By Lauren C. Leiman, White House Cancer Moonshot Senior Director External Partnerships
Identifying the Mission
Thanks to remarkable scientific advances, we know that tumors shed a variety of signals into the blood, leaving behind small hints to help identify cancer type, location, and disease-stage. For this reason, researchers are especially interested in developing new ways to use this knowledge to transform how we detect and diagnose cancer, making it possible for a future wherein simple blood draws could help physicians and patients more accurately and successfully manage disease.
The technology — commonly described as liquid biopsies —could offer a less invasive and easily replicable alternative to standard biopsies, experienced by the patient as a simple blood test as compared to, for example, an often painful bone marrow biopsy. In the past decade, there has been some momentum around enhancing the science and clinical utility of liquid biopsies where tumors shed breadcrumbs into blood, urine and saliva.
With the launch of the Cancer Moonshot we’ve seen an amplified commitment in this area. In response to the Vice President’s call to collaborative action in support of the Cancer Moonshot, a team of deeply committed individuals from for-profit companies, professional societies, and universities have come together to accelerate the timeline to achieving their shared vision of developing safe and effective liquid biopsies. They will start by focusing on blood profiling diagnostic technologies, to dramatically improve the lives of cancer patients and their families.
“We are going to start. There are 14 individuals representing a couple of institutions and companies that are doing liquid biopsies, and my team is getting them all together in one room.” —Vice President Joe Biden, September 10, 2016. Los Angeles, CA
On September 10, 2016, in Los Angeles, CA, the Blood Profiling Atlas came to life. An initial group of 14 representatives from government, academia, foundations, pharmaceutical and diagnostic companies joined together to form the “Blood Profiling Atlas” group to jump start the creation of an open blood profiling database, which will make raw, unprocessed datasets free and publicly available.
“From our first conversations, the group believed liquid biopsy could play a pivotal role in achieving the Vice President’s goal of a decade of progress in half the time. It was clear the atlas could be something tangible to bring all of the stakeholders together and to create a common resource for the scientific community — both critical for the paradigm shift liquid biopsy represents.” –John Simmons, Translational Science & Diagnostics Personal Genome Diagnostics (PGDx), Co-Chair Blood Profiling Atlas
The Vice President’s Cancer Moonshot team met in late summer 2016 with the FDA to discuss liquid biopsies, and determine the value of a collaborative group approach to developing the science of blood profiling. The goal was to understand if there was a benefit to demonstrating the level of evidence required to identify performance characteristics of blood profiling assays for cancer treatment, and to developing standard protocols for sample collection, processing, and analysis.
In strong alignment with the Cancer Moonshot, the Blood Profiling Atlas recognizes that a collaborative, well-integrated approach is essential to accelerating positive developments in patient care — detecting tumors faster, diagnosing disease earlier, and tracking disease progression and treatment response more efficiently. The Atlas anticipates that it will also be integral in making sure that the regulatory pathway for supporting these advances is robust.
“The patient is experiencing the disease as a time space continuum with the key questions of when will the disease go, where and which treatment will work right now. Proteogenomic characterization of the cells and delineation of the cellular components escape from the tumor and travel through the blood, giving us a real-time window into the disease. Only if oncologists, patients, scientists, regulators and healthcare providers work closely together can we get clarity on this window.” –Peter Kuhn, Professor at the USC’s Michelson Center for Convergent Biosciences, Co-Chair Blood Profiling Atlas
On October 17, the release of the Cancer Moonshot Fact Sheet officially announced the Blood Profiling Atlas and the following day a group of 45 individuals representing 20 stakeholders convened by the Vice President’s Cancer Moonshot launched the official pilot to aggregate and harmonize raw datasets for further analysis. The pilot project is designed to improve care for patients by creating a new model for how work being done at companies, universities and government agencies can be brought together to accelerate the development and potential approval of highly reliable blood tests for individualized cancer treatment and monitoring.
“To transform the clinical management of prostate cancer in the near term, it is essential to develop new drugs and to use those already available in more precisely defined and biologically relevant patient groups. To this end multidisciplinary teams of scientists and clinicians are now collaborating to develop assays for predictive biomarkers of sensitivity and resistance from a tube of blood, which will limit trial enrollment to patients most likely to respond. This new paradigm is critical for shortening drug development time lines and to reducing patient exposure to unnecessary toxicity from ineffective treatment.” –Howard I. Scher, Chief of the Genitourinary Oncology Service at Memorial Sloan Kettering Cancer Center, Co-Chair Blood Profiling Atlas
As we look ahead for the Cancer Moonshot, through the end of the Administration and beyond, we see a future filled with researchers, clinicians, patients, non-profits and government agencies coming together to more efficiently and effectively utilize resources and resolutely improve patient care.
“The concept of a ‘Moonshot’ is an ambitious, exploratory and ground-breaking project that — (a) addresses a huge problem, (b) proposes a radical solution, and (c) uses breakthrough technology. Liquid biopsy fits the bill. It is a bigger task than any single institution can tackle, and to realize the potential in the next five years instead of 20, there needs to be a true collaboration with strong coordination.” –Andrew Schade, Distinguished Medical Fellow at Eli Lilly and Company, Co-Chair Blood Profiling Atlas
Lauren Leiman is the Senior Director for External Partnerships of the Vice President’s Cancer Moonshot Task Force. Lauren returns to the White House after serving as a member of the advance team for President Bill Clinton and Vice President Al Gore between 1998 and 2000.