NACNR 5/2018 – Director’s Report

>> Patricia Grady: It is now
my opportunity to give you an update of what has happened
since last we’ve met, whether it was
by teleconference [laughs] or in person,
and just let me know — we’re wired up here, so let
me know if it doesn’t work. So, this, as I said before, is the 95th meeting
of our Council, this is the open session.
I have an opportunity today to give you a bit
of a budget update, and we have more news today
than previously, and also to remind you of some
of the things that are happening or acquaint you with some of
the things are happening at HHS and NIH
as well as the NINR updates that you look forward to. So, we do — this is a year
when we do, despite some of our difficult
steps along the way, we do have a budget
and it is a good budget, and so we’re really — I’m excited to be able
to tell you this. If you look, this shows the
recent appropriations history, which despite some of
the difficult or torturous paths that we’ve taken to get here,
if you look, the budget history for NIH
over the past couple of years actually is a bit better
than you might think when you reflect
of some of the journey that we have traveled
to get here, but this year in particular we have a really much
better budget. We have a 5.2 percent
increase appropriated to us. The overall NIH increase
at 8.8 includes set-aside funds for things that you have heard
me speak about previously: The BRAIN Initiative,
Alzheimer’s disease, and also the Precision Health
or the All of Us initiative. Those funds do go
to a central place and then are distributed out, and some but not all of those
become part of the base and many of those funds do not because they’re earmarked
one-time-onlys. But our increase
is 5.2 percent, which is the appropriate
increase. There may be some — the Secretary has some transfer
authority for central programs, as does the NIH Director, but typically what
our appropriation is listed as is quite close
to what we do get. In fact, when we look back
at last year — I’ve been waiting for us
to break through the $150 million mark [laughs], and so it turns out
that we did last year. It was sort of one of those
of mathematical approximations and I wasn’t sure that we would,
so I didn’t announce it to you, but it turns that we did
just over the mark, but this year we’re very
comfortably over that at $158 million. So, we are really excited
that we will be able to fund more of the really good science
that’s coming in to us. It’s always a struggle and we are appreciative
that you’re bearing with us and also appreciative
that you are helping us articulate the importance
of the science and, first of all,
articulate the science and help us to advertise
to get that word out, and also to underscore
the importance of it. It makes a difference
when Congress and the community at large hears it from you because you speak with
such authority and such passion and it’s really your work. We speak with authority
and passion as well, but we’re really speaking it — it sometimes seems
a little more self-serving when we speak about it
because we are the government to whom the appropriations
are given. So, we’re very excited
about this. It will enable us to move
forward in new directions based on some of the science that you all will see coming
before you in this Council. So, when we get
an appropriation, what does it look like? I know I show you
this pie graph each time and the proportions do not
change substantially, but the numbers
within them of course do. So, you can see,
most of our funding, the appropriation that we get,
the majority, close to 80 percent, goes out to
the extramural community to fund research and training. That includes the centers,
the other research, which are primarily
all K awards, and the training,
which is the 5 percent. So, some of the R&D
goes out to you, some of that is used up
in taps to support things such as review and CSR and some of the clinical things
that are available, et cetera, but the RPG, Centers,
Other Research, and Training all go out
to the extramural community. Intramural program is 8 percent, which is compares
to the 10 percent which is the average
across NIH, 10 to 11. The RMS is our overhead which —
it’s not fair to compare it to the 50+ percent
that the universities get, but just to give you
a relative approximation. The 11 percent overhead
is considered reasonably modest in most
corporations these days. So, moving into
some of the changes that have taken place in HHS, recall that we are
one of the major — we’re actually
the largest component of Department of Health
and Human Services, and that brings
a lot of attention to us and it also underscores
why we sometimes — you have commented that we’re
a little conservative here, but we actually,
we are the government, and also we are,
as the largest component of HHS, we are a component
that many people look to for modeling of behaviors. So, we have a new Secretary.
Alex Azar is confirmed as the Secretary of Health
and Human Services. He has been on board
less than a year now and he’s already visited NIH and spent a substantial amount
of time with us. We’re very excited
that he is someone — he jokes about that
he’s a lawyer and he is in charge
of a number of people in the health professions,
including physicians, and so he says he feels like
he has a lot of homework to do to work
on that communication system. He is someone who has been
in the private sector, he’s been in industry, he was ultimately,
before he left, the Senior Vice President
and then President of Eli Lilly, and he also was part of
the previous Bush administration under Tommy Thompson
as a Secretary, and he rose during
that period of time to be the Deputy Assistant
Secretary to Secretary Leavitt. So, he was in the department
for eight years in really high-level positions, and so he does understand
how the government works, he understands
how the department works, and he also understands
health systems and pharma in particular. So, we’re really pleased
that he’s so tuned in and seems also very positive
about NIH and what we will be able to do. So, we have gotten off to
a really terrific start with him and are really quite pleased. Robert Redfield was named
the Director of the Center for Disease Control
and Prevention, CDC. He has really just been sworn
in recently. He is a well-known
AIDS researcher for a number of years. He has about 40 years
in the field, experience. He was the cofounder
of the Human Institute for Virology
at University of Maryland and has had other positions
in the government. He is quite well-known
and prestigious in the scientific arena
of HIV/AIDS. So, moving to National
Institutes of Health, you will be hearing in just a few minutes
from Dr. Mike Lauer, who is the Deputy Director
for Extramural Research, and he will talk to you
about the changes in the clinical trials and some of the rules
and regulations governing that and some of the principles
that have changed. So, we particularly
wanted to hear from him because so much of what we fund,
the majority of what we fund, is clinical research
or has a clinical thread to it, so we wanted to make sure
that he could come and you could get the benefit
of hearing him discuss this in person, but also to have the opportunity
to ask questions. So, I hope you have some, you know,
good questions lined up for him. Now, I’ll just briefly go
through his, but not going to read. Essentially, the four components
of the changes with the clinical trials
would be that clinical trials now come in response
to announcements. So, it has to be either a
program announcement or an RFA, so that they don’t come in
over the transom anymore. Now, those are reasonably
generic announcements and we have signed on to them, so that it does need to come
in response to one of those. There are also
clinical-trial-specific criteria that are more detailed
than what was previously used. So, they will focus a little bit
more on patient safety and on some of the details
of the design. The other two are that
there will be a new Human Subjects
Information Form. So, this is a new form,
which makes sense because since the rules
have changed you would need a new form.
We are the government and we need to make sure
that that form fits. But that’s a form
which we have tried very hard to make certain that
it’s reasonably straightforward, it’s fairly easy to fill out,
et cetera. So, and because of this, we’re still
rolling these things out, we are much more receptive
to feedback on these forms. So, that’s number three. The fourth one is one
that you have heard about because it’s been
a long time coming, and that’s the use
of single IRBs, even for multi-site studies.
We’re particularly — I’m actually particularly
excited about that one because so much of the time
that you spend getting things up and running
is getting IRB clearance, and the more IRB clearances
you need to get, the longer it takes. And often, you know, each one —
you pile them up in line but then some of the later ones
you’re looking for have different guidance
or different requirements than some of the earlier ones, so we feel that this will be
an enormous help. It takes a little time
to get the clearance, but at least you’re operating
with the same set of rules. So, you know, we feel that that actually
will be an enormous help. This is something
that many of you know that we pioneered
in the HMO Collaboratory. The projects that we were — that was a major initiative
of about five years ago and still continues
on today at NIH. So, some of those opportunities that we invite you
to join us with, and suggest that you apply
for funding in, turn out to be really like
experimental think tanks and places where
we can try out things that we then can learn from and then to scale up
to larger audiences, and this is an example of that. So, but Mike will be here
in a little while, and he will go into
more detail on this. So, an update on the All
of Us project, which used to be called
Precision Medicine. The biggest component that is
All of Us, and that really is
the large-scale enrollment study to sign up a million
plus individuals as part of this endeavor to be able
to eventually collect data, that they will put
their data into this, and that that data will be
available to do clinical studies and studies on the data. So, the idea is that this would
ultimately reduce the need for creating new cohorts
for each clinical study that you propose to do
or anyone else proposes to do, and then those studies disband,
the cohorts disband, then you start over again
with the next study. So, kudos to Michelle
for doing that and for bringing the Institute
front and center in this effort. So, just a quick — I’m not going to read through
all of this, but this just as a refresher
for those of you that have
additional questions about this. There are a number of advantages
of this study, of this initiative, for both the participants
and the researchers. And so we look — we’re still
in the formative stages, it just rolled out
for people across the country to sign up last week,
so that were just — the actual signing up for this for the general public
has just opened, but we already have
a number of people signed up from the satellites
that have been held, so that there are opportunities
for moving forward in a number of
different kinds of ways. Now, the major pieces of this,
just so you know, the major pieces of this include
these six components: There’s a Data
and Research Center which will over time
be available to everyone. There’s a Biobank for specimens. The Participant Technology
System Center is really where we’re trying out a number
of new web-based platforms to communicate with all of
the folks across the country as well as those in the study. The Participant Center Network
is where the direct volunteers can participate and communicate
with us to join into the All of Us. Also, the Healthcare
Provider Networks. We have a number of new
and creative partners in this endeavor that NIH has not been able
to partner with before, and so we’re very excited. This opens up
a number of new opportunities and we intend to help you
take full advantage of those. And also the Communications
and Community Network which most of you know we’ve
been particularly active in. In fact, Francis went
to Columbia in York as part of the rollout and that’s something
that many of you know that Liz Cohen has been working
with that group with that historic church
for about 20 years now and was instrumental in getting
that into the application. So, we’re excited about that. Also, NIH has a new initiative
in response to the concerns about opioid and the additional funding
moving in that direction. One of the early things
that we have done is to launch the national — the HEAL Initiative for
the national opioid epidemic. So, this really is — this is going to be a rather
comprehensive initiative that involves scientific
participants, involves patients, also involves,
and this is very important, the drug companies
and the pharma companies. We’ve been engaging with them
for some time in other initiatives,
but this is a large one. You may have read recently,
the Advisory Committee to the Director
weighed in on our partnership with the drug companies
and indicated that they were supportive
of the partnership — this is the Advisory
Committee for Francis — supportive of the partnership, but that we are not accepting
funds from those companies. So, we are sharing
intellectual capital from them but not green capital. The Lasker Clinical Research
Scholar program is open again for applicants,
and we encourage you, if you have talented young folks
at your universities, in your programs,
to please be in contact with our intramural program. Dr. Ann Cashion will help you
get to the right place and help you to be able
to mount a response to this. Recall that we do have
one Lasker Clinical Scholar, Jessica Gill, who is actually
in the audience here. So, we’re really —
so, it is possible and it is relevant
to all of you, so please sharpen your pencils and think about putting
your really talented people to work on this.
We’re happy to help. So, just looking —
recall also that NIH has sponsored
activities and announcements the same way that
each of the institutes do. So that, although we all have
our own initiatives that are scientifically specific
to institutes and center, the NIH has — we participate
in the ones that are trans-NIH, so I want to make sure that we
bring those to your attention. We have done particularly well
in many of these, especially the Microbiota
has really had an enormous impact on our field
and is changing it in ways that we might not have
imagined early on. So, moving a little bit closer
to home, the last part, we’ll tell you some of the things
that have changed here, all of which
are pretty exciting. Again, I want to thank
our retiring Council members, James Corbett, Nancy Redeker,
and Meredith Rowe, for their willingness
to participate in yet
one more Council meeting while we’re waiting for the
onboarding of the next group, the next cohort. You have all been
very strong members, very vocal in a good way
because we really like that, we like the lively discussions. The one advantage
of your coming back, besides the advantage that we
have in having your input, is that we will be able
to celebrate tonight because, as you know, we were not able to meet
in person at the last Council. To remind you of the upcoming
Director’s lectures, Jackie Taylor is coming on
May 22nd to talk about her work and her programs
in health disparity and improving the health
of African-American women in particular
with cardiac issues. So, we’re looking
forward to that. And also, in September, Ann-Marie McCarthy
will come talk to us about her scientific programs
in pediatric pain. She’s well-known in that area
and it’ll be good to hear all of that about her programs
in one setting. So, just a reminder that all of
the Director’s lectures are recorded
and archived on the NIH YouTube, so we want to bring
your attention to the last one if you haven’t seen it yet. These are a wonderful resource
for students because we do have the leaders
in the field describe their entire programs
of research in a very economic,
less-than-one-hour setting. So, the Boot Camp
for this year — I’m sorry, the Boot Camp
for ’17 was held, From ‘Omics’ to Data Science. That is also available
on the website. The first-day lectures
will be available. The ’18 workshop
will be starting in just a short period of time. The enrollment
for that is closed, but just to let you know
that those are very popular, they are timely,
they change each year, and we do — if you think
you might want to be part of it, if you think you want
your students or anyone, the minute you start thinking
about it check the website, because when the enrollment
in it opens, it does fill up literally
within hours, so please — you know, we post ahead of time
when it’s going to be. Also, the summary for the
Caregiving Summit from last year and an accompanying editorial
is now available, and Nursing Outlook has just come out
this last month’s issue. We also have a very detailed
summary of that on the website so that you can look at some of
the ideas that were put forward, some of the gaps, and some of the scientific
thinking moving forward from the very illustrious group
that was there. The National Research Roundtable
papers from 2017 are now published in Journal
of Nursing Scholarship. The four major talks
from that meeting were all, you know, very well received
and peer reviewed and are in the ’17 Journal.
The papers from this workshop, even though we had to do that
by teleconference because we were closed
because of wind [laughs]. That was not the snow, that was
weather, but it was wind, and so we did that
by teleconference, but the papers were just
as good on teleconference, we just couldn’t present them
to such a large — the larger group. But those papers will be
available, so you will have — everyone will have
access to those. So, just a few honors
as we’re closing today. We like to make note of
when our staff accomplish — they’re always accomplishing
wonderful things, but in particular when
they’re accomplishments are noted by outside groups. So, we have NINR scientists
who have received the honors from the American Academy
of Hospice and Palliative Care, and so we really want
to commend them for the presentations
that they did at the meeting which received Best of the Year Research Honors
for those papers. So, we’re very pleased
that that honor has been given to the staff, and also that it’s been
given to the science, which is really exciting for us. We also have a MedlinePlus
collaboration which is intended to work
with patients and families. It really is a — Medline has extended
its research of its magazine and it now has an arm
that communicates with the patients
and families, and this is intended
to address patients and families who are living
with a serious illness. So, it is a way that we can
reach out as a research agency to be able to reach out
to the families and patients
in a more personal way. As I said before, we have
a number of announcements that are active in addition
to the trans-NIH announcements and those you see before you. I won’t read them,
but you can see it is a good way to focus on the important
areas of science that we want to continue
to create critical mass. The Summer Genetics Institute
last year was another big success. I have never still been able
to figure out how people can work so hard
and enjoy it as much as those who come to participate
in this Institute. So, we will be holding that. This year’s will begin
in the first week in June. Obviously, the registration
period is closed, but again,
this is very popular, but it takes a little bit longer
to fill up than the Boot Camp, so you have a better chance
of getting into that. So, the Boot Camp,
I mentioned before, for this year for
the Methodologies Boot Camp is entitled Precision Health: Smart Technologies
and Smart Health. So, it does focus on the use of some of the newer
smart technologies to do measurements
and clinical studies. We also, as part of this,
have the first day in the afternoon
will be an NIH-wide symposium, so that it will involve
a much larger group and therefore more people
have access to the information. That also will be filmed
and archived, but the format’s
a little bit different. It’s a way to try to open up
the course a bit since we do have a large enrollment
of close to 175 people, but the demand is such
that it fills up in hours and so we want
to try to make it more open, and so this first afternoon will
be larger and more inclusive. I also wanted to bring
to your attention — I know that you know
we have many opportunities in the intramural program and I’ve said it’s from
high school on, so this — but a week ago we had
the NIH Postbac Poster Day. So,
the postbaccalaureate students or postbaccalaureate individuals who come to NIH
to participate in research in the summer
have a poster session where they can talk
about what they do. So, we had nine of these
postbacs this summer. Pam Tamez has outdone herself
in getting them to sign up and also monitoring them
throughout the summer. So, this is the group that we
had last week who’ve been here, you know,
for a period of time working on these research
projects, and they all — and as you see,
we have, as always, have a really diverse group. They were extremely articulate
in describing the science, they had obviously
all practiced, but they really were very good
at describing it, they could answer questions, they were very supportive
of each other, which is always good to see. The young man in the center
with the reddish shirt is applying to nursing school, so he’s setting the bar
for the rest. We’ll have to see
how that goes, but anyway, they’re
very excited to be here. So, after spending
a period of time at NIH it was good to see that their
level of enthusiasm was so high. I was reflecting, you know, that you don’t always see
that level of enthusiasm in some of the more
advanced students, and so I’m wondering
at what stage we start to extinguish that
and what we can do about it. [laughs] So, Jessica Gill has been
asked to serve on the National Academy
of Sciences Committee on looking at issues
related to the VA system, clinical issues
and safety issues, and to look at some
of those processes. So, we’re really
excited about that. They actually came to find her as opposed to us seeking them
out, which is always nice. She’s also received
an award of her funding from the Chuck
Noll Foundation, which is dedicated
to brain injury research, and so we’re really pleased that
that gives her an opportunity to extend her work even further.
So, congratulations to Jessica. We also have another intramural
tenure-track individual who’s making a name for NIH
and for our program. So, it turns out that
the American Association of Gastroenterologists
has their version, a national version of a shark
tank at their national meetings, and so it’s very much like
the television Shark Tank, and so people present
their inventions and their work
at this shark. So, it was quite a large group,
it was well over — it was actually several hundred,
as I recall, people who had presentations
in the shark tank. So, Wendy Henderson from our
intramural program tenure track, and Chang Hee Kim, who is
her collaborator from GoDx, won the shark tank. So, we’re very,
very proud of them. I think they’re thrilled,
of course, and they’ve gotten quite a bit
of publicity for themselves and for NIH, which we
are always excited about. So, we don’t know where
it’s going to go from here, but the group always
follows through with, you know, trying to promote
these inventions, so we’ll see how that goes. Paule Joseph, our assistant
clinical investigator, also in the room
over in the front row, has just received the
Penn Nursing Alumni Award, so they obviously are
as proud of Paule’s efforts as we are at NIH, so we want to make sure
that everyone is aware of that. It’s quite an honor
from a very good school. These hits just keep coming.
So, Kristen Weaver, who was part of our
Graduate Partnership Program, who just graduated last year
with her Ph.D., received from
the American Association of Colleges
of Nursing, received the
Outstanding Dissertation Award for the year
for the entire population. As you know, the AACN
covers 650 schools, about 400 of which
have graduate education, and it’s a very large meeting, so Kristin received the
Outstanding Dissertation Award for the entire group,
so we’re very proud and pleased. She is now doing a postdoc
at Johns Hopkins, and so we feel
that she’s launched now. So, just a few more in closing. We have some
more changes at NINR and things to brag about, one of which,
Jeri Miller has received a very prestigious
national award from the American Association
of Hospice and Palliative
Care Medicine, and this award is for people who
have made major contributions to the field
over a period of time. So, it’s not specifically
for the presentations of science that I showed you before,
this is for her overall efforts and her contributions
to the field, which is a very unusual thing
for a fed to get actually. So, congratulations Jeri. Lynn Adams —
we’re on a roll here [laughs]. Lynn Adams, also from
the palliative care and end-of-life group, has received the Purdue
University Hall of Fame Award,
which is also — as you know, Purdue is well known
for a number of programs, one of which is
their nutrition program, which Lynn was part of and has
received the Hall of Fame Award. So, that’s quite — it is,
as it suggests, quite an honor. So, congratulations Lynn. David Banks,
who is our training officer, has received the very first NIH
Diversity and Inclusion Award from last year’s NIH Director’s
Award ceremony. This is an award
that was created in honor of Dr. Yvonne Maddox,
who is on the left side, and you all know
her really well. She was the Deputy Director
for the Child Health Institute for many years
and is now the Research Dean at Uniform Services
across the street, but is known for her work in
diversity while she was at NIH. So, David, also known
for his work in diversity, as well as training, received the very first award
of this new award, so we’re really excited
that he received the award, but also that it was the —
that he’s the first recipient and that’s a particularly
strong honor. So, David, congratulations. And David is modest enough
that he refused to let us put the award
in the first time, the application [laughs],
so hopefully by now he’s glad. So, that brings us to the end of
my update and report for today. There are additional handouts
of a number of things that have happened
that are available at the door. So, I would like to —
so, I’ll close my comments now and then we’ll hear
from the next speaker as soon as I introduce him. [end of transcript]

Leave a Reply

(*) Required, Your email will not be published