touch on industry trends we’ve been following here on the blog. One of these was today’s session entitled “A New Kind of Non-Dilutive Financing and Fundraising: Partnering With Not-for-Profits,” which we’ve been following as commercialization by non-profit foundations. Our coverage of that trend started off focusing on the financial advantages to companies of finding a commercialization-minded nonprofit partner, but recently we’ve also noted the strategic advantages of these collaborations.
At today’s panel discussion, Genzyme’s Jim Geraghty added to the list of strategic advantages of nonprofit collaborations, echoing Avila’s CEO Katrine Bosely who recently acknowledged the value of the Leukemia and Lymphoma Society’s network of clinician and patient relationships. Geraghty added:
- access to scientific data that may have benefits to other company programs; and
- relationships with governments and other clinical gatekeepers.
Most interestingly, Geraghty noted the contribution that nonprofit collaborations can make to employee goodwill and morale in an environment where pursuit of profit can run contrary to the norms that attracted employees to the field of biotechnology in the first place.
The panel also drove home the enormous role the Bill & Melinda Gates Foundation has played in changing the way nonprofits think of their roles in health. Gina Rabinovich from the Foundation was unwavering in stating their commitment not to publications or conference output, but to measurable health outcomes like reducing infant mortality. Kudos.
I just came from a breakfast meeting between Ontario’s Ministry of Research and Innovation and the Governor of Victoria, Australia. Everyone agreed on the importance of quantitative assessment of the biotech industry, and everyone agreed that finding and measuring (and communicating) success is difficult.
So I was glad to be able to head straight for the Battelle-BIO session presenting data gathered by Battelle, BIO and PMP Public Affairs Consulting tracking “the development of the U.S. bioscience industry on a state and metropolitan area basis .. since 2004.” Much of the data in this year’s report ends at 2008, so it predates the worst of the recession and much of the recent pharma M&A (and associated synergies R&D job cuts). Still, there is some interesting hard data on jobs, investment and best practices to add to this blog’s collection of biotech statistics. Notably:
- The only job growth 2001-2007 has been in “Research, Testing & Medical Labs,” which Battelle says includes CRO and startup jobs. Jobs have been flat at best in Ag, Drug/Pharma, and Med Device. Reflects increased pharma outsourcing.
- This data shows a high multiplier, with 5.8 other jobs created per new bioscience job.
- 27 states have grown at least 1,000 jobs since 2001.
What are the policy initiatives that stand out?
- 38 states have R&D tax credits, with 7 of these being refundable programs and 4 allowing transfer of credits.
- 20 states offer tax credits to investors in angel and/or early-stage VC funds.
- 13 states have fund-of-funds programs, 10 states have made direct LP investments and 14 states have made direct investments in bioscience companies.
Here’s a link to the full report: http://www.bio.org/battelle2010
April 28, 2010
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As I’m preparing for the BIO conference in Chicago next week, I’m excited to see that several of the biotech trends we’ve been following on the blog are showing up as conference sessions.
- Interested in “A New Kind of Non-Dilutive Financing and Fundraising: Partnering With Not-for-Profits”? Get an early start at our trends page on Commercialization by non-profit foundations!
- Does “Comparative Effectiveness Research and the Government Role” or “Transforming Health Care Through Personalized Medicine” catch your eye? Check out the stories we’ve highlighted on Comparative Effectiveness and Personalized Medicine!
- Of course, with the new regulatory pathway created by Health Reform legislation in the U.S., Follow-on Biologics (aka Biosimilars) are all the rage at BIO this year.
- and the whole thing kicks off with Lilly’s General Counsel speaking on “Leveraging IP to Spur Global Biotechnology Innovation, Investment and Jobs” – emphsizing the link between IP Constituencies and Global Innovation that we have been following for some time.
Stay tuned for news from these and other sessions as we hit the conference next week!