Last week former Vice President Joe Biden and his wife Jill Biden, M.D., announced the launch of the Biden Cancer Initiative with the declared intent to “inject a sense of urgency” into cancer research.
The initiative is designed to build upon any progress achieved under the Cancer Moonshot, which when announced in 2016 had the goal of achieving a decade’s worth of advances in cancer prevention, diagnosis and treatment in five years. It was headed by Biden in the last year of the Obama Administration.
The stated aim of the new initiative is to “develop and drive implementation of solutions to accelerate progress in cancer prevention, detection, diagnosis, research and care, and to reduce disparities in cancer outcomes” by reimagining how government, academia, nonprofits and the private sector can “better organize their resources and systems to collaborate to take on cancer.”
One key area the initiative will focus on is that of drug development and delivery. In an interview with CenterWatch, Greg Simon, president of the Biden Cancer Initiative, said that as more and more research is focused on areas such as immunotherapy and immune-oncology, it has become apparent that the research community’s ability to leverage many of the available research tools—whether its huge amounts of clinical trial outcomes data, genomic data or data from electronic medical records—“requires a much more robust system of data collection and sharing than we have.”
Clifford A. Hudis, M.D., chief executive officer of the American Society of Clinical Oncology, agreed that greater collaboration when it comes to sharing data is desirable. “I know the vice president likes to talk specifically about genomic data sets and their aggregation,” he said. “And I think there is some mileage to be gained there if we can put together some modestly-sized high-quality data sets into larger sets to make discovery faster.”
That same principle could apply to aspects of drug development. “From a broad, societal perspective, having more than some modest number of drug entities in a class or field at one time could represent a duplication of efforts,” Hudis said. “So collaboration at that level would be interesting, although a little challenging.”
Hudis referenced the work being done on immune checkpoint inhibitors. An article last year in The Cancer Letter called the rate at which these drugs are being developed “unprecedented in scale and scope,” and reported that as of October 2016, there were 803 registered trials, involving 166,736 patients, testing 20 of these drugs.
“It might be a little hard to see the scientific and societal benefit in having so many resources poured into that one approach to cancer therapy,” Hudis suggested, adding that while the economic and business reasons for why this happens is clear, in a “utopian” world, there might be a way to push some of these resources in other directions.
“In this way, we could broaden the approach to treating cancer, rather than commit resources in a duplicative way to the same targets,” he said.
Simon said the number of trials being conducted on checkpoint inhibitors illustrates another issue with the way clinical trials are being conducted.
“One of the problems in drug development is finding the right populations to test these new targeted drugs on, and then finding enough patients in these specific cancers to go a trial with the experimental drug, or a standard therapy, or in some cases a placebo,” he said. “But that’s difficult to do when you have so many trials going on right now that are looking at the same thing.
“We’re using a scarce resource—the patient—in a very inefficient way,” he added. “All of these drugs are being tested against some of the same standard treatments, so we need to have a standard data set that we can substitute for putting patients in a control arm where we know we’re going to find out something that we already have plenty of data about.”
These are the kinds of things that slow down drug discovery and make development more expensive than it needs to be, Simon said, adding that the Biden Cancer Initiative’s method of operation will be to use its board and advisory committee with a variety of technical and medical experts to identify and examine new, innovative approaches to dealing with these kinds of issues.
As an example, Simon referred to the I-SPY trials, which have been called an innovative model for streamlining the testing of new agents for the treatment of breast cancer.
As described by the co-principal investigator for I-SPY, Laura Esserman, M.D., of the University of California, San Francisco, the trial is designed to test many drugs simultaneously and test new drugs earlier at the time of diagnosis, and then have them confirmed and qualified for early use in the phase III of the trial. The goal is to get highly targeted, effective drugs to the market in a quarter of the time, at the quarter of the cost, and by using one-quarter of the patients traditionally necessary to conduct trials.
“We, at the Biden Cancer Initiative, are looking to find the best examples of these new kinds of trials, learn all we can about them and put together a team to figure out how we can scale these innovative approaches,” said Simon. He added that former Vice President Biden’s “convening and convincing” powers could help players like the heads of cancer centers, clinical research operations and pharmaceutical company research divisions get behind efforts to adopt these new kinds of models at faster rates.
This article was reprinted from Volume 21, Issue 26, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »