Teri Manolio: All right, why don’t we go ahead and get
started?
I’m Teri Manolio from the National Human Genome Research Institute.
My -- I and my coach here, Neil Shear, are delighted to welcome you to this meeting on
research directions in Genetically-Mediated Stevens-Johnson’s Syndrome/Toxic Epidermal
Necrolysis.
I thought it might be nice to start off by introducing ourselves around the table, so
I’m Teri Manolio.
Oh, yes, and don’t forget to push your button.
I just did that so you would remember.
[laughter]
Neil Shear: Neil Shear, from the University of Toronto.
Lois La Grenade: Lois La Grenade, from the FDA.
Carolyn Hutter: Carolyn Hutter, from NHGRI.
Wen-Hung Chung: Wen-Hung Chung, from Taiwan.
Lauren Trepanier: Lauren Trepanier, from the University of Wisconsin.
Shuen-lu Hung: Shuen-lu Hung, from Taiwan.
Rika Yuliwulandari: I’m Rika Yuliwulandari, from Universitas
YARSI, Jakarta, Indonesia.
Jay Hoofnagle: I’m Jay Hoofnagle, from NIDDK.
Steven Leeder: Steve Leeder, from Children’s Mercy Hospital
in Kansas City.
Mike Pacanowski: Mike Pacanowski, from F.D.A.
David Veenstra: David Veenstra, University of Washington in
Seattle.
Wasun Chantratita: Wasun Chantratita, from Ramathibodi Hospital,
Mahidol University, Bangkok, Thailand.
Munir Pirmohamed: Munir Pirmohamed, from University of Liverpool,
U.K.
Michael Lee: Mike Lee from RIKEN, Japan, and Academia Sinica
in Taiwan.
Cynthia Sung: Cynthia Sung from the Singapore Health Sciences
Authority and also Duke-NUS.
Maja Mockenhaupt: Maja Mockenhaupt from Freiburg University,
Germany.
Josh Denny: Josh Denny, Vanderbilt University.
Elizabeth Phillips: Elizabeth Phillips, Vanderbilt University.
Wimon Suwankesawong: Wimon Suwankesawong, from Thai FDA.
Simone Pinheiro: Simone Pinheiro, FDA.
Robert Davis: Bob Davis, University of Tennessee.
Surakameth Mahasirimongkol: Surakameth Mahasirimongkol, Department of
Medical Sciences, Ministry of Public Health, Thailand.
Stephen Katz: Hi, I’m Steve Katz, Director of National
Institute of Arthritis and Musculoskeletal and Skin Diseases.
Eric Green: I’m Eric Green, Director of the National
Genome Research Institute.
I also want to add my own welcome to all of you, especially those who traveled far to
get here.
It’s great to have you.
I also want to point out, our institute’s video crew is back there videotaping this.
We’re broadcasting live and we’re also going to be video archiving this, and -- which
we’re delighted to do, because we think it’s important to have people who can’t
get to Bethesda be able to either watch it live or watch it after the fact.
It is going to be important, though, to make sure that people are using microphones at
all times, because without the microphone the video is just not going to pick it up,
which makes me wonder how we’re going to go around the rest of the room.
But maybe for the introductions, we won’t have everybody jump to a microphone, but when
we get into question and answer sections, everybody needs to use a mic.
Thanks.
Teri Manolio: That’s a great point, Eric, and unfortunately
I think we’ll skip introductions from the side just because it would be a little too
hard to pass a microphone.
But welcome, everyone, and we are delighted to have you here.
One of the really neat things about being at NIH. is that we can basically, you know,
propose a topic for a meeting, invite people from far-flung regions of the globe, and really
have the world’s experts coming here even on miserable weather days to be able to give
us advice on research direction.
So we very much appreciate all of you coming.
I would note that this meeting is really a collaboration among multiple institutes, and
the Food and Drug Administration.
These are the various institutes that are providing the funding, and then of course
the -- our institute, the Human Genome Research Institute.
I’m sort of charged with addressing a couple of important questions, kind of, how did we
get here?
Why this topic at this time?
And also, what’s going to -- what are the goals of today?
And then we are asking you specific questions: Where do we go from here?
And that’s really the purpose of this meeting, is to get the brightest people that we could
-- we could find around a table to address that.
And a little bit of how do we get there; we worry a little bit more about the “how”
after we define the “what,” but at any rate -- and then you may have some questions
for us, so we’ll get into a little bit of the housekeeping things, like where are the
bathrooms and that sort of thing, so we’ll get to that.
How did we get here?
One of the -- as I said, one of the nice things about being at NIH is, you can call people
to address lots of very interesting questions, and we have a series of meetings in Genomic
Medicine or using a person’s individual genetic results in their clinical cure.
The sixth meeting that we held about a year and a couple of months ago, in January of
2014, was a meeting of global leaders, really sort of asking, “What’s going on, internationally,
that could inform our efforts to implement genomic medicine?
And could we learn from our individual models, perhaps in smaller settings that were more
efficient and flexible?”
So this, like all of our genomic medicine meetings, is video cast and archived, thanks
to Alvoro [spelled phonetically] and his colleagues, and so it’s on our website.
If you can’t remember this particular number, which I can see would be a problem.
If you just Google “NHGRI genomic medicine,” it should come up.
And this is the group that met in collaboration with the Institute of Medicine of the National
Academy of Sciences.
We were fortunate in having representatives from 25 countries, including a number of countries
that we don’t as often have as representative in our meetings, and we were just delighted
to get this part of the world to -- coming to talk with us.
One of the models that was discussed was Stevens-Johnson, and particularly our colleague Wasun described
the high prevalence of the risk of alleles -- particular risk allele -- in these parts
of Southeast Asia.
And an innovative approach that they’ve used, using just a simple card like a credit
card -- and here, I hope this photo will describe better than I’m doing here -- that basically
has a person’s genomic results related to the risk of Stevens-Johnson on the -- you
can see here the -- I guess I need this pointer -- the patient’s name, the outcome of the
assay, the date, the interpretation, and this particular person is at high risk.
And then on the back of the card, further information that this person has this risk
allele, and if you need more information, here’s who you can contact.
This was something that seemed so simple and so really, truly effective that it really
caught the attention of the various groups in the meeting.
And the idea was then, “Is this something one could generalize, or at least try to spread
beyond Thailand and, potentially, into -- in broader parts of Southeast Asia, which I understand
has been going on in other parts and in other ways -- and potentially even more broadly
around the world?”
When we came back from that meeting, we then sort of looked at what NIH is doing in this
area, and it turns out that we have almost zero portfolio in this condition, so maybe
two or three grants at the most that we’re funding, and that’s out of the thousands
and thousands that NIH funds.
So we agreed among a group of institutes, since this does touch on multiple institutes
-- mandates -- to pull together a meeting, this meeting, to review the current state
of knowledge in surveillance, pathogenesis, and treatment; look at the role of genomics
and pharmacogenomics and etiology treatment and eradication; and then identify gaps, unmet
needs, and priorities.
And that’s the work part of your day today, is really be getting you to address that.
Many thanks to the planning group shown here.
We very much appreciate your efforts, and I think you’ll see how effective they have
been.
Just a quick review of the agenda.
This morning, you’ll hear about the state of the science in three keynote talks, and
then the first part of international experience -- this includes a working lunch, and I’ll
say a little more about the lunch in a minute.
In the afternoon, we go on to talk about case-finding, and then we have working groups, and the working
groups have already done some work in advance, and we very much appreciate that.
On the next day, then, we have a second part of international experience.
Some special topics in areas were waited to SJS TEN, but not specifically that.
Again, we make you work during lunch for our [inaudible], and then report of the working
groups and wrap up.
And then we’ll have a shuttle to take you back to -- either to the hotel or to nearby
airports.
As Eric mentioned, we have a video livestream.
It’s being broadcast live, so you may -- and you might be caught on camera, so you just
might want to be aware of that.
There’s a link available, if you wanted to log on and see what’s being shown.
And this is very important: Please use the microphones, and one of the reasons for going
around the table was to give everybody practice at turning it on, and also very importantly,
turning it off.
So, if I could ask --
Male Speaker: Robert.
Teri Manolio: -- Robert, thank you -- if you could just
turn your microphone off?
Yes, thanks.
That’s great.
It’s -- so, that’s the way that you know that it’s --
Male Speaker: At least I wasn’t mumbling under my breath.
[laughter]
Teri Manolio: Yeah, so --
Female Speaker: And then we do have like a hand mic for people
who aren’t at the table, so either come to the table, sort of work your way in, or
raise your hand, and we’ll bring a hand mic around to you.
Teri Manolio: Yeah, we think it’s a nice way to, you know,
to stimulate collaboration, to actually have you coming to the table and lean in.
There is a floor mic, but it’s way over at the end there.
But it really is important that you use the microphones and we’ll be relentless about
reminding you to do that.
So, let’s see.
Food.
So, food is a very sore topic here, and we are really, really sorry.
There are certain government regulations; we are a government agency, and we apologize
-- we are not allowed to pay for meals in any way, shape, or form.
We can’t even give you coffee.
We can -- we can still give you water.
That may -- by the end of today, it may disappear, so drink it now.
But at any rate -- so, our sincere apologies.
This is just the state of things.
There is a cafeteria on the first floor.
It’s a little bit tricky to find, and so I might just ask, is anyone planning to buy
lunch from the cafeteria?
Just raise your hands -- oh, you poor souls.
Okay.
[laughs] Okay.
So --
Male Speaker: It’s a nice cafeteria.
Teri Manolio: It is a nice cafeteria.
Finding it -- so do you know how to get to it, Mark?
Okay.
So Mark Williams, in the purple sweater, will be the pioneer that will lead you down -- to
take you down to the cafeteria.
It’s a little tricky to get out of and then back up here, so -- and we have a relatively
short break for lunch, so we would encourage you to kind of grab what you can, come back
up here, and we’ll be able to sit at the tables here and eat.
So it is a working lunch.
Those of you who ordered lunch online, which was no small feat -- the first time I went
onto that website, it was -- it was really quite a challenge to navigate.
But at any rate, it’ll be delivered up here, and we’ll eat here, and unfortunately the
speaker during lunch will have to listen to our munching, and then we very much hope you
can join us for the conference dinner tonight at Bistro Provence.
Again, we apologize, we can’t buy you dinner so it’s sort of cash-only, but please sign
up at the registration table by the end of the first break, if you’re planning to come
to the dinner.
And there’s a map in your packet for how to get there.
So we have a registration desk out front.
You’ve probably met Jennifer and Josh from Capital Consulting -- they will help with
logistics questions and any problems logging into the guest network and taxi arrangements,
if you need them tomorrow.
There’s a shuttle to the hotel -- I believe it’s actually the three-level -- is that
correct?
Yes.
So, our apologies.
This building is built on a hill, and so every door is like on a different floor, which gets
increasingly confusing, but it’s actually the B3 level if you go down to those elevators.
And that will be leaving at 6:00.
We finish at 5:45.
And then we’ll pick you up again at 7:15 tomorrow.
And just sincere thanks to the planning committee, who did really a fabulous job.
Particularly, I have to call out my colleagues Carolyn Hutter and Deborah Colantuoni, who
did just the lion’s share of the work here.
It’s really a fabulous job.
And then we have a working group that helped us to identify the need for this conference
and some of the people to bring in, and other institutes that are collaborating with us
on this.
So with that, it’s my great pleasure to introduce the co-chair, Neil Shear, from the
University of Toronto, and he’ll be giving the first keynote.
Would you like the --
[end of transcript]