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.

  • (Signing off from #pmc10. Apologies for spotty tweet coverage. Alas, not all clients tailor their business around conference schedule.)
  • SR: multi-solution approach to Dx is necessary. Linking FDA approval to reimbursement is key, but incremental steps necessary.
  • SR: reimbursement uncertainty increasing R&D & depressing investment at faster rates for Dx than therapeutics.
  • Sara Radcliffe, EVP of BIO speaking on dx reimbursement. (reimbursement cont. to be shout-at-top-of-lungs theme of #pmc10)
  • On Dx panel, missed Risa Stack of Kleiner Perkins speak about KP’s role in backing pm (am told it was not very substantive #pmc10)
  • #pmc10 audience poll: “the planned legislative efforts are…” 78% say “are good for personalized medicine”. Sympathetic audience.
  • SW: also specific language in bill re: timing of FDA dx review, incl for tests already on market.
  • SW: recognizes need to address reimbursement as well. May be some language in Hatch bill recognizing this.
  • Audience question emphasizes, rightly, that regulatory reform for Dx does not work w/out reimbursement reform #pmc10 (& I would add, IP too)
  • SW: reality is market will not support large-scale RCTs for Dx; need new, appropriate standards (accuracy and reliability)
  • SW: underlying goal is to provide greater clarity to investors, companies seeking to develop advanced dx
  • SW: goal: set out clearer pathway for diagnostic regulatory review (rather than co-opting existing device pathway, eg de novo 510k)
  • SW: hoping to have draft legislation out for review by end of year.
  • Sheila Walcoff talking about Sen. Hatch’s proposed advanced pers diagnostics legislation. Many stakeholders involved, inc FDA
  • (Response to last poll seems trivial, but 14% did say when cost of WGS equals cost of panel test, which is also reasonable)
  • Audience poll at #pmc10: when do you switch from MDx point mutations or panels to WGS? 65% say when clinical utility is proven for WGS.
  • MS says #pmc10 audience is “cheap” in waiting for $100 genome. I think “patient” is likely a better adjective.
  • Audience #pmc10 poll: at what cost will *you* pay for whole-genome sequencing? 46% say $100. (30% say $1K, 9% say free, 15% say never.)
  • MS: focuses for next-gen seq dev are ease of use & accuracy. Expects $3K genome next year.
  • Now talking at Dx panel, Mark Stevenson of Life Tech. Talking about developing tools designed for Dx.
  • Audience poll: will health plans pay for whole-genome seq if <$1K? 51% say no, only 34% yes. (Cost of interpretation the barrier.)
  • #pmc10 poll: what must change in order to integrate MDx into hc workflow? 49% say reimbursement policies. (Audience is consistent at least.)
  • DNADirect has been surprised/expressed by level of enthusiasm for genetic platform tools from community hospitals/hc providers
  • #pmc10 audience poll: who is more important to companion dx, FDA or payors? 65% say payors. (Reimbursement continues to dominate discussion)
  • Next #pmc10 MDx audience poll: on success of Plexxikon & Roche in dev targeted BRAF inhibitor…45% think it can be reproduced frequently.
  • (Re: #pmc10 poll on LDT regulation, easy to desire clarity while you can still imagine you’ll agree with regulatory approach.)
  • Next MDx #pmc10 poll: how do you view FDA’s intent to regulate LDTs? 57% view it positively. (Suggestion is clarity is in high demand.)
  • Now at #pmc10: MDx panel. Audience poll: most underappreciated aspect of MDx strategy? 39% say “commercialization/reimbursement pathway”
  • Panel on clinical utility. Compelling audience comment that clinical utility also needs to be personalized-not assessed at pop level
  • (Interesting to see IP, reg, reimburse uncertainty as separate categories. Combined as one choice they’d be voted biggest barrier)
  • Poll at #pmc10: biggest barrier to pers med success? 33% say lack of clinical utility evid (Last year: 51% said reimbursement uncertainty)
  • Now speaking, @claymarsh of OSU on bringing pers med into practice. Need to push care down-can’t rely solely on MD uptake
  • MB sees pathologists as logical supplement in battle for genomic education given limited #s of clinical geneticists, GCs
  • Mark Boguski, BIDMC describing exp moving into 2nd year of offering Navigenics testing to residents; high-uptake, satisfaction
  • Final audience poll for #pmc10 gene patent panel: do you agree w/ DOJ amicus brief position? 69% agree.
  • (Congressional clarification would be nice, but incredibly unlikely given divisiveness of issue and current political climate)
  • Audience q: should Congress address this? CH: Congress has shown no interest. JG: significant change should req Congressional action
  • Patents vs sequence/multiplex testing one of the most pressing issues. Unfortunately, gets short shrift at #pmc10 gene patent panel.
  • New topic: how do gene patents intersect with rise of whole-genome seq? CH sees as a problem, JG: “patents do expire”
  • CH thinks even a win will have limited impact. Will simply remove ability to patent basic science; spur more research/innovation
  • JG: could have follow-on effects for other areas of biotech BUT patent attys are creative and will find ways to cover inventions
  • #pmc10 panel now considering downstream implications of Myriad, particularly if upheld. JG worried about conseq of emotional decision.
  • CH: disagrees-sees it as a 100% win and will be very influential. (I’m more w/ JG on this one.)
  • JG: notes (rightly, in my opinion) that hole in DOJ’s brief is failure to weigh in on the method claims
  • JG disagrees – DOJ took middle of road and patent lawyers can easily draft to gov’t’s “engineered” threshold req
  • Discussion on #pmc10 now moves to DOJ amicus. CH takes a pause, literally, to “feel gleeful”. Characterizes it as a win for ACLU.
  • (This is a mistake: diagnostics impacted by IP, reg & reimbursement relationship. CH’s newness to area shows here)
  • CH: doesn’t see the connection b/w gene patents & FDA regulation of diagnostics.
  • Audience q: if FDA regs LDTs, labs won’t develop tests as readily. If patent innovation also removed, is there sufficient incentive?
  • Not surprisingly, CH argues in response that patents on basic sci (genes) stifle innovation. And research driven by other factors
  • JG: to realize diagnostic, pers medicine we *must* have this incentive. Consensus is stripping patents will pull plug on investment
  • Focus now shifting to why gene patents are important. JG argues it creates incentive for long-term investment, research
  • (Editorial note re: #pmc10 gene patent debate. Nothing new said here, but clear audience buzz & more panelist emotion than other segments)
  • CH: no arguing that isolation only works b/c DNA still “identical” to what’s in patient’s body. JG: disagrees re: identical
  • Pause for #pmc10 audience q: do you agree with Judge Sweet’s decision invalidating Myriad’s patents? 56% yes, 38% no.
  • JG: there are other arguments to make here – obviousness, etc, but Section 101 shouldn’t be at issue
  • JG: positions being taken in Myriad case are not consistent with the actual claim language
  • JG: Myriad’s patents claim something man-made; no patents on your genes in your bodies.
  • JG: a terminological distinction – claims need to show new, useful. Myriad’s claims meet this test by isolation and/or purification
  • JB (bio) shares her perspective as a patent attorney of 35 yrs. For her, it is a question of statutory interpretation (Second 101)
  • CH: believes “entire medical establishment” supports the ACLU’s suit.
  • CH: describing strategy, logistics that went into building plaintiff class and lit strategy for Myriad gene patent suit
  • CH: after 2 years, determined his common sense reaction was legally correct – decided to sue Myriad over BRCA
  • CH: when he learned of patents on human genes his first reaction was “that’s wrong, let’s sue somebody”
  • Myriad gene patent panel at #pmc10 structured as a debate b/w Bio (Jennifer Gordon) and ACLU (Chris Hansen) attorneys
  • Next up @ #pmc10 is a panel on Myriad gene patent case moderated by @Globecarolynyj. Surprisingly, only 76% of audience familiar w/ case
  • #pmc10 audience q: do we have good info about pers med benefits relative to costs? 84.5% say “no”. (“Hell no” not an available option.)
  • #pmc10 audience q: is investment in pers med at societal level a good idea? 95% say yes (compared to 54% last year). (Strong sample bias…)
  • NC: move to univ coverage, or at least univ access solves many of these fragmentation, value problems. (Me: but how do we get there?)
  • JB: collection of patient-specific data valuable, but shouldn’t get ahead of our ability to house, use that data.
  • SL: Permanente has invested $6 billion (with a b) on EHRs; sees tremendous value, not going to give it away to pers med cos
  • Sharon Levine, Permanente: true, but requires new partnership b/w healthcare providers, pers med developers & patients
  • DP: robust EHRs could take a lot of the cost out of clinical utility demonstrations, spark innovation/investmnet
  • NC: employers see genetic testing prices as extremely high, arbitrarily set. Leads to rise of genetic testing benefit mgrs (new PBMs)
  • Niteesh Choudry, HMS/Brigham & Women’s: over last year, 1/3 of employers have reduced benefits or shifted costs to employees.
  • JB: MedCo priorities: pgx, research into clinical utility, patient/md/payor edu programs, coverage mgmt (right test, right patient)
  • Jane Barlow, VP, MedCo: how to leverage prescription data and claims data to provide better, personalized care?
  • DP: reform needed is not healthcare reform but innovation reform – need this to realize pers med benefits
  • DP: fundamental problems w/ coding (not granular), coverage (new paradigms needed to demonstrate efficacy)
  • David Parker, Boston Healthcare: reimbursement simply “breaks down” in face of personalized medicine, care

Part II: Twitter Roundup

  • GLR Post: Digging Deeper into the EEOC’s Final GINA Regulations: http://bit.ly/93bqyW
  • Why aren’t lawyers this creative / musical? RT @matthewherper: music for joining DNA http://bit.ly/9GV4dF
  • Great #ASHG2010 update by @shwu: http://bit.ly/bXJHzA Incl. key themes & tangible evid of how (justifiably) reliant we are on @dgmacarthur
  • Unpacking the Cleveland Clinic study comparing family history to SNP-based testing for cancer risk over @23andMe:http://bit.ly/c373aj
  • Or GET-Evidence. RT @Duncande: guess no one told students competing to annotate genes abt SNPedia: http://bit.ly/atbhgj
  • I’ll be at the 2010 Personalized Medicine Conference (http://bit.ly/cVq28) starting tomorrow. Will you? #pmc10
  • Big pharma’s comeback? http://bit.ly/c8xgUa Looks likely, at least on the marketing side, writes @matthewherper
  • RT @GenomeWeb_News: NIH to Award Grants for Gene-Environment Bioinformatics: http://bit.ly/9Ky5BM
  • CMS Launches its open “innovation center” to find new ways to deliver/pay for healthcare: http://www.innovations.cms.gov/
  • Update on Sen. Hatch’s rumored-but-not-yet-proposed bill for “advanced diagnostics” http://bit.ly/aZnOKc by @GW_The_Sample
  • GLR Post: EEOC Issues Final Genetic Nondiscrimination Rules: http://bit.ly/cYlmkl
  • RT @MishaAngrist: Helicos we hardly knew ye http://bit.ly/b4s1RU
  • RT @dgmacarthur: On @genomesunzipped, my one-point summary of #ashg2010: lots of data, but not many results yet:http://bit.ly/9SQold
  • RT @MishaAngrist, @newscientist: Glenn Close reveals “fabulous genes” to the world’s top neuroscientists at #sfn10:http://bit.ly/atdIF1
  • Review of @MishaAngrist’s (aka “genomic Hamlet”) “Here is a Human Being” by @mattwridley in WSJ:http://on.wsj.com/ctDBOY
  • RT @dgmacarthur: Handy overview of next-gen sequencing by @GoldenHelixInc: http://j.mp/aLRJVo Looking forward to the rest of the series…
  • NHGRI hopes to crack 40+ mendelian diseases/yr RT @MishaAngrist: beginning of end of genome oligopoly?http://bit.ly/dsWsSI
  • RT @genomesunzipped: GNZ’s Caroline Wright didn’t learn anything from her genome data. Is she disappointed?http://bit.ly/c03HWm
  • The decision for Rules-Based Medicine: No NGS? No IPO. http://bit.ly/ah4cfH
  • DTC tests for cardiovascular disease risk flunk EGAPP’s review: http://bit.ly/8ZuCQU via @pgx_reporter
  • Ion Torrent provides preliminary specs for Personal Genome Sequencer: http://bit.ly/dgZzfi via @InSequence
  • Nice review of next-gen sequencing, current, future and far-future from Genome Technology: http://bit.ly/cGbNS0
  • Thorough recap of var. DTC studies presented at ASHG: http://bit.ly/bw57vE Good start, need long-term follow-up & larger samples.
  • My exp as lawyer diff-must know ID of client. MT @scotthensley @healthblawg: how hedge funds get insider info from MDs.http://bit.ly/c7Pgn5
  • RT @JohnCFierce: Future CEO? Biotech vet Robert Kamen joins Third Rock as entrepreneur in residence.http://bit.ly/d9vQWB
  • Re: Plavix ad, interested to see if this means pharma marketing groups – in addition to scientists – now embracing PGx
  • Clinical genetic testing (for Plavix) makes 1st appearance in DTC TV ad: http://bit.ly/cZoJHz via @GW_The_Sample
  • GE’s Clarient Purchase Heightens Company’s Focus on Tests for Cancer Drug Personalization: http://bit.ly/9MhuZW v @pgx_reporter
  • A policy approach to the development of molecular diagnostic tests: http://bit.ly/9flAXQ In NBT via @MishaAngrist
  • Re: @23andMe’s Series C fundraising round, Form D (http://bit.ly/bfXUl5) shows only $22.M of $30M sold. 2nd close coming?
  • Ousted lawmakers: frame science as a national security issue & “sell the sizzle” to avoid cuts: http://bit.ly/9zltsP
  • Final Genetic Info. Nondiscrimination Act (GINA) regulations are out today from EEOC: http://bit.ly/bOw7v4 HT @blaine_5
  • GLR Post: Next-Gen Sequencing Update: Sequencing for Thousands, Suing for Millions: http://bit.ly/9KcWye
  • RT @bmahersciwriter: Francis Collins warns NIH success rate could drop from 1/5 to 1/10 thanks to GOP takeoverhttp://bit.ly/cH2d3c
  • $22M more for @23andMe: http://bit.ly/agi0Nn Series C round incl J&J (new investment) & NEA, Google (return investors)
  • Re: @carlzimmer’s excellent NYT feature, #6 is Haussler on genomes. Prediction: immune genomics debuts in 2011.
  • RT @carlzimmer: For the morning shift: What’s Next In Science: My interactive feature in today’s New York Timeshttp://bit.ly/aXhEDI
  • RT @lukejostins: Final blog post of #ASHG2010: Doing it with exomes http://bit.ly/cFHMf4
  • Congrats to @geochurch for well-deserved Bower Award: http://bit.ly/9nihTr Past winners incl. Einstein, Marie Curie HT @jasonbobe
  • Nice to eat/drink w/ @GenomeWeb_News crew this evening. Indispensable industry coverage, particularly @GW_The_Sample & @pgx_reporter
  • Genomic Health revenues up 17% in Q3: http://bit.ly/cb4o9Q that won’t do anything to dampen acquisition speculation
  • More on Affy/PacBio employee/trade secret litigation via @InSequence: http://bit.ly/dhaAX4 IPOs = more $ = more litigation
  • Re: DTC, it appears @23andMe is offering a $100-off code (M68PCV) through Tuesday night.
  • Absolutely. “Kaufman [@dkgppc] said long-term follow-up of [DTC] was needed to evaluate how they affect people’s health.”
  • More coverage of @dkgppc’s research on DTC genetic testing & consumer satisfaction: http://reut.rs/de6sHO #ashg2010
  • Depressing. MT @mikesgene: 28% of Canadian teens believe science has no relevance to everyday life. #sciwri10
  • Money for Scientific Research May Be Scarce With a Republican-Led House: http://nyti.ms/dc4EHy (HT @Duncande)
  • Family history v. @Navigenics in predicting cancer risk. No surprise that best method is to use both. http://bit.ly/b4FX51 (HT @GeneSherpas)
  • RT @girlscientist: Collins showing that when adjusted for inflation, NIHs ability to fund research has decreased or leveled since 1990.
  • RT @dgmacarthur: BB: ppl only tend to remember results that indicate increased risk; tend to binarise risk as “average” or “high”
  • RT @dgmacarthur: TD: @23andMe now has 60,000 people genotyped, 35,000 have taken surveys, 800+ traits being studied
  • RT @dgmacarthur: DK: DTC customers are older, richer and better-educated than general population
  • RT @dgmacarthur: JB: most people feel that return of research results should be built into study design, and the NIH should pay!
  • RT @dgmacarthur: SG: Broad has sequenced over 5,000 exomes so far, have developed highly automated pipeline -> 800/week
  • RT @dgmacarthur: Stacey Gabriel: we can currently sequence 8 exomes for the cost of one whole genome.
  • RT @dgmacarthur: Jay Shendure: 115 abstracts this year on exomes vs 10 last year; estimates 60-80,000 exomes currently underway
  • RT @lukejostins: Consanguineous recessives easiest to find. Do your part for genetics: have a large family with a close relative!
  • RT @MishaAngrist: @dgmacarthur says “we are all dysfunctional”
  • RT @dgmacarthur: Francis Collins: there are >6000 rare diseases, most genetic, but <200 have drug therapies available
  • RT @genetics_blog: Jmb: participants want return of results more than monetary compensation
  • RT @genetics_blog: RT @jxchong #ASHG2010 this could become a motto for the next decade: It doesn’t matter. My genetic info is mine.
  • RT @dgmacarthur: RCD: the value of genetic information depends on people sharing it, yet we tell them it’s incredibly private
  • RT @dgmacarthur RCD calls the GAO study “sloppy and unscientific” – but (fairly) criticises the inadequate counsellor training it revealed
  • RT @shwu: RCD: Mainstream genetics won’t be driven by current ppl but by srvcs that don’t yet exist (may look more like @23andMe than MDs)
  • RT @MishaAngrist Evans calls for a whole-genome REVEAL study…Does NIH have the cojones to fund it?
  • RT @dgmacarthur Evans: we don’t know what most of the genome does, so disclosing full sequence to patients is irresponsible
  • RT @dgmacarthur Evans just said he would publicly release his genome sequence to show how useless it is. New @genomesunzipped member?
  • RT @MishaAngrist Jim Evans: From genetics to genomic medicine–this is the theme of #ASHG2010
  • RT @MishaAngrist 20% of people would pay $500 or more to learn APOE status…wow! #ASHG2010
  • RT @MishaAngrist sorry to note that in two hour discussion on identifiability no one has mentioned PGP, GNZ, CC0 etc.
  • RT @MishaAngrist P. P. O’Rourke: The discussion of identifiability in human subjects research is increasingly becoming irrelevant.
  • Agree RT @MishaAngrist IMHO obsession with HIPAA & Common Rule means human subjects researchers will look to private and/or micro funding
  • Not much progress since this: http://bit.ly/aRpjmO RT @MishaAngrist NHGRI still groping for “final” data sharing policy….
  • RT’ing #ashg2010 highlights from #ashg2010 for those (like me) who were unable to follow in real-time last wk. #ashg2010 has full coverage.
  • Step closer to spitting on iPhone to get genome RT @kashhill: STD testing-is peeing on cpu chips is in our future?:http://bit.ly/aUeZyr
  • More litigation for PacBio: Affy suing over allegedly stolen employees: http://bit.ly/b08rhQ (via @gw_dailyscan)
  • In silico research in the era of cloud computing: http://bit.ly/c7t8EL 1st author @jdudley in NBT
  • RT @MishaAngrist: “It’s something you can only learn from other patients.” Terriric article by @virginiahughes.http://bit.ly/ceq8S9 (sub)
  • RT @burrillreport: U.S. Supreme court says its won’t hear first healthcare reform challenge. http://fb.me/NwJpgxIH
  • RT @wellcometrust: New members sought for the UK Biobank Ethics and Governance Council http://bit.ly/bfSQZ3
  • RT @JohnCFierce: San Diego-based Ambit filed for $86M IPO. Look for other biotechs to follow as # of new IPOs spike. They face steep odds.
  • Just discovered @PLoS Currents: Evidence on Genomic Tests: http://bit.ly/ab19pJ Anybody using / finding this useful?
  • Re: clinical utility of DTC paper, also confused by abstract seeming to suggest BRCA is DTC. Does anybody have copy of full paper?
  • Only 133/4K responses RT @eurogene: DTC genetics: over 50% of clinical geneticists said they were “clinically useful”http://bit.ly/8Z9ROa