Our Take on Personalized Medicine World Conference 2012: The Road to Commercialization

Theral Timpson

This week we attended the <a href="http://pmwc2012.com" targe=_blank">Personalized Medicine World Conference 2012 in Mountain View, CA. Though sequencing continues to dominate the show, this year there was much more focus on the commercialization of existing technologies for better, more tailored health outcomes. Some news that came just after the conference gave a nice punctuation to the feeling that personalized medicine is here to stay.

Sequencing (of course)

The conference began with presentations by two emerging startups with new sequencing technology: Genia and NABsys. (Look for our upcoming interviews with both companies.) The Genia story is particularly fascinating. Founded in 2009, the company has been working on what they call the ‘holy grail’ of sequencing technology, single molecule and electronic. So convinced is the management team at Genia, who all come from the world of high tech, that they’re calling their technology ‘last gen sequencing.’ “It’s not that there won’t be newer developments, it’s that we’re working with the ultimate model,” said the CEO, Stefan Roever, in his presentation.

Full interview with Stefan and Roger

Though Roever is German, he spent time in Silicon Valley when he was a boy. His dad worked for IBM. He feels that he’s come full circle co-founding Genia in Mountain View with an IT team who previously worked at Maxim Integrated Products in Sunnyvale. Roever came to DNA sequencing through a chance meeting with Genia’s CSO, Roger Chen, at a Starbucks in Mountain View.

“I asked Roger what he was doing,” relates Stefan Roever in our interview, “and he said he was working on this new sequencing machine in his garage. I asked him if he had investors and a business plan. He said no, and we began working together.”

Now the company has their first chip back from a fab in Taiwan. The technology is based on ‘natural nanopores’ which are created by the chip itself with a lipid bilayer. “We use nature to do what we couldn’t do in the world of high tech,” says the always enthusiastic Chen, who is fascinated by the ability of biology to create smaller more complex structures than man has been able to duplicate.

With single molecule technology, the DNA sample goes directly on the chip without the need for amplification or time consuming prep. When ready, the chip will be disposable, sell for $100, and be used with a reader that itself costs less than $1,000. And not only extremely affordable, the small portable system is said to be able to read millions of bases per second with higher quality than current technology. When will this ‘last gen sequencing’ be ready? The company plans sending the chips out to a group of “friendly beta customers” as soon as later this year.

Roever’s claims no doubt turned a lot of heads. What is intriguing about Genia, is not only that they would have a technology that would take sequencing to the clinic, but they talk about the development of the new product with so glibly.

“This is not new technology. We’re just operationalizing a technology that is widely available in the high tech world and bringing it to bio,” Roever says in a matter-of-fact tone.

The other significant news with sequencing, I thought, was the fact that <a href="http://genomichealth.com/" targe=_blank">Genomic Health is moving to the ever more popular technology. They have been one of the most successful companies to take genomics into the clinic with their 21 gene PCR-based OncoTypeDx(TM). With sequencing they plan to beef up their tests with more known mutations. PCR will be used as a quality control.

Listen to our interview with Cliff Reid, CEO, Complete Genomics

Practical Gains and Challenges

The theme of the conference was “Road to Commercialization” and despite the presentations about some pretty whiz bang sequencing technology, I thought there was less hype this year and more practical stories.

The morning of Day 2 was a several hour panel discussion on Rx/Dx, or companion diagnostics, populated by representatives of three major drug companies and two diagnostics enterprises. Leading the discussion, Scott Patterson of Amgen asked very practical questions such as when to contact a diagnostics company during drug development or what is the life cycle of Dx compared to that of Rx?

David Parkinson of <a href="http://nodality.com/" targe=_blank">Nodality, winner of the PMWC 2011 award for most promising company, had the most to say. He talked about basic assumptions that were driving the new industry. “The value,” he said, “is in knowledge of disease. Not only in small or large molecule creation.” This statement led to a discussion about the need for a new classification of disease based on biological pathways. Up to now, diseases have been classified by organ or by symptom.

Another basic assumption in the industry has to do with how therapeutics and diagnostics are paid for. “What if we change the payment system to payment only if a patient benefits,” Parkinson asked, speaking of incentives. “This will lead drug companies in the right direction.” Many of the existing drugs on the market, especially those for treating cancer, have high failure rates because they are ‘one size fits all.‘

Ted Snelgrove of <a href="http://crescendobio.com/" targe=_blank">Crescendo Biosciences, a new company developing tests to characterize the biology of rheumatoid arthritis, brought some great experience to the panel. He helped develop and market Genomic Health’s OncoTypeDx(TM). Ted pointed out that in marketing the new tests for Crescendo, he is mindful that there are 2,000 pharma reps for every 10,000 doctors in the field. Why do it yourself, when a partner in pharma is already in the space, he asked.

Snelgrove also pointed out that he has found a sweet spot of 30% in what he called the ‘discordance impact.’ This means that a test which changes treatment decisions 1 in 3 times is most likely to succeed. If it is lower, say 10%, the benefit doesn’t justify the use. Yet if the test is affecting treatment say 50-60% of the time, doctors just don’t believe it and therefore don’t use it. “Rx has been much easier to teach to doctors than Dx,” he observed to a round of chuckling throughout the panel. David Parkison of Nodality was quick to suggest the “carrot and stick” approach. Because of their presence and success in the clinic, big pharma is able to offer the carrot. When that doesn’t work, getting Dx written up in physician guidelines can be the stick that does the trick.

Out with a Bang

Each year there are more and more examples of the move to medicine which is tailored to a person’s biology. Perhaps one of the strongest bits of news came at the end of the day, not at the confernece, but over the wires: <a href="http://news.businessweek.com/article.asp?documentKey=1376-LYGF8K1A74E901-3MIQF1UMSJP1QKGJJJFIIH98RA" targe=_blank">Roche announced a hostile takeover of Illumina. Though a deal is by no means inevitable, the move by the Swiss drug giant is widely seen as one that will enhance their ability to create drugs and diagnostics which are more personalized. Sequencing has dominated conferences on personalized medicine and many have questioned whether the rapid evolution of the technology was outpacing its practical use. Perhaps there is an answer to this question in the move by Roche. The practical use of sequencing by several companies at the conference and the news that Genomic Health is transitioning to sequencing as a platform for their tests goes toward removing the question about whether the age of the genome has arrived in medicine.

The organizers of the PMWC, Tal and Gadi Behar of Silicom Ventures, do an outstanding job with the conference. Each year, the top names in the field appear and present to a growing audience, which this year numbered over 900. The growing conference now boasts three tracks, including the run through of companies competing for the most promising company award. (The 2012 award was given to Auxogyn, a company focused on improving the percentage of in vitro fertilization procedures that result in a live birth with their Eeva(TM) system.) I wonder how long the conference will keep it’s current name. With personalized medicine becoming more and more the standard, one can see the time not far off when the names of the tracks of this year’s conference turn into independent stand alone conferences: Emerging Technologies, Into the Clinic, Rx/Dx Opportunities, Evolving Regulation, and Reimbursement Dilemma.