CANADA: Genomics and Personalized Health Competition – Pierre Meulien
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CANADA: Genomics and Personalized Health Competition – Pierre Meulien

Pierre Meulien:
Good morning, everyone. So, my name is Pierre Meulien. I am the President/CEO of Genome
Canada. I’d like to thank Geoff and Eric for inviting us to give a little bit of information
on what we’re doing in Canada regarding the implementation of personalized medicine, personalized
health. I would just like to acknowledge that we do
everything in personalized health with colleagues from the Canadian Institutes of Health Research,
and Paul Lasko is here this morning. And also I have my colleague; Cindy Bell is also from
GM Canada in the audience. So what I’d like to do today is to give you
a very quick introduction to the Canadian healthcare environment because this is the
receptor into which we’re going to translate stuff. And I think it’s very important that
we understand what that receptor is like, what its culture is, in order for us to do
that. Then I’ll tell you a little bit about genomics in Canada, and then go right into
the meat of the presentation, which will be on a program that we have designed with our
colleagues from CIHR in genomics and personalized health, which we launched in 2012, and then
a few conclusions and looking forward. So, in terms of the Canadian environment,
it’s a publicly-funded health care system. It’s provincially delivered through a series
of regional health authorities. So the regional health authorities are the payers of the systems,
and they decide, to a great deal, what gets funded and what doesn’t get funded in terms
of technologies, and so on and so forth. It costs the country around $200 billion per
year; growth is currently around the 3 percent annually, and given the general economic growth,
this not sustainable. But we know that biomedical research is very strong in Canada; in fact,
we spend roughly 2 percent of global research, but produce 4 percent of the highest impact
factor publications, and we also have very strong clinical networks. A lot of those were
funded through the CIHR body, and for some diseases has among the best outcomes in the
world through those networks. But the challenges are really our ability
to move the latest technology into the health care system, which we do not have a very good
track record of doing, and new technologies are often seen from the payer standpoint as
just an added cost, and economic analyses performed are not obviously convincing enough
for the payer to adjust their offer. So, in terms of genomics — and we’ve benefited,
I guess, from a sustained focused investment from the government over the last 13 years.
We were kind of playing catch up to a little bit of a degree. And we’re organized — we
looked like the federal-provincial government because we’re organized Genome Canada and
six administrative regional genome centers, and their job is really to monitor large-scale
projects and fundraise for us through looking for provincial dollars and other dollars that
we can match federal dollars with. We also have five Science and Technology Innovation
Centers, and they’re the big either DNA sequencing centers or proteomics or metabolomics, and
I’ll be talking a little bit about those and their role in some these projects. And we’ve
invested about $2 billion; $1 billion has come from the federal government over the
last decade and a bit, and $1 billion then from other sources, including the provinces. I’ll just talk a little bit about some of
the challenges with translating new technologies because, obviously, we’re not going to translate
something that has not been clinically validated. And something like DNA sequencing, where there
are multiple platforms, where the technology is probably — some platforms are more stable
than others, and there will be new platforms coming forward as well as we go forward because
the technology is moving so fast. So that decision point as to when to transfer is going
to be a key one. And then we have to ask the questions, well,
once again, the receptor in terms of the clinical laboratory structures, are they going to be
turned upside down and what are the implications for that? And who will be making these decisions
and based on what criteria in terms of technology assessment, based on sound economics and clinical
benefits, and who will pay for the stuff. So we decided, then, with talking with our
colleagues at CIHR that what we needed in Canada was some kind of demonstration that,
one, the technology can deliver real value to patients; and two, integrating this technology
within the healthcare system would be cost effective. And so we decided that we would
design a program, and this is where were hoping for some value-add from a funder perspective,
in terms of we had to make sure that the right team is going to be formed to do this translation,
that the right deliverables are achieved, and that we have — we ensure true demonstrations
of value that are obtained. And, obviously, that is then linked with how you organize
— not only design the RFA, but organize the review panel, which was very, very critical. So, in 2012, then, we came together with our
colleagues at CIHR and designed a new program. This was a major partnership between the two
organizations. We pooled together $65 million of our monies, and we were able to leverage
that up to $150 million through partnerships. And it was very interesting that, obviously,
having a genome Canada/CIHR partnership within this area was a focal point for others who
were interested in personalized health, and we were able to attract other investments
into this pool. So, going from 65 to a 150 was, I think, a good — it obviously demonstrated
that we could attract others and that others were very interested in joining us in our
— in our efforts here. So I’m going to skip over this one and tell
you a little bit about the key features of this competition. We insisted that the project
teams come with a rationale and an economic analysis for why the particular application
that they were proposing would add value to the healthcare system. We insisted that the
assembling of the team and who those people were, including, you know, end users, health
authority personnel, who would actually be the pull mechanism for some of these technologies.
And a detailed development plan was acquired to demonstrate the integration into the healthcare
system, including engagement by end users, considerations of the regulatory framework
existing in Canada, and then looking at challenges and barriers to translation that we put under
the GE3LS acronym, and I’ll tell you — I have a specific slide on that. So, GE3LS is the Genomics and its Ethical,
Environmental, Economic, Legal, and Social aspects. I think you have similar programs
in your own countries, probably called a little bit differently. And this, traditionally,
in Genome Canada language, has been related research undertaken from the perspective of
the social sciences and humanities disciplines. In the context of this RFA, it was extended
to cover researchers in the fields of health administration, health management, health
services research, health technology assessment, evaluation, and comparative effectiveness
studies. And those were integrated into the project in a mandatory way. There also was
a possibility of a standalone project which would only deal with GE3LS aspects of this
technology. And we’re also going to bring the successful applicants together early next
year, or early this year, rather, to talk about, do a little bit of cross fertilization
and testing to see if there are common themes, common barriers, common issues of translation
that we could fund some further GE3LS type activities in this domain. So the review was in two phases. We had 146
pre-applications that were reviewed by a very large group of people, and full proposals,
that was whittled down to 40 full proposals, and they were reviewed by 40 international
translation researchers, social scientists, and health economists. The panel chair was
Raju Kucherlapati from Harvard Medical School, and I know that some of you were also involved
in the process; Geoff was involved in the process and Howard McLeod was involved in
the process, and others may have been that I’m not recognizing. But that review of full
proposals took place over three days, with face-to-face meetings between members of the
review panel and project team applicants. And the review criteria were obviously research
merit, but also, very importantly, socio-economic benefits, finance, and management. And those
review criteria were measured — were reviewed equally, so it wasn’t as if we would say,
well, the research merit is more important than the socio-economic benefit. No, you could
fail a project on any of the criteria. And we ended up funding 17 projects that are
now — have been all launched, and with an average size of — dollar size of 8.8 million.
So there are some that are 12 million, there are some that are 6 million, but that’s the
average size. And we, traditionally, in Genome Canada, have always been milestone driven
in terms of our — how we manage our projects. They are closely monitored by personnel at
the genome centers. We’ve introduced with our partners a new type of oversight committee
as well for this competition, and that oversight committee, the ROC, reports to the funders
on progress, provides advice to the project teams, and helps ensure team’s focus on reaching
project milestones and objectives. So I’m just — I think I have a few minutes,
2:40 exactly — [laughter] — to tell you a little bit about some of
the projects. First of all, we were pleasantly surprised at the broad scope of the disease
areas that were funded. We thought, at the beginning, is it just going to be cancer and
pharmacogenomics? But no, it’s across epilepsy, autism — well, you can read them there; I’m
not going to go through them. They do have a common theme, however, and it’s to do with
— and that’s not surprising in molecular medicine — molecular stratification of patient
populations to inform decision-making, re: effectiveness of drugs, adverse drug reactions,
intervention strategies, and disease management. And they all have an economic rationale behind
that. So, for example, the first one on the list is epilepsy, and, you know, a third of
the epilepsy patients that come do terribly on traditional anti-epileptic drugs, so you
don’t want to put those people on traditional anti-epileptic drugs. And so the project has
to do with getting a new diagnostic test together to differentiate those populations that will
do well and not. And I thought I’d just the give you a flavor
of the type of project, so this one is in lymphoid cancer by Joseph Connors at the British
Columbia Cancer Agency, with a link to, of course, the high-end sequencing center there
directed by Marco Marra. And in this one, the beauty of this project was that Joe had
gone around the province of British Columbia and had signed on every single clinical oncologist
specialized in hematological cancers and wrote them into the team and got them to sign on
to say that, you know, yes, if this works, then we will apply it to my cohort of patients,
et cetera, et cetera. So that’s a very interesting one. There’s also one on prenatal aneuploidy screening,
and this is looking at direct comparison with several technologies head to head, and, obviously,
as you can imagine, some of the GE3LS-related research that’s going on in that project.
Everybody has their favorite story on rare disease. This one, these guys have gone through
the usual diagnostic odyssey and –for over a decade, and, of course, three weeks after
their genome sequenced, their disease was solved. And now Kim Boycott and her group
have solved over 150 cases out of 250 families that have been looked at, so that’s a 60 percent
hit rate. I’m not going to go through this because I’m
now running out of time, and I’ll just go through some of the conclusions and the future
aspect. So, obviously, we need to concentrate on the receptor, and we’re hoping that some
of these projects that were funding will deal with some of these issues. Involvement of
the private sector is key. There are 20 companies that are involved in the portfolio of the
17 projects that we’re funding, so there is a quite a lot of industrial interaction. And
you can read, the other things on the list are obviously very similar to what you’ve
already heard from the others. We have created in Canada, and this is a unique thing in Canada
for the moment, it’s one of the first pediatric clinical genomics centers in the world. It’s
a partnership between Sainte-Justine University Hospital and Genome Quebec, and will be a
very interesting one to follow as a model for the system. So, as Frances Collins always says, you know,
“This is the beginning of something, not the end of something.” And the knowledge base
will be totally different in five years once again. And we will be layering proteomics
epigenomics, and microbiome data on top of our personal genome sequence, and that is
going to have huge informatic challenges that Dan told us about earlier on. But it will
mean that in 10 years technology will allow us to do things that are totally unimaginable
today. So I’d just like to acknowledge the genome
centers, which is very much a family in Canada in terms of the genomics enterprise that we’ve
created, and, of course, our partners. It has been a superb partnership with CIHR, and,
of course, all my colleagues at Genome Canada for all of their help in putting this together.
Thanks very much for your attention. [applause] I’ve allowed a couple of minutes for questions
if there are any. Dan Roden:
This is a question that I have because I’ve sort of been involved in the Genome Quebec
post-award evaluation. You’ve invested a huge — or you are investing a huge amount of money
in 17 different projects. Is there some kind of plan to create a common infrastructure
in terms of a genomic database, or exchange of information, or lessons learned across
the 17 individual projects? There’s a big investment in the individual projects; how
about the, sort of, the collective, and how are you approaching that? Pierre Meulien:
Terrific question, Dan, thank you. And I mentioned that we were going to bring these — once
they were launched, we’re going to bring these 17 together in April of this year and we’re
going to ask them exactly that question. What can we do to try and harmonize what you’re
doing, to integrate datasets, to make sure that we’re harmonizing as much as we can do
across the 17 different projects that are scattered across the country? And there is
a link here between Canada getting prepared to be a credible partner in the Global Alliance
and being able to integrate some of this stuff across the 17 projects. So it’s a great question,
and I’ll be able to tell you more after the April meeting, Dan, so, thanks.

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