The Cross-Border Biotech Blog

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

Category Archives: Trends in 2009

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

This 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 [...]

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

This 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 [...]

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

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 [...]

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. On Wednesday, two Democrats told the Obama administration where to stick its 7-year “generous compromise”:  Howard Dean published an op-ed supporting a 12-year exclusivity period and Bloomberg wrote up a renewed effort [...]

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

New 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 [...]

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

Toronto’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 [...]

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 [...]

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 [...]

Brain Dump: Vacation Edition

A bit of catching up from the last few days: Sanofi makes a further move into generics, continuing the trend we’ve noted of big pharma moving in a big way into international small molecule generics and domestic biosimilars. A new tool from the NIH — RePORT, which replaces the CRISP system – is a powerful way to search for [...]

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

A 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 [...]

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

One 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 [...]

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

GE 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 [...]

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 [...]

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

As 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?) [...]

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

Since 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. [...]

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

CNET 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.   Dragging health records into the Digital Age; Microsoft, [...]

Trends Update — IP Constituencies: China Moves to Boost Biotechnology

An 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 [...]

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

One 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: 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 [...]

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

Two 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 [...]

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

One 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 [...]

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

The 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 [...]

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

Dr. 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 [...]

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 [...]

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.   [...]

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 [...]

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 [...]

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. [...]

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 [...]

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: 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 ensured that comparative effectiveness research accounts for advancements in genomics and personalized [...]

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: A report from Seeking Alpha on the ChinaBio Investor Forum that was recently held in Hong Kong, noting domestic companies GeneHarbor [...]

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