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Initiative Updates: Project Data Sphere
Are registries the key to advancing treatment of rare cancers? We hope to find answers to that question and to identify obstacles blocking the promise of registries and solutions to overcome those challenges in the FDA-PDS Symposium IX on Oct. 7.
This symposium will be held online for the first time but the goal is the same as in past years: elevate the conversation about this research area, which is ripe for fresh attention and energy from academia, industry and FDA. The event will run from noon until about 3 pm EDT.
We are honored and excited to welcome keynote speaker Dr. David Fajgenbaum, a groundbreaking physician-scientist, disease hunter, speaker, and author of the national bestselling memoir, Chasing My Cure: A Doctor's Race to Turn Hope Into Action.
Fajgenbaum nearly died five times battling Castleman disease. To try to save his own life, he developed and led an innovative approach to research through the Castleman Disease Collaborative Network (CDCN) and discovered a possible treatment that has put him into an extended remission.
We are eager to hear the unique perspectives and insights of Dr. Fajgenbaum. This is a session that’s sure to inspire.
The symposium brings together multiple stakeholders representing most aspects of the rare disease challenge: practice in the clinic, pharmaceutical research, policy and regulatory science, and patient advocacy to brainstorm the operational dynamics between the groups.
Mark your calendar. More details and registration information will be coming via email soon.
More than 2,400 researchers are using the Project Data Sphere® platform to answer important questions about cancer. Many of them have offered feedback on how we can make the platform even easier to use. We are delighted to announce that we expect an updated platform to be available early in 2Q 2020.
A new PDS website will be launched at the same time, offering more information on our programs, introductions to new program managers and easier ways to communicate with us.
The website will be a place that you can register for important events like the PDS Symposium IX on rare cancer registries that we are planning for Oct. 7, 2020, in the Washington DC area.
This annual symposia series has consistently elevated the conversation about research areas that are ripe for fresh attention in the realm of cancer clinical trials, often deriving major new thrusts from academia, industry as well as from our FDA.
Rare cancer registries hold potential to solve some of the most difficult challenges to advancing treatment of these rare cancers, which account for more than 25% of the cancers reported worldwide.
The symposium attempts to bring together multiple stakeholders representing all sides of this challenge: Practice in the clinic, Pharmaceutical research, Policy and regulatory science, and Patient advocacy to brainstorm the operational dynamics between the groups.
Registries can impact these four areas in the following ways:
- Refine clinical decision making and more effectively manage patient therapy.
- Assist pharma in designing comparator arms efficiently, thus accelerating the drug development process.
- Inform regulators who must decide whether to approve new medicines and how to use them in rare cancers.
- Provide relief for the suffering patients with better treatment strategies.
Symposium IX will consider how registries for rare tumors might address these existing shortcomings and drive improvements in patient care. More information will be coming soon.
More than 90 experts in the oncology community were convened on April 17, 2019, in Bethesda, Md., to focus on immune-related adverse events (irAEs) that can occur with the use of combination checkpoint blockade therapies. Co-sponsored by Project Data Sphere, LLC (PDS) and the U.S. Food and Drug Administration (FDA), this symposium focused on ways to strengthen irAE and toxicity reporting and data collection so as to better understand which patients are more likely to suffer these often-devastating adverse events. As attendees learned from a patient advocate who spoke, it is not unheard of for a patient who succumbs to an irAE to be tumor-free at the time of death.
Thought leaders organized presentations and panels on the clinical presentation of irAEs and toxicity during combination therapy, preliminary findings from immune checkpoint inhibitor (ICI) clinical trial data submitted to the FDA and post-marketing surveillance data, and current initiatives to accelerate knowledge with biorepositories and patient registries. The Symposium was distinguished by the FDA presentations of selected clinical trial data on ICIs and the post-market surveillance (FAERS) data on adverse events associated with ICIs; neither of these rich FDA data sources had ever been presented.
Now that Project Data Sphere has established itself as a world-class data-sharing platform, the group's leadership is planning for its next phase of the struggle against cancer. In this In Vivo piece, PDS President Bill Louv talks about how the organization has "raised the bar on what is possible to achieve in cancer research."
More than 60 oncologists, data scientists, pharma/biotech industry leaders, patient advocates, health science research investigators, and regulators representing myriad esteemed institutions convened in Bethesda, Md., on August 8 for Project Data Sphere, LLC’s (PDS) sixth symposium co-sponsored with the U.S. Food and Drug Administration (FDA). With the goal of accelerating new options for small cell lung cancer patients (SCLC) in a stagnant treatment landscape, PDS is collaborating with the FDA on the development of an external control arm for SCLC clinical trials. This would enable patients to be enrolled directly into a trial’s new drug investigational arm, which ultimately would reduce the number of patients per trial as well as the cost and time of discovery for new treatment options. The daylong event featured a combination of individual and panel presentations and lively discussions
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
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 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.