Thursday, March 8, 2012

How "Perfecting Medicine" will reshape the life science industry

At his talk this morning at KGI, Dr. Paul Billings argued that the vision for 21st century medicine needs to go beyond personalized medicine to “perfected medicine.”

The chief medical officer of Life Technologies, Billings started by reviewing where medicine was for centuries, and the progress that was made in the 20th century to improve upon that. He illustrated the 19th century state of the art with “The Doctor,” pained by Sir Luke Fildes after his son died in 1877 of tuberculosis. As an MD working for a life science company, Billings argued for a world that both keeps the personal attention of the caring physician while providing doctors with the best science for preventing and curing illness.
Unfortunately, while the 20th century brought many lifesaving therapeutics, the approach towards selecting and dispensing these therapies is remains one of “trial and error.” He showed a chart that failure rates for post-heart attack medications and mammographs of are more than 10%, while airline flights have a fatality rate of less than 1 PPM. Billings lamented that having hospitals "more like bagging handling is not what I'd like to see about healthcare delivery".

From the perspective of systems biology, a solution proposed for this existing paradigm has been proposed through approach of “4P medicine”: predictive, personalized, preventive, participatory.

However, Billings argues that we need to go further: "We want 1P medicine: perfected medicine.” Such an approach would rebuild healthcare from the ground up, to tailor solutions for individuals make choices based on scientific understanding. To support this vision, he cited the 2008 report of a presidential advisory board, “Priorities for Personalized Medicine.”

Billings wants sequencing to be more mainstream in healthcare, the way that imaging and other modalities are: "I don't want to be in the basement of hospitals any more — I want it to be on the ground floor”. (Of course, Billings works for one of the major vendors of sequencing products.)

Based on the research of Jonathan Rothberg (of Ion Torrent), DNA sequencing has shifted optical-based sequencing to semiconductor-based sequencing. For the audience, Billings waved around a DNA sequencer chip the size of a postage stamp. A $50k sequencer that in 2013 will soon do a sequence in 2 hours for a marginal cost of $1,000.

Billing predicted that the performance improvements by this CMOS-based sequencing will continue indefinitely — as did microprocessors — and allowing sequencing to shift from sequencing specific genes to whole genome sequencing. (Of course, there is the nagging problem of the cost of the data analysis to make sense of that data).

But, Billings argues, the benefits are not just limited to price. Instead of sequencing in batches and taking weeks, the results will come back in hours. Various conditions — such as a heart attack, TV or sepsis — need answers much much sooner than weeks to make the appropriate clinical intervention. Cheap sequencing will also allow applying therapeutics — especially expensive biologic compounds — only for those patients who will benefit.

In an era of limited resources for healthcare, there’s a need to also demonstrate this technology can (as in the case of Sir Luke’s personal tragedy) to deliver "outcomes that matter". He provided the example of the May 2011 fatal E. coli outbreak in Germany, in which a DNA sequencer was used to characterize the bacteria and develop a scalable screening process in less than a week. (See the PLOSone article for more info.)

This is going to be highly disruptive to existing business models. For example, when Billings put up a slide showing how a series of existing tests might eventually be replaced by a singled sequencing test, I immediately thought about all the buggy whip makers that are going to put out of business.

I raised this question during the subsequent panel discussion, a discussion that included Billings, Board of Trustees chairman (and health care VC) Bob Curry, Advisory Council member Russ Teagarden of Medco, and Professor Jim Osborne (formerly of Beckman Coulter).

To Billings, I suggested that if firm can’t sell diagnostic tests, they’ll try to extract patent royalties from their gene patents from companies that are selling the all-in-one tests. I’ve lived this world in my previous research, as it’s S.O.P. for cellphones and other parts of the telecom industry. Diagnosing human disease with a single whole genome test will bring patent stacking that will go far beyond any pocket-sized device (at least until the patents expire).

Billings noted that companies who have such gene patents are aware of the problem (although he doesn’t know or wouldn’t say what they think the solution is). As an example, he mentioned the controversial diagnostics company Myriad Genetics, whose sequencing of cancer genes has done so much to improve our understanding and treatment of breast cancer. (At lunchtime, we discussed whether the gene patenting industry needed an Apple to impose an iTunes-like pricing model, or whether it could organize an ASCAP or BMI to collect and allocate royalties among rightsholders).

Ready or not, the existing businesses are going to be disrupted in a classic Schumpeterian example of “creative destruction.“

On the other hand, based on past experience it seems unlikely that the US regulatory bureaucracy — or the rest of the healthcare payment or delivery system — are ready to be disrupted. As Advisory Council member Weaver Gaines put it, it takes 20 years for a new medical approach to be adopted — or even a generation for the old guard to die off.

Bob Curry was a little more optimistic about FDA cooperation due to the pressure it will face from regulatory arbitrage: if the US won’t approve new approaches, then other countries — like Denmark or Switzerland — will.

However, adoption of a new paradigm also requires acceptance by healthcare providers and also healthcare payers. Both Teagarden and Curry noted the delays (and often unrealistic evidentiary expectations) required to get payers to agree to reimburse for diagnostics. The panel agreed that adoption will increasingly require that new approaches not only save lives, but also save money.

The panel also discussed the challenge of getting new practice accurately explained and adopted by frontline health providers. Curry pointed to the ongoing trend for doctors to leave their individual practices and affiliate with regional hospital groups, which he predicted would make it easier both to reach and to incentivize these M.Ds. to adopt the new scientific paradigm.

Photo credit: “The Doctor” (1891) by Sir Luke Fildes, courtesy of Wikimedia Commons.

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