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

Tag Archives: Personalized Effectiveness

Biotech Trends in 2011: Comparative Effectiveness and Personalized Medicine

When this blog was launched in 2009, comparative effectiveness and personalized medicine were fairly new features in the North American landscape. Our initial argument that they were related topics — determining which treatment is best depends on which patient is being treated – was soon bolstered by the comparative effectiveness provisions in the U.S. stimulus bill and new personalized [...]

Biotech Trends Update — Personalized Medicine: Duncan’s Personalized Health Manifesto is Primarily Preventative

Journalist David Ewing Duncan’s “Personalized Health Manifesto” was published this week by the Ewing Marion Kauffman Foundation. The most interesting thing about the manifesto* is that it assumes that the technical hurdles to generating and understading a full set of personalized health data have been overcome, and focuses on how that information can be deployed [...]

BIO Panel on Comparative Effectiveness Research Notes “Silver Lining” of Personalized Medicine

Speakers Daniel Todd, from EMD Serono, and Steve LaPierre, from Boston Scientific, were led by Foley Hoag lawyer Jayson Slotnik in a discussion of the final CER legislation and predictions about implementation. The overall tone was skeptical — the panel noted the potential for CER data to ultimately contribute to CMS coverage decisions, and worried about [...]

Comparative Effectiveness and Personalized Medicine are “Part of the Same Question” Collins Confirms

In a very informative Kaiser Health News interview (via GenomeWeb), Francis Collins says that “personalized medicine strategy and CER strategy are part of the same question. … There will often be more than one therapeutic intervention, so you have to compare them. But you also want to know what’s different about the individual that might have an [...]

Biotech Trends Update: A Personalized Critique of Comparative Effectiveness Misses the Mark

As the U.S. and Canada move to invest and rely more on comparative effectiveness research (CER), lack of personalization has been the loudest and most frequent objection.  That is why we have been following the interaction between comparative effectiveness and personalized medicine as a key industry trend. Yesterday, an opinion piece in the WSJ by Leonard [...]

Biotech Trends Update: Costs Savings from Personalized Medicine Sought by PBMs, Employers, Pharma Face Legal and Privacy Hurdles

When AstraZeneca announced a companion diagnostics collaboration recently, their head of oncology development said the goal was to get “the right treatment, to the right patient, the first time,” a nice turn of phrase* that is becoming a chorus in the healthcare industry. This week, giant PBM Medco purchased DNA Direct, saying “[o]ur whole thing at Medco [...]

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 [...]

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 — 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 — 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 — “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 [...]

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