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Category Archives: Trends in 2009

Trends in 2009: Direct-to-Consumer Genetic Tests Come to Canada

B&W_DNA_sequenceThis week saw the introduction of what I believe is Canada’s first personal genomics service offering.  Toronto’s Medcan Clinic paired up with California-based Navigenics to scan individuals’ genomes for a variety of disease markers.

Personal genomics is a burgeoning trend this year, which according to a special report in April’s Economist, will only be further boosted by a Moore’s Law-type improvement in sequencing power and price.  Available service offerings range from whole genome sequencing (e.g., Illumina and Knome) that costs tens of thousands of dollars to targeted scans typically offered for under $500 by a much wider variety of providers (Navigenics, 23andMe, deCODE and Pathway Genomics).

Regulation of DTC Testing:

In the U.S., the regulatory environment has settled down somewhat over the last 6 months, with most U.S. states regulating DTC genetics companies as clinical labs and the providers registering as such on a regular basis, including CLIA certification.  However, the HHS Secretary’s Advisory Committee on Genetics, Health and Society is due to meet in October to further discuss whether DTC genetic tests should be regulated as medical devices.  The CDC has released a report entitled “Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions” setting out best practices both for testing and interpretation.

In Ontario, there are a number of regulatory considerations (thanks on these points for input from Will Chung, of our renowned Life Sciences team):

  1. Private labs and specimen collection centres require licenses and are governed by the Laboratory and Specimen Collection Centre Licensing Act (LSCCLA). However, blood collection at such facilities is governed by separate legislation which controls who may draw blood and for what purpose.
  2. The LSCCLA requires that only “legally qualified medical practitioners” are permitted to examine specimens, which means that patients may not directly order testing of their own blood at private licensed labs.
  3. Ontario’s Regulated Health Professions Act stipulates that communicating a “diagnosis” is a “controlled act” which may only be performed by a person authorized by a health profession Act, although it is not clear that DTC genomics results are a “diagnosis.”

Medscan seems to have navigated the regulatory waters, but time will tell how these laws are applied and/or modified.

In the EU, the European Society for Human Genetics advocates for pre-market review for “truthful labeling and promotion” as well as post-market evaluation of DTC genetic tests. In May, Germany passed a law restricting the availability of DTC genomics services by requiring testing to be carried out by a licensed doctor following the patient’s consent.”

How much protection do consumers need?

Many commentators are concerned with the public’s ability to understand these tests and distinguish between those that are clinically meaningful and those that are more … snake-oily.  Others object on the basis that there is little value added absent any available treatment — many preventive measures are things we already know we should do, like eat well, exercise, etc.  A number of groups, including advocacy group Genetic Alliance and the Genetics and Public Policy Center at Johns Hopkins University have called for a national registry of DTC genetic tests that would include performance data.

Others (and not just 23andMe’s founders) take a more libertarian view.  Ronald Bailey, the science columnist at Reason, agrees that people probably don’t need to be “protected against learning such information without the guidance of a knowledgeable physician or genetic counselor.”  In fact, a lawsuit in May brought by a girl born with Fragile X syndrome against the sperm bank that didn’t test for the predisposition may drive  higher demand for genetic testing in the fertility context which may in turn drive supply of services and diagnostic tools and may contribute to normalizing broader parental testing and pre-implantation screening.

Interestingly, a NEJM report a couple of weeks ago showed no lasting psychological damage from a genetic prognosis of increased Alzheimer’s risk.  By the time a year passed after the results, subjects who had an increased Alzheimer’s risk were no more depressed, anxious, or distressed than when they started the study.

Most importantly, 98% of patients in the Alzheimer’s study who tested positive said they would still get tested if offered the choice again.  98% is a lot. It suggests that DTC services will be increasingly popular, particularly as the price drops and the quality of the data, the analytics and the available counseling continue to improve.

Stay tuned to this page for further DTC genetics news and analysis.

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Trends Update — Comparative Effectiveness and Personalized Medicine: Genetic Test Identifies Patient Subpopulation for Benefit, Avoids Wasted Money and Time for Others on Erbitux, Vectibix

B&W_DNA_sequenceThis is exactly how personalized medicine and comparative effectiveness can interact to benefit patients, pharma companies and payors:

  • data shows that patients with KRAS mutations don’t benefit from anti-EGFR antibody meds Erbitux or Vectibix;
  • the FDA approves a labeling change identifying the patients who won’t benefit;
  • payors see costs savings from eliminating pointless prescriptions;
  • patients without the KRAS mutations have added incentive to take the drugs, benefiting themselves and the pharma companies who make the drugs.

As the WSJ Health Blog says:

“Erbitux and other expensive cancer medicines have faced repeated questions about whether drugs that prolong life for short periods of time are worth the high costs… Not using Erbitux as a first-line treatment for [KRAS-variant] patients could save about $600 million a year.”

The manufacturers Bloomberg’s reporter spoke to are fully supportive:

“‘The inclusion of KRAS as a biomarker in the Erbitux labeling helps physicians to better understand the most appropriate use of the drug in the management of patients with metastatic colorectal cancer,’ said Fouad Namouni, an oncology executive for Bristol-Myers …

Physicians can eliminate Vectibix and Erbitux for colon cancer patients with the KRAS mutation and ‘redirect those patients to alternative therapies, avoiding unnecessary treatments in patients who are unlikely to benefit,’ said Sean Harper, Amgen’s chief medical officer.”

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Pfizer and Ontario BIP Program Funding New $6.9 million “POP-CURE” Project for Colorectal Cancer Genomics

B&W_DNA_sequence Pfizer Global Research and Development is contributing $6 million and the Ontario government is contributing $900,000, through the Biopharmaceutical Investment Program (BIP), for a new project “to discover and validate new targets for the diagnosis, prognosis and treatment of colorectal cancer.”  Brad Wouters, a Senior Scientist with the Ontario Cancer Institute (OCI) and a Senior Investigator at the Ontario Institute for Cancer Research (OICR), will lead the project.

Here’s the scoop from the OICR press release:

“Dr. Wouters and a team of scientists at OCI and OICR will use genomic and molecular pathology approaches and develop a large clinical biobank to identify molecular signatures in colorectal cancer. These molecular signatures will be used to accelerate the development of biomarkers for early detection, monitoring and treatment of cancer.”

The Canadian Press article includes some additional background info on the project, which Paul Lévesque, president of Pfizer Canada, says began with a trip by Ontario researchers to meet Pfizer scientists in San Diego almost two years ago.

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Trends Update — Biosimilars: Sen. Kennedy, Gov. Dean and NVCA Study all Support 12+ Years of Exclusivity

The debate over the proper data exclusivity period for innovator biologics (as protection against biosimilars/follow-on biologics/subsequent-entry biologics) had a busy week last week.

A couple of thoughts:

  1. The exclusivity period in the EU is 8 years (data) +2 years (marketing) +1 year (for new indications), and the current proposal in Canada is 6 years, so a baseline of 12-14 years’ protection would leave the U.S. system paying for exclusive pricing longer than other major markets.  I’m fine if the U.S. decides to further subsidize pharma innovation, but I’d prefer a more transparent approach with less market distortion; and
  2. It’s hard to balance rationally between data exclusivity and patent exclusivity when the patent system is in significant flux.  Having patent reform as a moving piece (or as part of biosimilars legislation) only muddies the debate.

Update: The WSJ picks these up this morning too.  Here’s the NVCA story, and here’s the one on Kennedy’s efforts and the debate it’s generating in committee.

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Trends Update — Electronic Medical Records: Ottawa Telehealth Success, Privacy Fiasco in Alberta, Beta Test in Montreal

floppy-disk1New data yesterday from a home telehealth monitoring program developed by the University of Ottawa Heart Institute claims a whopping 54% cut in hospital readmission for heart failure patients.  Readmission rates dropped to under 15% for patients on the program, which includes daily vitals monitoring and immediate contact if anything seems amiss. UOHI says they realize up to $20,000 in savings for each patient safely diverted.

Of course, any time you create electronic medical records, you create privacy risks, as this week’s fiasco in Alberta shows.  Over 11,000 patients were notified of a privacy breach after a virus infected over 100 Alberta Health Service computers.  A follow-up CBC story quotes a computer security expert who is appalled (the virus is 7 years old).

If you still want to hop on the electronic medical record bandwagon, McGill University Health Centre is collaborating with Medical.MD to promote a 300-subscriber beta test (first-come, first served) for Medical.MD’s web-based personal health records management tool — MedforYou.  Medical.MD says the service will be very user-friendly and will include information on allergies, procedures, providers and medications as well as a journaling function.

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Trends Update — Comparative Effectiveness and Personalized Medicine: Study by CAMH in Toronto will Integrate Genetics, PET Brain Imaging and Pharmacology

CAMH logoToronto’s Centre for Addiction and Mental Health (CAMH) will use a $2.8 million grant from the Canada Foundation for Innovation, along with expected Ontario matching funds, for their ambitious neuroIMAGENE initiative.  The neuroIMAGENE program aims

“to combine the power of genetics and sophisticated brain imaging to personalize treatment … for common psychiatric conditions like major depression, bipolar disorder, schizophrenia, as well as addictions.”

Specifically, CAMH will compare DNA characteristics across 18 different psychiatric conditions and integrate that data with PET scans showing individuals’ neurochemical changes induced by drug therapies. The idea is to create tools to identify the medication that will work best for each individual’s brain chemistry and genotype,

“helping to avoid trial-and-error prescribing, treatment failure, relapse, and serious side effects.”

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Trends Update — Commercialization by Nonprofit Foundations: Not All Coming Up Roses

An article in Mass High Tech yesterday points to the trend we’ve been following of increasing commercialization activity by non-profits, but looks at things from the foundations’ point of view. While the economic crisis is, as expected, causing companies to seek out more foundation funding, those collaborations are having as much trouble as the rest of the biotech world:

  • The Cystic Fibrosis Foundation had to reclaim rights from Altus Pharmaceuticals, and spent $3 million continuing a Phase 3 trial while looking for a new partner;
  • The Michael J. Fox Foundation is putting more money than it planned into its corporate ventures because of the dearth of for-profit investors; and
  • the Juvenile Diabetes Research Foundation has “had to walk away from some really good science” at companies that look “too vulnerable financially.”

The article also has a good list of foundation-biotech collaborations:

Cystic Fibrosis Foundation with Alnara Pharmaceuticals, Epix Pharmaceuticals, FoldRx Pharmaceuticals;

Michael J Fox Foundation for Parkinson’s Disease Research with Alnylam Pharmaceuticals, FoldRx Pharmaceuticals Inc., NeuroHealing, LINK Medicine and Codman & Shurtleff;

Leukemia and Lymphoma Foundation with FoldRx Pharmaceuticals Inc.; and

Juvenile Diabetes Research Foundation with Tolerx Inc., Smart Cells Inc.

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Trends Update — Biosimilars: Obama Administration Supports 7-Year Exclusivity Period

The Obama administration offered up a 7-year data exclusivity period for biologics, calling it a “generous compromise” in a letter to Rep. Waxman from Nancy-Ann DeParle, director of the Office of Health Reform, and Peter Orszag, director of the Office of Management and Budget, picked up by Bloomberg this week.

I’ve had my money on an 8-10 year period for a while now as the compromise between the competing Waxman and Eshoo-Barton bills … The InVivo Blog has a funny take on how a 10-year period might be injected into the dialogue.

BIO points to a post by Prof. Holman criticising Waxman’s 5-year period (now clearly an outlier) and also the patent challenge/enforcement provisions of Waxman’s bill.

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Brain Dump: Vacation Edition

A bit of catching up from the last few days:

Finally, a video that will brighten your day, even though it’s an ad:

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Trends Update — Comparative Effectiveness and Personalized Medicine: Patient-Centered Outcomes Research Act of 2009 Increases Personalized Medicine Focus

story on GenomeWeb yesterday takes a close look at the Baucus-Conrad Comparative Effectiveness Bill and notes that the influence of personalized medicine that we’ve flagged as a trend in 2009 has shown up in this year’s verison of the bill as

language specifying research approaches such as “molecularly informed trials” and “genetic and molecular sub-typing.”

This year’s version of the bill also

includes more emphasis on involvement with the diagnostics community and calls for an expert in genomics to serve on a methodology committee.

In addition to a focus on personalized medicine, the changes to Baucus’ bill incorporate another idea from Sen. Kyl’s amendment in April — adding some hurdles before CER results could be used (by CMS) for coverage decisions. 

Even so, the bill continues to meet procedural impediments and substantive objections, resisting Baucus’ efforts to re-brand the concept.

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Trends Update — Nonprofits Funding Commercialization: TB Alliance Splits Development Costs With J&J Sub for TB Drug

Mycobacterium_tuberculosisOne of the trends in 2009 we have been following is the increasing willingness of non-profits and disease advocacy groups to fund commercial product development by for-profit companies. 

Today, the nonprofit Global Alliance for TB Drug Development announced that it will share the development costs for J&J subsidiary Tibotec’s drug TMC207, and that the TB Alliance and Tibotec will collaborate on future pipeline products.

This is not the TB Alliance’s first foray into commercial development.  In May, they announced four other drug development collaborations, including 3 with academic institutions, and one with Anacor Pharmaceuticals.  Under the Anacor collaboration, Anacor gets unspecified “support” from the TB Alliance, and the TB Alliance gets a non-exclusive, royalty-free worldwide license for TB.

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Trends Update — Electronic Medical Records: GE’s First Healthymagination Project Aims to Speed EMR Adoption, May Also Help GE Sell Stuff

floppy-disk1GE has put $100 million — the first installment of a promised $6 billion commitment to its “healthymagination” goals — into funding zero-interest loans to physicians’ offices, hospitals, clinics, etc. to support the purchase of (GE’s own) electronic medical records (EMR) systems.

The program is called “Stimulus Simplicity” and it has a couple of very smart features:

  1. 1.    The interest-free period extends through 2012, a year after the U.S. stimulus funding will give credits to EMR purchasers; and
  2. GE will include a “certification warranty” that will ensure the systems qualify for the stimulus funding.

Highly Ymaginitive, GE!

[A side note for the lawyers in the audience: GE says Stimulus Simplicity contracts feature "extremely simple language."  Truly plain language contracts ... that could be a $6 billion benefit right off the bat.]

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FTC Weighs In: Favors Compromise on Biosimilars Exclusivity, Disfavors Pay-For-Delay

The FTC released a report today that explores the economics of biosimilars’ market entry and competition.  It predicts that biosimilars will be priced only 10 to 30% under their corresponding pioneer biologics; and that pioneer biologics will retain 70-90% of their market share subsequent to biosimilar market entry. 

Based on these predictions, the FTC concludes that the proposed 12-14 year exclusivity period (here’s looking at you, Eshoo-Barton) is “too long.”  I’m sticking with my guess that we see a compromise from Waxman on the exclusivity period, landing around 8-10 years.

The report also reiterates the FTC’s opposition to pay-for-delay deals and corresponding support for H.R. 1706.

P.S. The InVivo blog says there’s convergence on “biosimilars” over  “generic biologics” and “follow-on biologics” as the nomenclature of choice (presumably “subsequent-entry biologics” loses too), so I’m running with it.

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Trends Update — Personalized Medicine: DxS’ Latest Companion Diagnostics Deal

B&W_DNA_sequenceAs personalized medicine inches toward becoming the standard of care for cancer, the question of who pays for the genotyping becomes more important.  A deal announced Friday between DxS, a molecular diagnostics company, and Boehringer Ingelheim suggests that pharma companies will end up footing at least part of the bill by paying for the development (and marketing?) of companion diagnostics.

As noted by IVB in their Deals of the Week this week, the Boehringer Ingelheim deal is only one of several that DxS has done recently:

Last December, DxS signed a US-centered deal with Amgen to provide a companion diagnostic for the Big Biotech’s colorectal therapeutic Vectibix. The test maker’s so-called TheraScreen K-RAS test is already on the market in the EU and is used to help doctors determine which patients are unlikely to respond well to anti-EGFR therapies such as Bristol-Myers Squibb/ImClone’s Erbitux (cetuximab) and Amgen’s Vectibix. Moreover, DxS and Amgen have collaborated since last year on selling TheraScreen K-RAS alongside Vectibix in Europe, where the drug is cleared for patients with refractory metastatic colorectal cancer in which there is no K-RAS mutation.

Also notable: this statement in the press release attributed to Dr. Manfred Haehl, Corporate Senior Vice President Medicine of Boehringer Ingelheim…

As this year’s theme at ASCO highlights, it is very likely that personalised medicine will play an important role in selecting the most effective treatment for patients with cancer.

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Trends Update — IP Constituencies: Rumors about GSK-Shantha Biotech

B&W_BlankMap-World-nobordersSince we’ve been following innovative activity in India and China as part of our Trends in 2009 series, we had noted a report at the end of March that GlaxoSmithKline and Sanofi-Aventis were each in talks to buy a majority stake in the Indian company Shantha Biotech from France’s Merieux Alliance, which owns 80 percent of the company.

A report in India’s Economic Times today, picked up by FierceBiotech, says that Sanofi had dropped out and that the deal with GSK has “[o]nly a few matters relating to the valuation” remaining.  This is a bit like saying Israel and the Palestinians are close to a peace accord with only a few matters related to borders remaining.  Hopefully GSK and Shantha/Merieux are closer (and friendlier) than that, but valuation is obviously a big issue, so I wouldn’t be counting any biosimilars before they hatch.

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Trends Update — Electronic Medical Records: Your eHealth Future from CNET News

floppy-disk1CNET News has been taking a look at electronic medical records over the last few days in a feature called “Your eHealth Future” (hat tip to the WSJ Health Blog).  They are covering health care reform from the IT side, presented in six articles, all accessible through this link:

  1. 1.   Dragging health records into the Digital Age;
  2. Microsoft, Google in healthy competition;
  3. What you need to know about e-health records faq;
  4. Politicos prep for another health care showdown; 
  5. Why are doctors such Luddites? and
  6. Taking your health record with you.

 

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Trends Update — IP Constituencies: China Moves to Boost Biotechnology

world_map_2002An announcement by the State Council in China that was picked up by Fierce Biotech yesterday touted $9.2 billion in technology spending that will include biotech and genetically modified products (as well as large-scale aircraft, broadband wireless technology and new oil, gas and coalbed methane exploration).  The cabinet also reportedly approved new policies with the goal of creating large internationally competitive biotech companies as well as fostering the formation of smaller biotechs.

Check out the Trends in 2009 page for our other posts on increasing innovative activity in China and India and the effect on global IP policy.

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Trends Update — Comparative Effectiveness: To Head-to-Head or Not To Head-to-Head?

Goats_butting_heads_in_GermanyOne of the challenges of comparative effectiveness implementation is figuring out when to look for comparative data. Two developments this week shed light on current comparative effectiveness thinking by regulators and pharma:

  1. Vanda’s new antipsychotic, iloperidone (Fanapt) was approved by the FDA last week without any head-to-head comparison against competitors (Zyprexa, Risperidol).  This approval indicates that so far, as the In Vivo Blog points out, the FDA is sticking to the view expresed by Bob Temple last year to the RPM Report that “[i]n most settings, especially for symptomatic treatments, we [the FDA] do not get or ask for comparative data and are perfectly willing to approve a drug that is shown effective.” (emphasis added).
  2. Nevertheless, reports today indicate that AstraZeneca decided to find out at Phase III whether its heart drug Brilinta is more effective than Plavix.  AZ conducted one of the largest head-to-head studies ever undertaken before regulatory approval.  FierceBiotech says that “offers a clear indication of the path developers will be more willing to take as they angle for market share among increasingly cost-conscious payers.”

Would Vanda have had an easier time if it had done a head-to-head trial? Could they have sustained the company long enough to find out? Maybe the only moral of these two trials is to look for comparative data as soon as you can afford to.

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Trends Update — Electronic Medical Records: Telus/Microsoft and GE’s Global Healthcare Initiative Come to Canada

floppy-disk1Two Canadian developments on the electronic medical records front:

Telus-Microsoft:

Telus and Microsoft are developing a patient-centred system that would allow individuals to access and manage their medical records and would interface directly with health care providers’ systems to gather and share the data.  Canada Health Infoway wants to make sure it’s secure.  The CBC story mentions that the IBM/Google Health team is looking at a Canadian implementation as well.

GE Healthcare:

GE held an event today at MaRS launching a global healthcare initiative — called “healthymagination” — with announcements in 4 other cities around the world including Washington

GE is devoting $6 billion over the next 6 years to meet three goals by 2015: reduce the cost of healthcare by 15% (focusing on procedures and processes); increase access by 15% (to services, technologies and health education); and improve quality by 15% (partner with physicians and stakeholders to simplify procedures and accelerate adoption of standards of care). 

The initiative was introduced in Toronto by Elyse Allan, President & CEO of GE Canada, and by Peter Robertson, General Manager of GE Healthcare Canada, who did a good job of speaking to Canadian-specific issues.  One program that was heavily discussed was the Pan Northern Ontario PACS Project (PNOP) agreement with GE Healthcare for the creation of a Diagnostic Imaging Repository (DI-r) and longitudinal patient records across northern Ontario.  The program is being funded in part by Canada Health Infoway and the Ministry of Health and Long Term Care’s eHealth Program.

 

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Trends Update — Shifting IP Constituencies: AstraZeneca’s R&D Investment in India’s Jubilant

world_map_2002One of our trends in 2009 series is following the increasing innovative activity in India and China, which has the potential to reshape WTO debates around IP protection.

Yesterday, FierceBiotech picked up a Reuters report that AstraZeneca will be funding five years’ work in neuroscience R&D at India’s Jubilant Organosys.  Jubilant was… well … very happy about the deal, which could lead to up to $200 million in milestone payments.  Jubilant also works with Eli Lilly on drug discovery and partnered drug development.  Interestingly, the article juxtaposes Jubilant’s R&D deal with its Monday FDA approval for a generic product.

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Trends Update — Personalized Medicine: No Medicare Funding for Warfarin Testing, For Now

dna_sequenceThe WSJ Health Blog reports that Centers for Medicare and Medicaid Services (CMS) has decided there is not enough scientific evidence for Medicare to pay for genetic testing to customize Warfarin dosing.

CMS proposes paying for more research, and the New York Times story questions the cost effectiveness of a prospective study; but as we reported in February, NIGMS is already working on a prospective study that Frank Torti boosted at the time.

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Trends Update — Electronic Medical Records: Health IT and EMR Have an Advocate in New OMA President Suzanne Strasberg

floppy-disk1Dr. Suzanne Strasberg took over as the incoming president of the Ontario Medical Association (OMA) Saturday night at their annual gala.  The OMA press release headlines Dr. Strasberg’s call for access to family physicians, but health IT also figures prominently. Dr. Strasberg indicated that she would focus on a number of initiatives, including “expansion of the use of IT and eHealth” and cited support for “Electronic Medical Records, which have enhanced patient safety and improved the quality and continuity of care, as examples of where further expansions should be made immediately.” 

Click here for our other posts on electronic medical records.

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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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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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Trends Update — IP Constituencies: Sanofi Buys Medley in Brazil

Continuing a trend we have been following of increased “innovator” pharma investment in global generics and biosimilars, Sanofi-Aventis is spending €500 million to acquire Medley, a  privately-held Brazilian manufacturer. The acquisition will make Sanofi Latin America’s biggest generics manufacturer.  A post at the WSJ Health Blog on the acquisition includes a nice overview of the other recent pharma-generics deals.

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Trends Update — Electronic Medical Records: Military and Vetrans System Should Speed Adoption, Standards

In a speech Thursday, President Obama announced that the Defense and Veterans Affairs departments will set up a system that will ultimately provide “unified lifetime electronic health record” for members of the armed services. 

Any large-scale government implementation like this is bound to help set standards and encourage adoption by other providers.  With luck it will also, over time, provide data on cost-savings and care improvements.

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Trend Update — Electronic Medical Records: View From HIMSS

The 2009 Healthcare Information and Management Systems Society (HIMSS) conference was in Chicago this week, and was obviously energized by the stimulus money in the U.S. and the budget allocation in Canada, which have greatly increased the available funding for Electronic Medical Records.

There’s a great overview of trends at HIMSS from Dr. John D. Halamka, chief information officer and dean for technology at Harvard Medical School, at his blog: Life as a Healthcare CIO.

His headlines: Stimulus; Economy; Software as a Service; Security; Open Source; PHR; Appliances for HIE; Home Healthcare Care/Telemedicine; Performance Measurement and Outcomes; and Decision Support. 

Read the whole thing.  Read our other electronic medical records posts.

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Trends in 2009 Update: Hospital Hits Electronic Medical Record Milestone

As the momentum behind electronic medical records builds, New York-Presbyterian Hospital — with the help of the Microsoft Health Solutions Group — has  kicked it up a notch with MyNYP.org, an electronic personal health record.  According to a report in the New York Times on Sunday:

NewYork-Presbyterian Hospital … is the first large institution to move beyond the pilot stage this week as it begins to offer consumer-controlled health records for patients…

The NYP initiative facilitates the transfer of medical information into personal electronic records that are not tied to any institution.  According to the Times, Google has entered into similar partnerships with large healthcare providers so there’s more to come.

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Trends in 2009: Comparative Effectiveness Meets Personalized Medicine in the Senate

Yesterday Senator Kyl (R-AZ) introduced a “comparative effectiveness amendment” (SA 793) to the budget which would have:

  1. required that legislation resulting from the health care reserve fund not use data obtained from comparative effectiveness research to deny coverage under Federal health care programs; and
  2. ensured that comparative effectiveness research accounts for advancements in genomics and personalized medicine, the unique needs of health disparity populations, and differences in the treatment response and the treatment preferences of patients.

As I noted in our earlier Trends post, I believe the comparative effectiveness advocates in the Obama administration are perfectly on board with point (2), a point I made again with further examples when the U.S. Stimulus allocated $1.1 billion to comparative effectiveness research.  It’s point (1) that most likely caused the amendment to be rejected, 44-54. 

Bottom line:  until the research is done, we won’t know how much of what appears to be “comparative effectiveness” is actually accounted for by “personalized medicine” (i.e., individual, genetically-based response variation to the subject medication/treatment), as compared to different “effectiveness” (i.e., response to a medication/treatment in a (relatively) homogeneous population). 

My guess is that the vast majority of apparently differential effectiveness will boil down to underlying genetic differences in patient subpopulations. 

But ultimately, there may be some treatments that are genuinely less effective than others in comparable populations.  As a patient and as a taxpayer, I’d like to know what those are and avoid taking or paying for them.

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Trends Update: ChinaBio and Shantha Biotech

One of our Trends in 2009 posts last week talked about the increasing innovative activity in India and China and increasing generics activity among innovator pharma.  This week starts with a relevant update on each front:

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