Project Data Sphere Builds on Five Years of Success by Expanding Open-Access Data Platform and Broadening Research Programs that Accelerate New Cancer Patient Therapies

CARY, N.C.–(BUSINESS WIRE)–Five years ago, visionary researchers made a bold decision to create an
open-access platform for cancer clinical trial data designed to
accelerate the development of urgently needed new therapies. As
pharmaceutical companies began to see the value in contributing what had
historically been tightly guarded patient data, the power of the Project
Data Sphere® platform to spur research and speed drug development
became clear.

Today, with 150 datasets representing more than 100,000 patient lives
and with 21 peer-reviewed publications derived from that data, Project
Data Sphere, LLC (PDS) – an independent initiative of the CEO
Roundtable on Cancer Inc.’s Life Sciences Consortium – is
expanding the capabilities of the platform to integrate the power of
machine learning and artificial intelligence.

Leveraging a strong relationship with the U.S. Food and Drug
Administration, the synergy between PDS’ powerful data platform and
recently launched research programs grows as it answers the challenge
issued by the CEO Roundtable’s Founder President George H. W.
Bush to “do something bold and venturesome about cancer.”

“Over its five years of existence, Project Data Sphere has distinguished
itself as both the largest and most productive open-access data platform
for de-identified, individual patient-level data in oncology,” said Mace
L. Rothenberg, Chief Medical Officer at Pfizer and Co-Chair of the Life
Sciences Consortium. “The 21 peer-reviewed publications by
independent investigators from around the world have had a measurable
impact in the field, including the development of a practice-changing
outcome predictive model for prostate cancer. Advances like this would
not have been possible without the data and tools provided by Project
Data Sphere.”

The Project Data Sphere® digital “library-laboratory” will be
providing new capabilities, including expanded data types encompassing
imaging, genomic, and real-world data. New advanced analytic solutions
provided by SAS, including machine learning and updated visual
analytics, are being added to the platform’s already rich set of
analytical offerings, enabling new types of investigations to be
performed.

“The opportunities to increase our impact are driven by information
technology breakthroughs, innovative data science, and the fact that
patients want their data shared for the benefit of all patients,” said
Bill Louv, President of PDS. “We will stage our expansion to deliver
value quickly in areas where PDS has differentiated strengths. We will
continue to focus on innovation in drug development, with guidance from
our partnership with the FDA.”

The U.S. Food and Drug Administration and PDS co-host biannual symposia
focused on targeted research topics. The seventh such gathering, planned
April 17, 2019, will center on PDS’ newest research program,
Immune-Related Adverse Events (irAEs), which is examining the rare but
serious reactions that can occur with the use of immune checkpoint
inhibitor drugs.

“Project Data Sphere, through world-class publications, has ‘proven the
principle’ that data-sharing innovates,” said Martin J. Murphy, Chief
Executive Officer of PDS. “Its unique role may be summed up in three
words: convener, collaborator, catalyst. We are uniquely positioned to
serve as a facilitator between industry, academia, and government. By
convening disparate bodies, we foster collaboration that serves to
catalyze innovative research discoveries. Cancer patients are the
beneficiaries.”

PDS’ Images and Algorithms (I&A) Program will be the theme of a November
symposium. Manually quantifying the size of tumors is both slow and
subject to variability. The I&A Program was created to accelerate these
measurements and reduce variability by developing a machine-learning
algorithm, or “supportive radiologist,” leading to reduced time and
costs associated with cancer clinical trials.

Through its External Control Arms Program, PDS is developing a control
arm based on historical data, initially for small cell lung cancer
(SCLC). This may eliminate the need to enroll clinical trial
participants in a standard of care comparator arm for future novel SCLC
drugs. Finally, PDS’ Rare Tumor Registries Program, which seeks to
leverage real-world evidence for research purposes, is developing a
prototype registry for Merkel Cell Carcinoma, a very aggressive form of
skin cancer.

The research programs underscore the sentiment that it’s not enough to
simply present data on the platform – that “build it and they will come”
is ultimately not enough. Rather, PDS sees a responsibility to provide
context that will illuminate the meaning of its data.

“The value of data depends on context,” said Louv. “What is the
hypothesis to be tested? By adding research programs to the PDS scope,
our data acquisition strategy is value-driven.”

“Since its launch five years ago, Project Data Sphere has been a world
leader in developing a platform that permits open access to
comprehensive cancer data,” said David M. Reese, Executive Vice
President of Research and Development at Amgen and Co-Chair of the Life
Sciences Consortium. “As we seek to further leverage the power of
large datasets to deepen our understanding of disease and the
effectiveness and safety of therapies, Project Data Sphere, through both
its own remarkable dataset and the general model it epitomizes, provides
an opportunity to transform the way we harness science in the battle
against deadly disease.”

About Project Data Sphere, LLC

Project Data Sphere, LLC (PDS), an independent, not-for-profit
initiative of the CEO Roundtable on Cancer’s Life Sciences
Consortium (LSC), manages multiple research programs and
operates the Project Data Sphere® platform (www.ProjectDataSphere.org),
which provides one place where the global research community can broadly
share, integrate, and analyze historical, patient-level cancer data with
the goal of advancing future research to improve the lives of cancer
patients and their families.

About the CEO Roundtable on Cancer

The CEO Roundtable on Cancer, Inc. was founded in 2001, when
President George H. W. Bush challenged a group of executives to “do
something bold and venturesome about cancer within your own corporate
families.” Initiatives of the CEO Roundtable on Cancer
include the Life Sciences Consortium, the CEO Cancer Gold
Standard™ workplace wellness accreditation program, and the CEO
Roundtable on Cancer – China, which was established in 2015 to bring
the CEO Cancer Gold Standard’s employer-led health and wellness model to
China.

Contacts

Sara Schweiger
[email protected]
(919)
531-0973