The Clinical Research Data Sharing Alliance
Developing Collaborative Solutions
Established in 2021, the Clinical Research Data Sharing Alliance (CRDSA) is a multi-stakeholder consortium that serves the clinical data sharing ecosystem. Our members include biopharma companies, nonprofit data sharing platforms, academic institutions, and service and technology partners. This diverse and growing group of stakeholders comes together with the shared goal of accelerating the discovery and delivery of life-saving and life-changing therapies to patients by expanding the research value of the high-quality data collected through the clinical trial process.
CRDSA is governed by a Board of Directors, with representation evenly balanced between industry and non-profit/academic organizations. A Board-chartered Steering Committee, comprised of 20 senior-level member representatives, governs CRDSA’s Work Groups. The Steering Committee ensures that Work Group activities support CRDSA’s strategic objectives with actionable and achievable deliverables.
CRDSA creates a forum to:
Address challenges across the life sciences data sharing ecosystem
Ensure the integrity, quality, and usability of contributed data through common data standards and best practices
Advance a FAIR data environment to promote consistency, reuse and broad access
Drive policy change to support the data sharing ecosystem, facilitating broader access and research value
Advocate and promote the value and use of shared data across the stakeholder landscape
Develop new and innovative approaches to advance data sharing principles
CRDSA Team
Board of Directors
Peder Blomgren
Vice President and Head of Data Office, AstraZeneca R&D
Peder serves as a leading data pioneer in the global biopharma AstraZeneca – a company that has geared its strategy to rely on Data, AI, and Digital as a foundational capability, to push the boundaries of science to deliver life-changing medicines.
He is the leader behind the Data Science & AI value program, the acclaimed Responsible Data & AI approach, and the rapid build of a Science-driven Data Office, geared to deliver world-class open analytics-ready science data with compliance by design. Leading data governance, his team rallies the organization around data strategy, policy, and a range of FAIR data services, to achieve the highest priorities for pipeline and ecosystem impact.
Over his professional career, he has led businesses, departments, and drug projects – self-motivated with passion and drive, to achieve the unprecedented, and make a difference where it matters the most.
Jules Desmond
Executive Director, Amgen
Jules Desmond is the Executive Director, Head of the Strategic Development Organization, Global Clinical Development at Amgen, and workstream lead for TransCelerate’s Historical Trials Data Sharing Initiative. Jules is an experienced clinical developer, working on product clinical strategy across the clinical development life cycle. His 15 years industry experience, across multiple disease areas, follow 10 years of academic molecular and cellular oncology research.
Elaine Hoffman, PhD
Senior Director, Head of Gastroenterology Statistics and Operations, Takeda
Elaine Hoffman, PhD, is the Head of Gastroenterology Statistics and Operations for Statistical and Quantitative Sciences within the Data Science Institute at Takeda. She has over 20 years of experience as a biostatistician within industry and academia with prior faculty appointments at Harvard Medical School and UNC-CH. Elaine is a recognized leader at Takeda both in operational delivery excellence and in the statistical aspects of drug development. Externally, Elaine continues to be published in high-profile journals and she was the plenary speaker at the Phastar Life Science Summit in June 2021. Elaine’s ongoing work with the UNC-Chapel Hill SPH Foundation Board and ASA Biopharmaceutical Section highlight her contributions to the public health and biopharmaceutical communities outside of Takeda as well. She earned her MS and PhD in biostatistics from the UNC-CH School of Public Health.
Rebecca Li, PhD
Executive Director, Vivli
Rebecca Li, PhD, is the Executive Director of Vivli and on faculty at the Center for Bioethics at the Harvard Medical School. Previous to her current role she was the Executive Director of the MRCT Center of Brigham and Women’s Hospital and Harvard for over 5 years and remains a Senior Advisor at the Center. She has over 25 years of experience spanning the entire drug development process with experience in Biotech, Pharma and CRO environments. She completed a Fellowship in 2013 in the Division of Medical Ethics at Harvard Medical School. She earned her PhD in Chemical and Biomolecular Engineering from Johns Hopkins University.
Richard Liwski
Chief Technology Officer, Critical Path Institute
Richard Liwski is the Chief Technology Officer and Director of Critical Path Institute’s Data Collaboration Center, where he is responsible for aligning C-Path’s Technology strategy with the organization’s goals, for the architecture and development oversight of data sharing initiatives in support of C-Path consortia and for the data curation, management and standardization activities to support all of C-Path’s Data Collaboration Center projects. In addition, he oversees the development of data standards projects in partnership with the Clinical Data Interchange Standards Consortium (CDISC). Richard also serves as C-Path’s Chief Privacy Officer, responsible for the definition, implementation, training and monitoring of C-Path’s policies for handling of clinical data to ensure that all applicable government regulations are met.
Bill Louv
President, Project Data Sphere
Bill joined Project Data Sphere in March 2018 as President.
Bill held key leadership positions in the pharmaceutical industry for nearly 30 years. He joined the pharmaceutical industry in 1986 as head of biostatistics at Merrell Dow and advanced to the position of VP of biostatistics, epidemiology, and clinical data management at GlaxoWellcome in 1998. Bill made a significant career change in 1999 when he became VP of IT for GlaxoSmithKline’s R&D organization. Bill was named Chief Information Officer for GSK in 2007. In 2011, Bill was promoted to Senior VP of Core Business Services which included IT, Procurement, Accounting, and Real Estate. Bill was a member of GSK’s Corporate Executive Management team from 2007 until his retirement in May 2016.
Peter Mesenbrink, PhD
Executive Director of Biostatistics, Novartis
Peter Mesenbrink, PhD is an Executive Director of Biostatistics at Novartis Pharmaceuticals Corporation in East Hanover, New Jersey. Peter received his Bachelors of Science in Mathematics from the University of Vermont in 1989 and a PhD in Statistics from North Carolina State University in 1995. He joined Novartis in 1995 (then Ciba-Geigy), first working in Neuroscience Biostatistics and in Immunology, Hepatology, and Dermatology since 2001.
Professor Andrew Morris
Director, Health Data Research UK
Professor Andrew Morris became the inaugural Director of Health Data Research UK in August 2017, the UK’s national Institute for health data science. Its mission is to unite the UK’s health data to improve people’s lives and is supported by 12 funders. He also convenes the International COVID 19 Data Alliance (ICODA) supported by the Bill and Melinda Gates Foundation and Minderoo Foundation. He is seconded from his position as Professor of Medicine, and Vice Principal of Data Science at the University of Edinburgh, having taken up position in August 2014. Prior to this Andrew was Dean of Medicine at the University of Dundee.
Virginia Nido
Global Head, Product Development Industry Collaborations, Roche
Virginia Nido is an experienced leader with over 25 years of industry experience in late phase drug development. Virginia is passionate about innovation in clinical research through pre-competitive industry collaborations. Virginia is the global head of Industry Collaborations at Roche. Virginia serves on the TransCelerate Integrated Leadership Team, the Clinical Trials Transformation Initiative Steering Committee, the Global Impact Partnership Board of the Society for Clinical Research Sites, and the Board of Trustees of the Association for Clinical Research Professionals.
Liz Roberts
Senior Director, Data Policy and Privacy, UCB
Liz Roberts is Senior Director, Data Policy and Data Privacy at UCB and an advisor to Real Life Sciences. She is lead for TransCelerate’s Provenance workstream and co-lead for its Data Protection Methodology workstream as well as having been an active member of the COVID R&D Alliance. Her career spans almost 30 years, starting in Biostatistics before transitioning to various aspects of data disclosure, sharing, anonymization and privacy. Her current responsibilities blend data enablement (maximizing the potential of available data sources) with data privacy (performing the role of a data protection officer). Particular areas of interest include increasing the value that responsible data sharing can bring to people living with severe diseases, the legal framework supporting data sharing activities, and the co-creation of forward-looking, ethical policies and deliverables.
Frank Rockhold, PhD
Professor of Biostatistics and Bioinformatics, Duke Clinical Research Institute and Duke University Medical Center
Frank is currently Professor of Biostatistics and Bioinformatics at the Duke University Medical Center, Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Managing Partner of HunterRockhold, Inc. He has diverse research interests and consulting experience including trial design, data monitoring, benefit/risk, and pharmacovigilance and has been a leader in the scientific community in promoting data disclosure and transparency in clinical research. His career includes numerous senior management positions in industry, most recently as Chief Safety Officer and senior vice president for pharmacovigilance at GSK. Dr. Rockhold has served as Chairman of the board for CDISC and president of the Society for Clinical Trials. He also served on the inaugural PCORI Clinical Trials Advisory Board and is currently Chairman of the board of the Frontier Science Research Foundation and an advisor to EMA. Frank serves on numerous Independent Data Monitoring Committees.
Sam Volchenboum, MD, PhD
Director, Pediatric Cancer Data Commons
Dr. Volchenboum is an associate professor of pediatrics and the associate chief research informatics officer for the biological sciences division at the University of Chicago. He is the Dean of Masters Programs, and he designed and launched the UChicago Master’s in Biomedical Informatics. His clinical specialty is pediatric hematology / oncology, caring for kids with cancer and blood diseases. His research group includes the University of Chicago’s Pediatric Cancer Data Commons, a group dedicated to liberating and democratizing international data for pediatric malignancies. He is the director of the Informatics Core for the Clinical and Translational Science Award (CTSA), and he is director of the UChicago Clinical Informatics fellowship program.
Advisors
Bron Kisler
Senior Advisor
Most recently, Bron worked with the Founders and Board of Directors for the Clinical Research Data Sharing Alliance to launch the non-profit alliance in 2021. As Senior Advisor, he will continue to work with leadership and the Board of Directors. Bron is globally recognized for his leadership in clinical research and international standards development with more than 20-years of experience across a number of SDOs.
Bron is a Founder of CDISC and served on the leadership team for many years, playing a pivotal role in CDISC’s success around the world. Following CDISC, he worked with the NCI Center for Bioinformatics, applying his expertise across a number of big data programs under the Cancer Moonshot Initiative. He is a well-known public speaker and has been chairman of prominent councils and committees in clinical research, healthcare and currently chairs the ISO Genomics Informatics Committee.
Barrie Nelson
Chief Standards Officer, Nurocor
Chair, CRDSA Steering Committee
With more than 25 years of experience in the BioPharma industry (Biostats, Data Management, and Data Standards) Barrie Nelson has broad operational understanding of the clinical development process. With a focus on clinical data standards for the latter part of his career, Barrie has first-hand knowledge of the application of standards in Clinical Research. Barrie proved the value of comprehensive standards, after setting up an end-to-end standards group at Amgen (Protocol to TFL). Barrie is now working with Nurocor clients to realize the vision of a standards driven digitalized clinical development process. Barrie strongly believes that the marriage of data standards and the Nurocor Clinical Platform provides the digital backbone for clinical trials and that digitalization is the future for the Pharma industry, to serve patients, and, to bring new therapies to the market sooner.