The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Genetically Engineered Animals

Biotech Trends of 2009: Three Biggest Losers

When we started the blog almost a year ago, we identified what we thought would be key trends for biotech investors and companies to watch.  Most panned out, but a few turned out to be… not so trendy.  You can call them premature (if you’re feeling generous) or call them dumb (if you’re feeling mean); but you can definitely call them losers, since they clearly failed their appointed purpose (making us look smart informing you, the reader).

Without further ado, 2009’s three biotech trends that weren’t:

  • Genetically engineered animals.  Way back in February, the FDA released final guidance on GE animal approvals and approved ATryn (a drug produced in the milk of GE goats).  We thought 2009 would be a year of approvals and other successes in this area, but we’ve hardly herd (sic, sorry) from anyone since.  We’ll keep an eye out for ewe, but this is one trend that probably won’t be baaaaack.
  • Commercialization by Foundations.  Despite a late-breaking story on this front about creative approaches in ALS and Diabetes communities, this “trend” has been another loser.  When we kicked things off, we identified two driving forces behind this trend, and each has taught us a lesson: (1) never use the words “availability heuristic” in a blog post about biotech; and (2) a sinking tide sinks all boats.  The crappy economic environment in 2009 was really no better for foundations than for anyone else, but we look forward to more creativity and private enterprise in this area next year.
  • Patent Reform.  It huffed, and it puffed, but with S.610 still in committee, patent reform carries over to another year.  Maybe now that health care reform is almost done using up all the reform oxygen, the patent system will get another turn. Don’t hold your breath, though.

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Allocating Spending to Support R&D: UK, U.S. and Canadian Approaches

The U.S., Canada and the UK have all acknowledged the central importance of R&D even in these recessionary times.  However, the three national governments have decided to focus their spending on different steps of the R&D equation:

  1. Education: UK Takes the Long View
    British PM Gordon Brown, in a speech this week, identified three priorities: research, education and training, and public discourse.  However, only one of the three, education, was the subject of specific increased targets and spending:  retraining to increase the number of science teachers, a goal to double the number of pupils in state schools taking ‘triple science’, and a new Diploma program.  The U.S. and Canada have increased funding for graduate studies, but the UK effort is focused at an earlier stage, to rebuild the interest and capabilities of domestic graduates. 
  2. Publicly-Funded Research: U.S. Takes the Lead
    The focus of the U.S. R&D spending increases has absolutely been on research.  The increases for the NIH and NSF in the stimulus and the budget will go largely to increasing the volume of publicly-funded research.  PM Brown’s speech also vowed to protect funding for science from competing demands for Government support during the downturn, but did not propose increases over the existing 10-year plan.  Canada’s budget actually cut research funding across the three main granting agencies.
  3. Commercialization: Canada Takes Off 
    Canada’s focus was on commercialization.  The 2009 budget included $200 million allocated to the National Research Council’s IRAP program — $170 million to double the program’s contributions to companies, and $30 million to help companies hire over 1,000 new post-secondary graduates.  It also provided significant additional funding to BDC.  The only comparable spending in the U.S. was the $400 million for ARPA-E, which is allocated to energy programs, and supports research as well as commercialization.  PM Brown’s speech recognized the importance of maintaining the country’s struggling start-ups, and he has reached out to big pharma, but promised no specific action.

What’s still missing:  Stimulating Output

  • Despite calls in the UK, the U.S. and Canada, there have been no major tax policy changes enacted in this round of budgets and bailouts that ease the burden on, or return money to, early-stage technology companies.  Ontario has actually taken some steps in this direction with the Ontario Venture Capital Fund and the Ontario Tax Exemption for Commercialization.
  • Nor have there been many changes that increase the value of outputs: in the bio/pharma area, the UK has probably moved farthest in this direction, with upcoming reforms of the National Institute on Comparative Effectiveness (NICE), while the U.S. has seen decreasing FDA approvals and is allocating new comparative effectiveness funds.  On the other hand, approvals of GE animals, support for personalized medicine and big spending on electronic medical records will provide support to specific industry initiatives.

Stay tuned to our Bailout Page for updates.

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GTC Biotherapeutics goes for a Regulatory Double Combo Shot

GTC Biotherapeutics, which recently saw ATryn approved, announced a collaboration agreement with AgResearch Limited, a New Zealand Crown Research Institute. 

AgResearch will develop genetically modified animals capable of producing the building blocks for “biosimilar” versions of existing products that will begin coming off U.S. patent in 2014.

The double combo shot:  the success of the collaboration depends on

  1. a continuing trend of GE animal approvals, as well as
  2. the successful introduction of a biosimilars pathway in the U.S., (which is called for in Obama’s budget).

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Trends in 2009: Genetically Engineered Animal Approvals

The past few weeks have seen at least three conspicuous developments towards a functional regulatory regime that will lead to increasing numbers of FDA approvals for Genetically Engineered (GE) animals:

  1. The FDA released their final Guidance on Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (pdf), as well as a FAQ and comment responses.
  2. The FDA approved ATryn, a drug produced in the milk of GE goats.  Consistent with the Guidance, CBER approved the human biologic based on its safety and efficacy, and CVM approved the rDNA construct in the goats that produce ATryn.  In keeping with the comment responses, the FDA took steps to increase the transparency of the process by holding a public hearing prior to approval.
  3. Yesterday, a report surfaced (so to speak) about the FDA’s visit to Aqua Bounty Farms, in Prince Edward Island, Canada for an inspection in connection with Aqua Bounty’s application for approval of GE salmon, and the FDA spokesperson reached by CBC said approval could come “soon.”

All in all, it looks like the FDA is not wasting any time trying out its shiny new guidance.  Other Canadian products noted in the FAQ are “pigs with smaller environmental footprints, as well as GE animals intended to produce human pharmaceuticals.”

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