Developing Collaborative Solutions
CRDSA is a multi-stakeholder nonprofit alliance whose members include biopharma companies, academic institutions, and nonprofit organizations engaged in clinical data sharing. Established in 2021, CRDSA creates a neutral forum for organizations to collectively address the logistical, cultural, and policy challenges faced by both data contributors and research users. Our work to-date includes publishing standards for sharing clinical study data and for secondary research use; best practices for data reuse in regulatory submissions; external controls policy advancement; and tools for evaluating data sharing plans and data contributions.
Our membership spans data contributors, researchers, and data platforms, giving us insight into the data and interoperability challenges at every stage. Our flagship initiative, Project Concordia, is designed to support the research ecosystem by addressing critical gaps in clinical research data interoperability.
LEADERSHIP
Team & Advisors
Aaron Mann
Chief Executive Officer
Aaron is the principal architect of CRDSA’s Project Concordia, an agentic AI platform to deliver clinical data harmonization as scalable and reproducible infrastructure. He led the 2021 multi-stakeholder effort to establish CRDSA and initially served as its Senior Vice President, Data Science. Before co-founding CRDSA, he led Roche’s industry collaborations data sharing initiatives and, as the industry lead for TransCelerate BioPharma’s data-sharing platform, drove the industry’s COVID-19 patient-level data-sharing initiative.
Aaron’s current work sits at the intersection of AI strategy and clinical research infrastructure — applying agentic AI and large language models to solve data interoperability challenges that have historically blocked secondary use of patient-level data at scale. With over 25 years of experience spanning global enterprises, high-growth technology companies, and early-stage startups, he brings deep expertise in AI-enabled data strategy, cross-organization collaboration, and the regulatory and governance frameworks that shape how AI can be responsibly deployed.
Andrew Freeman
Senior Advisor, Standards Development
Andrew has been involved in clinical study transparency for over 20 years. He was previously Head of Medical Policy at GlaxoSmithKline, and led the company’s clinical study disclosure initiatives including the industry leading program to share patient level data from clinical trials for further research. This led to the development of the ClinicalStudyDataRequest.com web site and Vivli.org where researchers can now access patient level data from a number of sponsors. In addition, Andrew is the non-executive chair of the not-for-profit ISRCTN company which owns the ISRCTN clinical study registry, the UK’s clinical study registry.
Annie Curti
Commercial Director, Hematology Oncology, Novartis
CRDSA Growth Strategy Advisor
Annie Curti is an accomplished business leader whose influence spans across consulting and industry, with a deep-rooted focus on growth strategy and revenue management. Renowned for her ability to transform organizations, Annie has a proven track record in leading new product planning, accelerating market penetration, and optimizing commercial performance. Her expertise in harnessing data-driven insights, scaling digital platforms, and deploying innovative solutions has enabled companies to achieve sustainable growth and robust profitability. Beyond her corporate achievements, Annie plays a pivotal role in championing diversity and innovation in the venture capital ecosystem. As a limited partner at “How Women Invest,” a women-led venture capital firm, she actively advises female founders on go-to-market (GTM) strategies, empowering them to break barriers and redefine industry standards.
Virginia Nido
Global Head, Product Development Industry Collaborations, Roche
CRDSA Co-Founder, Past Board Chair, CRDSA Steering Committee Member
Virginia Nido is the global head of Industry Collaborations for Roche and Genentech. She is the co-founder and past board chair of the Clinical Research Data Sharing Alliance. Virginia serves on leadership teams for the Clinical Trials Transformation Initiative, the Society for Clinical Research Sites, the Association for Clinical Research Sites, and the Tufts Center for the Study of Drug Development, and she is a former member of the TransCelerate Integrated Leadership Team. She holds an undergraduate degree from Barnard College, a Master degree in education from the University of Pennsylvania, and professional certificates in Bioethics from Columbia University and Precision Medicine from the Harvard Business School. Virginia is passionate about the power of industry collaborations to improve the efficiency and quality of clinical research.
GOVERNANCE
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.
Prior to joining Critical Path Institute, Richard spent 26 years at IBM that included roles in storage product development, functional area management, program management, brand/marketing management and customer relationship management. His IBM experience included assignments working with major US pharmaceutical companies and healthcare providers as the technical focal point for their data storage needs.
Jon McDunn
President
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.
Stephen Pyke
Executive Committee Member
Clinical Trials Transformation Initiative
Stephen Pyke was the Chief Clinical Data & Digital Officer at Parexel, where he was responsible for leading and directing the design, operational execution, and development of all facets of Parexel’s clinical data strategy. Stephen trained as a statistician, and prior to joining Parexel held various senior leadership roles in major pharma companies over 25-plus years. Stephen has served on the boards of a number of professional and not-for-profit organizations, with roles including PSI (Statisticians in the Pharmaceutical Industry) Board Chair, RSS (Royal Statistical Society) Council Vice President, CDISC (Clinical Data Interchange Industry Consortium) Board Chair and Chair of the ACRO (Association of Clinical Research Organizations) AI/ML Committee.
Frank Rockhold, PhD
Professor of Biostatistics and Bioinformatics
Duke Clinical Research Institute
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.
Dr. Rockhold holds a BA in Statistics from The University of Connecticut, an ScM in Biostatistics from The Johns Hopkins University, and a PhD in Biostatistics from the Medical College of Virginia at Virginia Commonwealth University. He is an Elected Fellow of both the American Statistical Association, the Society for Clinical Trials, and the Royal Statistical Society. He is an Accredited Professional Statistician, PStat®, and a Chartered Statistician, CStat.
Jennifer True
Executive Director
Takeda
Jennifer True is an Executive Director, responsible for the therapeutic programming department within the Statistical and Quantitative Sciences organization at Takeda. Jennifer received her Master’s in Public Health from Drexel University in 2010 and her BA in Mathematics from Arcadia University in 2000. She has spent 20+ years in the pharmaceutical industry, providing clinical and statistical programming support for clinical development, medical affairs and worldwide submissions in various therapeutic areas having held positions at both pharmaceutical and clinical research organizations. Having spent years working with data and looking for quantitative decisions stemming from that data, CRDSA is a great organization to further those pursuits.
Sam Volchenboum, MD, PhD
Director, Pediatric Cancer Data Commons
University of Chicago
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.