The Cross-Border Biotech Blog

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

Tag Archives: Personalized Medicine

Genome BC and PROOF Launch Phase Two of Biomarkers in Transplantation

RecycleMeGenome British Columbia and the Prevention of Organ Failure (PROOF) Centre of Excellence at UBC announced the launch of the second phase of the “Biomarkers in Transplantation” project, which aims to use a simple blood test to identify patients who are rejecting a transplanted organ.

The current test for rejection is a biopsy — which costs somewhere between $5-10 thousand dollars — and the average heart transplant recipient will need between 14 and 16 biopsies in the first year alone.

The new test is a biomarker test that has been “validated … in one group of patients” and is now being readied for the Health Canada and FDA approval process.

Bookmark and Share

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.

Bookmark and Share

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.
 

Bookmark and Share

Wednesday Brain Dump: Two of Everything! Edition

Two Camels!  Dolly the cloned sheep, meet Injaz the cloned camel.

Two R&D Heads!  The combined Pfizer-Wyeth will have Mikael Dolsten heading up the newly created BioTherapeutics Research Group and Martin Mackay heading up the small molecule PharmaTherapeutics Research Group.  (Two CapitalLetters!)  The In Vivo Blog has a podcast interviewing both.

Two VA Initiatives!  In addition to the electronic medical records initiative we mentioned earlier this week, the Department of Veterans Affairs is also setting up a large cohort genetic study that will establish a database of genetic information from patients that will be linked to the participants’ electronic health records.  This is great news for personalized medicine because it will ensure that the EHR standard that comes out of the VA project will accomodate and utilize individualized genotypic data.

Two R’s, Two L’s, Two B’s!  G. Steven Burrill (two r’s, two l’s, one b) says he’s confident he can raise $1 billion (there it is!) to develop the Pine Island biotechnology project and a private equity/venture capital fund, which will support development of new technologies out of the Mayo Clinic and the University of Minnesota, among others.

Two Guidance…s!  Health Canada issued a finalized version of a Guidance Document on data protection (only applicable to qualifying innovative drugs that received an NOC on or after June 17, 2006) AND a revised version of the draft Guidance Document on Subsequent Entry Biologics, (which includes a 6-year data protection period).  More to come on this.

Two Border Crossings!  Simponi, a biologic developed by Johnson & Johnson and Schering-Plough, crossed the border Northbound — gaining approval from Health Canada before the FDA; and Molecular Templates Inc. crossed the border Southbound — leaving Ontario for the Texas Life-Sciences Collaboration Center.

Bookmark and Share

Friday Science Review: Good News, Bad News Edition

Good news: If you happen to be in Montréal on Monday, you should check out the opening of the  Centre de pharmacogénomique Beaulieu-Saucier de l’Université de Montréal (that’s the Beaulieu-Saucier Centre for Pharmacogenomics at the University of Montréal, y’all).  It will be great to see what comes out of this centre for Canadian personalized medicine.

Bad news: If you happen to have been relying on a Nature paper from 2000 in which researchers in Canada and South Korea said they used gene therapy to reverse Type 1 diabetes, you should reconsider.

Good news: If you happen to do a science fair project that dovetails with a Minister’s legislative efforts, you could be famous.  Also, don’t drive and talk.

Bad news: If you were excited about the availability of private clinics in Canada offering CT and PET scans, you should read this new study from the Canadian Center for Policy Alternatives first, which found that there are prevalent misconceptions about the safety and regulation of these screening technologies.

Bookmark and Share

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.

Bookmark and Share

Trends in 2009: Personalized Medicine and Cancer Update

The Boston Globe reported this week on current trends in genetic testing of tumors:

  • Massachusetts General Hospital will be adding $2,000 per patient worth of genetic testing as part of its standard of care for cancer.
  • Dana-Farber tests selected patients, including patients with certain melanomas, where doctors know those malignancies can carry abnormalities that are susceptible to certain drugs.
  • Memorial Sloan-Kettering Cancer Center in New York, will start screening most patients with lung cancer within weeks.

This week has seen some scientific developments reported in tumor screening as well:

  • A study in PNAS reports on an analysis of genome-wide expression and copy-number data in endometrial cancers and finds a couple of prognostically-relevant results.
  • A study in the Journal of Clinical Oncology reports on the use of a 50 gene array to successfully identify four breast cancer tumor types that have been previously defined: luminal A, luminal B, HER2-enriched and basal-like.

We’ll see if the accumulation of data is sufficient to make a case for insurance coverage.

Bookmark and Share

Allocating Spending to Support R&D: UK, U.S. and Canadian Approaches

The U.S., Canada and the UK have all acknowledged the central importance of R&D even in these recessionary times.  However, the three national governments have decided to focus their spending on different steps of the R&D equation:

  1. Education: UK Takes the Long View
    British PM Gordon Brown, in a speech this week, identified three priorities: research, education and training, and public discourse.  However, only one of the three, education, was the subject of specific increased targets and spending:  retraining to increase the number of science teachers, a goal to double the number of pupils in state schools taking ‘triple science’, and a new Diploma program.  The U.S. and Canada have increased funding for graduate studies, but the UK effort is focused at an earlier stage, to rebuild the interest and capabilities of domestic graduates. 
  2. Publicly-Funded Research: U.S. Takes the Lead
    The focus of the U.S. R&D spending increases has absolutely been on research.  The increases for the NIH and NSF in the stimulus and the budget will go largely to increasing the volume of publicly-funded research.  PM Brown’s speech also vowed to protect funding for science from competing demands for Government support during the downturn, but did not propose increases over the existing 10-year plan.  Canada’s budget actually cut research funding across the three main granting agencies.
  3. Commercialization: Canada Takes Off 
    Canada’s focus was on commercialization.  The 2009 budget included $200 million allocated to the National Research Council’s IRAP program — $170 million to double the program’s contributions to companies, and $30 million to help companies hire over 1,000 new post-secondary graduates.  It also provided significant additional funding to BDC.  The only comparable spending in the U.S. was the $400 million for ARPA-E, which is allocated to energy programs, and supports research as well as commercialization.  PM Brown’s speech recognized the importance of maintaining the country’s struggling start-ups, and he has reached out to big pharma, but promised no specific action.

What’s still missing:  Stimulating Output

  • Despite calls in the UK, the U.S. and Canada, there have been no major tax policy changes enacted in this round of budgets and bailouts that ease the burden on, or return money to, early-stage technology companies.  Ontario has actually taken some steps in this direction with the Ontario Venture Capital Fund and the Ontario Tax Exemption for Commercialization.
  • Nor have there been many changes that increase the value of outputs: in the bio/pharma area, the UK has probably moved farthest in this direction, with upcoming reforms of the National Institute on Comparative Effectiveness (NICE), while the U.S. has seen decreasing FDA approvals and is allocating new comparative effectiveness funds.  On the other hand, approvals of GE animals, support for personalized medicine and big spending on electronic medical records will provide support to specific industry initiatives.

Stay tuned to our Bailout Page for updates.

Bookmark and Share

Warfarin and Personalized Medicine

dna_sequenceThe optimal dose of Warfarin for an individual can vary across a 10-fold range, and depends in part on genetic variation in two genes, CYP2C9 and VKORC1.  In 2007, the FDA required a labelling change to warn of patients with increased risk of bleeding due to these variations.  However, population-wide assessments of outcomes based on genetic testing were not definitive.

A paper in the current issue of the New England Journal of Medicine uses retrospective data to build a new dosing algorithm and predicts significant benefit from the use of the algorithm for the 46% of patients who require lower- or higher-than-normal doses.  The algorithm and data used to derive it will be made available via PharmGKB, a database managed by researchers at Stanford, and the research has prompted a full-scale prospective study of the personalized approach.

Frank M. Torti, M.D., acting commissioner of Food and Drugs said that the prospective study

is precisely what is needed to advance the promise of personalized medicine, ensuring that patients receive the safest and most effective drug dose.

Read our other posts on personalized medicine.
 

Bookmark and Share

Personalized Medicine: The “SNP Doctor”

BIO SmartBrief picked up a story today about a device being tested called the mohel Snip Doctor, a hand-held diagnostic device that:

looks for known single nucleotide polymorphisms (SNPs) – single letter changes in the genetic code – that can affect an individual’s response to medical treatment.

While most current approaches to personalized medicine are mechanistic (e.g., HercepTest), this device raises the possibility of a correlative approach.  Of course, it’s only a temporary measure to hold us over until our full genomes are a normal part of our electronic medical records.

Bookmark and Share

Comparative Effectiveness Stimulus Stimulates Reactions

The $1.1 billion in the stimulus bill for comparative effectiveness research has, not surprisingly, generated a good deal of public attention.  Friday’s Washington Post and the front page of today’s New York Times both have stories covering the political jockeying.

Although both pieces focus on potential problems from the lack of individualization, either from libertarian or advocacy perspectives, neither has picked up our strain that personalized medicine, also favored by the Obama administration, will change the shape of the entire comparative effectiveness debate.
More on a recent example after the jump…

Personalized Medicine: First SAEC Data

The FDA (as part of the Critical Path Initiative) and the International Serious Adverse Event Consortium (SAECannounced the release of their first data on the genetic basis of adverse drug reactions today.
Read more of this post

Personalized Medicine: Local to Global

Two local developments in personalized medicine in Canada, one at the forefront of global efforts, one making recommendations on how to play catch-up:

Read more of this post

Friday Science Review: January 23, 2009

Interesting science developments in and from Canada this week:

Read more of this post

Trends in 2009: Comparative Effectiveness and Personalized Medicine

Two potentially conflicting trends may see a dramatically increased profile in 2009: Government Bailouts and Free-Market Capitalism Comparative Effectiveness and Personalized Medicine. Both have been highlighted by the incoming Obama administration.  Details and analysis after the jump…

Follow

Get every new post delivered to your Inbox.

Join 129 other followers