The contract for operations and technical support at the Frederick National Laboratory for Cancer Research could be accepting proposals as early as next month—but NCI advisors said they are hoping to slow the recompetition process to reform the laboratory’s mission.
Moreover, NCI should consider how the laboratory could contribute to Vice President Joe Biden’s National Cancer Moonshot Initiative, members of the Frederick National Laboratory Advisory Committee said at a recent meeting.
The lab, located on a 68-acre campus in Frederick, Md., and at the Advanced Technology Research Facility, a 330,000-square-foot complex with a biopharmaceutical development wing, is one of 42 Federally Funded Research and Development Centers.
The Frederick lab is the only FFRDC dedicated to biomedical research, specifically in the areas of cancer and other diseases. FFRDCs receive 70 percent or more of their financial support from the federal government. By statute, these centers are designed to be operated by contractors.
Since it’s run through a contract, the Frederick lab has greater flexibility than NCI’s intramural program in funding projects. This means that the laboratory has more independence to initiate and conduct research that complement NCI’s. When all works well, this allows researchers at Frederick to pursue innovative ideas expeditiously.
However, the flow of funds at FNLCR hasn’t always been clear or transparent. Since funding is project-specific, even NCI leadership and members of the laboratory’s advisory committee may not always know exactly how federal dollars are being used at the laboratory.
The Frederick lab is currently operated by Leidos Biomedical Research Inc.—formerly known as SAIC-Frederick—the same contractor that has ran the lab since 1995.
The current contract, which was awarded in 2008, is scheduled to end in September 2018. Leidos received $400.2 million to run the lab in fiscal 2014. According to a recent job posting, Leidos said it employs about 1,900 staff and manages a $450 million annual operating budget. It is not publicly known how much NCI is budgeting for the 2018 contract.
“There is no established budget at this time,” NCI officials said to The Cancer Letter. “Any previous references to the estimated ceiling for contract award do not represent an annual budget and are subject to change.”
Leidos manages a subcontract for the NCI Genomic Data Commons, a portal that consolidates NCI’s diverse datasets. The $20 million project, funded through President Barack Obama’s Precision Medicine Initiative, was recently designated by Biden as the foundation for the moonshot’s data-sharing goals (The Cancer Letter, June 10).
As the institute prepares to re-compete FNLCR’s contract, NCI officials see the process as an opportunity to:
- Assess the FNLCR’s potential for contributing to big-picture goals in oncology, including the goals set out in the moonshot,
- Review how federal funds are used at the laboratory,
- Select a contractor that can best meet NCI’s most “urgent needs”—including fostering collaboration between FNLCR and the extramural academic community, and
- Focus FNLCR resources towards conducting research that would be difficult to perform elsewhere.
NCI to Set Research Agenda
How much independence should FNLCR have when deciding which funds should be spent and which projects should be pursued?
NCI officials say recompetition, which comes up once a decade, is the time for redrawing the lines of command.
At a recent meeting of FNLCR’s advisory committee, NCI Acting Director Doug Lowy opened the discussion with a request for suggestions on how FNLCR’s mission should be redefined.
“We were interested in your talking about the capabilities of the Frederick National Lab and particularly thinking about the future,” Lowy said. “We’re really interested in hearing about your perspective on this in terms of where you see the potential for the FNLCR going, now that we have the model of various kinds of initiatives, etc.
“What is your perspective on how we should thinking about positioning the FNLCR for the future?”
Operating the national laboratory via a contractor gives NCI the flexibility to fund programs and hire staff without having to use government mechanisms—giving the institute the ability to shift projects and move dollars with greater ease.
In the past, NCI directors have sheltered their pet projects from peer review by funding them as subcontracts of the SAIC contract. Under previous directors, the institute has been known to use the contract as a place for “parking” funds left over at the end of the fiscal year, thereby preserving these funds for the following year’s budget, sources said.
The Frederick National Lab evolved from a little-understood outpost of the NCI into a national laboratory in February 2012, two years after Harold Varmus was appointed NCI director.
To align the contractor with the institute, Varmus created the Frederick National Laboratory Advisory Committee to guide its programs and, in his words, to “reuse resources in a sort of very sensible way to foster the best use of NCI’s money.” (The Cancer Letter, Feb. 28, 2014).
Varmus was succeeded by Lowy on April 1, 2015 (The Cancer Letter, April 17, 2015).
FNLCR staff should be able to propose research ideas, but the final decision needs to be made by NCI, said Joe Gray, chair of the Frederick National Laboratory Advisory Committee.
“It seems to me that a reasonable model that one could aspire to for Frederick is where the NCI actually defines, with reasonable granularity, areas of interest, and Frederick has the opportunity to propose to address topics in those work areas of interest,” Gray said at the May 11 meeting of FNLCR’s advisory committee. “This would be done in collaboration with the community: they would develop within Frederick a proposal to address a particular NCI need.
“NCI would then say, ‘Yes, we like it,’ or ‘No, we don’t.’ If the answer is no, then you’re back to the drawing board, but it seems to me that this would give the Frederick lab the opportunity to engage the community and to have initiative on their own. That would be quite the workable model.”
Other committee members expressed support for an NCI-driven research agenda.
“First of all, I don’t think Frederick should be independent from the NCI, I think that’s not correct, but I’m open to other people’s views. That’s my initial response, pretty strongly,” said committee member Cheryl Willman, director and CEO of the University of New Mexico Comprehensive Cancer Center. “Is Frederick its own independent, idea-generating laboratory in which it pursues projects? Is it more of a highly-advanced technology, almost like a shared resource where the NCI intramural program and other entities are bringing projects that aren’t easily reproduced at other centers, because of technologic demands?
“That’s the direction I think we’ve been moving in over the last few years, which I think is pretty satisfying,” said Willman, the Maurice & Marguerite Liberman Distinguished Endowed Chair in Cancer Research and professor of pathology at the UNM School of Medicine. “Or is Frederick also—and none of these are necessarily mutually exclusive—a convening function for high performance computing problems applied to cancer where there is science going on here and collaboration with DOE, but also could involve the extramural community?
“All of those are possible, but I think the mission has to be tightly linked to NCI’s mission.”
The process by which FNLCR identifies promising research projects is unclear—an issue that the recompetition needs to address, said Kenneth Pienta, advisory committee member and director of the urology research laboratories at Johns Hopkins Hospital.
“The root question we need to ask moving forward is, ‘How does Frederick elevate us as a scientific community in decreasing the morbidity and mortality from cancer?’” said Pienta, professor of oncology, pharmacology and molecular sciences at Hopkins. “I think what’s really cool is that over the last three years, we’ve seen two examples of that in this community, very clearly, that started with the RAS project and get around a problem and attack it in a way that nobody else is and how it’s going to give us downstream output.”
The RAS Initiative was established in 2013 to explore innovative approaches for attacking the proteins encoded by mutant forms of RAS genes and to ultimately create effective, new therapies for RAS-related cancers. All 180 RAS pathway genes are now available.
“The question is, what’s the process that Frederick sets up to identify that type of science, and do we, or do we not, involve the extramural community in those decisions? Is it purely NCI-driven intramural, is it NCI-driven around this table?” Pienta said at the advisory committee meeting. “But I think the whole idea around how to define that process is key, because I think we’ve seen a glimmer of, ‘Wow, this can be really great!’
“I think that we are going to have to do it with awareness of the moonshot, that’s going to affect this somehow. I don’t know how, but we’re going to have to be aware of that.”
NCI: Delay, Wait for Moonshot
Committee members should consider delaying the process and create a plan for how FNLCR’s resources can be used for the moonshot, Gray said.
“This competition comes at an interesting time in history, that is to say right in the middle of the moonshot,” Gray said at the meeting May 11. “It’s not clear to me what role Frederick is going to play in this moonshot project, but it is a fast track enterprise. One of the things that you are running the risk of is changing management right in the middle of the time when Frederick would be really well positioned to play an important role in moonshot activities.
“I will just not ask for an answer on this question, but at least ask that you think about whether or not this is the right time to be competing this contract considering the timeliness of moonshot activities.”
The timeframe is urgent, but compromise should be possible, said committee member Robert Grossman, director of the Center for Data Intensive Science and professor at the University of Chicago.
“This is a unique time in terms of some of the large-scale initiatives going on with the moonshot and related things that are going to have an impact for a long time,” Grossman said. “The Frederick National Lab has a very important, I think, role to play in that.
“One thing that this committee might want to discuss is part of the challenge right now is there’s a certain level of distraction as you prepare for a recompetition, at the same time, there has to be a certain level of focus to prepare for these larger changes related to the moonshot.
“I know money is very tight, but one thing that could be done is to consider providing some mechanism or funding so that you could protect and provide focus for the current lab to engage in some long term planning at the same this other distracting activity is taking place.
“It’s a compromise, but you almost need a little bit of protection so they can think of the long term, no matter what that looks like.”
NCI has the authority to move FNLCR funds for the moonshot, said NCI Acting Director Lowy.
“I think just that as we can modify the amount of funds at the Frederick national lab down, we can also modify them up,” Lowy said. “But there needs to be really strong justification for doing it.
“Let’s just take a hypothetical example that something that comes out of the Blue Ribbon Panel that people feel the Frederick national lab would be an excellent place to do this, because it has certain characteristics that aren’t met my the usual extramural activities etc.
“The funds for doing that could be added.”
A detailed breakdown of FNLCR’s current flow of funds would be necessary to inform NCI’s decisions going forward, Gray said.
“Maybe some document that goes along with all of this that in essence describes the current Frederick National Laboratory operation, that would be very helpful,” Gray said.
Several FNLCR staff members objected, saying that research projects might be disrupted if the recompetition does not adhere to a strict timeline and the process is not completed by September.
Nevertheless, NCI should consider how FNLCR can contribute to the moonshot, Gray said.
“I can see expressions of angst, but let’s just say we put it on the table as something that the NCI should at least think about in the context of the moonshot,” Gray said.
Responding to numerous, tense moments of awkward silence, Gray said:
“OK, I’m going to look around the room at my fellow advisory committee members here and make the following statement:
“This is probably the single most important contribution that we could’ve made in the last five years, is to help get this recompetition right.
“It’s going to have a major impact on the way that Frederick is run in the future and if now is not the right time to be making comments that would be helpful, there certainly is an opportunity to make comments publicly about this to give some pretty deep thought to this.
“I think we’ve got a really good thing going here. If we’re going to change things, let’s make sure that we help them do the best that we possibly can in terms of making it greater.”
Gray: Struggle to Understand Frederick
Some members of the advisory committee expressed frustration at how difficult it was for them to understand FNLCR’s complex flow of funds and research activities.
NCI and the laboratory will work on making those details more transparent, Gray said.
“All of us on this committee have gone through the same struggle to try to understand how Frederick actually works, and obviously, we have not succeeded in making this perfectly transparent to people who are new to the enterprise,” Gray said. “I think we also haven’t made it particularly transparent to people who may be thinking about competing for the operating contract, and I think that’s a really important thing for people who are going to try to put proposals together to know in some detail.
“I think we do need to aspire as the Frederick National Lab to have information out there readily consumable about what they actually do as we go forward to help the community understand how to engage it.”
Gray provided a critique of the FNLCR’s draft of the request for proposal for the recompetition, saying that it isn’t sufficiently informative.
“My take on this is the statement of work was sufficiently general as to not actually convey a lot of the information that we just spent the last two hours discussing,” Gray said. “For example, how Frederick actually operates, how it interacts with NCI, what the actual funds flow are—the real money, there were sort of ballpark numbers given, but I didn’t actually find the details that we’ve seen posted today.
“To me, the RFP was sufficiently high level, but it didn’t give me a sense of how to actually operate it or what the NCI would consider to be a good proposal.”
Other committee members agreed, saying that the proposal needs to re-envision its statement of work.
“The way this is written, it seems almost that it’s encouraging business as usual, and I’m just slightly rewording what people say,” Grossman said. “There’s going to be a lot of effort put into this by a lot of people, and it would be good just to sort of frame it with the vision of encouraging this and presenting this as more of an opportunity to create even better pipes of technology development and translation.
“I just didn’t get that sense of possibility from this document.”
Frederick should be an “interface” for NCI to establish greater collaboration with other scientific communities, they said.
“I’ve always looked at the Frederick opportunity as one that’s, in part, the innovation driver for the NCI’s program,” Willman said. “But I also think it’s become almost the advanced technology component, when you think about bioengineering, computing, about the science that many of the national labs are engaged in.
“What’s the most important question we could address now using this structure here at Frederick and who would need to be engaged in that, is, ‘How can the Frederick lab be NCI’s interface to those communities that you need to pull together?’
“So that’s why I still think there really needs to be mission alignment between the NCI’s national agenda or the national agenda for cancer research and sorting out the unique role Frederick can play with its innovative funding model and its ability to convene great science.”
Gray set out a number of questions he said should be answered in the RFP:
“What are the things that the NCI is really hoping to accomplish through this recompetition that in the eyes of the NCI would make it better? Is there a role for an academic collaborator and if so, what? How much flexibility does the potential competitor have to actually change the business model?
“You could imagine that people would bring in a lot of new creative ideas about how to run Frederick national laboratory. Those were some of the things that came to my mind as I read it,” Gray said. “To me, it was just too high level.
“It would be useful to have some set of rather quantitative criteria by which the proposals would be judged so that people could understand where to put the emphasis on the development of the proposal.”
Gray, who has served as chair of the advisory committee since 2016, will be succeeded by Lawrence Marnett, associate vice chancellor for research and senior associate dean for biomedical sciences, the Mary Geddes Stahlman Professor of Cancer Research, and professor of biochemistry, chemistry and pharmacology at Vanderbilt University School of Medicine.
