A Smilow Town Hall with Dr. Ned Sharpless

September 17, 2020

Information

Hosted by: Charles S. Fuchs, MD, MPH Director, Yale Cancer Center Physician-in-Chief, Smilow Cancer Hospital

Guest Speaker: Norman E. “Ned” Sharpless, MD, Director, National Cancer Institute

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00:00Smilow town Hall.
00:01And before I introduce our our special guest,
00:05just want to let people know that?
00:10You know we'll have, will we?
00:11We took a bit of a break in August,
00:14will be getting back to the full schedule.
00:17Probably at coming,
00:18town halls will update on the clinical
00:20transformation efforts updates on
00:22our clinical research restart,
00:24but one reminder I want to make for
00:27everyone on the call and also tell
00:29your friends are team challenge awards,
00:32which is our our next round of
00:35pilot grants to launch new teams.
00:37Focus on a pivotal trial.
00:39The deadline for the letters of
00:41intent as a reminder is October 1st
00:44and people if people have questions,
00:47please email us.
00:48This is really an important
00:50initiative for us and we really
00:53want to enable as many teams as
00:56we can for this for this effort.
00:58So let me now introduce our special
01:01guests in Speaker Doctor Ned Sharpless,
01:03as many of you know is probably
01:06all of you know,
01:08doctor sharp list was nominated and
01:10sworn in as the 15th director of the
01:13National Cancer Institute in October 2017.
01:16Prior to his appointment as NCI Director,
01:19Ned served as the director of the lineberger.
01:22Comprehensive Cancer Center at the
01:25University of North Carolina where
01:27he held that position since 2014.
01:30Needs background was he received his
01:32medical degree at at UNC School of Medicine,
01:36then did his residency at
01:38Massachusetts General Hospital,
01:40his medical Oncology Fellowship
01:42at Dana Farber,
01:43then joining the faculty at Harvard,
01:46and then then being recruited
01:48to the faculty at UNC,
01:50where Hilton became the welcome
01:53professor of Cancer Research.
01:55Beyond those accomplishments,
01:57Ned has had a prolific karere
02:00in Cancer Research,
02:02having studied important pivotal aspects
02:04of Cancer Biology, generating novel,
02:07genetically engineered mouse models,
02:09studying the agent cancer,
02:11and frankly translating that
02:13work really into clinical impact,
02:16among other things.
02:18Sorry, my lights go out when I don't move.
02:23Have beyond that,
02:25starting companies that actually could
02:26move that great science into clinical care.
02:29If that wasn't enough to keep you busy,
02:32bee probably all know that in 2019
02:35Ned was also the acting commissioner
02:37for the Food and Drug Administration
02:40before again returning to being
02:42NCI director in.
02:43We asked her to join us today to give
02:45us an update on the perspectives
02:47from the NCI going forward and
02:50and that obviously will also be
02:52available for questions.
02:53So Ned welcome to Smilow,
02:55at least an Yale on a virtual standpoint
02:58and thank you for doing this.
03:00Well,
03:00thank you for having me.
03:02It's great to be back at Yale at least.
03:05Virtually this is as good as it gets
03:08during the pandemic. I guess I'm
03:10really glad to actually speak today.
03:13I thought I'd take some time to
03:15talk about some NCI ongoing issues,
03:17including the response to the pandemic.
03:20Uh, as well as some new things coming out.
03:23The National Cancer Institute and
03:25a word or two at the end about our.
03:28Our budget and immediate upcoming plans
03:29that I think are relevant to Yale.
03:32My slides around somewhere where
03:34we get the slides up.
03:36Thank you. So next slide please.
03:41So I often start talk like this
03:45by showing everyone where we are
03:48in terms of the NCI budget.
03:51This year is a more complicated
03:55funding year than.
03:57Certainly any I've been involved
03:59with in government because of the
04:01pandemic is really the appropriations
04:03process is always interesting.
04:05This year.
04:05It's a particularly so this slide
04:07shows the NCI Budget since 2013 and
04:10shows a nice increase in funding for
04:12Cancer Research throughout period.
04:14I think this is really a testimony to
04:17the bipartisan support in Congress
04:19for the National Cancer Institute work
04:22we do to try and cancer suffering.
04:24It shows the Orange bar here.
04:27Appearing is the.
04:28Cancer moon shot 20% secures which
04:30is a 1.7 billion dollar package over
04:33seven years and goes beyond 2021
04:35and then also the slim green bar
04:37that appeared in 20 is the childhood
04:39cancer data initiative which we
04:41really just begun was a White House
04:44like priority and it's been a very
04:46exciting initiative to try and
04:48really maximal use cancer data for
04:50benefiting pediatric cancer patients.
04:51Uh 21's house mark so that the the
04:55appropriations package approved
04:56by the house is shown in the light
04:59blue here that includes moon shot
05:01funding and CCD funding,
05:03and the base appropriation for the NCI.
05:05Importantly,
05:06within that funding is 440 million
05:08dollars of so called emergency
05:10funding that the NCI would use
05:12to for pandemic related costs.
05:14You know,
05:15restarting clinical trials and
05:16training costs that have been caused
05:18by disruption of the pandemic.
05:20It is not clear that this.
05:23This package will ever get past
05:24as the Senate has not taken
05:26up appropriations yet.
05:27Now it's very clear we will not have
05:29a federal budget by the beginning
05:31of fiscal year in October 1st,
05:33and we will be in a continuing
05:35resolution for some period.
05:36You know,
05:37funding at the 2020 level until
05:38Congress can pass an appropriations
05:40budget that is not uncommon.
05:42In fact, I think every year,
05:43except maybe two years ago,
05:45we had a CR for some extended period,
05:47so that is certainly how will
05:49be ending this year.
05:50As I mentioned at the end,
05:52I think there is a reason
05:54why the instance I need to.
05:56Continued strong support from Congress
05:58in the funding area because of our
06:01goals to really try and increase
06:02funding the external community,
06:04particularly in the RPG.
06:06Pulled apart of the NCI funding
06:08that pays Ferraro ones in peo ones,
06:11and the investigator initiated
06:12cyantific rains. Next slide, please.
06:16We've seen a lot of media coverage,
06:18you know, and rightly so,
06:20about the pandemics effect on
06:22cancer patients and show I'm going
06:25to show a little bit of that here.
06:27So this is an analysis that was done by
06:30the National Cancer astuces. Net network,
06:33which is a cancer modelling group.
06:35It's both intramural neral within CI and
06:38working rocky for your colleagues working
06:40with scientists at Michigan and Harvard,
06:42sort of estimated the impact of
06:45disruptions to cancer care on
06:47outcomes for breast and colon cancer.
06:50This is where we had sort of the best
06:52modeling available to us and this effort,
06:55which you know we did.
06:56We started several months ago when
06:58early in the pandemic suggested that
07:00we would likely see about on the
07:03order of 1% excess deaths from those
07:04two cancers over a 10 year period,
07:07and there's no reason to believe this is
07:09true solely of breast and colon cancer.
07:12We suspect similar disruptions,
07:13disruptions in care would provide similar
07:15bad outcomes for other kinds of cancer,
07:17and now we know that the assumptions we
07:20built into that modeling effort early on.
07:22We're in fact very conservative,
07:24so we, for example,
07:25estimated only a 75% decrease in
07:27colonoscopy and we now know that that's
07:29been greater than that in many institutions,
07:31and we also estimated only a sort
07:33of six month disruption to care
07:35in terms of new diagnosis.
07:37And we now know that this disruption
07:39is going to last longer than that.
07:41So even using very conservative assumptions,
07:43I think it's likely the pandemic
07:45will have a significant impact on
07:47cancer outcomes for decades to come.
07:49Next slide, please.
07:52And you know,
07:53here's some visuals that Time
07:54magazine crafted around this topic.
07:56And then I, I think,
07:58you know,
07:58has been supplemented not only by
08:00our analysis,
08:01but other other analysis done by other
08:03groups using different kinds of data.
08:05And I think that the message
08:07is really converging to one
08:09where we're going to see you.
08:11It's really a story in four parts,
08:13you'll see decreased screening,
08:15decreased new diagnosis,
08:16deferred care,
08:16and then worsened outcomes in
08:18particular worse than mortality.
08:20And for those of you more interest
08:23in this topic.
08:24This Time magazine setup is
08:25is nice to look at.
08:27We're also worried very much about
08:29the topic of cancer morbidity,
08:31so while mortality has gotten
08:32most of the focus,
08:34we have good reason to believe that
08:35the burden of Kansas symptomatic burden
08:37cancer is also being worsened in
08:40patients with cancer by the pandemic.
08:42For variety of reasons.
08:43And then also the NCS very focused on
08:45the issue of cancer health disparities.
08:47You know why certain populations
08:49have worsened outcomes with cancer,
08:51and we have every reason to believe
08:53that racial disparities in cancer
08:55outcomes that we've long fought against.
08:57DNC I will inform unfortunately
08:59exacerbated by COVID-19 because of its
09:01disproportionate impact on communities
09:03of color communities of color.
09:06So you know, we really.
09:07I think a collectively as a group
09:09of terrific institutions like
09:10Yale working with the NCI and
09:12caregivers throughout the nation.
09:13You have to come together and figure
09:15out ways that we can innovatively
09:17and creatively care for our patients
09:19in a way that's safe that won't
09:21provide risk to the patients or
09:23caregivers for coronavirus infection,
09:24but will also really get back
09:26to work and get patients in for
09:29the care that they need because.
09:31The disruption will be significant,
09:34had a significant impact on our patients.
09:37Next slide, please.
09:40I'd like to also mention a few of
09:42the NCI's activities related to the
09:45pandemic that I think are important.
09:48Whoops,
09:48that wasn't the slightest expecting OK?
09:50Well, let me mention this first that one,
09:52yeah, so this is.
09:55A number of things in CI is done,
09:57so it might not be obvious
09:59why the National Cancer 2.
10:00Was asked by Congress to work
10:02on coronavirus serology.
10:03The National Cancer has a long tradition
10:05of virology research related to cancer.
10:07So for example, uh, as many are aware,
10:10HIV was identified in
10:11National Cancer Institute.
10:12The virus that causes aids,
10:13the first therapeutic for HIV was identified.
10:16The National Cancer Institute.
10:17A lot of the work for HPD was done
10:19in this case for it including the
10:21intellectual property letter that
10:23scene by Doug Lewis and John Schiller.
10:25So we have a strong history of our
10:28research and we still have a very good.
10:31You know,
10:31cutting edge state of the art of
10:33virus serology lab in Frederick
10:34National lab so early in the pandemic.
10:36It was not difficult for the
10:38National Cancer student pivot that
10:39Frederick National Lab Serology
10:41lab to study coronavirus,
10:42which turned out to be very important
10:44for the federal government.
10:45So for example,
10:46we did a number of a lot of
10:48testing for the FDA to decide
10:50what devices would be useful for.
10:53Public health benefit.
10:54So there's a an Congress
10:55appropriated funds to the NCI.
10:57306 million dollars in 2020 for serology,
10:59research and these are monies
11:00that are different from our
11:02usual appropriation for cancer.
11:03It is supplemental emergency funding
11:05solely for strategy research and
11:07that is being used for a number of
11:09purposes and areas of research related
11:11to virology and Sorolla G that are
11:13exciting and will be making a lot
11:15more announcements about that shortly.
11:17We've also started this in catch study.
11:19This code in cancer patients
11:21study that is enrolling at.
11:23Over is now 700 sites nationally
11:24and is really trying to look at
11:27the Natural History printed virus
11:28infection in patients with cancer.
11:30We even issued a raft of
11:32guidances for cancer trials,
11:33allowing things like shipping medicines
11:35through the Mail instead of requiring
11:37patients to the hospital pick him up,
11:39allowing consenting by phone for example,
11:41that we were discussing earlier and
11:43and I think these are flexibility
11:45zarine clicker trials that we developed
11:47with the FDA in many instances
11:49have been really popular with the
11:51investigators have told us they like these
11:54these new clinical trials changes and.
11:56They don't want to go back to the old days.
11:59We've recreated a number of
12:01flexibility for grantees,
12:02probably most importantly
12:03around the issue of carryover.
12:04So if scientists are unable to spend
12:06$2020.00 in this fiscal year because
12:08their lab is closed or research is paused,
12:11we're allowing them in most instances
12:13to carry those funds over 21 so
12:15that they can be used in a manner
12:17that still beneficial for science.
12:19We've also allowed some repurposing
12:21of funds and some extensions of
12:23deadlines and things like that,
12:24so we've tried to bend over backwards to
12:27accommodate the problems for search the
12:29pandemics caused for basic scientists.
12:31And then we had a lot of other stuff.
12:33Includes some Genomic studies around
12:34COVID-19 that are interesting in the whole
12:36package is described at this website,
12:38showed at the bottom.
12:39For those of you who are further
12:40interested in this topic,
12:42next slide please.
12:44I want to say a word more
12:46about the Sorolla G work,
12:47so one of the things we have created is
12:49this network for serological research
12:51that is going to be called Sirnet.
12:53The grants and contracts that will
12:55stand this up will be announced
12:57in the next few weeks.
12:59This will include it's a hub and spoke model,
13:01so it will include coordinating
13:02center at the NCI run through
13:04Frederick National Lab to coordinate
13:06research nationally on these topics
13:08and I think what's exciting about
13:09this is it's a great lot of great
13:12basic science related to immunity.
13:13Environ viral responses.
13:14But I think it will also have a basic
13:16science efforts that will translate it
13:18into understanding how save the innate
13:20immune system works in cancer and and
13:22new ways of treating cancer patients.
13:24Three antibody based therapies for example.
13:26So I think it's a very interesting network.
13:28It was really an amazing amount
13:30of administrative effort to
13:31stand this up so quickly,
13:32and I think real testimony
13:34to the professionals at the
13:35National Cancer is do too good.
13:37You know,
13:38despite the difficulties
13:39of Tele work and what not,
13:40have been able to kind of keep
13:42work apace and even take on really
13:45exciting new efforts like this.
13:46Next slide,
13:47please.
13:49So as as mentioned, uh in cap study
13:52includes this enrollment at Minisites,
13:54it's being done through the NCTN and in
13:56court networks and will now soon allow
13:59for the enrollment of pediatric patients.
14:01And I think this will be useful for a
14:04number of purposes, but importantly,
14:06this is a real clinical trial
14:08that involves consent in Lanja.
14:10Tude will follow up and Biospecimen
14:12Collection and it will allow us to
14:15really look at a number of biomarkers
14:17to see if we can find the ones that.
14:20Predict outcome in this population
14:21and I think the study will also
14:23be useful to look at the long term
14:25sequelae of kovid infection.
14:27Something we're seeing a lot more data
14:29emerge on right now and it is concerning
14:31a set of studies that many patients are
14:33having a neurological and Cardi map,
14:35neurological Square,
14:36Lion Cardiomyopathy in other issues
14:37that persist post kovid infection,
14:39and I think this study will be
14:41a nice study to look at that in
14:43a cancer population as well.
14:45A next slide please.
14:47I wanted to briefly talk about
14:49clinical trials accrual,
14:50so this is data for the national
14:53clinical trials network.
14:54The NCT in I believe this is phase
14:56two and phase three trials in
14:58the in CTN bye week.
15:00And so you see,
15:01you know prior to the pandemic in February,
15:03the NCT in accrued about 300 patients
15:05week or in those sorts of trials and then
15:08seeing accrued on that level and then
15:11when the pandemic really got started.
15:13That accrual was cut in half
15:14down to 1:50 at its nadir,
15:16and now is slowly starting to
15:18catch back up and is returning.
15:20You know mostly back to normal,
15:23but we're not fully there yet.
15:25You know this is obviously
15:27very concerning for the eye,
15:29clinic trials were really the way
15:31we make new advances for patients
15:33with cancer and accrual accrual
15:35declines markedly than that extends
15:37the period for which the trial
15:39has to be conducted and is is both
15:42expensive and delays cancer progress.
15:44So we are, I think,
15:46bound as stewards of federal monies
15:48to consider the impact of these.
15:51To make the decreases in a cruel to
15:53some of our larger ongoing trials.
15:56To really see if they can, you know,
15:59address the endpoints they were
16:00designed to meet.
16:02Given the struggles of pandemic is caused,
16:04and so we're.
16:06In fact,
16:07standing up a working group to the
16:09clinical Trials Research Advisory
16:11Committee seatac to look in particular
16:13at large prevention and screening
16:15trials to see if those are going to
16:17work the way we initially envisioned.
16:19Pre pandemic.
16:21Next slide.
16:22Ah,
16:23it you know,
16:24if there is a silver lining to the pandemic,
16:27it really has been to me.
16:29To my mind you one of the most important
16:32has been the rapid adoption of Tele Health,
16:35and this is clearly a boon for
16:37patients to have an option that's
16:39more convenient than an office visit,
16:41and this remarkable rapid uptake
16:43really does present an important
16:44research opportunity for
16:45Health Services researchers.
16:47I've been telling people that
16:48you're an implementation scientist.
16:50Your moment has arrived because an
16:52experiment this size of this rapidity.
16:54National scale,
16:55you know it's never likely to occur again.
16:57There's a really interesting report
16:59from Memorial Sloan Kettering
17:00about rapidly pivoting to provide
17:02tobacco treatment for patients
17:04with cancer via Tele health,
17:05including a look at patient engagement
17:07as measured by attendance rates for
17:09in person counseling versus remote
17:11Tele health counseling visits,
17:12and they look at the how much the
17:15patients in the clinicians and
17:16healthcare systems benefit from this
17:19Tele health and also the challenges
17:21encountered in such a rapid expansion.
17:23And this particular effort was
17:25supported by cancer syphilis Cancer
17:28Center supplement for tobacco
17:29cessation under the cancer moon shot
17:32and I know Yale has received such
17:34supplements as well for cessation.
17:36Ann,
17:36I think is really led to some important
17:39studies through application program.
17:41Next slide,
17:41I'd like to talk briefly about
17:44some non kovid stuff.
17:45So one really important report
17:48that was really gratifying to
17:50see came out a few weeks ago in
17:52the new internal medicine from.
17:54This is net,
17:55researchers in NCI working with
17:57Harvard in Michigan to look at lung
18:00cancer mortality and we already
18:02knew from other lung cancer.
18:04Mortality studies and reports like
18:05the annual report to the nation
18:08on status of cancer that lung
18:10cancer mortality and incidence
18:11had been declining United States.
18:13For decades,
18:14but you know this analysis really
18:16try to understand why that was
18:18happening and in particular,
18:20why in the last few years mortality
18:22for lung cancer and also Melanoma
18:25has been declining faster than
18:27incidence declines.
18:28And in both instances,
18:29based on this sort of analysis,
18:32we believe that treatment is now paying
18:34playing an ever larger effect on
18:37national population level statistics.
18:39So there's this background of decreasing
18:41incidence attributable to smoking cessation,
18:43but on top of that,
18:45new therapies for lung cancer,
18:47particularly through this period,
18:49surgery, radiation,
18:50chemotherapy,
18:50and kinase inhibitors seem
18:52to be very important.
18:54This analysis only went through
18:562016 and therefore antedates most
18:58of the adoption of immunotherapy.
19:00For lung cancer,
19:01and I think that's good news because
19:03I think the effects we've seen on
19:06treatment with those of modalities
19:07alone you know they're going to be
19:09even greater and and more beneficial
19:11as immunotherapy permeates through the
19:13national mortality statistics as well.
19:14And and that's not even to
19:16mention lung cancer screening,
19:17which I think is also an opportunity
19:20for doing better in this disease.
19:22In this study,
19:23they using a novel analytic technique.
19:25The investigators were able to look
19:27at non small cell lung cancer where
19:29there's been market improvement
19:30in mortality the last few years
19:32as well as small cell lung cancer
19:34where there's been virtually no
19:35improvement in survival or mortality.
19:37And I really,
19:37really makes the point that we
19:39still have a long way to go in
19:41that very terrible cancer.
19:43Next slide,
19:44please.
19:45Hi,
19:45I think some of you may be aware we
19:48recently launched a major new partnership
19:50with Cancer Research UK to fund a
19:53multidisciplinary global teams to take
19:55on some of cancers toughest challenges.
19:57This is the cancer grand
19:59challenges initiative.
20:00The approach here is to really sort
20:02of build on the history we have with
20:05team science through peo ones and
20:07Spores and those kinds of mechanisms,
20:10and then try and expand that team
20:12science model even greater to a
20:14greater degree internationally.
20:15And the challenges are framed as questions
20:18that are created by an expert panel,
20:20and these are questions that are really
20:22limiting our progress in Cancer Research
20:25and then we invite multidisciplinary
20:27and international teams to propose very
20:29ambitious grand projects to tackle them.
20:31CR UK has been doing a program
20:33structures way for a few years and as
20:35you are probably aware the NCI is had
20:38its provocative questions initiative,
20:39and so the what's new is initial partnership.
20:42Will kind of merge those two initiatives in
20:44a way to to involve both the NCI and CR UK.
20:48Importantly,
20:48this uses funding from the Cancer
20:50Research provocative questions
20:51program every other year,
20:52so in even years or whatever will
20:54have the peak use and in the out years
20:57will have cranberry and challenges.
20:59So this is budget neutral from the NCI
21:01is not taking funds away from other
21:04initiatives it is allowing us to.
21:06Try this in addition to the Baraka
21:08question program and I see this
21:10as a way to really encourage and
21:12support high risk innovative Cancer
21:14Research projects on a large scale.
21:16And in this well, as I said,
21:19not supplant science in the important
21:21investigator initiated portfolio
21:23that is also a need for the NCI.
21:25Next slide,
21:27please.
21:28When we talk about challenges of
21:30overcoming barriers,
21:31one issue stands out and certainly
21:33the national level and that is issued
21:35promoting equity inclusion in our
21:37society and within the NCI in particular.
21:39Cancer Research really can't solve
21:41an issue like systemic racism
21:43and injustice alone,
21:44but I think the I can look at our
21:46work as individuals in his community
21:48and commit to trying to take actions
21:51to make things better where we can.
21:53And you know,
21:54as we thought about this and had a lot
21:57of internal conversations, the NCI.
21:59We've sort of come on to the idea
22:01that there are three broad aspects
22:03of our work that really bear
22:05afresh assessment and new action,
22:07and we're creating very substantial
22:09internal effort in a committee structure
22:11to sort of work on each of these in.
22:14This includes an equity account,
22:16so that serves as a sort of steering
22:18committee and then working groups to
22:20address the topics of cancer disparities,
22:22research workforce diversity,
22:23and then the culture within the
22:26NCI to make sure that we are a
22:28good and welcoming place that.
22:30Promotes and welcomes diversity.
22:31I chair the equity account stolen.
22:33I'm really taking a lot of time
22:35listening to leaders and staff across
22:37the working groups and the Institute.
22:40So I understand both internally and
22:42externally you're the experiences
22:43of racial injustice and its impact
22:45on Cancer Research in cancer care.
22:46And I, I think really now is the
22:48time to do this to take meaningful
22:50action to effect positive change.
22:52I'm sure you know Yale is facing
22:54these issues like every institution
22:56in the country right now,
22:57and I think it's really interesting
22:59discussion how different institutions
23:01are trying to do their part here.
23:02One thing that has been gratifying about
23:05this is that this is an area where the
23:07NCI is 100%, institution is behind.
23:09I mean, there's a.
23:10Uniform enthusiasm and zeal across
23:12National Cancer to try and make
23:14progress in each of these areas.
23:16Next slide please.
23:19I'd like to highlight A2 a quick
23:21items related to data science,
23:22so the cancer search data Commons,
23:24maybe something that some of
23:26you have heard about.
23:27It's an initiative VNC I've been
23:29working on for a long time and that is
23:31to kind of create a one stop shopping
23:33for all our desperate cancer datasets.
23:36So things like the cancer genome Atlas
23:38in the Genomic Data Commons and target,
23:40which is the pediatric version of
23:42the cancer genome Atlas and Seatac,
23:44which is a proteomic and integrated data set,
23:46and the newest node shown here is
23:48the integrated canine data Commons.
23:50Some of us believe that companion
23:52animals serve a useful.
23:53Cancer model that's in between rodent
23:55models and human clinical trials,
23:56and so we think collecting Genomic
23:58and clinical data from a veterinary
24:01you know K9 trials is a valuable
24:03data set as well,
24:04and so we really built out the hard drives.
24:07The RDC now to start handling these
24:09disparate datasets and allowing
24:10them to be linked and searched
24:12in a way across the mall.
24:14And so we have a standard data
24:16model now called the kfor.
24:18The harmonizing data across the CDC.
24:20Rather the repository's and also we
24:22are working diligently on a tool.
24:25Here to help researchers query data
24:27across these various repository's
24:29and lead to multi modal analysis.
24:30There's a new video on the topic that
24:34is available on the website on the
24:37Cancer Research data Commons and.
24:39As mentioned,
24:40we have recently added the canine
24:42data comments just in time for
24:44International Dog Day and shown here.
24:46By the way,
24:47is as my dog who is now an Internet
24:50sensation thanks to mojo thanks to the
24:53cancer letter, let's see next slide,
24:56please.
24:56Uh, uh,
24:57this is a really great new development,
25:01so coming very soon.
25:02State of the art tumor infiltrating
25:04lymphocyte production facility to
25:06support Steve Rosenberg's work.
25:08Steve, for many years,
25:09has done these trials and the
25:11intrinsic internal program with
25:12really spectacular results in
25:14patients with solid tumors.
25:15But capacity has been limiting,
25:17and so now with this new till facility,
25:19we will have a major increase
25:21in our capacity.
25:22Allow us to do more patients and
25:24do real research in this area if
25:26you know how to make the cells
25:28and various scientific questions
25:29that can be addressed with
25:31this technology.
25:32This is also matched with a new
25:34effort of Frederick National Lab
25:36to make car T cells for usage.
25:38With Intramurally at the NCI as well
25:40as Extramurally and consortia trials.
25:42And that facility is now open and we
25:45have aspirations of creating a vector
25:46facility up there as well to provide
25:49vector for Carty in other kinds of
25:51cellular therapy trials nationally.
25:53So a lot going on in cellular
25:56immunotherapy both inside the NCI
25:58and extramurally next slide please.
26:00I'd like to highlight a few uh,
26:02items from the annual plan
26:04and budget proposals,
26:05so I think many of you are probably
26:07aware the National Cancer Institute,
26:09because the National Cancer Act is
26:11has a special ability to provide a
26:14bypass budget to directly to Congress
26:16and the White House by passing some
26:18of the usual process every year.
26:20And it's done for the next next fiscal year.
26:23So in this case is 2022,
26:25and we use that opportunity to
26:27talk about some opportunities
26:28in Cancer Research as well as.
26:30You know budgetary priorities
26:32going into the future,
26:33and you know this year we
26:37talked special specifically.
26:38I already's like drug resistance
26:41and Molecular Diagnostics for
26:43cancer treatments and the role.
26:45Sure,
26:45and the topic of cancer survivorship
26:47and and really focus opportunities
26:49in those areas. Next slide.
26:51But from my perspective,
26:52here is probably the most
26:54important graphic in the plan,
26:56and that's looking at the dollar amounts
26:58that I showed before of the NCI budget.
27:01But now in relation to the RPG pool,
27:04which is a set,
27:05is the pool funds that funds are ones
27:07and peo ones an investigator initiated
27:10awards that are familiar to scientists,
27:12Yale and it shows the pay lines of those.
27:16You know one of those grant
27:18mechanisms dro one mechanism,
27:19which is a good proxy for pay lines in
27:22general at the NCI starting in 2013.
27:24And it really makes clear are for
27:26explicit goal of the National Cancer
27:28Institute of reaching up a line
27:30of the 15th percentile by 2025,
27:32or this 15 by 25 plan.
27:34Please note the left Y axis that
27:36it shows dollars.
27:37The amount of funding needed to
27:39increase to really get pay lines up
27:42from the 8% they were in 2019 after
27:44the 15% to which we aspire in 2020 alone.
27:47That's on the order of 200 million dollars.
27:50That was the increase this
27:51fiscal year to the RPG pool.
27:53To go from 8th percentile to 10th percentile.
27:56For comparison,
27:57the entire cancers Jenner program,
27:58which is one of the most popular things,
28:00and I would argue one of the best
28:02things the NC ideas and certainly
28:04is not an area where many people
28:06have complained that the cancer
28:07program is over resourced,
28:09but the entire budget of the
28:10cancer program is $300.00,
28:11so this is really kind of creating
28:13a program of that size every year
28:15for a few years to get pay lines up.
28:18That's how expensive the RPG pool
28:19is to get a
28:20lines up to the area where we need them to
28:23be, but I think this is really important.
28:26Welcoming career for junior scientist Abdon.
28:28Come to Cancer Research and see 8% pay lines.
28:30I think that we will lose key scientists,
28:33other fields and I think it's
28:35really just very hard to run a lab.
28:37You know with that sort of
28:39uncertainty around funding.
28:39And so I think that getting RPG
28:41funding up is really important.
28:43There is no way to do this just by taking
28:46monies from other parts of the NCI and
28:48spending more in the RPG pull that.
28:50That will not work because of
28:52the amounts of money needed.
28:53So really the only way we will
28:55be able to match this goal.
28:57Highly aspirational goals with
28:59some support from Congress.
29:00But as I showed,
29:01the good news is the Congress
29:03has been very supportive of the
29:04eye of the last few years,
29:06and hopefully that strong
29:07bipartisan support will continue.
29:09Next slide, please.
29:10And Lastly,
29:11I just won't wrap up by mentioning
29:14the 2021 is the 50th anniversary
29:16of the National Cancer Act.
29:19This legislation did not create
29:21the National Cancer Institute,
29:22but it did authorize a number of programs
29:25that really now form the backbone of
29:28the National Cancer research effort.
29:30This includes things like the seer program,
29:33the Epidemiology program includes
29:35the cancer centers program.
29:36It includes Frederick National Lab,
29:38where the nations national
29:40applicants research.
29:41It made the NCI director presidential
29:42appointee and created the
29:44National Cancer Advisory Board.
29:45You know,
29:45the NCA really did a number of very
29:47important and critical things for Cancer
29:49Research and the 50th anniversary
29:51of this is really worth celebrating.
29:53You know,
29:53we can talk about our progress
29:55over the last five decades,
29:57but as I see as I see it,
29:59what's more important?
30:00What the National Cancer act provided
30:02in terms of Cancer Research was what
30:04it meant to patients back then.
30:06In a world where cancer at that time was
30:08still something that no one talked about,
30:11it was a diagnosis that you
30:12spoke up in whispers and the axe,
30:14you know,
30:15led by Mary Lasker and others
30:17really drew the nation's attention
30:18not just to the tragedy of cancer,
30:20but the hope of research.
30:22And that hope is not limited to cancer.
30:24Francis Collins calls the NIH
30:26the National Institute.
30:26Hope I'm sure many of you have
30:29heard him call it that.
30:30And I think you know during
30:32this difficult period,
30:33hope is is something we could all
30:35use a bit more of and and I think
30:38that the NCA really started us down
30:40this very important path to turn
30:42cancer from a scene is sort of a
30:44death sentence to a hopeful disease
30:46where we were making this since
30:48we're making really a lot of progress,
30:50although we still have importantly
30:52a ways to go,
30:53it is an area where one can certainly hope.
30:58Next slide please.
30:59So those are my remarks for today.
31:01I you know I want to thank you all for
31:04coming and listening and letting me wax on.
31:07I also want to thank the scientists
31:09and clinicians of Yale for their
31:11efforts during the pandemic.
31:13I know this has not been
31:14an easy period for anyone,
31:16but I think you know it's really
31:19the efforts of great doctors and
31:21scientists at a place like Yale
31:23that have made this less bad for
31:25our patients than it had to be.
31:27So I'm very appreciative.
31:28Efforts and you know, as I said,
31:30the NCI is very eager to help
31:32out in ways if we're able.
31:34So thank you, thank you.
31:36That was a
31:37fabulous update and I invite our
31:40colleagues to submit questions
31:41either on the chat or Q&A Lines,
31:44but while folks who are
31:46submitting their questions,
31:47let me ask a few things.
31:49First, I know you you recently offered.
31:52What are the sort of initiatives are
31:55priorities for the coming budget,
31:57and I wonder,
31:58I wonder if you wanted to share
32:01some of that and elaborate on it.
32:05Sure, I think.
32:09You're just going with the
32:10bypass budget here, so that is.
32:12We we highlighted a few scientific areas,
32:15for example obesity and cancer,
32:17or cancer resistance to therapy.
32:20But I think it's an interesting story.
32:22How best to use the bypass budget
32:24in the NCI's waiver due at one
32:27point one 500 Page document and
32:29now it's down to a slim pamphlet.
32:31But I, my belief is it's most
32:33effective as a means to talk to
32:35Congress about a limited number of
32:37issues that are very important in
32:39CI and the one that I think we've
32:41highlighted this year for sure,
32:43and this too a little bit last year.
32:47The lines because Congress
32:48just heard about that.
32:50So a number of scientists and
32:52particularly number of people from
32:54the Cancer Center Program have gone
32:56on the Hill and explained that,
32:58you know, eight percentile is
33:00just no way to run science,
33:02and the reason our pay lines have
33:05been solo in fairness isn't that
33:07we're not eager to fund such grants.
33:10It's that we've been inundated with the
33:12number of applications to the National
33:15Cancer suit has rapidly increased.
33:17We've gotten.
33:17Bigger, increase the number inside and
33:19the rest of the United combined right?
33:22So Cancer Research is hot,
33:23it's what.
33:24It's it's where it's at and mini
33:26basic scientists now want to come
33:28into Cancer Research for sending
33:30us new applications for funding.
33:31And that's a real opportunity.
33:33I certainly don't think the
33:35NCI is interesting,
33:36discouraging the scientists and saying,
33:37well, you can write a grant,
33:39but you have no chance of getting funding.
33:42I think we really have to realize that
33:44this moment there's a reason why everyone
33:47is is considering case researchers clear.
33:49And sending us grants and we
33:51have to take advantage of this
33:52opportunity and trying to fund it
33:54as many of those as we can,
33:56and in particular for early career
33:57scientists and and by the way that that
34:00pay line is for established investigators.
34:01The pay line for early stage
34:03investigators is a bit higher.
34:04It's on the order of 5% higher than
34:06whatever the RO one pay line is.
34:08So 8 to 13 or something.
34:10But that's still pretty low
34:11for a new investigator,
34:12and so we need that number
34:14to be higher as well.
34:15To really make a cancer a
34:17welcoming career for early stage
34:18an established investigators.
34:20Yeah, thank you. So then Demayo,
34:22who's our deputy director for the L
34:25Kansas Center, asked the following,
34:27which is could you comment on the NCI
34:30commitment and plans for the PO1 grants?
34:34One is an interesting thing.
34:36So First off, there's a bit of data the
34:39National Cancer has done an analysis of,
34:42you know, sort of the.
34:44Research productivity by dollar
34:46for various mechanisms and you
34:48know the finding is that by some
34:50metrics at least the peo one.
34:52Maybe the best way to spend
34:54the science dollar at the NCI.
34:56It's highly effective in terms of
34:58leading to publications and new funding
35:00and clinical trials, for example.
35:02And so and I think I I that
35:04result feels right to me.
35:06I had a PO1 at one time and you
35:08know it was a self assembled
35:11group of scientists that had a
35:13similar research interests and.
35:15Synergy research efforts and we also were
35:17a little competitive with each other.
35:18Nobody wanted to let the team
35:20down and we all wanted to publish
35:22and make advances and share our
35:24science with each other.
35:25So it worked because they
35:26you know it was it was.
35:28It was self initiated in self assembled
35:30and really not not by disease or by
35:32center or some of the other criteria
35:34that are used to create research teams.
35:36But really driven by cyantific you know.
35:39Shared interests,
35:40and so I think the pier one is a
35:42successful mechanism and one at the
35:44NCI should try and fund against
35:46that backdrop for a bunch of strange
35:48reasons that I don't totally understand.
35:50The number of people once submitted,
35:52the NCI went down strikingly up
35:53until about 2017, so there was,
35:55I think, word had gotten out.
35:57They become very hard to get.
35:59They were, you know,
36:00there are a lot of work to put together
36:02and I think for variety of reasons,
36:05investigators sort of decided they were
36:07going to go on to multi PR ones or
36:10spores or some other mechanism and so we.
36:12We saw a decreased in peo and
36:14applications and the NCI didn't like that.
36:16I mean we think this is an important
36:18mechanism and enter the last few years
36:21we've been trying to encourage that
36:22pool to come back by funding more of
36:25them by putting more money into the
36:27PO1 pool through within the RPG pool,
36:29tapio ones or one part of that.
36:31But also by talking about this.
36:33You know,
36:33we've been very Frank that we think
36:35there are a lot of great people.
36:37One ideas that we need to get
36:39and then most recently creating
36:41even a supplement program.
36:42We had this for cancer supplements
36:44to try and really incentivize the
36:46cancer centers to put together
36:48some peo one teams to apply.
36:50Some of those efforts may lead to
36:52other kinds of team science like spores
36:54or maybe Cancer Research challenges.
36:56Or that's fine.
36:57You know they don't have to turn into ones,
37:00but I do think that that model of team
37:03science is successful on something
37:04the NCI wants to support, so I.
37:07I hope my comments will encourage
37:09any of you thinking about writing
37:11a video one to do that.
37:12The the the chance of getting one of those
37:15is not bad now compared to the other parts
37:17of the RPG Bowl mean it's not easy to
37:20get any grant from the eye to be honest.
37:22But the peo ones are really no
37:24more difficult than Nuoro ones.
37:25For example, and and you know it
37:27is an area in the NC I would like
37:30to see more applications.
37:31Well, now that's
37:32music to our ears and I think the reason Dan
37:36asked that question is we recently started.
37:39I actually alluded to it.
37:41A pilot program of team science.
37:43Yeah, where we provide about
37:45$150,000 in pilot funds to teams
37:47with the goal that they wouldn't,
37:49you know, submit appeal,
37:51wanna you grant us four so
37:53really thrilled to hear that.
37:55'cause I know a number of investigators
37:57are interested and you're absolutely right.
38:00I think the rumors.
38:01Of the period of the death of
38:03the PO1 program were probably
38:05there are these spirax C theories
38:06that we did like it or something.
38:08You know that that is not true.
38:10And when I started it is NCI director.
38:122017 I heard a lot about this.
38:14You know people have pulled
38:15me aside and meetings and say,
38:16why did you guys kill off the pier one?
38:19I will say I think the idea of some
38:21institutional funds like you described
38:22is really good idea because you can
38:24be competitive with like a fake team.
38:26You have to have a real team that's
38:28worked together that has some shared data
38:29and so there is some sort of investment
38:31costs to get these things off the ground.
38:33And that's.
38:34Also, behind the supplement program,
38:36recreated it,
38:36Ryan catalyzed some of these teams,
38:38but I think institutions
38:39like Yale they're able to
38:41do that will really have an advantage.
38:43Yeah, thank you Roy Herps fellow
38:45alumn from the Dana Farber and
38:47our chief Medical College.
38:48He actually offered a few questions
38:50but just related to the topic
38:52we discussed at Roys asking,
38:54do you envision peo ones
38:56mostly on basic science,
38:57or could they also be
38:58clinically focused, including
38:59incorporating a clinical trial, right?
39:01I can get really specific issues that
39:03some of our mechanisms are clinical trial.
39:06Not allowed. Obviously, dysport program
39:09is all about clinical trials and so,
39:11but you know whether or not appear.
39:13One could include in one of the parts of it.
39:16A clinical trial would be a
39:17question for our grants office,
39:19and anyone who has such a question
39:21can email me and I could forward them
39:23to the right person or Ordina singer,
39:25I think, would be very helpful too,
39:27but we could get you an answer if
39:30it's a specific around a trial.
39:33I will say that all the divisions at
39:35the NCI can fund people one so they
39:37don't have to come from the basic
39:40science division of these CB decd,
39:42the clinical trials division does
39:43fund peo ones as well, and there's.
39:47You know,
39:48certainly lot of great clinical science
39:50can be funded through the PO1 mechanism,
39:53but whether or not ORF are specific
39:56funding announcement related people ones
39:58allows clinical trials is the question I.
40:00After you get advice from from
40:03Adino in and then
40:05Roy follows up with the other questions,
40:08particularly and congratulations
40:09on the any engine,
40:11any any JM paper wants to know.
40:14What do you see is the potential
40:17for immunotherapy in the next few
40:19years further improve these outcomes
40:22and then on a related note.
40:26You know, as we seek biomarkers
40:28in better combinations,
40:29how do you see the role of public
40:31private partnerships in mass?
40:35Yeah, so two really interesting topics.
40:37You know, I I think we specifically
40:39looked at the potential impact of
40:42immunotherapy on those data and
40:44and came to the conclusion that it
40:47really isn't in the data by 2016 that
40:50the the dramatic effects of immuno
40:52oncology drugs in non small cell lung
40:54cancer seen in well designed phase.
40:57Three trials hasn't circulated into
40:59the population level data yet,
41:01so that should happen in 2017 eighteen 1920.
41:04In the next few years,
41:06we should continue to see a decline
41:08in mortality that exceeds the
41:10decline in incidents.
41:11The way that really happened for Melanoma.
41:13It's still happening for Melanoma,
41:15but for Melanoma was very evident
41:17a few years before was evident for
41:19non small cell and is actually one
41:21of the rationales for this analysis.
41:24So we think that population
41:25statistics should improve,
41:26continue to improve for a few more years,
41:29hopefully for many more years.
41:31The problem is never quite easy to say,
41:33why they're there.
41:34In Fairness,
41:35the NCI is described a lot of this treatment,
41:37but some of our critics have not.
41:39You know there are other
41:42potential explanations.
41:43It was really knows.
41:44Screening really hasn't made
41:45it in lung cancer.
41:46The extent we would like it,
41:48it's unlikely that screening other
41:50screening is certainly useful on
41:52cancer for specific populations based
41:53on Packers smoking and then see I
41:55would like to see more screening occur.
41:57I don't think that's the explanation.
41:59You can come up with more complicated
42:01models about tobacco associated
42:02cancers having a different
42:03prognosis for not backing it.
42:05So whatever,
42:05but I think the most parsimonious simple
42:07model is just the treatment starting to work.
42:09You know this is not in breast cancer
42:11sisnett that is similar analysis
42:12included with the majority of the benefit
42:14breast cancer mortality of the last
42:16few decades is not due to mammography.
42:18That's significant and important,
42:19but the majority of the benefit is
42:21actually related to treatment as well.
42:22So I think it's consistent with diseases,
42:24but we'll have to see how the day to go.
42:27But hopefully, you know,
42:29but why you know,
42:30really,
42:30the major paradigm shift in my
42:32lifetime is an ecologist has been
42:33treating like all lung cancers.
42:35One thing so you know,
42:3720 or 100 different diseases and
42:38having a good therapy for all of them,
42:41and you know we have written any.
42:43We have 9 new drugs in lung cancer.
42:45I think approved this year.
42:47You know Ret Inhibitors and you know,
42:49new alcohol for example.
42:50So I I think lung cancer is very exciting.
42:53And screening plus new therapies could
42:55really impact outcomes in that disease
42:57are channels and ash Cancer Institute.
42:58You know,
42:59it's almost amazing that I've never
43:01thought I'd be saying this 10 years ago,
43:03but our challenge now is to try
43:05and make other diseases as hopeful
43:07as non small cell lung cancer.
43:09You know we don't have such a
43:10great story for small cell lung
43:12cancer or pancreatic cancer,
43:13biliary cancer etc etc.
43:15So you know, I, I think this serves
43:17as a nice tale of wind science works.
43:19It can really work,
43:20but how do we do that in legacies?
43:23And then the question about public
43:25private partnerships is, you know,
43:26interesting important topic at the NCI
43:28is a big believer in these partnerships.
43:30They have been very effective
43:32way to allow private resources
43:34to support trials in the NCI.
43:35Also thinks is laudable and you
43:38know a great example right now as
43:40well as in the lung map trial that
43:43allows you know second line therapy.
43:45You know working with Pharma sponsors
43:48and also NIH and France research,
43:50and I think that.
43:53At successful effort could
43:55be useful in other models.
43:56Public private partnerships do have some
43:58challenges to initiate and maintain,
44:00and certainly doctor hurts more familiar
44:02with the most with those issues,
44:04but I think that they can really work.
44:07The one that I'm very excited about right
44:10now is this thing called impact initiative,
44:13which is created.
44:14These four simak sites through moon
44:16shot funding and then it's got an
44:18additional funding from Pharma companies
44:20to the tune of about $60,000,000 and
44:22is using those funds to really study.
44:25In its standardized way,
44:26various biomarkers of response
44:28stimulant cology drugs,
44:29so site off and next generation
44:30sequencing and RNA expression profiling,
44:32and importantly,
44:32they've committed to make the
44:34data reproducible across sites.
44:35So if it works at once iMac,
44:37the asset can be done another place
44:39so it's really industry grade data
44:41and many of the trials that have
44:43been studied initially or in CI
44:45trials where we have, you know,
44:47the clinical trials outcomes data,
44:48but we also will be doing more and
44:50more of the pharma sponsored trials as
44:53they supply the materials, so I think.
44:55You know, these initiatives can be great,
44:58and they are certainly worth
45:00it in some instances,
45:01but you know they also have.
45:04A whole set of challenges regarding
45:06their setting them up and keep it going.
45:09Thank you and by the way,
45:12Roy adds that your dog is impressive.
45:14Yes, thank you, so Kevin Vest,
45:17who's our deputy director
45:18for administrations finance,
45:19actually asked about Cancer
45:21Center support grants,
45:22and I think he, you know,
45:24with regards to growing the RPG pool,
45:27he asked about specifically about
45:29any change in the terms of size,
45:31rewards or number of institutions,
45:33but I guess I'll ask because, you know,
45:36when both hats you've you've led a.
45:39A major Cancer Center at the same
45:41time you've run the NCI and sort
45:44of what's your perspective on CCS?
45:46GSN you obviously regarding
45:47Kevin's question and just
45:48sort of a larger vision for
45:50that. Yeah I think.
45:53You know that the cancer program
45:54is Unitarian, created by the
45:56National Cancer Act, an it was.
45:57It's probably in my mind,
45:59the most important part of
46:00the National Cancer Act.
46:01I mean, you know the cancer program has
46:03been so successful and one of the theories,
46:05by the way for why we see this
46:07massive influx in Cancer Research and
46:09all these new grants is the Cancer
46:11Center program is a lot of these
46:13people are affiliated with cancers.
46:14Institutions are being told by the
46:16director of smitten CI grain so
46:17that it may be as simple as that,
46:19but it works.
46:20You know,
46:20it's really driven people to
46:22the field is created at this.
46:23A shared infrastructure.
46:24It's provided a great source of
46:27advice and counsel for the NCI,
46:28and it's a very effective program.
46:30And importantly,
46:31it's probably from a cost point of view.
46:34The most efficient dollar we spend
46:36because every dollar we give to
46:38a cancer separate center it is
46:40typically leveraged by state
46:41and philanthropic monies and the
46:43extreme example here in Oklahoma,
46:45the Oklahoma Cancer Center raised on
46:47the order 400 million dollars from
46:49the state and philanthropy over 17
46:51years to build this gorgeous new hospital.
46:54Recruit a bunch of faculty and create
46:56a national program so that they get
46:58in CI designation so it's all so
47:00they can get the CSG Grant which is
47:02on the order of a few $1,000,000
47:04a year so you know it's a great.
47:06It's a great deal for the NCI
47:08and I often wonder why the other
47:10institutes don't do this.
47:11You know why doesn't everybody at
47:13the United have a Cancer Center
47:14program like this?
47:15You know,
47:16other institutes certainly have
47:17center programs,
47:18but they're more sort of P / 1 size.
47:20They don't have the cachet and
47:22half of the NCI CSP program.
47:24And I think the secret for us really
47:26is this this designation by Congress.
47:27You know,
47:28having this stood up in the National
47:30Cancer Act and having it be seen as
47:31a metric for being a great hospital,
47:33has been very favorable to
47:34the National Cancer Center.
47:35So, given that it's such a success,
47:37there are couple of things.
47:38So First off, is it the right size you know?
47:41Shouldn't be the program be
47:42increased or shrunk or whatever?
47:44From a budgetary POV,
47:45there was an analysis of the
47:47funding of the cancer centers
47:48that went for a few years.
47:50Is starting back in the Harold Varmus Terra,
47:53and the conclusion was that the
47:55Cancer Center funding is not uniform,
47:57that we need to.
47:58Could you could tie research
47:59productivity to funding in a
48:01better way and led to this new
48:02funding model that was rolled
48:04out now I think three years ago.
48:05And with the way it works is whenever
48:08anybody comes in for renewal,
48:10there grant gets modified such that
48:11they can typically get an increase in
48:13funding related research productivity,
48:15and it seems to be working
48:16pretty well in most
48:17instances. Most places budgets are going up,
48:19so that's meant for the last couple of years.
48:22The cancer program has grown because of
48:24implementation of this new model based on
48:26renewals of CSG grants and it's growing
48:28faster than the rest of the NCI budget,
48:30but certainly not grown in the way that the
48:33RPG pool would have to grow to get us to the
48:3615th percentile that are described later.
48:38As I mentioned, you know 300 million dollars
48:41the entire cancer program and we need to put,
48:43you know, like 200 million dollars in
48:45a year for several years in a row to
48:48get the RPG pull up to the fingerprint.
48:50Also, I think the cancer budget will grow
48:53and continue to grow because of this,
48:55you know, renewed funding model as well as
48:57the occasional designation of a new center.
48:59And so we've had a few new centers
49:02designated last few years and.
49:04You know, I,
49:04I think I'm worried about runaway
49:06growth of the cancer program because
49:08it is a great brand and we need to
49:10protect it and we need to make sure
49:12that NCI designation really stands
49:14for something and its rigorous.
49:15And it centers really meet all
49:17the goals that we need for them.
49:19But at the same time it is.
49:21There are parts of the country that
49:22don't really have access to a Cancer
49:24Center in generally there's intense
49:26interest in having a Cancer Center
49:27in those areas and often strong
49:29congressional interest as well.
49:30Last thing I'll say about the cost
49:32of the program that is really become
49:34apparent in the last few months is.
49:36You know it is one of the most
49:38important things.
49:39The NCI is ever done in terms
49:40of health disparities research.
49:41You know this focus on catchment area
49:43that I think was really devised by,
49:45you know people like Henry Ciolino
49:46and Bob Croyle and others has worked.
49:48It is forced every Cancer Center to
49:50think about what is my population of
49:52patients and how can I do better for them.
49:54And I would argue that the NCI is
49:55one of the best portfolios of health
49:57disparities research in the world,
49:59if not the best and it.
50:00A lot of that is really been driven
50:02by the cancer program,
50:03so highly successful program needs to
50:05grow modestly, but not to the same extent.
50:07The RPG would have narrowed to
50:09get the numbers I mentioned.
50:10Yeah,
50:11thank you know that's and we
50:14really appreciate your perspective.
50:15Linda Irwin, who's our associate Kansas
50:18director for population science,
50:20asked two questions.
50:21One, you're sort of views for
50:24implementation science research,
50:26particularly on how modifiable causes
50:28such as tobacco and obesity in
50:31terms of implementation counseling.
50:33And the second question just given
50:35the pandemic and awareness of
50:37strength in the need to strengthen
50:39public health infrastructure,
50:40the NCI's view in that space as well.
50:42Yeah, so I
50:43think as I said, I the specific topic of
50:46implementing care through Tele Health.
50:48You know that that moment has arrived,
50:50and I suspect we'll be seeing a
50:53lot of research in that area.
50:55And that's a really interesting
50:56part of innovation science that
50:58I think is going to mention.
51:00The NCI recently had an RF eye on this topic,
51:03and we're going through the response is now
51:06really trying to identify the key risk.
51:08Ridge questions,
51:09I think there will be many.
51:13But the rest of implementation science
51:15you know the non Tele health portion
51:17is still of great interest as well.
51:20David chambers and Bob Kroll and
51:22others at the NCI have let us strong
51:24portfolio extramurally in that area and
51:27I think it's really important set of
51:29questions because the hallador paper
51:31shows that we now have these effective
51:33therapies for certain kinds of lung cancer,
51:36but that doesn't help anybody.
51:38If we can't then get those therapies
51:40used in throughout the population of you.
51:43From way and and and that is,
51:45you know,
51:45provides a number of interesting challenges.
51:47So the NCI is very interested in
51:49supporting efforts to understand
51:50the uptake and implementation of new
51:52therapeutic advances and other other
51:54other aspects of cancer care treatment
51:56and will continue to do so at.
51:58You know,
51:58I'd probably another item worth
52:00mentioning that portfolio, by the way,
52:01is related to HP research, where you know,
52:04I think one of the more important
52:06cancer control trials in the world is
52:08presently going on in Costa Rica led
52:10by the NCI to see if one vaccination is.
52:13Equivalent to two shots, you know,
52:15one shot versus two shots, which is,
52:17you know,
52:18a very important implementation question
52:20of how to use national vaccination
52:22program to in cervical cancer in
52:24HPT associated head neck cancer.
52:25So you know an area where we have
52:28increased our portfolio in recent
52:30years and I think will continue
52:32to do so in terms of focusing on
52:34the public health infrastructure.
52:36I mean I think you know the pandemic
52:38has made clear some of the strengths
52:41and weaknesses of the American system.
52:43Not having a National Health Service
52:45so allows make certain things
52:47more difficult in United States,
52:48but also provides some advantages
52:50when you when you do something
52:52that national scale.
52:54At one of the issues that
52:56I think has become clear,
52:58as our ability to aggregate and collect
53:00national data to really tell what's
53:02going on with patients quickly is is
53:04challenging and this is a topic the
53:07National Cancer Institute has been
53:08interested in long before coronavirus.
53:10I mean, we've been trying.
53:13And we have seer Medicare.
53:14We have those kinds of national
53:16datasets that link with state
53:18and other kinds of registries,
53:19but we want to augment that it
53:21really trying to understand better
53:23what's happening with patience.
53:24And so we've been studying ways to
53:26link across datasets that are privacy
53:28protecting and involved unification.
53:30But you know, the data,
53:31public health, infrastructure I think is
53:33an area where the inside is particularly
53:35focused in making improvements.
53:36I will say one of the things we
53:38also saw around the issue of new
53:41clinical trials when the clinical
53:42trials network already exists.
53:44You can get a new trial done pretty
53:46quickly so that in caps study I mentioned,
53:48you know, we conceive that March
53:50and it opens six weeks later.
53:51I mean, that was a very important trial
53:53that we were able to stand up immediately.
53:55'cause it was an in core and NCT in when the
53:58clinical trials infrastructure doesn't exist.
53:59You know, clinical trials can really
54:01take a long time to get off the ground.
54:03the United States,
54:04and so some of the other obvious
54:05questions related to coronavirus didn't
54:07get into trials for a bit longer
54:09for variety of complicated reasons,
54:10but generally it was a lack of sort
54:12of National Health infrastructure.
54:13So I think that.
54:14You know these lessons are going
54:17to be remembered.
54:18I think the you know trying to understand
54:20how we can better aggregate data nationally.
54:23And make this data available for clinical
54:25decision making and trying to understand.
54:27How we can be with click trial
54:30design in the future will be.
54:32Key questions going forward when
54:34coronavirus is gone and we were
54:36just back to Cancer Research and so.
54:38But still you know those areas
54:41are going to be.
54:42Those problems are going for
54:44awhile now then one last question
54:46this is from Katie Pelini,
54:48who leads our cancer
54:49signaling networks program.
54:51KDS, you know, wondering whether
54:52you comment on the NCI's effort
54:54to ensure more stable funding,
54:56long term funding for investigators like
54:59the outstanding investigators award,
55:00which I think has had a.
55:03The positive impact your thoughts
55:04on expanding programs like that?
55:06Yeah, so we've done experiments here.
55:08So a couple of experiments.
55:10So there's nothing in law that
55:12says grants have to be 5 years.
55:14You know we have two year grants
55:16and we can even have up to 7 year
55:20grants and relatively straightforward
55:22way converting over from a from
55:24a smaller grain to Lauren Grant.
55:26That is not trivial for reasons
55:28that I care about is a long,
55:30bureaucratic story, but.
55:31But the apps any investigator award
55:34the R35 program was first effort
55:36by this in the NCI and Unit 7 year
55:39awards grant is more of kind of,
55:41uh, my vision for research rather
55:42than M1M2M3 of you know experiment.
55:44I'm going Thursday versus Friday.
55:46I think the people who write those
55:48grants enjoy that format better.
55:50They think they think they can really
55:52think more about the scientific questions.
55:54And I've heard from many investigators have
55:56over 35 that they like the flexibility.
55:58They kind of have to give up
56:00tomorrow one funding.
56:01But then they have stable.
56:03You know, two or oh one level funding for
56:07seven years and and really feel freed.
56:09And so I.
56:11I think the in the R35 program
56:14is a success and.
56:16Although we're still evaluating it,
56:17we haven't been through a full class yet,
56:19so we I think we need a little
56:21more data were up to, you know,
56:23over 100 total in the program for year,
56:25but.
56:27But based on that experience,
56:29we tried another experiment.
56:30When I first arrived at the NCI,
56:32which is the R37 New Investigator Award
56:34and the idea here was to see if you
56:36know establish senior famous scientists
56:38were able to compete for our 30 fives.
56:40Can use two more years of funding.
56:42What about new people who are not tenured?
56:44You know who have a lot
56:46more demands on their life.
56:48That seemed to me maybe a population
56:50that would benefit even more from
56:51a more stable funding source and
56:53the way we've created we wanted to
56:55learn we wanted to be an experiment.
56:57So the idea was that if you
56:59were in the pay line.
57:01Uh,
57:01as an ESI Oro stage investigator,
57:03you would get seven years
57:04of funding and are 37.
57:05And if you were outside the pay line
57:07but you were still going to get funded
57:09through select pay in about 1/3 of our,
57:11our ones are funded.
57:12If resizer funded through select pay,
57:14then you would just get a regular one,
57:16which is still pretty good news.
57:17You know,
57:18Korea,
57:18you gotta narrow one and you might say,
57:20well,
57:20that's not a fair comparison 'cause
57:22the R 37 population got a better score
57:24than the R35 in the R1 population.
57:26But we know from other studies at the
57:27NCI that doesn't really matter that much.
57:29That study sections aren't
57:31that good at telling.
57:32Outstanding grants from great grants.
57:33They're good at telling
57:34great grants from bad grants,
57:36but they're not so good when you start
57:38getting it at the 10th percentile
57:39or 8th percentile are those ranges
57:41all the all? The scientists do
57:43equally well over the long haul,
57:44so we're now in sort of year three of this.
57:47We've given out a lot of our 30 sevens.
57:50We have a good sense of what the budgetary
57:52heft of that will be in out years,
57:54and it's manageable.
57:55Certainly the people are getting.
57:56These awards are very excited and happy,
57:58but the people are getting are
58:00ones are pretty happy too.
58:01And a few years we will start to know.
58:04If the people who got longer period of
58:06funding are more successful by some metric,
58:08are they happier?
58:09Are they more likely to get their next grant,
58:12or are they able to publish?
58:13Do they have more time to think and
58:15write and do experiments instead
58:17of just writing their next Sprint?
58:19Ah yeah, I can see it both ways, I think.
58:22Also the frankly the pressure
58:24having to get your next friend does
58:26crystallized the mind of scientists.
58:27And Fortunately in the lab,
58:29so I think it is a real experiment to see
58:32if that is useful for that population.
58:34But we'll see I think,
58:36so far as I said,
58:37is very popular program and when we
58:40can afford and not an experiment,
58:42we plan to wind down anytime soon.
58:44So you know,
58:45that's two ends of the spectrum we have
58:47longer grants for established investigators
58:49and longer grants for early stage people,
58:51and I think,
58:52based on those two experiences,
58:54the NCI can then decide
58:56what else wants to do.
58:57There is one big disadvantage
58:59to long grant switches.
59:00They out your costs become
59:02much more considerable,
59:03and since we only get funded
59:05money year to year.
59:06You know, I can't bank funds from 21 to 22.
59:09You know, we have to spend everything
59:11in the fiscal year by federal law,
59:13then the more out your commitments.
59:15We have the more dangerous.
59:16It is for the NCI and you.
59:18You have all lived.
59:19This you know if there's a bad funding year.
59:22That's the year.
59:23Urara one gets cut by your noncompeting
59:25renewal gets cut by 7% or you know
59:27the first year gets cut by 19%.
59:29You know,
59:30these sorts of things that we have to
59:32do every every once in awhile when
59:34there's a bad funding year or really
59:36because of those extended out your costs.
59:38And I hated that.
59:39I really don't like telling
59:41people they're going to get so
59:42much funding they plan for that.
59:44And then any year three of the awards say,
59:46Oh, we're going to cut significantly.
59:48Sorry about that.
59:49So I I I that is 1 worries that
59:51these longer calendars will lead
59:52to less flexibility in future.
59:54But it's an ongoing experiment and
59:56will know more in a few years.
59:59Well,
59:59now that we are past.
01:00:00Shower and I just really want to
01:00:02thank you for taking time out of
01:00:05your very busy schedule to speak
01:00:06to us and answer your questions.
01:00:08Thank you for your leadership
01:00:10by you know I think the NCI and
01:00:13frankly cancer centers have really
01:00:15thrived under your leadership.
01:00:17I'd appreciate your perspective.
01:00:18So glad to have your support glad
01:00:20to have you here and thank you.
01:00:22Thank you for having me again.
01:00:24It's been really
01:00:24a lot of fun and a good to see old
01:00:27friends at least virtually, and you know,
01:00:29hopefully sometime we can do this in
01:00:31real life again when pandemic allows.
01:00:33But great seeing you all again
01:00:35and thank you for your work.
01:00:37Will be having cancer patients a
01:00:39great place like you have a
01:00:40good night. Thank you all.