The Cross-Border Biotech Blog

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

Monthly Archives: April 2009

Health Care Reform: Party’s Over for Medical Imaging

mri-kneeWell…it could be worse, but one could argue it’s the beginning of a slow decline for the medical imaging market in the U.S.  On Tuesday, Senator Baucus (D-Montana) and Senator Grassley (R-Iowa), Chairman and Ranking Member of the Senate Finance Committee, released a description of policy options for healthcare reform

The options included “Transparency and Evidence-Based Decision-Making for Imaging Services,” proposing a system that sets “national appropriateness criteria” for imaging procedures (see page 7).  Good so far. The system also includes standarized reporting to monitor rates of adherence to appropriateness criteria.  Uggh, but fine. Then, in 2013,  the Secretary would designate the imaging procedures for which reporting and differential payment will be mandatory and imaging procedures for which reporting will be voluntary based on baseline rates and amount of progress toward goals. This creates a system whereby access to specific imaging services and reimbursement can be further curtailed, and it will. Soon, we might see the term “medically necessary” thrown around in the U.S., a term many Canadians waiting months for an MRI have learned to hate.

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A Familiar Refrain From the UK

This story in Nature about the UK budget may sound familiar to Canadians:

“Britain’s government has unveiled an economic stimulus package designed to harness what it calls a ‘world-class science base’ — at the same time as it cuts funds for undirected basic research.”

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BioFinance Lunch Keynote: U.S. Health Reform

Just finished listening to Scott Gottlieb at the BioFinance lunch keynote. Scott was Deputy Commissioner at the FDA in the Bush administration, and is now a Fellow at the American Enterpirse Institute.

Here’s what he had to say. Stay tuned for questions from the audience, including Dani and I, at the end…

Healthcare in the U.S.

First, good flu vaccine news: current surge capacity for vaccine production is up to half a billion (500,000,000) doses, much better than even a few years ago.

Update: the MaRS Blog has a video of this part of Scott’s talk.

Health care reform:

FOB: Waxman can’t get his bill out of committee. Likely booted to next year.

Comparative Effectiveness: will be a committee in the fall that sponsors research and promulgates guidelines.

1) Medicare has tried to implement some CE: functional equivalence (legislated away), least costly alternative (e.g., wheelchairs) tried to apply to Sepracor, got sued, lost on appeal; tried to take accelerated approval drugs out of reimbursement, didn’t fly. Legislation likely to pass giving CMS back authority to do least costly alternative reimbursement.

Large private plans have hundreds of physicians and thousands of clinicans, CMS has at best 25 physicians. E.g., have made 160 decisions on cancer product reimbursement without a single oncologist on staff.

2) Price controls: private market will be increasingly able to pay off medicade pricing schedules. Drug benefit for dual-eligible patients will be moved to medicade best price schedule.

Similar changes: medicare advantage plans will want to be able to price off medicare if their reimbursement rates are cut.


“Regulatory creep” at the FDA: balance shifts on approval metrics debates because of increased public desire for and tolerance of regulatory caution.

Medical devices: changing regulatory paradigm for diagnostics. Laboratory-developed tests will likely be regulated as devices. Kennedy has a bill pending.

I asked about the regulatory environment for personalized medicine, and Scott pointed interestingly to different regulatory approaches taken in the U.S. vs EU to screening HER-2 as a precursor to Erbitux treatment for colon cancer. EU uses it based on retrospective data, U.S. has wanted to do dedicated prospective controlled trials.

Dani asked about drug reimportation: Scott thinks it will happen, but regulatory structure and currency changes will increase cost, and increased drug reimbursement in the U.S. will decrease demand.

Brian Bloom, a banker at Bloom Burton, asked about how the Obama administration’s vocal support for innovation meshes with the health care reforms and comparative effectiveness initiatives. Scott diplomatically focussed on the administration’s support for basic reseach, then segued less diplomatically to predict the end of cancer drug development that he says could follow if the NICE model in the UK is globalized.

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200th Post – State of the Blog

7 contributors, 106 days since launch, 200 posts, 1047 tags, 7604 hits.

BioFinance tomorrow.  Over and out.

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Monday Deal Review: April 27, 2009

Biotech deal activity in Canada was back on the upswing a bit this week, with some private placements, issuer bids, and an equity line of credit…

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Where We Will Be This Week

Fun week ahead.  BioFinance runs from Tuesday through Thursday. Dani and I will both be there.

I will be speaking on the Public Market Strategies for Cleantech Investing panel on Thursday, April 30 at 3pm.  Admission to the Cleantech day of BioFinance is free, and the whole conference is excellent, so come check it out at the Toronto Marriott Eaton Centre.

The rest of the week, I will be chained to my desk.

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Human Swine Influenza: Understaffed

The volume of Human Swine flu info has exceeded my ability to keep up.  I will try to post sporadically on interesting scientific, political or business implications.

In the meantime, I have added two widgets on the right side of this page:

  • Google news RSS for “swine”
  • Twitter RSS for #swineflu

That should help visitors keep up with the news and help me get back to my day/night job.

Also keep in mind:

  1. The CDC Swine Flu Page
  2. The WHO Swine Flu Page
  3. You can not catch swine flu by eating pork

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Human Swine Influenza Update: Canadian Cases Confirmed, Public Health Emergency Declared in U.S.

CDC transcript from today’s briefing.

White House Press Briefing transcript.

New York Times story:

  • Mexico data: 1,300 infected, 80 dead.
  • U.S. data: 20 infected, one temporarily hospitalized now recovered.
  • Canada data: 6 infected, all linked to travel to Mexico. 2 in BC, 4 in Nova Scotia.
  • No WHO decision on pandemic alert level until Tuesday.

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Human Swine Influenza Update: World Health Organization (WHO) Resources

The World Health Organization has a new page up collecting resources and news related to the Human Swine Influenza outbreak, including:

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Human Swine Influenza Update: Saturday CDC Call

While I eat lunch, I’m keeping half an ear on the CDC conference call updating media on their investigation of the human cases of swine influenza.  Original post here with some background and previous call info.

Speaking on the call:

  • Anne Schuchat, M.D., Interim Deputy Director for Science and Public Health Program
  • Daniel Jernigan, M.D., Ph.D., Medical Epidemiology, Influenza Division

Today’s news:

  • still 8 confirmed human cases in the U.S., all mild so far
  • serious situation in Mexico, with “a number” of confirmed swine influenza cases primarily among adults
  • reports in Mexico have described much more severe infections, some of which have been confirmed as the H1N1 virus (note, though, that Dr. Schuchat suggested the apparent difference in severity between U.S. and Mexico could just reflect different surveillance efforts underway so far in the two jurisdictions)
  • numerous ongoing investigations at state and local levels but no new confirmations
  • CDC teams on the ground in California and in Mexico collaborating with Canadian and WHO teams
  • deferred most questions to state and local authorities

That was anticlimactic.  Based on poking around at this the last couple of days, it seems like the CDC is releasing information more slowly than other sources (WHO, etc.) partly because of the process and partly because they don’t want to accelerate public anxiety. 

For example, the current process is:

  • state and local labs have tools to identify Influenza if it is either the H5N1 “bird flu” strain or this year’s “seasonal” strain
  • if a type A Influenza sample tests negative for both, it is forwarded to the CDC
  • many of those are successfully typed by the CDC (i.e., the negative results were technical flaws at the state and local labs)
  • the remainder may actually be the new Human-Swine H1N1 and are further tested by the CDC

However, Dr. Schuchat declined to say how many samples of “un-typeable” flu are awaiting testing at the CDC, likely because the number is alarmingly large and hard to put in context with the false negatives and the normal seasonal background.

Reports on the CDC call said there would be a New York call addressing the St. Francis school testing and other local efforts at 3pm, but I couldn’t find a link.

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Friday Science Review: Walk Before You Run Edition

Puijila the Primitive Pinniped:  Vertebrate paleontologist Natalia Rybczynski of the Canadian Museum of Nature in Ottawa and her team found the first skeleton of a land-dwelling relative of seals, sea lions, and walruses. The 20-million- to 24-million-year-old Arctic fossil has webbed feet — the first fossil found in that family that shows an intermediate step between feet and flippers.  Rybczynski’s team found the fossil when their ATV ran out of gas on the way back from their actual dig site one day.  Seal-endipity?

Puijila darwini

Puijila darwini

A Carbon Sink that Grows On You:  Canadian researcher Marco Rondon is pushing for the inclusion of biochar in carbon trading schemes so that he can use the credits to subsidize poor farmers’ use of biochar as a fertilizer.  Biochar is an excellent fertilizer for acidic and nutrient-poor soil and it’s also an excellent carbon sink, sequestering carbon for thousands of years.  Although it was once widely used, biochar is no longer readily available to farmers in the Amazon, where the soil is now too poor to produce the raw materials for biochar and farmers don’t have the financial resources to bring them in from other places.  Rondon is hoping to start with small, monitored, pilot projects and eventually convince backers to address more of the two billion hectares of degraded farming soil in the world.

Smart Underwear:  A group of resesearchers, engineers and clinicians in Alberta will receive $5 million over the next five years from the Alberta Heritage Foundation and the province to work on improving movement by electrical stimulation.  Here’s one of their projects:

“A … device affectionately called ‘smart underwear’ is designed to help prevent pressure ulcers, also known as bedsores, in people with spinal cord injuries … For Warren Fleury, who can’t fidget because of a spinal cord injury he suffered 20 years ago, the smart underwear makes the movements for him.”

Bit of a misnomer, though, since if the underwear was really smart maybe it would pick a different job…

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Updated: Swine Flu Outbreak

This is not good news.  FierceBiotech says at least 16 of 57 dead in Mexico have been confirmed killed by swine flu and hundreds more have taken sick, and that “there is abundant evidence that the flu is being spread from person to person.”

The New York Times reports that the Mexico victims died from the same new strain of swine flu that sickened eight people in Texas and California.

Update and Resources: 

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Cow Genome Sequenced: Meet the Bovine J. Craig Venter

The genome of a Hereford cow, L1 Dominette 01449, was sequenced by the Bovine Sequencing and Analysis Consortium, less than two years after J. Craig Venter’s team reported the sequence of Dr. Venter’s genome in September 2007.  The Bovine sequencing papers are in this week’s issue of Science, along with a podcast interview with the lead P.I.

Dare we compare (phenotypes)?

J. Craig Venter

J. Craig Venter

L1 Dominette 01449

L1 Dominette 01449










By the way, if you’re feeling jealous, don’t. You too can join the fun. Knome is auctioning an opportunity to have your genome sequenced. The starting bid on eBay is $68,000.

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Wednesday Brain Dump: Plant Matter Edition

Some stories from the world of plant biotech:

P.S.  After today, the Wednesday Brain Dump will be dropping the “Wednesday” and becoming an occasional feature.


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Canada’s First Subsequent Entry Biologic!

Guest post from Jill Daley, part of our all-star life sciences team at Ogilvy:

Today, Sandoz Canada announced that Health Canada has granted it a market authorization for Omnitrope™.

This announcement marks the approval of the first subsequent entry biologic (SEB, also known as a “follow-on biologic” (FOB) in the U.S. or a “biosimilar” in the EU) of a previously approved recombinant biotechnology drug by Health Canada.

Omnitrope™ has received similar treatment in the United States and in Europe where it has been approved as a “follow-on protein” and a “biosimilar”  respectively.

Interestingly, today’s announcement came less than one month following Health Canada’s issuance of the Draft Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics.  The Ogilvy Renault bulletin analyzing the draft guidance is here.

The draft guidance is open to consultation until May 26, 2009. Interested stakeholders are invited to submit written coments via email (BGTD_PPD_DPP@HC-SC.GC.CA), mail or fax (613-952-5364).

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Plan B OTC

The FDA’s press release on Plan B, which will soon be available OTC for women 17 and older.  The original FDA decision-making process for OTC Plan B was a multi-year ordeal.  This round was short and sweet:

“On March 23, 2009, a federal court issued an order directing the FDA, within 30 days, to permit the Plan B drug sponsor to make Plan B available to women 17 and older without a prescription. The government will not appeal this decision. In accordance with the court’s order, and consistent with the scientific findings since 2005 by the Center for Drug Evaluation and Research, FDA sent a letter to the manufacturer of Plan B that the company may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.”


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New OHA Site for Ontario Hospital Performance Data

The Ontario Hospital Association has put up a new website at that compiles some publicly available hospital data and puts it in a user-friendly, layman-accessible format.

The OHA site can provide data sorted by type of care (Acute, Maternity/Pediatric, Emergency, Rehab, Chronic and Mental Health) or by indicator (Clinical Outcome, Family Satisfaction, Patient Safety, Patient Satisfaction, Perception of Care and Wait Time).  The site can also be used to review performance metrics for individual hospitals but large swaths of data appear to be missing.  For example, I was unable to locate any data on clinical outcomes for UHN or Sick Kids.

It is possible the OHA initiative was undertaken in response to the Fraser Institute’s Ontario Hospital Report Card, issued in March, which strongly criticized the hospitals for refusing to be identified in the report — only 17 out of 136 evaluated facilities agreed to be identified.  The Fraser Institute report appears to provide much more complete and detailed information, but because of the anonymity, generally cannot be used to identify specific hospitals.

Both the Fraser Institute site and the OHA site provide resources (follow those links) to help assess and compare methodologies. 

Earlier this month, the WSJ Health Blog took a look at health care performance metrics, noting a Health Affairs paper renewing a call for emulating the airline industry’s approach to safety, and an editorial on some quality-of-care pitfalls.

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Audrey Fried-Grushcow (not no relation) is a U.S.-trained lawyer and mediator.  After law school, Audrey clerked for Judge William J. Bauer on the Seventh Circuit Court of Appeals and practiced in the area of complex commercial litigation for several years at a large Chicago-based law firm before turning her attention to mediation and conflict resolution.

She is now also the Editor and Marketing Officer of the Cross-Border Biotech Blog.  You’ll see her around as errors are magically corrected and the occasional post appears with news about the blog.

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Trends Update — Personalized Medicine: Clinical Data on Personalized Cancer Treatment

A study presented at the American Association for Cancer Research meeting this week showed benefits to patients from using molecular profiling to customize chemotherapy regimens.

The pilot study, with Daniel Von Hoff, M.D. as the senior investigator, used immunohistochemistry and microarray profiling to select treatment regimens for 66 patients who had ovarian, colorectal, breast and other cancers.   The data compared progression-free survival and tumor size after the patients moved to a new treatment regimen with the same patients’ progression before molecular profiling.  Forty percent of patients in the trial survived at least 15 months compared to 20 percent of the control population.

A story in Forbes notes personalized cancer treatment data in a colon cancer study and two glioblastoma studies that were also presented at the AACR meeting.

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FTC Proposed Rule for Medical Record Privacy for Non-HIPAA Entities

One of the concerns about the privacy of electronic medical records is that many of the major providers — notably Google and Microsoft —  are not “covered entities” under HIPAA and are therefore not subject to its privacy provisions.

The funding for Electronic Health Records in the American Recovery & Reinvestment Act of 2009 comes with a requirement that HHS study, in consultation with the FTC, “potential privacy, security, and breach notification requirements” with respect to entities not covered by HIPAA, and make recommendations within one year.

In the interim, Section 13407(g)(1) of the Recovery Act requires the FTC to promulgate regulations on breach of security notification provisions.

The FTC has proposed a breach notification rule, and is coordinating with HHS.  The proposed rule:

  • requires vendors of personal health records and related entities to provide notice to consumers following a breach, and reaches through to require the vendors’ service providers to notify the vendors;
  • sets the standard for what triggers the notice requirement, as well as the timing, method, and content of notice; and
  • requires FTC notification of any breaches.
Public comments are being accepted through June 1, 2009, and can be submitted online at  In particular, the FTC is seeking comments on:
  1. the nature of entities to which its proposed rule would apply;
  2. the particular products and services they offer;
  3. the extent to which vendors of personal health records, PHR related entities, and third party service providers may be HIPAA-covered entities or business associates of HIPAA-covered entities;
  4. whether some vendors of personal health records may have dual roles as a business associate of a HIPAA-covered entity and a direct provider of personal health records to the public; and
  5. circumstances in which such a dual role might lead to consumers’ receiving multiple breach notices or receiving breach notices from an unexpected entity, and whether and how the rule should address such circumstances.


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Monday Deal Review: April 20, 2009

A relatively quiet week for the deal review this week…

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New Data in Canada: BIOTECanada-PwC 2009 Life Sciences Forecast

The BIOTECanada-PricewaterhouseCoopers 2009 Canadian Life Sciences Forecast was released today.

The Forecast was produced from data gathered in October and November 2008, so is (unsurprisingly) a bit bleak, but there are a few bright spots to be found:

  • Canadian companies are increasingly flexible about exit scenarios.  In the 2009 Forecast, 66% of firms looked to mergers (down from 80% in 2007), while 48% looked to co-development partnerships and 46% saw licensing or selling IP as their success strategy.
  • Some problems were reduced from levels reported in 2007:
    • Only 26% of respondents identified “attracting and retaining key employees” as one of the three most challenging issues, down from 39% in 2007;
    • In 2007, 33% of respondents identified “attracting a licensing or strategic partner” as most challenging, which was down to 22%  in 2009; and
    • 21% instead of 29% of respondents cited “managing the regulatory process.”
  • Finally, there was a 66% increase in the number of respondents who believed “protecting intellectual property” would be a top-three challenge, which is excellent news … at least for lawyers.

The predominant issue weighing on the minds of respondents was clearly access to capital:

  • Sixty-one percent of respondents ranked “increased Canadian venture capital” as critical to the industry; and
  • While the overall percentage of companies expecting to raise between $10 million and $100 million in their next round remained the same as it was in 2007, the percentage expecting between $10 and $25 million tripled while the percentage expecting betwen $25 and $100 million was cut nearly in half.

The really good news about this, though, is that since the survey was taken last Fall, over $1 billion in venture investment funding has been budgeted in Ontario and Québec, and the Ontario Venture Capital Fund has already made several commitments … some of which are bound to end up with biotech VCs, right? Right?? Stay tuned.

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Canadian Science Funding Update — Open Letter From Canadian Scientists Generates Equal, Opposite Open Letter from Gary Goodyear

Canadian scientists, dismayed by cuts of $113 million to the three primary granting agencies in this year’s federal budget, sent an open letter of protest to PM Harper last week that collected 2,000 signatures.

The response, from Minister of Industry Tony Clement, was certainly better pitched than the response at budget time from the government’s initial spokes-o-practor, Gary Goodyear.   Mr. Goodyear also responded to the protest letter — penning a letter to Nature — and succeeded in not igniting any additional controversy.

I have three points in reaction to the budget and the protest letter:

  1. The federal government clearly chose an investment in infrastructure and training at the expense of basic research, but is clearly embarrassed to say so in light of peer country decisions.  The U.S. has prominently featured major increases in research funding, and the UK has pledged not to let science be a victim of the economy (though we will see Wednesday if they put their money, or their foot, where PM Brown’s mouth is).
  2. The Ontario government has done significant work to close the gap in research funding and infrastructure matching funds left by the federal budget
  3. We are starting to see local impacts of the funding decisions generate pressure on individual MPs.  For example, the federal minister of public works, Christian Paradis, was “angry” and said he will do everything he can to ensure that the famous Mont Mégantic Observatory, which is in his riding of Mégantic-L’Érable east of Montreal, receives funding to remain open.  The NSERC, which decided to drop the observatory’s funding, has cut a number of projects to cope with a $70-million drop in its budget.

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Friday Science Review: First Time for Everything Edition

First time for blood stem cell factors:  Dr. Guy Sauvageau of the University of Montreal produced a large number of blood stem cells in the lab from a smaller sample taken from bone marrow using a novel screening technique to identify mediators of the stem cell repopulating activity.  The study was published in this week’s Cell.  Dr. Sauvageau said that “[i]t could be possible to envision transplants for all adults from existing umbilical cord blood banks.”

First time for viral destruction of cancer stem cells:  A group out of Dalhousie used reovirus on fresh breast cancer tissue removed from a patient, while most cancer studies use cancer cell lines developed for laboratory use.  Not only does reovirus kill the cancer stem cells and cancer cells, it also stimulates the body’s anti-cancer immune system.

First time for a dual axis rotational cardiac X-ray:  The University of Ottawa Heart Institute (UOHI) has the first one of these X-ray machines for clinical use in North America.  It produces better images in less time with less dye and less radiation.

First time for driving into space:  The headlines said “Calgary scientists determine outer space only an hour’s drive away.”  Apparently all the debate about where the atmosphere stops and space begins could have been solved if the scientists involved had gotten out of the lab and into their cars a bit sooner.

First time for a meta-diet:  A group at McMaster conducted a meta-study of the effects of various diets on coronary heart disease and concluded that the Mediterranean diet is meta-good, and that trans-fats are meta-bad.  The WSJ Health blog said:  “So [the analysis] is a useful, if not particularly surprising, guide.”

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Reactions to In re Kubin: DNA Patents and Obviousness

Earlier this month, the Federal Circuit decided In re Kubin (pdf), invalidating one of Amgen’s DNA patents.  Here’s the short version from ScienceInsider:

“The court declared that an invention owned by Amgen Inc. … was so obvious as to be unpatentable. The invention … was the sequence of a gene for the protein NAIL, important in the human immune response. But those who opposed the patent argued that it took no original insight to work out the gene’s code. The U.S. Court of Appeals for the Federal Circuit agreed with the skeptics.”

Here’s the more patent-y version from Patently-O:

“The Kubin opinion found that the Supreme Court’s KSR decision overturned In re Deuel and its admonition against an ‘obvious to try’ test for obviousness.”

Since the decision has had some time to percolate, I thought I’d collect some of the reactions from around the web (with the able assistance of articling student Dr. Alison Varga)…

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Wednesday Brain Dump: Two of Everything! Edition

Two Camels!  Dolly the cloned sheep, meet Injaz the cloned camel.

Two R&D Heads!  The combined Pfizer-Wyeth will have Mikael Dolsten heading up the newly created BioTherapeutics Research Group and Martin Mackay heading up the small molecule PharmaTherapeutics Research Group.  (Two CapitalLetters!)  The In Vivo Blog has a podcast interviewing both.

Two VA Initiatives!  In addition to the electronic medical records initiative we mentioned earlier this week, the Department of Veterans Affairs is also setting up a large cohort genetic study that will establish a database of genetic information from patients that will be linked to the participants’ electronic health records.  This is great news for personalized medicine because it will ensure that the EHR standard that comes out of the VA project will accomodate and utilize individualized genotypic data.

Two R’s, Two L’s, Two B’s!  G. Steven Burrill (two r’s, two l’s, one b) says he’s confident he can raise $1 billion (there it is!) to develop the Pine Island biotechnology project and a private equity/venture capital fund, which will support development of new technologies out of the Mayo Clinic and the University of Minnesota, among others.

Two Guidance…s!  Health Canada issued a finalized version of a Guidance Document on data protection (only applicable to qualifying innovative drugs that received an NOC on or after June 17, 2006) AND a revised version of the draft Guidance Document on Subsequent Entry Biologics, (which includes a 6-year data protection period).  More to come on this.

Two Border Crossings!  Simponi, a biologic developed by Johnson & Johnson and Schering-Plough, crossed the border Northbound — gaining approval from Health Canada before the FDA; and Molecular Templates Inc. crossed the border Southbound — leaving Ontario for the Texas Life-Sciences Collaboration Center.

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GM Crops Report Aimed at a Straw Man Creates Kerfuffle*

Yesterday, the Union of Concerned Scientists released a report on genetically-engineered crops called “Failure to Yeild”  that did yeild a fair amount of press coverage.

However, the report’s focus on yeild is a bit of a … straw man … as UCS itself acknowledges in its FAQ:

“GE crops have provided other benefits important to U.S. farmers.  Bt corn provides protection against insect pests, and the GE traits are often available in varieties producing higher yields as a result of traditional breeding. GE soybeans provide increased convenience and save time.”

ScienceInsider, likewise, notes that

“[the UCS] results won’t surprise most farmers. They plant crops that have been genetically modified to tolerate doses of the herbicide glyphosate (widely known as Roundup) mainly because that trait makes it easier and sometimes cheaper to control weeds, not because it increases yields.  The UCS study is instead aimed at the general public, in an effort to counter claims by the biotechnology industry that genetic engineering offers the best solution to global food shortages.”

In the end, the report’s actual take-home message is unrelated to the any of the novel data:

“[I]t makes little sense to support genetic engineering at the expense of [non-GE] proven technologies…

[R]ecent studies have shown that organic and similar farming methods that minimize the use of pesticides and synthetic fertilizers can more than double crop yields at little cost to poor farmers in such developing regions as Sub-Saharan Africa.”

It’s hard to disagree with a call to apply all available tools to increase crop yeilds in the developing world.

A second story yesterday, which probably got a boost from the UCS report timing, was that Germany announced a ban on Monsanto’s GM corn, which the country had previously licensed.  This move has actually been anticipated since February, when the EU Committee of Experts failed to overturn bans in France and Greece, and is of a piece with other issues in the EU around GM crops.

* Kerfuffle: disturbance, disruption, commotion, flutter, hurly burly, to-do, hoo-ha, hoo-hah, kerfuffle (a disorderly outburst or tumult).

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Some Good Clean Tech Synergy: Biotech + Cleantech + Nanotech = $

A story today at GenomeWeb shows a collaboration among biotech, cleantech and high-tech interest groups successfully generating government support:

Illinois life-science industry advocates for the second straight year are urging state lawmakers to set aside $25 million in grants and tax credits to assist biotech, pharmaceutical, and medical-device startups commercialize new technologies.

Unlike last year, when the proposal died in a state House of Representatives committee, the state’s life-sci industry group expects this year’s version to pass. One key reason: The legislation … would award cash to other tech industries, including alternative-energy, or so-called “clean,” technologies, and the state’s fast-growing nanotech sector.

This type of cross-tech synergy has contributed to government support for other funding initiatives as well.  Look no farther than MaRS, or go as far afield as the UK; common needs for tech commercialization build stronger constituencies.

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Abbott’s ABT-888 Guinea Pig: First Phase 0 Clinical Trial Completed

A press release from the National Cancer Institute yesterday (picked up today by BIO SmartBrief and FierceBiotech) touts a successful first:

The first phase 0 clinical trial of a drug in cancer treatment, involving 13 patients with advanced cancers, showed that the drug, ABT-888, affected its target and was well tolerated. Most importantly, this trial showed that it is possible to enroll a small number of patients, treat them with a low dose of a new drug, identify whether the desired target of the drug was affected, and obtain all of this critical information relatively quickly.

The point of a “phase 0” (phase zero) trial is to focus “primarily on tolerance and the ability of the drug to hit a target.”  The advantage of phase 0 trials is that they:

involve nontoxic drug doses that are administered for short periods of time to small numbers of patients, [so] the preclinical toxicology data required … are less than those required to support a phase I trial; thus, these first-in-human trials can be initiated earlier in the drug development process than traditional phase I studies.

Phase 0 trials come with their own statistical evaluation scheme and endpoints, and although more long-term data is needed on the impact of this approach on timetables and success rates, “phase 0 trials will be a key part of a new approach” in the NCI Experimental Therapeutics (NExT) program.

Here’s NCI’s FAQ from the 2007 introduction of the program, with more info on NExT and phase 0 trials.

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Monday Deal Review: April 13, 2009

M&A, scads of securities, and a real, live IPO in the Canadian deal news this week.

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