Twitter Roundup: Personalized Medicine Conference Edition

With so many developments at the intersection of genomics and the law, there are often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In addition to the regular @genomicslawyer Twitter recap, this week I was also tweeting from the 6th annual Partners Healthcare conference on Personalized Medicine. So this version of the Twitter Roundup comes in two sections: tweets from the Partners conference, as well as a brief recap, followed by the regular Twitter roundup.

Part I: Personalized Medicine Conference. Much like last year’s conference, which I also attended and tweeted, the dominant theme voiced by both speakers and attendees was the need to overhaul the personalized medicine reimbursement model. From increasing up-front R&D costs to slowing patient and participant uptake, both of which depress investor interest, almost everybody agreed that reimbursement for personalized medicine products – and advanced diagnostics in particular – needs work.

Despite the focus on reimbursement, there was a greater recognition this year than last that personalized medicine faces other fundamental challenges. In addition to conquering the underlying science, particularly in fields beyond oncology, regulation and intellectual property also represent large potential obstacles to continued innovation in the field of personalized medicine. Panel discussions by Sheila Walcoff (McDermott Will & Emery) and Risa Stack (Kleiner Perkins Caufield & Byer) on Senator Orrin Hatch’s forthcoming legislative proposal to separately regulate advanced personalized diagnostics and by Christopher Hansen (ACLU) and Jennifer Gordon (Baker Botts) on the ongoing Myriad gene patent litigation were two of the most anticipated and well-attended sessions.

One of the nice features of the Partners conference is that most panels feature audience participation in the form of real-time polling. (For reference, the conference draws an audience of several hundred and is skewed in the direction of industry representatives.) Some of the more interesting returns from the audience polls:

Sequencing. 46% of the audience said they would wait until the price of whole-genome sequencing (WGS) dropped to $100 before taking the plunge. 30% would be buyers at $1,000, 9% thought $0 sounded more reasonable and a full 15% answered that they weren’t interested in a whole-genome sequence at any price. Panelist Mark Boguski (Beth Israel Deaconess Medical Center) joked that the audience was “cheap” but, given the rapid decline in the cost of WGS, “patient” may be a better adjective. By way of comparison, at last year’s conference 59% answered that $100 was their preferred price point, with only 10% declining WGS no matter what the price. Is it possible that some people are are getting cold feet as the prospect of actually having their own genome sequenced becomes more realistic?

When it comes to integrating WGS into clinical practice, the message from the audience was clear: “show me the data.” Only 34% thought health plans would be willing to pay for WGS at a cost of $1,000 or less, with a lack of clinical utility and the substantial additional cost of interpreting WGS data two commonly cited reasons for non-payment. Similarly, 65% of the audience would only consider switching from point mutation or multiplex diagnostic tests to WGS once the clinical utility of WGS testing was established. (Interestingly, only 14% agreed they would switch to WGS diagnostic testing if the cost was equal to that of a panel diagnostic, indicating that cost is likely not the only – and perhaps not even the most significant – barrier to broader WGS uptake in the diagnostic testing context.)

Legislation and Regulation. One of the most lopsided polls asked the audience whether the planned legislative efforts for advanced personalized diagnostics (discussed above) were a good thing for personalized medicine. A full 78% agreed that they were. A poll the previous day, however, was more equivocal. When asked to consider the FDA’s proposal to regulate all laboratory-developed tests (LDTs), only 57% viewed it in a positive light.

One likely explanation: Senator Hatch’s advanced personalized diagnostics bill is being developed with substantial industry input whereas the FDA, despite holding high-profile public meetings this past summer, remains much more of a black box. Last year, the audience adamantly agreed (84%) that uncertainty regarding FDA’s regulatory policy for in vitro diagnostic multivariate assays (IVDMIAs) was reducing investor appetite for personalized medicine. While that poll question wasn’t repeated this year (understandable, as the FDA has scrapped its plans to regulate IVDMIAs separately in favor of its more ambitious LDT regulatory proposal), panelists and audience members alike made it clear that, more than any specific regulatory proposal, it is the uncertainty of the current legal and regulatory landscape that poses the biggest challenge.

For more on this year’s conference see the tweets below or visit the conference website.

Part II: Twitter Roundup

Filed under: General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Industry News, Legal & Regulatory, Patents & IP, Pending Litigation, Pending Regulation
Tags: , , , , , , , , , , ,