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:
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.
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.
Jon McDunn
Executive Director, Project Data Sphere
Jon is Executive Director at Project Data Sphere, an independent initiative of the CEO Roundtable on Cancer. He currently leads research programs demonstrating how data science can streamline new medicine development in oncology. Those programs include innovative trial designs, pharmacovigilance in cancer immunotherapy, and AI/ML algorithm development to automate medical image analysis. Prior to joining Project Data Sphere, Jon spent over ten years in startup biotech companies. He co-founded Clinical Sensors, a medical device company where he led the development of materials and chemistries to enable next generation wearable sensors; led diagnostic development at Metabolon, a bioanalytical service provider; and began his career in technology development at Incyte Genomics. Jon has held faculty positions in Biomedical Engineering (UNC-Chapel Hill) and Anesthesiology (Washington University in St. Louis). He received his PhD in Biology from The Scripps Research Institute and BS in Chemistry from the California Institute of Technology.
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.
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.
Rebecca Sudlow
Global Lead, Data Sharing, Roche
Rebecca Sudlow is the Global Lead for Data Sharing within the Data Sciences department at Roche. Her team enables the responsible reuse (both internal and external) of patient level data to accelerate the generation of insights to further our understanding of diseases and treatments. Rebecca Sudlow has worked in the pharmaceutical industry for over thirty years. Rebecca began her career as a clinical trial statistician where she designed and analysed clinical trials across all phases of Clinical Drug Development and across a variety of disease areas. She has managed statistical teams and contributed to clinical development strategy for a number of filings. Since 2013, Rebecca has been involved in data transparency, particularly with regard to enabling access to patient level datasets from clinical trials. She was part of the Roche team who worked very closely with GSK to develop the cross-company patient level data sharing platform “clinicalstudydatarequest.com” which launched 01 Jan 2014. Rebecca has a BSc in Applied Statistics and a MSc in Statistics.
Amanda Tweed
Head of Operations and Technology for Statistical and Quantitative Sciences, Takeda
Amanda Tweed is the Head of Operations and Technology for Statistical and Quantitative Sciences at Takeda Pharmaceuticals. Her educational background is in Biostatistics, with time spent at both the University of Pennsylvania and Boston University. She served as a founding member and officer for the American Statistical Association’s Section for Statistical Programmers and Analysts (2009). While more than 20 years have passed since she began her career in clinical research, her exposure to data sharing and its corollaries has been limited to the last five years as the topic’s import to industry has really taken hold. Her current interests include methods for applying a technology framework to regulating access to clinical trial data and developing a deeper understanding of how best to address regional variations in data privacy policy. At Takeda, Amanda serves as an engaged and passionate thought leader in the data sharing space and is frequently called in to consult when questions and unforeseen challenges arise.
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
Stephen Pyke
Chief Clinical Data & Digital Officer, Parexel
Chair, CRDSA Steering Committee
Stephen is the Chief Clinical Data & Digital Officer at Parexel, where he is responsible for leading and directing the design, operational execution, and development of all facets of Parexel’s clinical data strategy. Trained as a Statistician, and prior to joining Parexel, Stephen has held various senior leadership roles in major Pharma companies over 25+ years. Stephen has also been honoured to serve on the Boards of a number of professional and not-for-profit organisations, including: PSI Board Chair, RSS Council Vice President, CDISC Board Chair.