A year ago, looking into the personalized medicine craze, I ran across an Australian Group, Brain Resource, that seemed dead-set on turning the idea into an entrepreneurial block-buster with everything from Brain Training to MRIs. Here’s founder Evian Gordon, Guru/Scientist/Pitchman in a short video [notice the techno-voice, also there when he speaks at the end of the Mayflower Conference below]:
- personalized medicine: BRAINnet…
- personalized medicine: the Brain Resources company I…
- personalized medicine: the Brain Resources company II…
International Study to Predict Optimized Treatment for Depression (iSPOT-D), a randomized clinical trial: rationale and protocol
by Leanne M Williams, A John Rush, Stephen H Koslow, Stephen R Wisniewski, Nicholas J Cooper, Charles B Nemeroff, Alan F Schatzberg, and Evian Gordon
Trials. 2011; 12: 4.
Background: Clinically useful treatment moderators of Major Depressive Disorder (MDD) have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators.Methods/Design: The International Study to Predict Optimized Treatment – in Depression (iSPOT-D) is a multi-centre, international, randomized, prospective, open-label trial…Discussion: First enrollment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide.
BRRZY: Initiating Coverage of Brain Resource – Analyst Blog
NASDAQ
by Zacks Equity Research
June 13, 2012
We have initiated coverage of Brain Resource [BRRZY]. See below for access to our full 18-page report on the company which includes our financial model and provides further discussion about the company, their landmark iSPOT trial, current brain health products, market opportunities and growth strategy. Brain Resource is a San Francisco headquartered company focused on improving brain health. The company has established the first and largest standardized and integrated international human brain database which it leverages to provide products for the consumer, employer, and clinical markets. The company notes that their products have benefitted more than 50k end-users and have been utilized by more 30 multi-national corporate employers and hundreds of clinicians and researchers since the company’s founding over a decade ago.Brain Resource has two businesses anchored off the same proprietary technology: Personalized Medicine Diagnostics and Brain Health Solutions. They expect to be the first company to lodge a brain biomarker based diagnostic with the FDA for personalized treatment prediction and also are the first company to penetrate U.S. corporates with a brain health offering. The currently commercialized products include two web-based products, WebNeuro and MyBrainSolutions. WebNeuro, currently used by insurance providers and clinicians, offers objective reports assessing cognitive strengths and weaknesses to help physicians make more informed decisions regarding patient care. Brain Resource notes that WebNeuro currently has more than 250 users and generated almost 11k reports in fiscal 2011 [6/30/2011]. MyBrainSolutions online brain training, chiefly targeting the corporate employer market, aims to increase employee performance and productivity. Per Brain Resource, MyBrainSolutions has over 50k users and has been accessed more than 300k times. In the company’s half-year report, they list key goals for 2012/2013 , including increasing the user base of its products to 1 million users and a five-fold increase of revenue from their web-products [excluding licensing income, web-based revenue was ~$650k in 2011].
Brain Resource expects growth in MyBrainSolutions to come from an increase in the number of channel partners and employer clients. Meanwhile, WebNeuro’s functionality is expected to be substantially enhanced with the inclusion of biomarkers related to depression and ADHD. This will be the catalyst to driving growth of the personalized medicine business, Brain Resource’s major focus and the area that is expected to be the impetus to the company’s long-term revenue and earnings growth. Findings from the iSPOT trial will be used to develop these depression and ADHD biomarkers. iSPOT is the world’s largest clinical trial to predict treatment response in depression and ADHD. iSPOT-D [for depression] has enrolled over 1,700 patients and analysis started on the first 1,000 patients. Data from iSPOT-D was presented at two major U.S. medical conferences during 2011, including an invitation-only presentation at The American Conference of Neuropsychopharmacology in December and more recently formed a panel of presentations at NCDEU in Arizona. iSPOT-A [for ADHD], has enrolled approximately 500 patients to-date. Brain Resource is planning to submit study outcomes to the FDA for approval [likely via PMA] of a depression and an ADHD test in the near-to-mid term [discussions with the FDA regarding the regulatory approval pathway are ongoing].
Aside from progress with iSPOT, other recent highlights include the sale of $10MM in convertible bonds to a large institutional investor, Och-Ziff Capital Management, the establishment of a joint-venture for the ADHD product which included a $4MM equity contribution from the JV partner [controlled by Och-Ziff], and an agreement with Aetna whereby the insurer will distribute the company’s web-products…
iSPOT purports to be looking for genetic polymorphisms and other markers that will help us choose antidepressants in advance. So, presuming that they find something, you’ll sign on to a web site to take a battery of tests [proprietary], send in a DNA sample, and get back a report that tells you whether you should take Celexa, Zoloft, or Effexor. I have no clue where the hypothesis that the response to antidepressants is genetic came from, but I’m betting heavily against any meaningful validity. This idea is also being pursued by Dr. Trivedi in his NIMH funded study, EMBARC. This all follows the tradition of drug picking schemes that arose in the Clinical Guideline era of the mid-1990s – the one that produced TMAP and all the other xMAP progeny. The movers and shakers for this treatment by algorithm were John Rush and Madhukar Trivedi, then together at UT Southwestern: TMAP, STAR*D, COMED, IMPACTS, and now iSPOT and EMBARC.
doing the same thing over and over again, expecting different results…
So what’s wrong with all of this? It’s the kind of thing that has psychiatry in such a tangle right now. It’s the topic of David Healy’s book, Pharmageddon. It’s the infrastructure of Robert Whitaker’s book, Anatomy of an Epidemic. It’s the thing that poisoned the DSM-5 Task Force. It’s the reason that Tom Insel needs to be removed as Director of the National Institute of Mental Health. And it’s why my favorite politician is someone who has never had a single political thought that I agreed with [Senator Chuck Grassley]. It’s entrpreneurialism prior to investigation. It’s hypothesis disguised as fact. It’s science fiction masquerading as science.
The whole idea that our brain was formed completely by genetic code and that that code is the primary source of dysfunction is guano. It’s as if development and all relationships do not form us in the least, as if we sprung full grown from the head of Zeus, albeit very slowly.
Aside from the absurdity of the idea that genetic code forms an homonculus that guides our every expression down to the reaction we have to psychoactive drugs independently of all other factors; this perspective denies our very nature— we are social animals whose very survival depends on particularly extended care during infancy and childhood, and whose physical and mental health relies on meaningful and reliable bonds throughout our lives.
Our brain is influenced and patterned by everything we are ever exposed to.
They (The Drug Cartel) just keep pushing junk science, marketing pipe dreams, & preying upon the innocent or afflicted for profit….. there is no end in sight…nothing short of intrenched & institutionalized evil. This is what “tyranny” is made of…
Thank you, Mickey, for just the best belly laugh! Loved your sentence: “And it’s why my favorite politician is someone who has never had a single political thought that I agreed with [Senator Chuck Grassley].”