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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

April 8, 2019

CARY, N.C.--(BUSINESS WIRE)--Apr 8, 2019--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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190408005079/en/

CONTACT: Sara Schweiger

sara.schweiger@ProjectDataSphere.org

(919) 531-0973

KEYWORD: UNITED STATES NORTH AMERICA NORTH CAROLINA

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS MEDICAL DEVICES ONCOLOGY PHARMACEUTICAL OTHER HEALTH RESEARCH OTHER SCIENCE FDA SCIENCE GENERAL HEALTH

SOURCE: Project Data Sphere, LLC

Copyright Business Wire 2019.

PUB: 04/08/2019 08:00 AM/DISC: 04/08/2019 08:01 AM

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