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Project Data Sphere®, LLC (PDS) is proud to announce the first peer-accepted publication reporting on the multidisciplinary Immune Checkpoint Inhibitor-associated Myocarditis Workshop convened by PDS with support from the Global Oncology Big Data Alliance (GOBDA) and the Parker Institute for Cancer Immunotherapy (PICI). This Checkpoint Inhibitor Safety Working Group included leading clinicians, academic researchers, pharmaceutical companies and regulatory agencies, including the U.S. FDA, China Food and Drug Administrations (CFDA), and the European Medicines Agency (EMA). It represents the power of PDS to bring together all key stakeholders in a safe common harbor on behalf of cancer patients.
This publication in the international cancer medicine journal, The Oncologist, is the 12th peer-accepted manuscript driven by the principle of data-sharing on which PDS was founded. The manuscript, “Myocarditis Associated with Immune Checkpoint Inhibitors: An Expert Consensus on Data Gaps and a Call to Action,” by Dr. Tomas Neilan, et al., identifies a path forward in understanding, diagnosing and treating this rare but serious heart condition arising in some patients whose cancers have been treated with Immune Cancer Therapy.
On June 1, Project Data Sphere, LLC (PDS) hosted a reception at the commencement of the 2018 ASCO annual meeting in Chicago to celebrate accomplishments of the Global Oncology Big Data Alliance (GOBDA). PDS founded GOBDA as a novel strategic organization to provide opportunities for collaboration and cooperation across industry, academia and global regulatory authorities. With our founding GOBDA partner, Merck KGaA, Darmstadt, Germany / EMD Serono, this new organization is initially focused on three areas critical to improving outcomes for cancer patients:
- Rare but serious immuno-related adverse events
- Rare tumor registries
- Expanded datasets to drive new research investigations
The University of Iowa has earned the CEO Cancer Gold Standardaccreditation from the CEO Roundtable on Cancer, a nonprofit that recognizes workplaces that are exceptionally committed to reducing the risk of cancer among employees.
“As a university, our most important asset is our people,” says UI President J. Bruce Harreld. “Since innovative health care is one of the major areas of education, research, and service at the UI, we are especially proud to earn this accreditation. The health and well-being of our university community is of paramount importance to our values and to our success.”
After George Weiner, director of the Holden Comprehensive Cancer Center, secured the gold standard accreditation for UI Health Care last year, Harreld sought to ensure the university as a whole also met the accreditation requirements.
Bill Louv has been appointed President of Project Data Sphere, LLC (PDS). Bill joins PDS after working in roles of increasing responsibility at GSK – Vice President of Information Technology, Chief Information Officer and Senior Vice President of Core Business Services – where he served as a member of GSK’s Corporate Executive Management team from 2007 through 2016.
Bill’s recognized expertise in not only Information Technology, but also mastery of scientific inference as exemplified by his PhD in Statistics from the University of Florida and executive responsibilities for Global Statistics and Clinical Data Management at Marion Merrell Dow, brings a new era of insight and investigation to PDS. This era will see the wealth of cancer clinical trial data that has been aggregated, and that continues to grow, in PDS’ cancer research platform yield further meaningful and novel insights to the community of cancer researchers, physicians and patients.
With data now representing more than 121,000 patient lives leading to the publication of 11 (and increasing in number) peer-accepted manuscripts, the PDS web-based library-laboratory stands poised to deliver new discoveries to improve cancer patient outcomes, and I’m thrilled to have Bill on board to enable the research community to identify these new insights.
On October 24 near US Food and Drug Administration headquarters in Bethesda, MD, we co-hosted our fifth FDA-PDS Symposium on “Growing Dimensions of Big Data in Cancer Research.” These forums offer a unique opportunity for collaboration between often competing research entries in the world of life sciences: industry, academia and the regulatory agencies that govern them.
Propelled by recent collaborative progress such as the New England Journal of Medicine (NEJM) Project Data Sphere-inspired "Sounding Board" article, "Advantages of a Truly Open-Access Data-Sharing Model" and the issuance of a Letter of Support from Dr. Pazdur, his first as Director of the Oncology Center of Excellence, participants will provide updates and data sharing innovations from the FDA’s Oncology Center of Excellence, the Project Data Sphere initiative, and highlight other advances and opportunities in oncology treatment, research and development and regulatory science.
These Symposia also provide opportunities for open dialogue among oncology and data science leaders from academia, government, and industry, combining rich blend of expertise with a common mission of improving cancer patient outcomes. The discussion at Symposium-IV, for instance, advanced our efforts to promote innovative data-sharing in Immuno-Oncology, one of the most promising areas of contemporary oncology clinical trials.
On October 12, QuintilesIMS hosted a CEO Cancer Gold Standard “Friendraiser” to celebrate the 10-years of Gold Standard leadership of QuintilesIMS, Duke Health, GlaxoSmithKline plc and SAS and to introduce the Gold Standard to other North Carolina-based employers. The following day, a workshop was held at QuintilesIMS' headquarters in the Research Triangle Park, NC, to provide hands-on accreditation assistance to HR staff whose employers accepted the invitation to “Go for the Gold.”
On September 10, 2017, Project Data Sphere®, LLC, entered into a strategic collaboration with Merck KGaA to jointly lead the Global Oncology Big Data Alliance (GOBDA). The signed Memorandum of Understanding described three critical pillars of this emerging alliance:
• Growing the value of the core Project Data Sphere cancer research platform by providing additional data (in terms of more patients and more trials), as well as new types of data.
• Enabling the development and implementation of a Rare Cancer Patient Registry. This Registry will aggregate in a common platform the limited data available on the treatment of rare cancers. This will help to amplify it as a shared resource for future investigation and analysis.
• Supporting novel investigations into rare but serious adverse events associated with emerging immuno-oncology therapies.
In September, CEO Roundtable on Cancer Founder, President George H. W. Bush, welcomed His Excellency, WANG Yu, MD, PhD, as Honorary Chairman of CEO Roundtable on Cancer-China. He is the recently retired Director General of the China-CDC. Professor WANG Yu has been a longtime and leading supporter of the CEO Roundtable’s work in China, and in 2016 established the China-CDC as one of its country’s first and foremost Gold Standard accredited workplaces in 2016.
In July of this year, the CEO Roundtable and China-CDC signed a Memorandum of Understanding to further promote the Gold Standard in China and collaborate on the expansion of cancer research, as well as health promotion and cancer prevention efforts in China.
Created with support from a Robert Wood Johnson Foundation (RWJF) grant to encourage university CEO Cancer Gold Standard outreach and accreditation, the recently launched University Toolkit provides an online resource of best practices, FAQs, policy models and supporting research publications.
The Gold Standard is an employer-led health and wellness initiative designed to both acomdate and encourage employers of diverse organizations who wish to lead by example through their workplace policies and culture.The current version of our Toolkit, however, is specifically designed to address some of the challenges unique to an academic campus environments.
More than eighty executives from more than thirty companies, more than ten hospitals and NGOs and nearly twenty government officials, including His Excellency Yupeng ZHOU, Former Vice Mayor of Shanghai, President of Shanghai Services Federation; Prof. Yu WANG, Director General, China CDC and Dr. Jinglei WU, Director General, Shanghai Municipal Health and Family Planning Commission, convened in the Four Seasons Hall, of the Xijiao State Guest Hotel on April 19, 2017 for CEO Roundtable on Cancer-China IV.
Prof. ZHAO Guoping, Chief Scientist of the Shanghai Health Academy Chinese Academy of Science (CAS) co-hosted the meeting, a highlight of which was the announcement of a Memorandum of Understanding between the CAS-MPG Partner Institute for Computational Biology and the CEO Roundtable on Cancer to align respective Big Data initiatives to facilitate overall global health research.
Dr. WANG Zefeng, Director of CAS-MPG Partner Institute for Computational Biology, said of the collaboration between the CEO Roundtable and Shanghai Institutes for Biological Science, CAS, "It’s time for us to use the data we already have to make some differences in the world. Data and science changes fast nowadays and changes our ways of thinking…I believe PDS will be the future of open access data-sharing.” Following his keynote address, CEO Roundtable on Cancer Chairman, Robert A. Bradway, participated in a signing ceremony with Prof. WANG Zefeng.
The CEO Roundtable on Cancer has signed its first-ever Memorandum of Understanding with a province of China. In this, the most recent of now four Memoranda executed in China, the CEO Roundtable together with the province of Hainan; agreed to a range of wellness promoting and research advancing initiatives. These include helping hospitals in the province lead by example in becoming CEO Cancer Gold Standard accredited, promoting HPV screening and vaccinations, establishing medical resource exchanges, and enabling collaborative big data research activities through the Project Data Sphere platform.
At the 20th Annual Meeting of the Chinese Society of Clinical Oncology (CSCO), Dr. Martin J. Murphy, CEO of the CEO Roundtable on Cancer, was presented with an Outstanding Foreign Advisor Award. Dr. Murphy was recognized for his longtime and ongoing contributions to the advancement of oncology research and treatment in China and around the globe.