publication date: Jan. 22, 2016

Biden’s Cancer Moonshot to Focus On Bioinformatics and Data Sharing 

 

The Obama administration will find the money to create a comprehensive oncology bioinformatics system, Vice President Joe Biden pledged Jan. 19 at a meeting of international cancer experts at the World Economic Forum in Davos-Klosters, Switzerland.

Biden, whose son Beau died of brain cancer in May 2015 at age 46, is leading the White House “moonshot” program, which was announced by President Barack Obama during his final State of the Union address Jan. 12 (The Cancer Letter, Jan. 15).

Obama is expected to announce the details of funding the moonshot in his budget proposal Feb. 9.

“The president asked me to lead this effort for the administration in areas where I can hopefully be some value added,” Biden said at the World Economic Forum. “One is raising, in the United States, federal funds—we were able to do that; added another $2 billion to this fight in last year’s budget, and I’m hopeful we can do more next year and beyond, coordinating all our federal agencies: the NIH, the NCI, HHS, DOD, VA, the Department of Energy, the national laboratories.”

At the meeting, Biden describes in detail the vision he initially laid out in a blog post published immediately after Obama’s Jan. 12 address.

“Our goal is to make a decade’s worth of advances in five years instead of 10, and eventually end cancer as we know it,” Biden said. “We’re not trying to make incremental change, we’re looking for quantum leaps.”

The full text of Biden’s remarks is available here.

Biden said the oncology community is in consensus on the following:

• The moonshot program arrives at an “inflection point,” where “research and therapies are on the cusp of incredible breakthroughs.”

• The future of cancer research lies in Big Data, and a shared, interoperative database can “speed up research advances and improve access to cures.”

• The importance of collaborating with the private sector “to share data and research and helping make this more collaborative.”

Biden listed three bioinformatics initiatives that are currently underway:

• the American Society of Clinical Oncology’s CancerLinQ;

• the American Association for Cancer Research’s Project GENIE, for Genomics, Evidence, Neoplasia, Information, Exchange;

• and ORIEN, the Oncology Research Information Exchange Network, founded by Moffitt Cancer Center and The Ohio State Comprehensive Cancer Center.

“I recently received a letter from the president’s chief technology office essentially recommending, ‘Why not just have a single place for this data?’” Biden said. “I’m not sure that’s possible, but it’s one of the things I’d like to discuss a little bit.

“The president and I also received recommendations from the president’s Council of Advisors on Science and Technology, made up of some of the most brilliant minds in the country…they recommended to improve interoperability between the systems to ensure accuracy and safe and secure sharing of data.”

Biden said he doesn’t expect his moonshot program to cure cancer in the immediate future.

“I’m not naïve to think that, as some have suggested, that we’re going to have a cure to every cancer in the world—that that’s going to come in the near term. That’s not what is happening,” Biden said. “I want to make it clear to everyone: I know I can be nothing more than a catalyst here. I’m the repository of little to no expertise in this area. But I had been, at least in the confines of my country, relatively good at convening people and bringing folks together.

“I want to make it clear: we don’t think the federal government is the answer to this. But we think the federal government can be value-added, and we want to be helpful. We need your help as to what we should doing that we’re not doing, and we will not be shy to privately tell you where we think we need more help from you and how to break down some of these barriers.”

 

NIH, NCI Roles

NIH will drive the effort to increase access to data if other stakeholders will partner with federal agencies, NIH Director Francis Collins said during a press call Jan. 14.

“We think that if in partnership with a whole range of folks, we may be able to change the incentives around how we drive that sharing of data,” Collins said. “The extent that we can find ways through incentives, through changes in the types of relationships between organizations to find ways to make it easier to make data available that does not touch on privacy concerns, I think that’s something that the vice president is also very interested in.

“This is obviously an issue that NIH is intensely interested in, and we have been moving steadily, and this will be another occasion to move even faster to insist that if NIH is providing grant funding that’s developing large datasets, that that data needs to be made accessible to qualified researchers, although done in a fashion that protects patient privacy and confidentiality.

“The vice president, I think, has a really wonderful opportunity here to further encourage that kind of data sharing in other organizations that maybe don’t get government funding. It’s the right thing to do, and I think you’ll probably be hearing that from him as he leads a lot of these discussions in the coming months as we move this forward. My sense is data sharing comes up a lot.”

NCI will be launching the Genomic Data Commons, a consolidated data portal that will serve as a centralized location to integrate and store the diverse datasets from the NCI Center for Cancer Genomics.

“In terms of the NCI, we are going to be launching the Genomic Data Commons in the middle of this year,” NCI Acting Director Doug Lowy said during the press call. “We have seen cloud pilots for it, but what it is going to do is to house data for up to about 50,000 patients.

“We can have detailed genomic analyses as well as annotation of how the patients have responded and the outcomes from their treatment. We have the capacity to incorporate not just data from NCI trials, but in addition, from other trials. And when we open the GDC, we are going to then see what is the degree of demand.

“It remains to be seen what that might be, but we agree that the vice president could make an enormous difference in creating a greater demand for data sharing and this GDC or some other publicly available database ultimately for research and health care providers and for patients—provided that all the privacy notions are maintained—this kind of database has enormous potential.”

The commons will be an interactive platform for future expanded data deposition and access, as well as co-located computational capabilities. Initially, the commons will house data from the Cancer Genome Characterization Initiative, The Cancer Genome Atlas, Therapeutically Applicable Research to Generate Effective Treatments, The Cancer Cell Line Encyclopedia, and other future cancer research programs.

Eventually, the GDC is expected to be broadly available as a repository and access point for data from other cancer genomic initiatives. GDC will facilitate investigation of its high quality genomic data by enabling users to make discoveries by repeatedly mining the data and combining it with data from their own research or from third parties.

GDC is under development and is managed by the University of Chicago through a subcontract with Leidos.

Biden and his staff members are meeting with policymakers, academic oncologists, patient advocates and other stakeholders to establish common goals.

“The vice president as well as many members of the administration have ongoing conversations with folks on [Capitol] Hill, including Republican members of Congress,” Don Graves, deputy assistant to Obama and counselor to Biden, said on the press call. “Given the vice president’s 40-plus years in the Senate, he has very good relationships with members of both parties, and he has had many conversations over the last several weeks and months with members of both parties on ways that we can advance the cause of improving care and advancing the field of science in cancer.

“Part of what we’re going to be doing over the coming few weeks is making sure that we’re all using relatively standard, commonly understood metrics and know what the progress is currently being make on a wide range of cancers in a wide range of ways.”

 

ASCO’s CancerLinQ: Quality and Safety of Care

The American Society of Clinical Oncology is working with Biden to ensure that CancerLinQ, the society’s Big Data network, is involved in the moonshot effort.

“We’re going to continue to work with all the players and to identify how we can facilitate it,” said Clifford Hudis, past president of ASCO and a member of the CancerLinQ Board of Governors. “In the end, clinical care is rendered by ASCO members, the education that was results from the learning—I think it is critically important that so much of the research is always going to be done ASCO members, so we want to facilitate all of that. We also want to make sure that there’s a role for CancerLinQ that we optimally deploy. I think that there’s a lot of ways we can collaborate in support of the VP’s initiative.”

Launched in 2010, CancerLinQ is expected to use patient care data from millions of physician and patient records from practices and hospitals to provide feedback and clinical decision support to care providers. When the system is completed, doctors will be able to receive personalized insights based on up-to-date findings (The Cancer Letter, Feb. 20, 2015).

“CancerLinQ is making really good progress,” Hudis said to the Cancer Letter. “It’s ingesting patient records now at an accelerating pace and we’re projecting to reach a million records this summer.

“Of course, ASCO is first and foremost interested in the fastest development of the best treatment for patients and broadest distribution of high quality care. I say that, because following on that, what we want and what we’ve spoken to the vice president’s office about is how to accelerate progress and how to distribute knowledge.

“And so [Biden] has rightly focused, as part of the initiative, on the potential role of big data and interoperability and data exchange and we’re contributing as best as we can to that discussion by highlighting the promise of CancerLinQ, but also in a broader sense the potential value of access to data.”

Hudis said Biden understands that data in oncology is often “siloed,” and that this presents an unnecessary barrier to progress.

“I hope that they are going to help to break down some of those barriers. If you’re going to find one concrete goal in all of this, it’s to get 10 years of progress in five years—that’s what he has said explicitly,” said Hudis, vice president for government relations and chief advocacy officer as well as chief of breast medicine service at Memorial Sloan Kettering Cancer Center. “I think that’s going to be multipronged. More efficient clinical trials development and also more rapid conventional drug development, and a contribution is going to be whatever we can do with data access and data sharing.

“Of course, it’s very complicated when you get down to it, but I think an outsider looking in will say, ‘Of course, the Internet works, data is stored in standard ways, it’s transmitted in standard ways, why can’t we achieve some measure of that in cancer?’

“One of the things I would say he has identified rightly is the way in which this is surprising to many people. Many people used to the fluidity of the rest of the digital economy are somewhat surprised when they learn about the barriers in medicine, and not just cancer medicine, all medicine.”

These barriers include different structures and transmission methods in recording medical information, and can be complicated by patient privacy concerns and the Health Insurance Portability and Accountability Act.

“At a minimum, you need to have an overlay system like CancerLinQ that extracts the data and standardizes it,” Hudis said. “I think the focus right now, of course, is always about money, but it’s on more than money—it’s on collaboration and coordination and cooperation, all of which, I think, are possible goals.

“Fundamentally, getting us all to agree on the most promising lines of research, on the most efficient methods to conduct that research, and on the data. These would be really important steps forward. And I think Vice President Biden is able to catalyze it.”

Biden’s moonshot represents the promise of evolving technology and how that is recognized by policymakers and leaders, Hudis said.

“I am not at all cynical about this, I think this is a really good step. It’s a new opportunity,” Hudis said. “In the end, Big Data is not the cure for cancer. The cure for cancer is, of course, treatments, intervention, understanding molecular biology, all of that, but Big Data in various forms is an important tool and it shouldn’t stand in the way of progress. It should be a facilitator.”

 

AACR’s Project GENIE: Clinical Decision Making

The AACR has been engaged in ongoing dialogue with Biden on the best ways to accelerate progress, said Jon Retzlaff, AACR managing director of science policy and government affairs.

“Our meeting at the White House on Jan. 8 with Vice President Biden’s senior staff, which was led by AACR President Jose Baselga, and included fourteen other AACR members from 10 of the top cancer centers and medical institutions in the U.S., provided an opportunity to discuss some of the important issues for advancing cancer prevention and treatment,” Retzlaff said to The Cancer Letter. “During the meeting, the AACR members in attendance talked about numerous issues, including the need for robust, sustained, and predictable funding increases for NIH and NCI, and the value of increasing data sharing, which provided an opportunity to describe the AACR Project GENIE.”

AACR Project GENIE, which stands for Genomics, Evidence, Neoplasia, Information, Exchange, was launched in November 2015.

The initiative, a multi-phase data-sharing project designed to improve clinical decision making, includes AACR and seven institutions in genomic sequencing: The Center for Personalized Cancer Treatment, in the Netherlands; Dana-Farber Cancer Institute; Institut Gustave Roussy, in France; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University; Memorial Sloan Kettering Cancer Center; Princess Margaret Cancer Centre, in Ontario; The Vanderbilt-Ingram Cancer Center; and two informatics partners—Sage Bionetworks and cBioPortal.

“One of the key ways of accomplishing this is by making the data open to everyone following varying times of exclusive access,” Retzlaff said. “The vice president and his staff have been extremely interested in learning more about the AACR Project GENIE, as well as indicated interest in many of the other data sharing efforts that are currently in place.”

Retzlaff said AACR has emphasized to the White House the importance of standardizing data and finding ways to reimburse for the sequencing of cancer tumors in order to get the data required to build an evidence base.

“The vice president, in effect, believes data provides the keys to better cancer treatments,” Retzlaff said. “They are also especially focused on and interested in finding ways to aggregate all of the data into one place and making it available and accessible for everyone to use.

“Bottom line is that the AACR is proud that it is being viewed as a trusted resource and reliable partner in this important initiative, and we are looking forward to continuing to work with and share information with the vice president and his staff throughout the year as they develop a comprehensive plan to accelerate progress against cancer.”

 

M2Gen’s ORIEN: One Standard Protocol

Biden is aware of how ORIEN, a self-governed alliance of NCI-designated cancer centers, has broken down the silos in oncology bioinformatics, said Michael Caligiuri, director and CEO of the Ohio State University Comprehensive Cancer Center.

“ORIEN is a perfect example of Vice President Biden’s plan to break down the silos and bring all the fighting together,” Caligiuri said to The Cancer Letter. “We’re really showing that we can streamline drug development and clinical trial development and do what the vice president said—make a decade of work in five years. That’s what I think ORIEN will do, and we’ve been doing it through banding together under a single protocol.”

To date, ORIEN has 11 member cancer centers, including the U.S. military and the Walter Reed Medical Center, which have agreed to pool data from their electronic medical record systems and cancer registries to accelerate discovery of targets and the development of biomarkers (The Cancer Letter, March 13, 2015).

Founded by Moffitt Cancer Center and the Ohio State Comprehensive Cancer Center, ORIEN was launched in 2014. The collaboration has accrued data from 140,000 patients and expects to accrue 50,000 patients each year.

ORIEN is built around a standard consenting and processing protocol called Total Cancer Care. To join ORIEN, each new member pays $30,000 a year to train staff and implement Total Cancer Care—efforts that are overseen by M2Gen, the Moffitt biotechnology and informatics company that runs ORIEN.

“ORIEN is a hub-and-spoke model. For example, we have a network here of six community hospitals that we’ve invited to join ORIEN so that Ohio State will not only be Ohio State but also involve six community hospitals throughout the state,” Caligiuri said, “And I think Moffitt has 11 at this time. What we’re imagining is each NCI-designated center will have a number of spokes to community hospitals where they will participate. That’s already functional.

“You can basically see the hub-and-spoke throughout the country, which is what we’re hoping for. A couple of the 11 centers have just gotten the protocol approved, they’re just moving through the paces, but other centers like ourselves, here at Ohio State alone, we’ve signed up 15,000 patients with a 92 percent success rate in the first 18 months of operation. I think the important point there is this is really something that patients want, and they want us to develop the ecosystem to generate some big data, they want us to share the data, they want us to learn from each patient.”

At least two more NCI-designated centers have signed up, according to Caligiuri, and six more are under review.

“We really realized that no one center can do it, given what’s called the molecular heterogeneity of cancer,” Caligiuri said. “This isn’t HIV where there’s one virus; there’s hundreds of causes and we’re going to need tens of thousands of patients a year coming in to something like ORIEN so that we can find those small subsets that should be uniformly molecular and uniformly treated.”

Caligiuri said he and other ORIEN leaders are scheduled to meet with Biden and his staff at the end of January to explain how ORIEN works.

“What is the moonshot? The moonshot is to increase funding, both from the government and the private sector to combat cancer, breaking down the silos and work together, share information and basically double the amount of work we get done,” Caligiuri said.

“What is ORIEN? ORIEN’s an approach that breaks down the silos—we’re 11 centers, ORIEN is patient-centric, every patient signs the protocol, and 140,000 patients have already signed on. It incorporates patients into the solution, and it connects all 11 centers, which will be speaking through a single interoperative system and those centers will each be connected to community hospitals. It involves everyone, and it’s data sharing to facilitate things like clinical trial matching.

“ORIEN can find those patients immediately through our interoperative system. We’ll be putting 50,000 patients a year on the Total Cancer Care protocol, and so we can find them because their clinical records will be in TCC, and get that trial done quicker across the country.

“We’ve already shown that we can save six months to a year on clinical trials. That will save time, money and get the treatment to the right patient at the right time. And it brings together private, public, government and industry—it’s cross sectional.

“So I really think that ORIEN, with regard to the moonshot, will hasten drug development, clinical trials will get done quicker and we’ll get that decade’s worth of advances in five years, and most importantly, it’s not pie in the sky, it’s already functioning.”

ORIEN allows its members to interoperate between medical records, Caligiuri said.

“First of all, with regard to interoperability, we’re connecting the Cerner medical record with the Epic medical record so that we can talk to each other and extract data from each other’s electronic record. Despite being different companies having their own processes, we’ve got a system now that can extract the data and translate it into a single language through this mechanism. That hits the interoperability piece squarely.”

Anticipating patient need is one of the core qualities of ORIEN that sets it apart from other systems, Caligiuri said.

“This is the unique thing about ORIEN: When a pharma company comes to us and says, ‘I want 50 patients with relapsed pancreatic cancer,’ we will already have hundreds and hundreds of patients with pancreatic cancer who have consented to Total Cancer Care, an IRB-approved protocol, which allows us to recontact the patient,” Caligiuri said. “So we can contact each of those patients in anticipation of a trial and say, “There is drug waiting for you should your disease comes back.” The protocol allows us to follow the patient for a lifetime and do whatever we need to do with the tissue, and then contact the patient at any point where we could be of help to them or they could be of help to us. That’s very exciting.

“We’re developing evidence-based clinical decisions as well, and that’s something that’s going to be for all physicians, both in academia and in the community at large. We anticipate using our Big Data system to be shared, to learn and then to share again with the community in terms of clinical decision making.”

Caligiuri said ORIEN will interface well with other oncology bioinformatics databases.

“I think NCI’s Genomic Data Commons will synergize greatly, because every single member institution of ORIEN will be free to share their data that’s generated in ORIEN with whoever they want, including the NCI’s effort,” Caligiuri said. “The University of New Mexico, for example—which is one of the 11 centers—brings in a very important underrepresented population into this, and they are free share that information with any other endeavor.

“What we’re doing really complements the AACR’s Project GENIE. I think both of these efforts are going to be very helpful to Vice President Biden’s vision. They’re different approaches, but they’re quite complementary and I suspect there’ll be some very helpful overlap very soon.

“ASCO’s CancerLinQ is important—I have to think more about how CancerLinQ can be streamlined into something like ORIEN or GENIE—CancerLinQ is much more around quality and safety, and those are critical elements as well.

“What we’re doing in ORIEN can only help other efforts that are out there as well.”

Copyright (c) 2020 The Cancer Letter Inc.