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Personalized Medicine: A New Industry Struggles Toward Birth

Some argue that medicine has always been personal. Personalized medicine as we think of it today has become the industry that is advancing the understanding of the human body at the molecular level. Since the sequencing of the human genome, this new industry has topped the news, often with much hype but little to show. Last week, Burrill and Co put on their 8th Annual Personalized Medicine Conference in San Francisco.

More and more, the focus at PM conferences is on reimbursement. Afterall, healthcare is an industry, an economy. Mendelspod is partnering with Personalized Medicine World Conference in January, 2013, and I just heard that the theme there is reimbursement. In the summer, I attended a conference put on by IBC focused on diagnostics, Drug and Diagnostic Development, and attended a terrific panel with Elaine Jetter of Palmetto (Medicare contractor) and Liz Mansfield of the FDA sloshing it out. I just received a program from CHI for an entire conference based on reimbursement.

The Burrill 2012 conference was no different in focus. To quote Steve Burrill, if you can’t get paid, it ain’t gonna happen.

PM to the Rescue

Steve begins his conferences with a sort of State of the Union address. Where are we at, where have we been, where are we going? Steve pushed this year’s audience--a room full at the Bently Reserve Hotel in San Francisco--to think of the struggling healthcare system. Giving the familiar lines about the soaring costs and aging population, Steve suggests that the birth of personalized medicine is part of the rescue.

Steve’s style is to provoke creativity and innovation. He has general comments and questions. How will we improve healthcare without increasing costs? Should we spend on the old or the young? Who should pay for healthcare? We ARE going to ration. A dead patient is a cheap patient. Etc.

I’ve heard this all from Steve before. But I felt this year he pushed us harder to look at healthcare in new ways. If the current path is unsustainable, what will the new model look like? I’m impatient. Surely from his seat on Mt. Olympus Steve knows where things are headed. After all, he just came back from a meeting with world leaders in Europe talking about the big issues. What did he learn? At the break, I teased him. Come on Steve, I prodded, you know where this is going. Just tell us. He smiled and replied, “I’ll tell you this. Innovation will come from the U.S, yet we will be late adopters.”

That’s tough for the investors, I replied.

“It depends on where and how you invest,” he came back.

The Georges

Two main fixtures of the world of PM were there. The two Georges each took a keynote. George Church talked about two new methods of DNA sequencing and about work the PGP is doing. Dr. Church has spent a lot of time investing in the idea of consenting patients for research. I asked him if he looked enviably on the UK’s recent decision to open up all the healthcare records of the NHS to research. He asked, “what do you mean open? They’re redefining the word ‘open.’ It’s not really open.” Dr. Church says the PGP is still the only place where complete genomic and clinical information is available for anyone around the world to access.

George Post of ASU employs a carpet bombing strategy to make his point about the complexity of PM. A quarter the way through his presentations I have enough questions to pursue for a year. By the time he’s done, I’m like, “George, I give--you got us all. Let’s just put our hands up in the air and give up.” For example, Dr. Poste thinks “genes for . . .” is an insidious phrase that does us no good. It’s more complicated than a gene for this and a gene for that. Going through the different fields, from genomics to proteomics to epigenomics to the microbiome, he leaves no rock uncovered and a terrible mess in his wake.

He is passionate about the need for standards. So the data can begin to be integrated. But this is a catch 22. Last year Cliff Reid, CEO of Complete Genomics, urged caution in this area. Standards too soon in an industry are not good. Yet if there are no standards, the different domains of data don’t communicate among each other. There’s a struggle between the freedom to let the data go its way, and the need to create standards that everyone can agree upon.

(Cliff Reid was originally on the program but didn't participate this year. I understand his absence now with the news this morning that Complete Genomics is merging with BGI.)

The Data Issue

A panel focused on making the data actionable included Illumina, LifeTech, Oracle, GE Healthcare and 23andMe. There’s tons of work to be done here. And the five companies are all pursuing different avenues. Illumina is betting on an iPad app. LifeTech, leveraging the recent purchase personal genomics company, Navigenics, is pursuing this community based program where they are starting with a focus on the patient first, then going back up the chain to doctor, provider, lab, etc. Oracle, naturally, stressed the importance of integrating not only omics data and clinical data, but also the economic data. Entire conference could be held on this topic.

Reimbursement

The crowning session for the conference was a panel of the pioneers in diagnostics showing the way on reimbursement. CardioDx has needed a strong, energetic spokesman pushing to get paid for what is a cool test, Corus CAD. They have one in Deb Kilpatrick. “Payers were terrified by the size of our market,” she exclaimed, referring to her struggle. Deb was congratulated by the others--XDx, diaDexus, Biodesix--on the recent Palmetto (Medicare contractor) approval of the CardioDx test. As the name suggests, the test is a first of its kind blood test to non-invasively assess whether a patient's symptoms are due to obstructive coronary artery diseasse (CAD). I've been in Deb's market. Several months ago I ended up in the emergency room thinking I was having a heart attack only to find out after thousands of dollars of tests that it was just heart burn!

One of the trends in the booming diagnostics industry is to go to Europe first. Yet this has its problems. Matthew Meyer of XDx said “it’s a big struggle to get the same reimbursement amounts for diagnostics in Europe than they get in the U.S.” There’s that word ‘struggle’ again. Brian Ward, CEO of diaDexus picked up the theme. “Prevention hasn’t caught on in Europe yet--especially in Eastern Europe.”

In a different note from last year, all four companies were optimistic about capital markets. Noting that it may not be as good as that for biotechs, raising money is not a problem for them. CardioDx announced just a couple weeks ago that they had closed a round of $58 million.

Seeing the Forest for the Flowers

A small beautiful moment in the conference gave me some pause. When we’re in the details, we can lose the bigger picture. We get caught up in the struggle. I feel the pioneer’s pain, especially in the diagnostics companies, who have had a rough road with no light to show them their way.

This moment brought me out of the labor and struggle. Sitting with Dr. Church at lunch, we were chatting along, and suddenly he pointed to the centerpiece on the table, a beautiful flower arrangement. What is that flower, I’ve never seen it before, he asked. A smaller flower, about an inch in diameter, with small globe blossoms themselves forming a kind of globe was mostly outdone by the dahlias and mums. Very delicate. And unusual. Heck, I hadn’t even noticed there was a flower arrangement on the table. Dr. Church pulled out his phone and took a picture of the strange blossom. We joked about what he’d do with the picture. Would he go look it up when he got home? Would he send it to a new Google program which identifies objects? Here was a scientist doing what scientists do. Spontaneously and effortlessly. Observing the world around him, and cataloguing what he sees.

It’s the science that has driven the industry of personalized medicine. And it’s the science that will hold the answers. Science unfolds like Dr. Church taking a picture of this new flower. Unfolds like a flower itself. It will not be rushed. Business is in such a hurry. I’m not so naive as to think that science is not itself a business. But at its best, science proceeds with awe and discovery. The business side could be more like that. Personalized medicine is being born. Even those who are involved in the birth can step back and look on in awe and wonder.

“Personalized medicine is the kind of thing that is overrated in the short term and underrated in the long term.” Steve Burrill.