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Guest Post: Highlights from the Personalized Medicine Conference

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Editor’s Note: Last week NGS Leaders joined GenomeQuest in hosting an executive workshop at the Sixth Annual Personalized Medicine Conference at Harvard Medical School. In a guest blog post, GenomeQuest's Chief Marketing Officer, Anthony Flynn, provides the following highlights from both the conference and workshop. 

November 15, 2011 

Tony Flynn : Last week, I attended the Personalized Medicine Conference (PMC), moderated by Dr Raju Kucherlapati. It was, yet again, outstanding in terms of quality of content, presenters, and networking. Immediately afterwards, GenomeQuest and NGS Leaders hosted over 30 moderators and Dx executives at a post-conference workshop to immediately exercise and apply the “best ideas” from the Personalized Medicine Conference across six topic areas. Below are my top “takeaways” from the conference and workshop:Personalized Medicine Conference 

1) 80% say sequencing value will be in “interpretation”
In the case study on “sequencing technology” run by Richard Hamermesh of HBS, the audience was asked:
In 2021, which of the following sequencing segments will be strongest: hardware, consumables, service, or interpretation?
The answer: eighty percent said interpretation. The viewpoint that interpretation of the data will be challenge #1 in personalized medicine was repeated by several presenters, including: Lee Hood of ISB, Stephen Spielberg of the FDA, Dave King of Labcorp, John Nierderhuber of Inova, and Hakan Kakul of Pfizer.

Immediate good news here: I think that we’re getting over the initial fear of the whole-genome sequencing (WGS) “ocean of data." Yes, we’re understanding that WGS is a technology and that we don’t have to digest everything it produces — we can focus on the data of most interest and use.  Just like we don’t have to watch all 800+ TV channels to justify and enjoy cable service, there’s amazing value in “targeted interpretation.” And, over time, we’ll learn more and expand our targets.

2) PM industry integration is happening
In order to take hold, personalized medicine requires a tighter integration of the healthcare pieces — otherwise, benefits won’t accrue to the investors and the new economic wheel won’t turn. Here, I am encouraged as I see a combination of top-down and bottom-up change agents at work.  Industry leaders such as PMC/FDA/VA are proactively creating an environment for motivating and guiding this integration.  And, industry players — including VCs, Dx companies, labs, sequencing vendors and payers — are working amongst themselves to understand and incrementally affect this integration.
(BTW, progress and thoughts on the regulation front: we heard from many Dx leaders that the FDA is open-minded and willing to be led in PM – so meet early and often in the development/approval process.) 

3) Our aim should be squarely on whole-genome sequencing
While the intermediate technologies of gene-panels and whole-exome sequencing will offer substantial rewards and lessons learned, the economies-of-scale and medical revelations granted by WGS justify that our major investments and best minds focus on this final destination.  After all, according to Partners Scientific Director, Scott Weiss, “WGS will render targeted sequencing obsolete in 4 years.
As breathtaking as the falling cost-curve of sequencing has been in the past decade, I think we’ll be equally awed by sequencing cost and quality improvements in the next few years. Specifically, I believe that the market force of an expanding set of 3rd generation vendors and technologies (over 10 listed in HBS case study) will enable whole new personalized medicine applications and create whole new markets.

4) VCs and Wall Street are becoming increasingly supportive of PM/MDx
I appreciated the inflective thoughts of Brook Byers of Kleiner (“we are entering the early days of PM“) and Amanda Murphy of William Blair (“we’re at an economic peak of uncertainty in PM“).  Byers was most enthused about the Dx side and influenced by long-term, wellness managers and payers. Also indicating enthusiasm are the funding of the above 3rd generation vendors and warming of MDx acquisition activity, including the $.5B acquisition of Clarient by GE Heathcare.

One of the more interesting dynamics as we arc from genomics for drug/disease research to clinical application is the associated pivot from a largely foundation-funded market to a commercial market — aiming to improve and provide economic value to a $5T global healthcare market.  In my opinion, this adjustment to a commercial market is where much of the management challenges and opportunities lie.

5) The industry needs to agree on a global “atlas” of genotype/phenotype database
This is front and center of many thoughtful personalized medicine talks over the past year.  At PMC, I began to see significant movement in this direction: a) organizations planning the integration of genomics with the EHR which will speed genotype/phenotype associations, b) teams structuring phenotype-rich, genotype-enabled clinical trials, and c) a proposal for a standard platform for research labs to establish and share clinical evidence.

6) Much effort/$ should be put into enabling PM at community hospitals 
Gregory Feero of NHGRI thought it worth noting — from a conference operating deep inside HMS — that 95% of healthcare happens outside academic medical centers.  Well played.  One example of progress is the KEW Group, which is building a national network of PM-based community cancer care centers.

7) The Dx industry is preparing its economic case for MDx
On the one hand, Dx informs 70% of medical decisions and MDx holds immense promise for fundamentally improving healthcare.  On the other, Dx amounts to just $40B of the $5T healthcare industry and the assigned skeptic at the conference (artfully played by Dr Ezekiel Emanuel) waged a blistering attack that personalized medicine makes little/no economic sense. What gives?

Clearly, MDx is undervalued in the healthcare industry — our payment system favors therapy/technology over diagnostics/interpretation.  One giant step forward would be to argue the economic case for MDx.  And I foresee the PM coalition and industry preparing two pieces: a holistic, multi-factor economic argument for MDx to spur reimbursement change and the associated decision support to inform day-to-day care.

8) We continue to be guided and inspired by Dr Lee Hood
n accepting his leadership award, Lee Hood offered a wonderful combination of science vision and medical practicality to guide the path forward.  In particular, he was most excited about: a) family-based studies, proven to reduce errors by 70% and shrink solution space by 100x, b) analysis of single cells, and c) system-level considerations and tools required to address the “grand challenge” of personalized medicine (complexity).

I-Study: Genomic Interpretation - Who Will Pay?
During this webinar, members of the study review team present preliminary findings of the I-Study, conducted at the Harvard Medical School's 2011 Personalized Medicine Conference.
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