The Cross-Border Biotech Blog

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

Monthly Archives: September 2009

In Praise of Universal Coverage From a Genomics Perspective

This could be the last chance in the U.S. to make good decisions about health care.  Why? Because now, before genome sequencing is fast and cheap and universal, we are in a political position rarely experienced outside philosophy books: we are still in the “original position,” behind the “veil of ignorance.”  I’ll try to make this quick, so forgive my mangling of Rawls.

Making “Just” Decisions

Rawls says that in order to make “just” decisions, you need decision-makers who do not know their “fortune in the distribution of natural assets and abilities, [their] intelligence, strength and the like.” 

That’s very close to the situation we have now — politicians don’t know much (beyond family history) about their own genomes or about their constituents’.  It has led to some good decisions, like the passage of the Genetic Information Nondiscrimination Act, but it’s temporary. 

Lifting the Veil with Genomics

Soon, genome sequencing will be fast and cheap and universal and there will be no more veil of ignorance.  Absent that, “[m]ore powerful parties rely on knowledge of their ‘threat advantage’ to extract favorable terms from those in less advantaged positions.”

For Example

A good example comes from the UK this week (via @jensmccabe).  According to The Times, new guidance from the General Medical Council (GMC) says that when a patient is found to have certain genetic diseases, doctors will be obliged to inform relatives about potential risks to their health.  As with any public health notification, there is a need to balance privacy concerns against public health concerns, but when you’ve struck that balance, should you have to re-visit the decision because of coverage gaps? 

Universal Coverage is the Cure

Universal coverage makes a just decision possible.  People with genetic diseases can be informed of their risk because they won’t lose their insurance or be forced into a high-risk high-cost pool as a result.  If there is no adverse coverage consequence — not availability and not cost — then there is very little “threat advantage” and people remain (functionally) genomic equals when deciding on healthcare policy.

My bottom line: If the U.S. moves into the genomic era without universal coverage, it will exacerbate existing inequalities and create new ones we haven’t even imagined.

First time here? Welcome! The Trends in 2009 page is a great place to start. Also check out the Twitter stream @crossborderbio.

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Biotech Trends in 2010: Crowdsourced Edition

We’ve been running with a number of trends since the blog started early in 2009, and though many of them will continue to be critical stories in 2010, I’ve been turning my thoughts lately to possible additions for next year:

Thoughts? Other suggestions?  Let us know

Update: Timely – see this New Yorker article on synthetic biology and a report on a poll on the topic via ScientificBlogging (both via @gw_dailyscan).

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Jeremy Grushcow Discusses Comparative Effectiveness and Personalized Medicine in Counsel to Counsel Magazine’s Life Sciences Feature

Trends Update — IP Constituencies: India M&A Spurs Pricing Concerns

world_map_2002We’ve been following the trend of increased innovative activity in developing countries, and have noted its likely effect on IP protection in those jurisdictions. In a variation on that theme, an article last Thursday in DNA suggests that

“Indian companies, which have been actively pursuing pre-grant and post-grant oppositions against the patents of MNCs, would become less aggressive after being acquired by Big Pharma.”

This seems like a plausible outcome, although it is counterbalanced by the increasing stake innovator companies are taking in generics and follow-on biologics companies.  It is also counterbalanced by statistics from Navroz Mahudawala at Ernst & Young (cited at the end of the article) showing that multi-national companies’ share of India’s pharma market has actually dropped by almost half over the last two decades. What is more interesting to me, though, is the nature of those investments, which appear to have been shifting to rely more heavily on India’s R&D capabilities. These domestic R&D capabilities will be the real driver of change in attitudes toward IP protections.

In light of shifting IP attitudes, the pricing of drugs is a legitimate concern, but consider what I’ll dub “the innovation cycle” — India’s increased R&D capabilities will fund higher incomes and help citizens afford higher-priced drugs, while countries that may have been importing India’s generics will be forced to develop their own generics production capabilities, which may eventually (as in India) lead to innovative R&D, etc., etc.

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Monday Biotech Deal Review: September 28, 2009

B&W_BigNickelLots of deal news this week, including the Canadian action noted at the time: the iCo-CPDD deal and ethica’s in-license transaction.  Plus there was plenty of international excitement today (repentance notwithstanding) with Abbott’s $6.6 billion Solvay play and J&J’s new 18% stake in Crucell.  Keep reading for a securities-palooza and plenty more after the jump…

Next Steps for Cardiome: activated Protein C Program will Seek Other Funding

Update: Cardiome extended its tender offer to allow time to digest the announcement below. Expiry is now October 13th.

When Cardiome (NASDAQ: CRME) (TSX: COM) announced its $27.5 million share buy-back program, the In Vivo Blog noted an earlier comment from its CEO, Doug Janzen, saying that Cardiome doesn’t “believe in the risks of building [its] own pipeline at this point.”

Well, it appears he meant it.  Cardiome has been developing its GED-aPC program via a subsidiary company, but has now decided that the drug “will be funded externally from Cardiome.”  The idea is that

“next steps for the program will be focused on finding external investors and/or partners to assist in future development of the asset.”

Also, Dr. Charles Fisher, CMO and EVP, Clinical & Regulatory Affairs, will be leaving the company and continuing as “a consultant to Cardiome.”

GED-aPC is a recombinant human activated Protein C (aPC) analog with a “broad” range of potential uses.

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Friday Science Review: September 25, 2009

A quiet week for journal publications but there were a few significant research related activities…

Canadian Stem Cell Charter: At the recent World Stem Cell Summit in Baltimore, Canada stepped up and demonstrated why we are one of the leaders in stem cell research.  This time it was not a lab discovery but the Canadian Stem Cell Foundation’s launch of a charter outlining ethical principals and a code of conduct to guide stem cell research in a responsible and ethical way.

The Stem Cell Charter upholds the following principles:
• Responsibility to maintain the highest level of scientific quality, safety and ethical probity
• Protection of citizens from harm and the safeguarding of the public trust and values
• Intellectual Freedom to exchange ideas in the spirit of international collaboration
• Transparency through the disclosure of results and of possible conflicts of interest
• Integrity in the promotion and advancement of stem cell research and therapy for the betterment
of the welfare of all human beings

Bartha Knoppers, a bioethicist at McGill University’s Centre of Genomics and Policy, authored the charter in collaboration with a working group of scientists, patients, ethicists and laypeople.  She describes the purpose of the charter:

“There have been a lot of spurious claims in this area, people doing the first of this or the first of that, and it not being true,”

“It’s a wake-up call to scientists to remind them that if they want to work in this field, they have to do so under a scientific code of conduct and it’s to reassure the public that this is not the Wild West.”

“We’d like to keep it a credible science,”

“We’d like to keep it a science that merits public investment and public funding.”

Signing on (www.stemcellcharter.org) and adhering to the charter is one way of doing just that.  It is also a way for the public to show their support for stem cell research and to make their voices heard.

By the way, September 23rd was Stem Cell Awareness Day!

The Michael J. Fox Foundation for Parkinson’s Research (MJFF): This was mentioned in yesterday’s post on this blog.  Michael J. Fox announced the charity status of the Canadian arm of his MJFF for Parkinson’s Research in association with The McEwen Centre for Regenerative Medicine (MCRM) and Toronto Western Hospital (TWH).  I just want to emphasize the significance from a research perspective.  He is an advocate for stem cell based therapy and his Foundation promotes and emphasizes the sharing of scientific information to facilitate quicker results – “We don’t just fund research.  We fund results.”

Flu shot increases risk of H1N1 virus:  An unpublished Canadian study is garnering attention by suggesting that a seasonal flu shot may actually increase an individual’s chances of catching the H1N1 virus.  The report is still under peer-review and the details are not available but it was enough for Ontario to modify its flu vaccination program this season.  Younger people will not be offered the seasonal flu vaccine until they receive the H1N1 vaccine, which will not be available until mid-November.  Other provinces are also considering making some changes to their programs.

The CDC and WHO are looking into this controversial study but are taking a cautious stance, refraining from acting too quickly:

“The reason why this may be different in Canada and in this particular study than in other places of the world is not yet identified. It may be a study bias, it may be that something is real,”

“None of the other countries have been able to find anything like that”

This enhancing effect would be unusual for flu viruses but not completely new from a biological perspective.

Dr. Danuta Skowronski of the British Columbia Centre for Disease Control and Dr. Gaston De Serres of Laval University led the research study.

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Trends Update — Commercialization by Nonprofit Foundations: iCo-CPDD Deal, plus MJFF Comes to Canada

One of the trends we’ve been keeping an eye on this year is the increasing willingness of nonprofit foundations to fund and support commercial product development.  Two updates today:

  1. iCo Therapeutics Inc. (TSX-V: ICO) is collaborating with the Consortium for Parasitic Drug Development (CPDD) to optimize one of iCo’s products for tropical conditions.  (That’s CPDD as in development of drugs to combat parasitic diseases, by the way, not a new and selfish approach to drug development.)  CPDD, a Bill & Melinda Gates Foundation grantee, is making an initial contribution of USD $182,930 to iCo’s work.
  2. The Michael J. Fox Foundation, which has been very active in providing funding to companies working on Parkinson’s treatments, has registered as a tax-exempt charity in Canada.  Hopefully this will open the door for more Canadian collaborations.

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Trends Update — Personalized Medicine: Montreal CRO ethica Licenses Artificial Intelligence Data Analysis Product for Stratification

B&W_DNA_sequenceethica Clinical Research acquired a worldwide exclusive license to Matrix Pharma’s  artificial intelligence (AI) data analysis platform.  Neither the form of consideration nor payment structure (up-front vs royalty etc.) was disclosed, but the deal is “valued at CAD1.25 Million.”  The companies say the AI can:

“extract interdependencies, correlations, and predictive models from complex data sets that conventional statistical tools are unable to detect.”

In other words, it’s an approach designed for stratification of clinical trial data to identify personalized subgroups for whom a drug may be particularly effective.

ethica says the product, which will be marketed as “eidyia™” (pronounced “idea”)

“has already yielded successful results in a series of clinical applications such as identifying biomarkers, optimizing the predictive power of biomarkers, identifying responder/non-responder indices, genotype-phenotype linkages, elaborating models for early diagnosis, and for classifying participants in Phase II clinical trials for the optimization of Phase III clinical trials.”

I don’t know if  “eidyia” is (or isn’t) the best platform for these tasks; but I am convinced that in many cases, the ability to stratify patient populations will be key to demonstrating the effectiveness of new drugs and winning approval and reimbursement.

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MDS Files Proxy Circular for Sale of Analytical Technologies Business to Danaher

If you wanted more details of MDS’ deal to sell its analytical technologies business to Danaher, today is your lucky day.  The management proxy circular for the shareholders’ meeting to vote on the deal was filed on EDGAR and SEDAR.  Here’s a direct link to the EDGAR filing.

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Trends Update — Personalized Medicine: Merck Strategy Head Skeptical

As I’ve been following personalized medicine on this blog, I have become almost convinced that recent advances in genomics technology put us at the brink of an era of personalized diagnosis and treatment.  Not everyone agrees.

Chris Morrison, reporting from the Pharmaceutical Strategic Alliances meeting, quotes Merv Turner (the head of strategy at Merck) as follows:

“‘You can reduce cardiovascular mortality by 50%’ by using statins, he said. ‘That means 50% cardiovascular disease is unsatisfied. Is that 50 different small diseases or one large one? Personalized medicine is like soccer in the US: it’s the game of the future and always will be.’” (emphasis added)

Maybe I’m missing some context here, but I think the answer to Turner’s question (50 different small diseases or one large one) is “we don’t know.”  It is an interesting question and I think it would be prudent to find out the answer.  Preferably before we try treating the 48th disease with a drug developed for the 35th.

Dani Peters Featured in California Healthcare Institute Podcast on Strategies for Government Funding

The California Healthcare Institute has a new podcast up that features Dani Peters (this blog’s government relations expert) talking about

“opportunities that now exist to find alternative forms of funding from government sources and tips for navigating the complexities of Washington and the new political landscape to help entrepreneurs find funding sources that were not previously available.”

Here is the podcast intro page.  Check it out!

Monday Biotech Deal Review: September 21, 2009

B&W_BigNickelIt was a somewhat quiet week this week (all over the place, apparently) but keep reading for the goods on a cross-border acquisition and a $176 million Canadian offering after the jump…

This Week in the Twitterverse

Here’s what I was Tweeting this week @crossborderbio:

Friday Science Review: September 18, 2009

Some “brainy” research this week…

brainy

Curiosity Driven <=> Intelligence: There is new evidence that “fostering curiosity should also foster intelligence and vice versa.”  Researchers have discovered what they believe is the region of the brain, the dentate gyrus in the hippocampus, that is responsible for generating curiosity.  They also identified that the interaction between the neuronal calcium sensor-1 protein (NCS-1) with the dopamine type-2 receptors (D2R) is what triggers the curiosity-like behaviour.  In the investigation lead by  Dr. John Roder at the Samuel Lunenfeld Research Institute, they modestly overexpressed NCS-1 in the dentate gyrus region of mice and observed an exploratory type behaviour, interpreted as curiosity driven.  Researchers also noted improvements in intelligence as demonstrated by the performance of the mice in spatial memory tests.  Conversely, these phenotypes were reversed when the mice were treated with a drug that inhibits NCS-1 from binding to D2R.  This study appears in the latest edition of Neuron.  So go ahead and let your mind go free…

Dream on: Here’s how you can enjoy your nice dream twice as long – have your doctor perform deep brain stimulations (DBS) on you!  When scientists specifically stimulated an area of the brain responsible for the deep REM (rapid eye movement) sleep in parkinsonian patients undergoing a surgical procedure, they observed an extended period of brain wave activity consistent with REM sleep.  This is the “dreaming sleep” that we enjoy and provides the refreshing recharge we all need.  Sleep specialist Dr. Brian Murray was the lead investigator in the study conducted at Sunnybrook Health Sciences Centre and published in Annals of Neurology “This finding is significant for patients as it confirms, in principle, that we can selectively adjust different stages of sleep and this may make a big difference to sleep quality as well as other affected neurological functions and brain health.” Now we just need a longer day to accommodate the extra sleep!

Helping the vision impaired to seeevSpex, is an innovative sunglass-type device that can help those who are nearly blind to see via a digital image captured on a high resolution camera and played on a small LCD screen projected onto the user’s eyes.  The key feature is that the image is first processed and customized to the user before it is presented to the part of the vision that is most functional, maximizing “vision.”  The device includes features such as zoom and recording capabilities that can be played back instantly in case the viewer missed something.  Many people with different types of visual impairments will be able to benefit greatly from this technology.

evSpex was developed by eSight Corp in Ottawa with help from Dr. Réjean Munger, a senior scientist at the Ottawa Hospital Research Institute.

OETF Awards Service Provider Contracts to Northwater and Covington

The RFP process for the Ontario Emerging Technologies Fund administrator has ended, with Northwater Capital and Covington Capital having been selected.

According to the news item from OETF,

“Northwater Capital Management Inc. will review applications to become a qualified investor.  Covington Capital Corporation will review applications from qualified co-investors in relation to qualified investments and will provide ongoing administration and monitoring of co-investments under the Fund.”

Don’t contact the service providers, though:

“All OETF-related decisions will be made by OCGC and all inquiries regarding the OETF should continue to be directed to OCGC.”

This is the last piece of the OETF puzzle, and in his recent presentation at the OBIO-MRI panel, John Marshall noted that they have already started looking at investors and deals.

Has NRC-IRAP Run Out of 2009 Grant Money?

NRC-IRAP LogoNRC-IRAP, which got $170 million in the 2009 Federal budget (spread over 2 years) for company funding, has been very active lately, including in biotech.

Maybe too active?  I heard rumo(u)rs (plural!) this week that IRAP may be out of funds for this cycle.  Are they?

Drop us a line.

OBIO Panel Presents OETF and BIP Information

The Ontario Bioscience Industry Organization (OBIO) and the Ministry of Research and Innovation (MRI) co-hosted an event a few days ago entitled: “Funding Opportunities in 2009-2010 for Bioscience Companies: What CEO’s Need to Know About Ontario’s ETF and BIP Programs.”

The speakers were:

  • Chair: Kevin French, Senior Act. Manager, RBC;
  • Industry:
    • Rocky Ganske (President & CEO, Axela),
    • Peter Pekos (President & CEO, Dalton Pharmaceuticals),
    • Tom Wellner (President & CEO, Therapure Biopharma);
  • Investors:
    • Rob Koturbash (Managing Director, Maple Leaf Angels)
    • Steve Ottaway (Managing Director, GMP Securities),
    • Peter van der Velden (CEO, Lumira Capital);
  • Government:
    • John Marshall (Director, MRI, responsible for OETF)
    • Ryan Lock (Acting Director, MRI, responsible for BIP)

Lots of great information on funding opportunities, and luckily, the whole thing is archived (here) online.  To access the presentation, enter “OBIO” when prompted.

Update Released by Patheon’s Special Commmittee

Patheon’s Special Committee provided an update today:

“The Special Committee of Independent Directors of Patheon Inc. … today provided an update on its discussions with Lonza Group AG … regarding Lonza’s previously announced non-binding proposal to acquire all of the outstanding restricted voting shares of the Company at a price of US$3.55 per share. The Special Committee also updated shareholders on Patheon’s litigation connected with the unsuccessful offer by JLL Patheon Holdings…”

You can check out the rest after the jump…

Is the IPO Window Open for Biotech and Pharma? Talecris and Anthera Aim to Find Out.

Biopharma IPOs come in pairs, apparently (a-pair-ently?).  A month ago, Cumberland and Emdeon created something that looked like an IPO window and now, Talecris Biotherapeutics and Anthera Pharmaceuticals have filed to go public:

If Anthera’s offering succeeds, I think we can officially declare IPOs back as a viable exit.

Update: Omeros, which has some late-stage spec pharma products as well as an early-stage CNS pipeline, and was the subject of IPO rumors a couple of weeks ago, has filed an amended S-1 indicating a $10-$12 per share price range.

Trends Update — Comparative Effectiveness and Personalized Medicine: Is Canada Ahead of the U.S. In the Use of HER2 Testing for Personalized Breast Cancer Treatment?

B&W_DNA_sequenceFor the 20%-30% of breast cancer patients with tumors that overexpress HER2, treatment with Herceptin (an antibody drug from GenetechRoche) is highly effective.  That’s why this article in the journal Cancer is so shocking.  The authors gathered data from a variety of published sources and estimate that:

“up to 66% of eligible patients had no documentation of testing in claims records, up to 20% of patients receiving trastuzumab were not tested or had no documentation of a positive test, and 20% of HER2 results may be incorrect.”

I asked a friend, who is a genetic counsellor in Toronto, if she thought the gaps here were as bad.  She said no, and that she would be extremely surprised not to see a HER2 result in a patient’s file.

Of course it’s not valid to draw conclusions about national health care from a comparison of the Cancer study to my anecdote.  Among other reasons, the authors admit their data is flawed and dated, and my friend works at one of Canada’s top teaching hospitals.  Nevertheless, the possibility that many U.S. patients could be falling through the cracks is extremely disturbing.

If clinicians can’t adopt and maintain near-universal use of a personalized medicine approach like HER2-Herceptin with recognized and measurable benefits, the future of pharmacogenomics is in some big trouble and we will never generate truly useful comparative effectiveness data.

H/T @FiercePharma.

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Trends Update — IP Constituencies: Amylin Partners with Biocon, PerkinElmer Buys Access and Capacity in India and China

world_map_2002Following up on Sunday’s post noting the new survey of Canadian biotech collaborations with companies in the developing world, it’s worth paying attention to two U.S. deals from last week that emphasize the growing role of India and China in the drug development process:

  • Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Biocon Limited (NSE: BIOCONagreed to jointly develop, commercialize and manufacture a novel peptide therapeutic for the potential treatment of diabetes, and will share development costs; and
  • PerkinElmer did one deal each in China and India:
    • In China, they paid over $60 million for SYM-BIO Lifescience, a Shanghai, China-based diagnostics firm that will double its access to hospitals in China and provide it with “substantial” manufacturing plant capacity
    • In India, they picked up the genetic screening business of Surendra Genetic Labs, a lab in Chennai, India, that provides fetal, maternal, and newborn screening.

The McLaughlin-Rotman survey distinguishes (usefully) between R&D collaborations and marketing and distribution activities.  Although Ellen Licking wonders whether “cheaper off-shore manufacturing [is] a reason for the deal,” Amylin is clearly focused on Biocon’s R&D capabilities.  The press release quotes Amylin CEO Daniel M. Bradbury praising Biocon as a “biologics innovator.”

Even if not all transactions in India and China are innovation-centric (cf the PerkinElmer deals), all involvement by innovative companies shifts the incentives of China, India and other participating countries towards a more innovation-friendly IP regime.

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Monday Biotech Deal Review: September 14, 2009

B&W_BigNickelThe Monday Deal Review is back in full force this week following a Labo(u)r Day vacation last week and there’s plenty of news including more information on the MDS-Danaher transaction and plenty of other companies finding ways to raise money and keep the lights on.  Keep reading after the jump…

This Week in the Twitterverse

Here’s what I was up to on Twitter this week @crossborderbio:

Trends Update — IP Constituencies: Rotman Article Explores Canadian Biotech Collaborations with Developing Countries

A very interesting article in Nature Biotechnology from a group at the McLaughlin-Rotman Centre for Global Health provides some empirical support for a trend we’ve been following of increased innovative activity in developing countries

According to the article, over 25% of Canadian biotechs collaborate with developing countries.  Of these, however, the vast majority of companies do so alongside collaborations with other developed country partners — only 4% collaborate exclusively with developing countries.  Also, gaining access to developing countries’ markets is the most frequent (66%) reason cited for collaboration.

Still, some of the data reflects the growing importance of developing country collaboration (China and India in particular):

  • Canadian firms’ collaborations with India (17) and China (22) nearly equal the number of collaborations with Japan (18) and Germany (23); and
  • Accessing knowledge from developing countries’ partners (24%) is approaching providing knowledge to developing countries’ partners (37%) as a reason for collaboration.

How do these collaborations look overall?

Collaborations article - nbt0909-806-F4

The figure from the paper on the left shows the geography of, and rationale for, the collaborations. Part “a” shows marketing and distribution collaborations, and part “b” shows those involving an R&D component.

 

What is the effect of all this activity?

Well, it’s hard to quantify, but the authors review revenue data from public company respondents and find that:

“average total revenues of firms that have North–South collaborations are nearly four times higher than firms that do not have such partnerships.” 

My bottom line: causal or not, that’s a correlation that should cause all biotech companies to take note.

Friday Science Review: September 11, 2009

Two great medical discoveries…

Stayin’ Alive:  During a stroke, for example, neurons deprived of oxygen undergo cell death.  In a recent discovery lead by Dr. Michael Tymianski’s team at the Krembil Neuroscience Centre at Toronto Western Hospital, the protein TRPM7 was found to play a critical role in mediating this detrimental effect.   After suppressing TRPM7 expression in a localized region of a rat’s brain, they simulated a stroke by cutting off blood flow to the brain for 15 minutes.  The subsequent analysis revealed a complete lack of tissue damage compared to rat brains expressing TRPM7.  The resistance to death by cells lacking TRPM7 even preserved the brain’s cognitive function and memory performance following the ‘stroke’.  This may have tremendous implications for preventing further cell damage following ischemia in any tissue and is not necessarily limited to the brain, although it is yet to be tested elsewhere in the body

Details of the discovery are reported in the latest edition of Nature Neuroscience.

Insulin Resistance Gene Discovery: An international effort led by Dr. Robert Sladek and Dr. Constantin Polychronakos at McGill University performed a genome-wide comparison and identified a single nucleotide variation in the genetic region near the IRS1 gene that is associated with insulin resistance and hyperinsulinemia.

Dr. Sladek explains it best:

“It’s a single-nucleotide polymorphism (SNP, pronounced ‘snip’), a single letter change in your DNA,” said Sladek. “What’s interesting about this particular SNP is that it’s not linked genetically to the IRS1 gene in any way; it’s about half-a-million base-pairs away, in the middle of a genetic desert with no known genes nearby. In genetic terms, it’s halfway from Montreal to Halifax. And yet we can see that it causes a 40-per-cent reduction in the IRS1 gene, and even more important, a 40-per-cent reduction in its activity. Which means that even if insulin is present, it won’t work.”

IRS1 is known to be the key signalling protein involved in the cell’s initial response to insulin.  This recently discovered variant allele affects the level of IRS1 protein expressed and reduces the capacity of the cells to respond to insulin. Unlike other diabetes risk genes that affect insulin production in the body, this is the first that is known to suppress insulin stimulation in the cells.

The research article appears in the early online edition of Nature Genetics.

Revised FDA Warning Letters Webpage To Feature Close-Out Letters

fda_logo_onlyImprovements to the FDA’s warning letters webpage were announced last night.  The most recent warning letters will be easier to find, and most notably, the warning letters table will now include

“the Close Out Date … and detailed information about the Warning Letters Close Out Program.”

Or at least it will for warning letters issued after September 1, 2009 (the date the Warning Letter Close-Out Letter Program kicked in).

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U.S. Stimulus Stimulates Health Care and Academic Jobs

The NPR Health Blog reports that in the cloud of U.S. unemployment numbers (pdf) there is a high-tech silver lining: the health care and education sectors actually added about 52,000 jobs in August.  It cites examples from a Boston Globe article that highlights stimulus-stimulated activity in Massachusetts research labs.

Also note this piece at GenomeWeb, which quotes Leerink Swann analyst Isaac Ro, who includes “stimulus funding” as one of the “theme[s]” justifying a higher target and rating for Millipore (NYSE: MIL).

Check out the birds’ eye view of NIH ARRA grants and zoom and click to get all the details for your favo(u)rite institution.

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I’ll Drink To That: Genome BC and Genome Canada Launch $3.4 million Grape and Wine Genomics Project

niagara_grape_vinesA team of researchers in British Columbia (UBC, SFU), Ontario (Guelph) and elsewhere (NRC, USDA) will be studying grapes and yeast to bring molecular techniques to bear on winemaking.  Ultimately, they aim to produce a hand-held device to “help growers monitor proteins in the vine or berry at any time” (a “vine-corder”?) that will be adapted from a detector developed by Paul Yager at the University of Washington.

Specific goals of the project are to:

  • Clarify how nitrogen fertilization affects hormone regulation of metabolic pathways important for berry ripening, chemical composition and wine quality
  • Determine the relationship between gene expression patterns and variation in amino acid composition at maturity in ripening berries
  • Develop biomarkers for vineyard monitoring of vine water stress
  • Use a systems biology approach to identify functions for each of the genes involved in the fermentation stress response and the regulation of molecular sugar and amino-acid transporters during wine fermentation
  • Deliver knowledge that leads to understanding the complex scientific, policy, industry and public issues involved in the application of genomics to the wine industry

They have a good head start, having identified 62 genes that are switched on during fermentation, so characterizing those will be a top priority.

Interestingly, the project also includes an ELSI-type component, to “help the Canadian industry and regulatory bodies better understand public concerns regarding the use of genomics technologies in the production of wine and the general food industry more generally.”

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Labo(u)r Day — Monday Deal Review Returns With a Double Edition Next Week

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