publication date: Sep. 18, 2015

Lowy: Increase for Cancer Center Grants Is Contingent on FY2016 Appropriations

NCI is planning to increase funding for the Cancer Center Core Grants, Acting Director Douglas Lowy said to the National Cancer Advisory Board at a meeting Sept. 16.

“We have had a number of internal discussions since the joint board meeting in June and we are going to be having a meeting of working group of cancer center directors—that’s chaired by Stan Gerson [director of Case Comprehensive Cancer Center] and Chi Dang [director of the University of Pennsylvania Abramson Cancer Center] in October, to go over some potential approaches for increasing the award size,” said Lowy during his second director’s report since he became acting director. “The goal is to try to develop a plan that can be presented at the joint NCAB and BSA meeting at the beginning of December.

“Whatever we do, I’m not going to talk about the FY16 budget, but I just want to point out that it has not been passed, and until it is passed and until we get an increase in our appropriation, we would need to hold in abeyance the commitment for full funding for the increases in order to be fiscally responsible.”

The following is a transcript of NCI Acting Director Douglas Lowy’s remarks to the National Cancer Advisory Board Sept. 16:

It is a real opportunity for me to try to tell you about some of the things that have happened in the last ten weeks since we had the joint board meeting. I just am going to hit a few highlights, because really the key goal today is to try to go through a number of grant applications and try to make decisions about those.

First, I want to mention that FY17 NCI Bypass Budget is going public tomorrow. Those of you who are members of the NCAB have been sent a website, accessible to you today.

I would like to go on and to talk about science with a clinical relevance. With the first slide—I have a total of six slides—this week, the United States Preventive Services Task Force made a draft report that recommended low-dose aspirin for men and women between the ages of 55 and (inaudible) at average risk of colorectal cancer. This is the first time that they have made such a recommendation.

And I want to remind the NCAB that we have had a number of presentations about the research related to aspirin and its potential to reduce the risk of colorectal cancer as well as a number of other cancers.

Barry Kramer [director of the NCI Division of Cancer Prevention] made a presentation a couple of years ago, and Andy Chan [of Massachusetts General Hospital] from Harvard made a presentation even more recently. There are at least three outstanding questions, and I want to emphasize that their report is a draft report—it’s open for comment—and what their final recommendation will be remains to be determined.

But from a research perspective, one question is, “What are the benefits in those who are over 59.” The second is, “What is the mechanism of action by with aspirin induces this activity?” and the third is trying to identify biomarkers that are predictive of benefit as an approach to try and further increase the benefit to harm ratio and we are supportive of research whose goal is to try to address all three of those areas and I just wanted to highlight, that this is a potentially important change in standard of care, but it is still very much in progress.

The second slide is to talk about the status of some new award types. The Outstanding Investigator Award, we have made the initial awards actually of forty for FY15, and there are going to be subsequently another 24 awards made for FY16 from the initial round.

There has been a reissuance of this award, and there are minor changes, perhaps the most salient is the page length for the research strategy has been reduced from 12 pages to 6 pages, but you can go and look at the FOA for details.

In addition, we have been discussing both within the NCI and well as with the NIH other types of awards, and two that I would like to highlight that are not yet quite ready for primetime, but that we hope to be ready in the not too distant future.

Our one for research specialist and the other for the graduate student to postdoc transition, which we hope will help in the very important area of training—a number of new initiatives that we are hoping are going to help our extramural colleagues in their development sustainability and their ability to conduct really cutting-edge research.

The third slide is that we are making progress towards the goal of increasing funding for the NCI Cancer Center Core Grants. We have had a number of internal discussions since the joint board meeting in June and we are going to be having a meeting of working group of cancer center directors—that’s chaired by Stan Gerson [director of Case Comprehensive Cancer Center] and Chi Dang [director of the University of Pennsylvania Abramson Cancer Center] in October, to go over some potential approaches for increasing the award size. The goal is to try to develop a plan that can be presented at the joint NCAB and BSA meeting at the beginning of December.

Whatever we do, I’m not going to talk about the FY16 budget, but I just want to point out that it has not been passed, and until it is passed and until we get an increase in our appropriation, we would need to hold in abeyance the commitment for full funding for the increases in order to be fiscally responsible.

As I mentioned at the joint board meeting back in June, one of the areas that we’re trying to focus on are cancers with health disparities as very important examples of high risk populations, and what to try to do about it. And we’re going to be conducting a workshop in the beginning of November, it’s going to be in Atlanta, because it’s just prior to the AACR conference on cancer health disparities, and we’re going to be emphasizing trying to look at biology, lifestyle and access in utilization.

The purpose of this workshop is to try to identify some high-priority areas of research for the NCI to consider supporting. It will bring together what research are we currently supporting and the goal is to try to make our research in this area to be more cohesive, comprehensive and to have an even greater impact than we’re currently having. The co-chairs for the conference are Edith Mitchell from Thomas Jefferson University, Lisa Richardson [director of the CDC Division of Cancer Prevention and Control] from the Center for Disease Control and Sandy Markowitz from Case Western Reserve.

In conjunction with this, I should also point out that we have established a new NCI center, which we are calling the Center for Research Strategy, and Michelle Bennett, who used to be a deputy director in the Intramural Center for Cancer Research, but who went to be a deputy director in the Heart, Blood and Lung Institute, has come back to the NCI and she is going to be heading up this center and helping to coordinate the workshop that I’m referring to.

The focus of the center is to focus on trans-NIH activities that span a variety of scientific disciplines, and so we hope that this will be one way of trying to make our research more cohesive than it is already.

Another area in health disparities is something that really has been spearheaded jointly by Sanya Springfield, the director of the NCI Center to Reduce Health Disparities, and Kevin Cullen at the University of Maryland, who heads up the cancer center. And this is the development of a pilot program for middle school students in Baltimore to select about 30 students from three schools to learn about the biology, cancer and research and there will be activities at the school as well as at the University of Maryland Cancer Center and I had the pleasure a few weeks ago of going with Sanya up to the University of Maryland and meeting with Jay Perman, the president of the university, and with Kevin and many of his colleagues and to hear something about the program.

Kevin, would you like to tell us briefly about some aspects of it?

KEVIN CULLEN: Thanks. We’re very excited about this. I want to thank Sanya and her staff for all their support. This is a program quite literally in the neighborhood of Freddie Gray, and it’s really an effort to help the opportunities for kids in the community around our cancer center. We’ve devised a very intensive mentoring and tutoring program for kids in middle school two afternoons a week and one day on the weekend with the goal of making kids more competitive for advanced training well before they get to college and we were very appreciative of the partnership with Sanya’s team in an effort to give back to the community.

I have to say that all of the faculty at the cancer center have been incredibly enthusiastic about participating.

LOWY: I just want to point out that the center that Sanya runs has been promoting the notion of long-term training for these students. So we’ve gone down as far as the high school level up to now, but this is our first foray into middle school, and the enthusiasm that was expressed when we visited the University of Maryland was quite impressive.

The last areas that I want to touch upon—and as Tyler said, I will turn the microphone over to Jim Doroshow [director of the NCI Division of Cancer Treatment and Diagnosis]—is the Precision Medicine Initiative in oncology. We had an excellent, vigorous discussion about this at the joint board meeting in June, and we have continued to try to refine and develop it, and we also certainly listened to that discussion and some of the questions and comments that were made there and in other venues.

We have had a workshop on organoids and reprogrammed cell lines that Lou Staudt [director of the Center for Cancer Genomics] organized—that was in July and it was an international workshop with investigators, especially from the United Kingdom and from the Netherlands, participating. At the end of this month, the Frederick Advisory Committee is going to be hearing a presentation from Jim Doroshow on the PMI initiative in general and also on preclinical models, and as well from Warren Kibbe [director of the NCI Center for Biomedical Informatics] on the bioinformatics aspect of it.

The MATCH trial, which was one of the aspects that was highlighted at the June joint board meeting, has now opened, and Jim also went to a meeting last week that was organized for White House officials. Jim is going to give us an update on the MATCH trial and that meeting at the White House.

JAMES DOROSHOW: Many thanks, Doug. First, I want to thank all of the individuals across the country who have made the launch of the MATCH trial, not only a major undertaking, but a major success.

As many of you know, the trial was actually open to accrual just a few weeks mid-late August. The first two weeks, 60 patients were accrued and accrual continues at the initial 400 plus sites that opened the trial and we expect to actually get close to the 2,000 plus sites in a relatively short period of time.

The initial trial opened with 10 therapeutic arms under the MATCH umbrella. By either the end of this month, or very early in October, another nine clinical trials will be approved, and then several more rapidly thereafter. We think that we will get to at least to the 22 trials stage under the MATCH umbrella relatively soon, and certainly by the end of October.

You might be interested in the following, that is the initial accrual, most of it has actually been at our community sites that have been very interested in participating and have shown their ability to obtain fresh tumor biopsies in the community and get those materials to our quality control site at MD Anderson, and then to have the analyses performed.

I would be absolutely remiss if I didn’t say a word about what has been a remarkable collaboration between NCI staff and the ECOG-ACRIN staff that have made the processing of materials in as short as nine to 10 days from the time of biopsy possible with a great deal of work in the middle, over the past year and a half to make that happen.

We’re very happy that this has launched so well, we’re very hopeful that the accrual continues, and we will continue to negotiate; and we are continuing to negotiate with a variety of additional pharmaceutical concerns to bring new arms under the MATCH umbrella.

Let me say a very brief word or two about last Friday—I was fortunate enough to brief a group of White House staff about not just the MATCH trial, but also the oncologic aspects of the Precision Medicine Initiative and they were very, very supportive, very interested—not only the clinical trials aspects that we hope to continue and expand, in fact, as new observations are made in the context of NCI MATCH, but also the basic attempt to try to develop more models that are relevant to both drug resistance and to a variety of tumors that are not well represented in current collections of PDX and other models for cell lines and xenografts.

I don’t think Dr. Kibbe knows this, but the most questions that I got were on the IT aspects of the Precision Medicine Initiative. I did the best I could under the circumstances—I’m just delighted that I know what a petabyte is—but they’re going to contact Warren more for further information.

TYLER JACKS [director of the Koch Institute for Integrative Cancer Research at MIT]: Thank you, Doug and thank you, Jim. The floor is open for questions for both Doug and for Jim.

Maybe I’ll start with one briefly. Doug, I know you won’t want to give great detail about your thoughts of increasing budgets for cancer centers, especially before the group next meets.

But if you could give us a sense of order of magnitude changes here: What kind of increases, broadly speaking, are you expecting might occur?

LOWY: I think that we are looking to try to increase the budgets by 15 to 20 percent.

JACKS: Thank you. Other questions?

MARCIA CRUZ-CORREA [director of the Gastrointestinal Oncology Program at the University of Puerto Rico Cancer Center]: Hi everyone. First of all, thank you for sharing this information with us. I was really excited to hear about the program that is being led in collaboration with Dr. Springfield and the Center for Cancer Health Disparities. Thank you for working on that. I have to tell you that I think we may have also participated in similar programs, not for high school students, but for the grad students, so again, congratulations on that effort. I’m a part of some of that so thank you for working on that.

It was mentioned that there’s a research specialist award—do you have a date?

LOWY: We don’t have a date yet, which is why I was trying to be somewhat vague. We are hopeful that there will be signoff and we’ll be able to have this pilot program up and running in the near future.

CRUZ-CORREA: That’s very much needed. Thank you.

OLUFUNMILAYO OLOPADE [director of the University of Chicago Center for Clinical Cancer Genetics]: Doug, thank you for your emphasis on developing a strategy to reduce disparities, and I particularly like it because you’re sort of putting this as priority at the same time that we’re putting Precision Medicine as a priority.

In view of the report on the NCI MATCH trial where you have actually good accrual from the community, I’m just curious as to the strategy of getting more resources in the community to be able to participate in the MATCH trial in terms of an expanded network that actually covers more geographically diverse community practices that could potentially bring in diverse populations to participate in NCI clinical trials.

DOROSHOW: I don’t have whole answer to your questions, but I have a little of an answer and that is that a couple months ago, actually spurred on by Dr. Cruz, we had a teleconference with several institutions to have a specific navigator program that’s well developed—one of them being UAB, and there are others.

Basically, we decided after that meeting to provide additional support for their navigator programs, specifically to enhance accrual in underserved populations to the MATCH trials. We were able to provide administrative supplements at the end of, well, we have done it this year to try specifically, and I think that’s one way where there are already infrastructures that possibly I have a track record, we could add resources specifically to assist in accrual to NCI MATCH.

LOWY: Funmi, let me respond to a related question that you didn’t ask about, because it was a comment made at the joint board meeting, which was, with the preclinical models that we should also pay close attention that underrepresented minorities are well represented in those preclinical models, and we have taken that concern to heart.

OLOPADE: Thank you.

LOWY: In closing, I just want to reiterate what I said at the beginning about the bypass budget, that it will publicly available tomorrow. It’s going to be different in its format from what it has been before. There will be a bypass budget online, similar to last year’s but it will be much more Internet user-friendly and there will be hyperlinks, videos etc.

If you like it, you should please compliment Peter Garrett [director of the Office Communications and Public Liaison] and his colleagues if you like the text. Rick Manrow [associate director of the Office of Cancer Content Management] has provided a tremendous amount of effort in a very short turnaround time, and if you don’t like it, complain to me.

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