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

Tag Archives: Personalized Medicine

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 [...]

Friday Science Review: June 11, 2010

Catch up on these genetics stories between World Cup soccer games… Genetic Links to Autism: Phase 2 results of the Autism Genome Project mapping the genetics of autism is reported this week in Nature. Researchers used the latest microarray technology to identify a trend that autism patients carry more insertion and deletion mutations affecting their [...]

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 [...]

Biotech Trends at BIO 2010

As I’m preparing for the BIO conference in Chicago next week, I’m excited to see that several of the biotech trends we’ve been following on the blog are showing up as conference sessions. Interested in “A New Kind of Non-Dilutive Financing and Fundraising: Partnering With Not-for-Profits”? Get an early start at our trends page on [...]

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: 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 [...]

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 [...]

Friday Science Review: February 26, 2010

A few medical research applications this week… Personalized Medicine – for Lung Cancer: To develop a personalized medicine approach to treating non-small cell lung cancer (NSCLC), researchers generated a xenograft model where they implant human tumour tissue into the renal capsule of a host mouse.  As the tumour establishes itself, the mouse then becomes the [...]

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 [...]

Biotech Trends Update — Personalized Medicine: The Case for Diagnostics Focuses on Cost and Effectiveness

A report in FierceBiotech today distilled the views of three life science VCs on trends to watch in 2010.  Along with other worthwhile observations (and I’d encourage you to read the whole thing) was this bullet pointing out the value of personalized medicine in addressing comparative effectiveness concerns: “Interest in molecular diagnostics is heating up. It’s [...]

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 [...]

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 [...]

In Praise of Universal Coverage From a Genomics Perspective

This could be the last chance in the U.S. to make good decisions about health care.  Why? Because now, before genome sequencing is fast and cheap and universal, we are in a political position rarely experienced outside philosophy books: we are still in the “original position,” behind the “veil of ignorance.”  I’ll try to make this [...]

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 [...]

Q3 Is Looking Up for Biotech: Emdeon, Cumberland, Domain, LOM BioQuest, OETF

This week has seen a continued upswing for biotech and other health industry companies in the U.S. (with two IPOs) and in Canada (with great VC news and the pending appointment of an administrator for the Ontario Emerging Technologies Fund): In the U.S. Emdeon (NYSE: EM) IPO’d today, pricing at the top of its range ($15.50) and [...]

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 — 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 [...]

No Company is an Island: More Pharma and Biotech Collaboration

Two deals this week showcase collaborative efforts between major pharma players:     Gilead Sciences Inc. entered a partnership with Tibotec Pharmaceuticals, a unit of J&J, to develop a single daily antiretroviral HIV pill combining Gilead’s Truvada with a drug Tibotec is developing called TMC278.  Gilead will take the lead in manufacturing and testing the combined drug, [...]

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 [...]

Bailout Update: New UK Life Sciences Blueprint Aims to Promote Innovation

The UK has a new Life Sciences Blueprint that sets as a goal the creation of an internationally-recognized life sciences cluster.  Here’s the press release and here’s the full report (pdf).  Innovation Pass and Changes at NICE: The Blueprint kicks off an “Innovation Pass” program under which certain novel medicines (criteria TBD) will be available for a 3-year period [...]

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 — 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 — 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?) [...]

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