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.