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NGS Leaders Blog

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).

Genome Center for Gotham

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new york genome center November 2, 2011  

Kevin Davies : A remarkable public-private coalition of universities, medical centers, technology partners and private philanthropists has created the New York Genome Center (NYGC). The center was officially unveiled in a ceremony at Frank Gehry’s ICA Building in Manhattan this morning.

The coalition is a triumph for Nancy Kelley, NYGC’s founding executive director, who made the creation and funding of the center something of a personal quest over the past 15 months, together with Columbia University’s Tom Maniatis and Sloan Kettering Institute director Thomas Kelly.

"When I first talked to Tom Maniatis and Tom Kelly about this, we were operating with a cell phone and a Hotmail account! 12 months later, to have raised $120 million and brought this number of institutions together is really quite extraordinary," said Kelley.

Kelley recently gave Bio-IT World her first in-depth interview about the creation and vision of NYGC. (Excerpts from her interview will also be published in the November/December issue of Bio-IT World.)

"This is one of the most exciting national developments in genomics and medicine," said Richard Gibbs, director of the Baylor College of Medicine Human Genome Sequencing Center. "This new venture will synergize the efforts of some of the nation’s strongest research institutions, most outstanding researchers and vibrant communities. New York will be a new hub of genomics."

"Nancy Kelley and Tom Maniatis have done a remarkable job of bringing the 11 academic institutions together around this shared purpose," Marc Tessier-Lavigne, president of Rockefeller University, told Bio-IT World. "It required vision, determination and keen diplomatic skills to get the leaderships of the different institutions to realize how much more we could accomplish together than in isolation, and then to get everyone to sign on the dotted line."

Tessier-Lavigne continued: "It is a terrific accomplishment in itself, and also provides an important model for cooperation among New York institutions, which will be increasingly important as we work to build the biomedical enterprise in New York City and to attract pharma and biotech companies here."

One of the frst decisions made by NYGC was to select Illumina as its initial sequencing platform. "By choosing Illumina as its next-generation sequencing (NGS) provider, NYGC is showing its commitment to making the vision of revolutionizing personal healthcare a reality," said Jay Flatley, president and CEO of Illumina. "The launch of NYGC ranks as a significant development in advancing the knowledge and understanding of health-related genomics."

Harold Swerdlow, head of sequencing technology at the UK’s Wellcome Trust Sanger Institute, expressed excitement about the arrival of a major genomics hub in his home town. "The coming together of so many great institutions to form the New York Genome Center represents the culmination of a lot of hard work and a clear vision. Nancy and the other founding members should be applauded for this achievement. As one of NYGC's nearest neighbours to the east, we wish them all the success in building a world-class facility."

Also offering congratulations was Spike Willcocks, VP business and corporate development at Oxford Nanopore, a British NGS company. "We are excited that the NYGC team is building an exceptional technology development team as well as building a world class core facility," said Willcocks. "This is the mark of a team seeking to lead with innovation as well as provision of genomics services. We are really looking forward to working with NYGC’s Innovation Center."

The funding for NYGC, which could open as early as March 2012 with a location in central Manhattan almost settled, comes from a variety of public and private sources, including 11 institutional founding members (see below), private philanthropists, founding member companies, technology collaborators, as well as the New York City Economic Development Corporation and the New York City Investment Fund.

Made in Manhattan  

Kelley is a lawyer and commercial real estate developer who spent much of the past two decades working on behalf of biotech and non-profit medical organizations. Several years ago, while working for Alexandria Real Estate, she oversaw the development of the East River Science Park in Manhattan -- three towers, nearly $1 billion and 1 million square feet.

Two years ago, Kelley began working with a client seeking to establish an institute for personalized medicine, discussions that flirted with New York as a possible location. But while that institute did not materialize as originally conceived, Kelley said it "opened up the idea and possibility of introducing a large sequencing operation in New York. Given the fact I’d been working there for ten years and had many long-standing relationships with scientists there, I brought it to New York to see if there was interest… Things developed from there."

Kelley admits there was enormous skepticism around the proposal, but she was undaunted. After consulting with Maniatis and others, she met with representatives from leading New York medical institutions in August 2010. "It started with Columbia, went to Sloan Kettering and Rockefeller University," she recalled. "They enthusiastically endorsed it, to the extent that within 30 days, we had eight institutions putting seed money into a feasibility study." The seed funding was less than $1 million, but enough to get the venture going.

Eventually 11 charter institutions signed on (see below) including Cold Spring Harbor Laboratory and the Jackson Lab from Maine (where Kelley serves on the Board of Trustees). Perhaps the only notable abstention among New York academic organizations is the Albert Einstein College of Medicine of Yeshiva University. A spokesperson told Bio-IT World: "Einstein chose not to join NYGC because we felt it was not the most cost-effective approach to providing our faculty with genome sequencing services."

Kelley says the vision for NYGC is "to achieve transformational results for healthcare and research… For a long time, [New York has] had the leading global institutions in healthcare, but for whatever reason, haven’t always come together to collaborate and leverage that strength. With this enterprise, it will allow them to do that and take their role on the global stage -- as they should be."

At the core of NYGC will be large high-throughput sequencing center, offering services to founding members and other organizations. Much of the research focus will be in bioinformatics. "There’s also the idea of an innovation center that would introduce new technologies that would be utilized throughout New York," she says.

Kelley said getting NYGC off the ground has been "very, very challenging," but the process was helped by institutional leadership "knowing how important this was going to be for New York." Another key factor was the "participatory and collaborative" nature of the process. "That helped everyone feel they were… on the same playing field, no matter what their size," she said.

Many issues inevitably cropped up about the way the center would be governed. "Some institutions stepped back and stepped forward again," says Kelley. "The reasons for hesitation by some Institutions were more organizational than financial. Some of the institutions are in the midst of major building projects and research programs, so [had to ask] whether spending capital in this area was more important to their ongoing operations."

Kelley’s Heroes  

Funding NYGC proved to be a massive undertaking. "There are a number of pieces to the quilt that had to be knit together to be able to put this all together," said Kelley. "One of the strengths of this effort is that its success is not dependent upon one funding source, especially a public funding source, which has proved to be a problem in some other large projects like this one."

Kelley says Maniati played a pivotal role. "He was the first person whom I talked to about this, and has been instrumental at every level in guiding this forward. So we’ve really done this together."

She also praised Kelly and the relatively new leadership at Sloan Kettering and Rockefeller University -- Craig Thompson and Marc Tessier-Lavigne respectively. Russ Carson (Welsh Carson/New York City Investment Fund) "immediately saw the benefits of this to the City," and is now chairman of NYGC’s Board of Directors.

NYGC’s bioinformatics center will be named after the Simons Foundation, the first major philanthropic donor, offering a $20-million matching challenge grant. The Bloomberg Philanthropies have kicked in $2.5 million. In addition to Tony Evnin’s "very significant commitment to the Center," Carson has also pledged what Kelley calls "a very substantial sum of money."

There are two industrial partners – Hoffman La Roche and Illumina. Kelley says both Illumina and Life Technologies were invited to make presentations on how they would partner with NYGC. "In the end, there’s just been enormous progress made by Illumina in their productivity and turnaround times this year, and that proved to be one of the deciding factors," says Kelley.

NYGC expects to launch with 30 next-gen sequencing instruments in its first year. "This will not be an exclusive technology in any way," Kelley noted. "In the Innovation Center, we’ll be testing new technologies and making them available to the scientists in New York."

A search committee (chaired by Evnin) has been assembled to recruit a world-class scientific director. In addition to the sequencing center, serving the founding members, pharma collaborators and hospitals, Kelley says there will be "a very robust bioinformatics presence" and an internal research program.

The Innovation Center will allow scientists to use the facility and develop new technologies and products. A training component is planned in conjunction with Cold Spring Harbor Laboratory and other organizations. And, Kelley said, there will be a small philanthropic unit.

Kelley fully expects there to be a strong clinical component to NYGC. "There will be a CLIA-certified portion of the facility and we’ll be interacting very closely with hospitals like NewYork-Presbyterian Hospital and North Shore-LIJ."

As for Kelley’s future role, she points out that creating the strategic plan and raising the money is only a small component of building a successful institute. "There’s a huge ongoing financial, executive and operational role that has to be put together with a large organization, and I’d expect to play a key role in doing that," she said.

"At one point, Richard Gibbs said something to me: ‘You have to be absolutely fearless to do this.’ He’s right… I don’t think there was one day this year when I had full confidence we’d actually make it, but I knew it was important to try."

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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