The Cross-Border Biotech Blog

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

Category Archives: Trends in 2009

Biotech Trends Update: ChemGenex and the Importance of Companion Diagnostic Development

Australian cancer drug developer ChemGenex was scolded by the FDA’s oncology panel for “fairly sloppy drug development.” The company’s mistake? It presented its leukemia drug, designed for patients with a particular genetic mutation, without a validated diagnostic test for the mutation. ChemGenex says it’s a matter of months, not years, before it gets a test [...]

Subsequent Entry Biologics (aka Biosimilars) get Final Health Canada Guidance, 6 Years of Data Exclusivity

Health Canada released the finalized version of its Guidance Document for ”Subsequent Entry Biologics” (SEBs).  The final version is mostly the same as the draft guidance released last March, and actually comes after the approval of Canada’s first SEB last April. SEBs are a class of drugs that the EU calls “biosimilars” and the U.S. calls [...]

Biotech Trends Update — Personalized Medicine: A Big Market, If We Can Just Figure Out How to Get People to Use It

Late last year, a PwC report made the rounds with a big headline number — $232 billion — as the size of the personalized medicine market.  FierceBiotech called it a “tipping point,” for personalized medicine.  George Church called us “the first genomic generation” in Newsweek, and Francis Collins’ new book ”offers practical advice on how to [...]

Biotech Trends of 2009: Three Biggest Losers

When we started the blog almost a year ago, we identified what we thought would be key trends for biotech investors and companies to watch.  Most panned out, but a few turned out to be… not so trendy.  You can call them premature (if you’re feeling generous) or call them dumb (if you’re feeling mean); [...]

Top Four Biotech Trends of 2009

These may not all be consensus picks (and don’t miss the IVB’s year-end deal-centric fun) but I’m sticking with these four trends as the ones that have really shaped the year that was: Follow-on Biologics. Call them what you want (we like “biosimilars”, but we’re internationalist like that), there’s no denying that biosimilars were a major [...]

Trends Update — Electronic Medical Records: Importance of Telemedicine, Implementation and Data Security

Since the Canadian and U.S. stimuli directed fuding towards electronic medical records (EMR), we’ve been following developments in the area as part of our Biotech Trends series here on the blog and have noted successes and failures.  A few recent stories highlight risks and benefits: A recent Scientific American story (H/T @mikesgene) turned an analytical [...]

Biotech Trends Update — Commercialization by Foundations: New Initiatives from ALS Organizations, Juvenile Diabetes Research Foundation

As part of our Biotech Trends series, we’ve been following the increasing commercialization activity shown by non-profits (although they’ve been having as hard a time succeeding as everyone else).  Two recent stories highlight the important role foundations are playing in this market environment. JDRF Canada – FedDev Ontario Clinical Research Collaboration.  The Juvenile Diabetes Research Foundation [...]

Personalized Medicine Conference Highlights a Busy Month

Last week, Harvard Medical School held a conference entitled “Personalized Medicine: The Time is Now.”  Is the time now?  Looking around, it seems like personalized medicine has had a pretty good month: PBMs Drive Demand CVS Caremark, the country’s largest pharmacy services provider, partnered with Generation Health to expand pharmacogenomic testing for cancer, cardiovascular diseases, and [...]

Trends Update — IP Constituencies: Novartis CEO Vasella Calls Upcoming Gleevec Decision a “Turning Point” for R&D in India

India and China both ranked in the third quintile of countries in the 2009 IPRI Report, with India ranking 46/115 and China ranking 68/115 for protection of IP rights.  In an earlier post, we predicted that this ranking would change rapidly, with both countries strengthening their IP regimes as their domestic R&D capacity ramped up. Both countries have [...]

Trends Update — Electronic Medical Records: Ontario’s New EMR Adoption Program

Ontario is providing up to $29,800 per physician over 3 years for new adopters of electronic medical records.  In the few weeks since the program has been implemented, the OMA has gotten over 650 inquiries and over 150 applicants.  There’s a local option and a cloud option, which runs off the eHealth Ontario servers.  Interestingly, up [...]

Trends Update — IP Constituencies: China On the Rise as an IP Enforcer

We have been tracking increased innovative activity in India and China as part of this blog’s Trends in 2009 series, because it has the potential to impact the constituencies that negotiate the IP aspects of global trade agreements.  Generally, with this blog’s focus on pharma and biotech, posts have mainly considered commercial collaborations to develop [...]

Preventing Bias in Comparative Effectiveness Research

Comparative effectiveness research has the potential to avoid wasteful spending and create net benefits for patients if approached properly, but it’s expensive.  Many of the large-scale comparative effectiveness studies include industry funding, and benefits managers are no strangers to the game, but giving those partners a say in study design risks introducing bias.  An interesting [...]

Trends Update — Biosimilars: The State of Play of U.S. Follow-on Biologics Legislation

With the Senate Finance Committee voting this week in favour of its health reform bill, the legislative process will now move on to an attempt to reconcile the House bill and the two Senate bills in conference. What does this mean for a biosimilars pathway?  Will there be one?  What will the exclusivity period be?  [...]

Biotech Trends in 2010: Get An Early Start at OGI’s Synthetic Biology Conference

In updating this blog’s Trends in 2009 series for 2010, I noted that synthetic biology has garnered recent attention in The New Yorker and The Economist and it may be poised to attract more commercial attention.   Here’s a great chance to get a jump on the topic… Ontario Genomics Institute (OGI) and Integrated DNA Technologies (IDT) are [...]

Trends Update — IP Constituencies: India’s Glenmark Pharmaceuticals Sets an Example for Canadian Innovation

This blog has been following the increasing innovative activity taking place in India’s and China’s biopharma industries, and Glenmark Pharmaceuticals is a great example of this trend. Forbes profiled Glenmark this week (H/T FierceBiotech), noting that it started in 1978 as a generics firm but now has 7 clinical-stage compounds and has partnerships with Forest [...]

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: Synthetic biology (this article at the Economist got a good bit of coverage); and The [...]

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

We’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 [...]

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: 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 [...]

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

ethica 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 [...]

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: [...]

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?

For 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 [...]

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

Following 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: BIOCON) agreed to jointly [...]

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 [...]

New York Times’ Brody Counsels DTC Genomics Caution

An article in yesterday’s New York Times calls direct-to-consumer genetic testing, a trend we are following on this blog, ”fraught with potential dangers.”  Although our original post on the subject discussed many of the regulatory and ethical issues around DTC genomics, Brody’s article raises some interesting additional points: The risk of false reassurance: “a man told he [...]

Trends Update — Comparative Effectiveness: Where Data Shows No Difference, Tie Should Go To the Patient

A post by Scott Hensley on the NPR Health Blog yesterday has some good food for thought in the comparative effectiveness debate: what to do when comparative effectiveness studies show no statistically significant difference between treatments. The post notes that insurance coverage will be a factor in these decisions, but that: “in the end, it might [...]

Trends Update — DTC Genetic Tests: NOVA ScienceNOW Program Takes a Look

Yesterday’s NOVA ScienceNOW program included a segment on direct-to-consumer genomics (H/T to GenomeWeb’s Daily Scan Blog).  The program was bullish on George Church’s Personal Genome Project; but it took a pretty dim view of the predictive value of current consumer technology. The program was accessible and interesting, but it went overboard in making a cautionary point about current DTC genomics [...]

Trends Update — Personalized Medicine and Comparative Effectiveness: HepC Treatment Gap, Leukemia Genetics and Beckman Coulter Genomics

A few interesting items hit the news this morning that continue the trend of explaining comparative effectiveness data by examining underlying genetic variation. Genetics explains why white patients respond better than black patients to standard Hepatitis C treatment. Bloomberg reported on a Nature paper showing that Hepatitis C patients with a genetic polymorphism near the [...]

Trends Update — DTC Genetic Testing: Survey of State Laws on False Advertising

One aspect of direct-to-consumer genetic testing that requires particular vigilance is the “consumer” aspect.  We should expect that as the underlying technology becomes cheaper and testing companies proliferate, there will be more who prey on insecurity and health fears to make a quick buck while providing little value (or worse, missing genuine concerns). GenomeWeb Daily [...]

Trends Update — “Personalized Effectiveness”: Amgen Gets Prospective Data to Back KRAS-Vectibix Plan

A few weeks ago, when the FDA changed the labeling on anti-EGFR drugs, Amgen was pretty enthusiastic about “avoiding unnecessary treatments in patients [with a specific genetic marker] who are unlikely to benefit” from Vectibix.  Avoiding these patients leaves more reimbursement available for patients who would benefit from Amgen’s product. Now Amgen has even better [...]

Trends Update — Electronic Medical Records: Salesforce.com Clouds the EMR Field

The WSJ Health Blog notes today that Salesforce.com’s investment in Practice Fusion, though not a large financial investment, follows an appealing trend in the EMR space.  Both Salesforce.com and Practice Fusion are cloud computing plays (aka hosted services / ASP) where software and data live on company servers rather than on local PCs in doctors’ offices. This will be [...]

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