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Daniel Vorhaus
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A More Personal Form of Personalized Medicine

As someone who has the privilege of working with researchers, entrepreneurs and companies at the forefront of personalized medicine, I've seen firsthand the promise - and the challenges - this field can offer. But as a lawyer I'm rarely on the front lines. Drafting informed consent agreements and negotiating technology licenses has its place, but even within the field of personalized medicine it can frequently feel rather impersonal.

But not always.

For far, far too long now, my friend Niko has been struggling to overcome a brain tumor. Niko's tumor is currently classified as Anaplastic Astrocytoma (WHO Grade III), a serious diagnosis in its own right. Unfortunately, an MRI last week revealed that the tumor has recurred and is growing rapidly in a new area close to the site of the original tumor. With standard treatment options (SRS and Avastin +/- chemotherapy) likely to be of limited long-term efficacy, a decision was made to try something new.

With almost no time to prepare, Niko and his family decamped for UCLA for enrollment in a Phase 1 clinical trial for Toca 511, a self-replicating retrovirus about which more can be read on Tocagen's website (http://www.tocagen.com/site/c.quIYL6MOJrE/b.6116599/k.9D00/Clinical_Trials.htm) and on the UCLA study website (http://www.uclahealth.org/page.cfm?xyzpdqabc=0&id=502&action=detail&ref=916&start=2&issueref=27). From Niko's perspective, and from mine, all that really matters is that if Toca511 works it will serve as the Trojan Horse to Niko's long-running war on cancer and, as Tamara writes at Niko's website, Anticancer, "end the siege and kill this thing Greek style." (http://anticancer.tumblr.com/post/14222787822/gmo-niko) (Tamara's analogy makes more sense if you know that Niko and his family are Greek-American.)

Toca511 is the embodiment of modern medicine in many ways. But what makes it different, for me, from the important work pursued by so many researchers and companies worldwide is its singular importance, today, to Niko. It's an important reminder of who stands at the end, waiting for the rest of us to resolve scientific uncertainty, budget shortfalls, regulatory squabbles and all the rest into meaningful, effective, personalized medicine.

I know that nearly all of us who work in this field have our own Niko. But if you'd like to learn more about the particular Niko I know and love, and especially if you'd like to help him through this next and most difficult stage in his fight against cancer, please head over to Anticancer and send Niko a few words of encouragement and, if you can spare it, a few dollars as well.

- Dan

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Great chart of how people in science see each other (HT +Brendan Maher). My question: where is the column for lawyers (or would that just be filled with skulls and crossbones)?

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xkcd illustrates one of the many reasons why cancer sucks.

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John Conley & I have written up our preliminary thoughts on the Federal Circuit's recent opinion in the Myriad gene patent litigation. Short version: most of Myriad's patents remain valid, for now, and it's on to the next appeal.

Please share your own analysis of the court's opinion - including whether you think the court reached the proper result - in the comments.

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I'm following +Daniel MacArthur's lead and starting an open comment thread on the proposed rulemaking from HHS and OSTP to overhaul US human subjects research protections (often referred to as the "Common Rule"), including informed consent goals and requirements.

The Advanced Notice of Proposed Rulemaking (ANPRM) is available here: http://www.ofr.gov/OFRUpload/OFRData/2011-18792_PI.pdf

This seems like a good test case for the #IRBreform discussion which breaks out at intervals on Twitter. I'll ask +Jonathan Gitlin +Jen Wagner +Greg Biggers +Eri Gentry +Chris Gunter +Andro Hsu +Jason Bobe +John Wilbanks +Sharon Terry +Robert West +Michelle Meyer and others to help spread the word and add their thoughts.
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