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, patient advocacy groups, and service and technology partners. This diverse and growing group 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 data collected through the clinical development process.

CRDSA is governed by a board of directors, with representation evenly balanced between industry and nonprofit/academic organizations. A board-chartered steering committee, with a senior-level representative from each member organization, 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

Board of Directors

Peter Mesenbrink, PhD – Board Chair

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.

Peter has active research interests in statistical methodology for estimands/handling of missing data, design of group sequential and adaptive/platform designs, machine learning methods, use of historical controls, methods for analysis of rare events, and how to maximize the sharing of data in the external scientific community.  Peter is actively involved in finding the best solutions for providing effective treatments and solve the unanswered scientific questions that have arisen during the Covid-19 pandemic. Peter has authored and co-authored around 40 papers published in peer-reviewed scientific journals and is a statistical reviewer for several peer-reviewed journals and in 2021 is the editor of the ASA Biopharm Report.

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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.

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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.

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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

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.

Bill has consulted with many organizations on health care analytics and opportunities to leverage big data. He is a Non-Executive Director of River Logic Inc., a leader in Prescriptive Analytics and Integrated Business Planning, and he is Deputy Chairman of ClinPal, a cloud-based clinical trial platform.

In his early career, Bill was a member of the technical staff at Bell Laboratories where he developed forecasting algorithms for signaling networks. Subsequently, he was Associate Professor of Biostatistics at the University of Alabama at Birmingham. Bill published more than 25 academic papers while at these research organizations.

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.

Andrew was Chief Scientist at the Scottish Government Health Directorate (2012-2017) and has served and chaired numerous national and international grant committees and Governmental bodies.

His research interests span informatics and chronic diseases. He has published over 350 original papers.

Andrew was previously Governor of the Health Foundation (2009-2017), a leading UK charity that supports quality improvement in health care, and chaired the Informatics Board at UCLPartners, London (2014-2017). In 2007 he co-founded Aridhia Informatics, which uses high performance computing and analytics in health care.

He is a Fellow of the Royal Society of Edinburgh and the Academy of Medical Sciences.

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.

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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.

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.

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Sam Volchenboum, MD, PhD (Immediate Past Chair)

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.

CRDSA Team

aaron.mann@crdsalliance.org

Aaron Mann

CEO

Aaron is the Chief Executive Officer of CRDSA. He led the 2021 multi-stakeholder effort to establish CRDSA and initially served as Senior Vice President, Data Science.

Before his role at CRDSA, he was Roche and Genentech’s Global Program Lead for Industry Collaborations Data Sharing Initiatives. As part of his role at Roche, Aaron served as the industry lead for DataCelerate, TransCelerate BioPharma’s data-sharing platform, and Platform Lead for the industry’s COVID-19 patient-level data-sharing initiative.

With experience that spans global enterprises, high-growth technology companies, and early-stage startups, Aaron has over 20 years of experience in data strategy and governance, technology development, and cross-organization information collaboration.

andrew.freeman@crdsalliance.org

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. This is the UK’s clinical study registry.

Advisors

Virginia Nido

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.

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.