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:
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.
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.
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.
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.
How we market: things with medical names are perceived as more serious, more likely to be a disease and more likely to be rare, according to a team at McMaster. Read this, or you’ll get cognitive malnourishment.
You may not know this, but Canadian researchers can compete for NIH extramural funds, and they do so quite successfully. I reviewed the 2008 data from the NIH budget site, which shows that Canadian researchers were awarded $47.4 million in 2008 (out of a total of $212.4 million total awarded outside the U.S.). Hopefully this amount will increase in 2009-2010 as the stimulus and budget money for the NIH is allocated. Considering the research funding cut in the Harper budget was $113 million, the NIH funds are a significant contribution to the Canadian landscape.
Some geographic breakdown: Toronto (69 awards, $18.4 million) and Vancouver (37 awards, $8.7 million) are the largest recipients.
In case you hadn’t heard, Basilea filed a claim for arbitration under their license agreement with J&J for the antibiotic ceftobiprole, based on the anticipated news, confirmed today, that the the EMEA has halted the EU Commission decision process on ceftobiprole pending EU led GCP inspections.
Brian Orelli has a nice post up on the wider ramifications of the mess that the industry will be in if the FDA has to scrutinize the reliability of every filing.
Wider ramifications aside, it is unusual to see a license and development agreement go to arbitration (as the WSJ Post points out, quoting Credit Suisse analyst Catherine Arnold).
Based on the description in Basliea’s 2005 annual report (pdf), the agreement with J&J appears to have contained the usual joint committee structure for managing the development process; so it will be interesting to follow the story and see if we can learn any drafting lessons.
British Columbia is the first jurisdiction in North America to offer a children’s vaccine called Infanrix-hexa™, which contains six immunizations in one, resulting in three fewer needles in the overall B.C. infant vaccine schedule, and
Sustainable agriculture, when the White House announced its nominee for second-in-command at USDA: Kathleen Merrigan of Tufts University, who had been a top choice of the Cornucopia Institute to run USDA’s National Organic Program;
The U.S. House of Representatives Appropriations Committee unveiled its Omnibus spending bill for Fiscal Year 2009 yesterday (pdf). The House is expected to vote on the package this week. For Health and Human Services, the Ombnibus contains $30 billion for the National Institutes of Health (NIH). This funding is in addition to the $10 billion added to NIH in the American Recovery and Reinvestment Act. The Omnibus also includes a new initiative to reduce hospital and clinic infections that cause nearly 100,000 deaths each year, and requires national and state plans to combat infections with $22 million.
IP Osgoode just linked to the Cross-Border Biotech Blog as the “IP Pick of the Week” this week. Thanks Rex!
The Osgoode IP Law and Technology program is hosting a conference on March 20th entitled “Commercialization of innovative research: Implementing solutions that work for Canada.”
Paul Carenza, a colleague of mine at Ogilvy Renault, is speaking at the conference. You may remember Paul as the helping hand responsible for our post a few weeks ago on how *not* to cut back in difficult economic times.
In the context of some discussion about the Canadian federal budget, I had blogged about the idea of “an Ontario-based commercialization award of international scope, like the Gairdner Awards, that would seek out and reward internationally outstanding achievement in entrepreneurship.”
A press release from Nuvo Research Inc.(TSX: NRI), a Canadian drug development company focused on topical and transdermal delivery technologies, pointed me to the Edison Awards. A quick scan of the product nominees this year makes the Edison Awards seem like an excellent model for what I would hope, through our discussions at the Life Science Coalition, to be achievable in Ontario.
I note the Ontario Premier’s Catalyst Awards, along these lines, but they appear to be geographically limited (OBCA and CBCA companies headquartered in Ontario). The beauty of the Gairdner program is its international scope and caliber, which could stimulate Ontario activity by reputation and example.
Have you heard of other innovation/commercialization awards? Is this a good idea for Ontario? Let us know in the comments…
The optimal dose of Warfarin for an individual can vary across a 10-fold range, and depends in part on genetic variation in two genes, CYP2C9 and VKORC1. In 2007, the FDA required a labelling change to warn of patients with increased risk of bleeding due to these variations. However, population-wide assessments of outcomes based on genetic testing were not definitive.
The NY Times Business section (and the WSJ Health Blog) this morning picked up the story — that we noted last week — that Waxman and Pallone plan to reintroduce legislation essentially reversing the Supreme Court’s ruling in Reigel v. Medtronic. Those stories also note a Senate version to be introduced by Sen. Kennedy and Sen. Leahy.
The basis for the Supreme Court’s decision in Reigel v. Medtronic is the interpretation of the Medical Devices Amendments of 1976, so by enacting changes that specifically disclaim preemption of state tort law, Congress could effectively moot the Supreme Court’s ruling.
However, two state-level developments may change the debate:
The Wisconsin Supreme Court’s decision this week in Blunt v. Medtronic, which was dictated by Reigel v. Medtronic, may create additional pressure in favor of federal action and maintaining state tort liability (although note that only two of seven justices signed on to the Wisconsin concurring opinion decrying the result); but on the other hand
The Georgia Senate Economic Development Committee held its first hearing yesterday on legislation protecting Georgia-based businesses or companies with more than 200 employees headquartered out of state from liability for defects in any drug or medical device that has been approved by the FDA. If this initiative is successful, and is replicated in other states, both the Supreme Court’s ruling(s) and the federal legislation would be moot, since there would be no underlying state tort liability.
The results of DiagnoCure’s (TSX: CUR) 5-year study of GCC as a marker for colorectal cancer recurrence, published in JAMA, showed that GCC is the strongest independent predictor of colorectal cancer recurrence in patients considered low risk by current assessment methods.
In Beni’s post earlier this week on Biosimilars, he identified two major challenges to introducing follow-on biologics into the North American market: technical proficiency, and the absence of a regulatory regime.
It is not at all apparent that the FDA approval process actually guarantees a minimum level of safety for medical devices.
However, the concurring justices are mistaken to rely on the cited concerns. The GAO and “dissident” scientist concerns, as I understand them, were about devices approved through the 510(k) process, not the PMA process, but only PMA-approved devices are exempt from State tort liability under Reigel v. Medtronic. Medtronic v. Lohr specifically denied preemption for 510(k)-approved devices.
That is not to say that as a matter of institutional competence, I believe the FDA is better suited than the courts to assess post-approval device safety. I don’t think we have the data to make that assessment. Certainly if the FDA is expected to competently act as the final arbiter of product safety, it would need more funds, and perhaps revisions to post-approval regulations. Or maybe Waxman will succeed and legislate tort un-reform.
Graeme’s talk, as usual, was very interesting and not very print-able.
Carol’s talk was also great. Of course, Atlanta, Georgia is hosting BIO 2009, which is moving ahead full-steam. Georgia also has some interesting capabilities and initiatives
One focus in Georgia is on healthcare IT. Atlanta in particular has an extensive fibre optic infrastructure from having hosted the Olympics, and this will be a valuable asset as Electronic Medical Records are more widely adopted.
Most interestingly, the State has a “life sciences facilities fund“ that provides low interest loans secured by fixed assets to assist start-ups with finding appropriate space. Carol mentioned that the program just funded a 15-year loan with deferred interest at 60% of Prime.
And on the topic of vaccines, the U.S. vaccine court issued three different rulings on a group of vaccine-autism claims, and didn’t mince words. The three Special Masters found the claims “speculative and unpersuasive,” “overwhelmingly contrary” to the evidence and relying on “scientifically flawed or unreliable articles”, respectively.
Last but not least, a few viruses turned up in new and interesting places:
A report from the French food safety agency, Afssa, saying MON810 is as safe as conventional maize leaked to the press just a few days before Envirmonent Minister Jean-Louis Borloo was due to appear before a committee of European biotech experts to justify France’s ban. This prompted French Prime Minister Francois Fillon to say Thursday that “France is maintaining the suspension while it awaits a (European) Commission decision which it will respect.”
When the committee of experts met Monday, they did not have the “qualified majority” (a population-weighted test) to overturn the MON810 bans in France or Greece, the same result as in December when the voting was to lift similar bans in Austria and Hungary. Now all four cases will be addressed by the EU’s council of ministers on March 2.
And globally, planting of GM crops grew by 9.4% in 2008, according to the reporting in Nature on the 2008 ISAAA report. Two countries — Egypt and Burkina Faso — joined South Africa as GM-growing nations in Africa.
The so-called biotechnology drugs or biologics (large, complex protein molecules derived from living cells, usually by use of recombinant DNA technology) are among the fastest-growing class of pharmaceuticals. Within the next two years, some market forecasts predict that biopharmaceuticals will amount to more than 50% of newly approved medicines. In addition to a growing market share, a substantial number of major biotechnology-based drugs will come off patent and enable the development of new biologics. The race by pharmaceutical companies to get into biologics, or further support their existing biologics capacities in order to start developing biosimilars or follow-on biologics (FOBs), is illustrated by the rapid pace of recent deals in this sector. The latest of these deals is the acquisition of Insmed by Merck, which was announced last Thursday; however I believe this deal was more about expanding state-of-the-art manufacturing facilities rather than acquiring extremely valuable FOBs.
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