October 29, 2009
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As part of the Gairdner Foundation’s 50th anniversary celebrations this week, there was a breakfast panel this morning with a lot of brainpower (even for MaRS). Cal Stiller lead a discussion by David Baltimore, Phillip Sharp and Corey Goodman who between them have three Gairdner awards and two Nobel prizes.
These top-notch scientists also have truly impressive corporate expertise: Board members of Amgen, Biogen and Limerick BioPharma. They turned their attention to “unclogging the pipeline.”
David Baltimore discussed reasons we’ve seen fewer approvals:
- Higher regulatory safety barrier.
- Low-hanging fruit is gone. A lot of targets are for diseases that are not fatal in the short term, which (see #1) creates a high safety barrier. Also, he says the molecular targets are harder.
Baltimore also identified potential areas of success: a subject area (immunotherapy) and a structural area (UCLA medical center’s translational research institute).
Phillip Sharp talked about the changing structure of early stage and translational funding.
- VC is re-thinking their model, but pharmas are reaching out earlier in the pipeline with incubators and academic outreach; and there is more public funding available to move products further along the pipeline.
- Trends he identifies: personalized medicine (patient-driven with $1000 genome); and a huge role for engineers and incremental improvements.
Corey Goodman starts with some stats:
- current success rate is closer to 1 in 25, not the 1 in 10 number still cited from the 1990′s
- cost of a new drug (R&D dollars divided by successful approvals) around $3 billion.
Nevertheless, Goodman sees upside due to huge unmet medical needs, deficient pipelines and vast academic output.
Will healthcare reform plans interfere with the United States’ (hidden) subsidization of global drug development through high prices?
- Baltimore points to $80 billion pharma deal that avoided price controls, but says prices are unsustainable.
- Sharp agrees that costs can’t be a bigger part of GDP, but it’s a big bucket even at current levels and there is room for efficiencies that don’t impact reimbursement.
- Goodman says importation can’t be prevented long-term based on a safety argument, so we’ll have to deal with pricing more globally [regardless of U.S. health reform efforts].
Aren’t early-stage acquisitions still (and permanently) the outliers?
- Baltimore thinks there will be a number of early-stage transformative technolgies that yeild early successes, but VC and other early funders need to be more stringent and keep an eye on the long term potential of even very early stage products.
- Sharp thinks that academia is not well-suited to disciplined discovery, and if the policy goal is to develop more products, we’ll need structural changes in academia.
The panel wrapped up on an optimistic note. Not surprising — how can you not feel good in Gairdner season? Speaking of Gairdner season, don’t forget to check out this year’s winners.
July 2, 2009
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Here’s a bit of Canadiana to start off the catching up:
May 19, 2009
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I was at breakfast yesterday morning with university and company members of the BIO Technology Transfer Committee. Some interesting tidbits, colo(u)red by my preception and commentary and not to be attributed to any other attendees:
- A lot of the stated support for the Senate patent reform bill is soft and is based on the assumption/condition that the House version won’t over-reach. Conversely, an equally moderate House version could consolidate support and draw new commitments.
- On follow-on biologics, the main bills have two differences: data exclusivity period, and a mechanism to challenge entrants before approval/sales begin. The structural problem that concerns people on the IP side is the risk of a product that is similar enough for FOB regulatory approval, but sufficiently dissimilar to avoid patent infringement.
- Access to medicines, both domestically (ALS New York Times article, ACLU-Myriad lawsuit) and internationally, is increasingly a point of pressure on academia and industry, and has been incorporated in AUTM’s Nine Points to Consider in Licensing University Technology document. Relatedly, there is apparently talk at the HHS Secretary’s Advisory Committee on Genetics, Health and Society about using Bayh-Dole to increase access to genetic testing.
- The SBIR/STTR program is up for renewal in the U.S., and many constituencies would like to see the programs opened up to allow venture-backed companies to receive SBIR/STTR support.
P.S. First time here at the Cross-Border Biotech Blog? Welcome! Check out who we are, check out our Trends in 2009 series, or hit the search and navigation tools on your right and see if you see anything interesting.