The Clinical Research Data Sharing Alliance
Developing Collaborative Solutions

A group of leading BioPharma companies, academic institutions, and data-sharing platforms have come together to establish the Clinical Research Data Sharing Alliance (CRDSA). The genesis behind the consortium is to collectively address the myriad of data sharing challenges, shared across the entire ecosystem.

Data Sharing

With increasing calls for sponsors to share data openly, CRDSA provides a single forum for all stakeholders to address the logistical obstacles and data challenges.

Best Practices

CRDSA ensures the resulting solutions have broad multi-stakeholder support, are applicable across all relevant sharing platforms, and can serve as an accepted best practice reference point for data contributors.

Policy & Advocacy

CRDSA creates the unified multi-stakeholder voice needed to effectively advocate for meaningful policy change.

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

Bron-Kisler-Headshot

bron.kisler@crdsalliance.org

Bron Kisler

CEO

Bron is globally recognized for his leadership in international standards development with more than 20-years of experience across a number of Standards Development Organizations (SDOs). He is a Founder of CDISC and served on the leadership team up to 2017 with primary focus on strategic partnerships, fund development, and launching major programs. Bron played a pivotal role in CDISC’s recognition and growth as a global non-profit with membership and partnerships, spanning many countries and life science sectors.

Following CDISC, Bron worked with the National Cancer Institute (NCI) Center for Bioinformatics, where he applied his expertise across a number of big data programs under the Cancer Moonshot Initiative such as Cancer Research Data Commons. He facilitated an important NCI workshop and follow-on activities, which led to the formation of the Center for Cancer Data Harmonization.

Bron is a well-known public speaker and chairman of prominent councils and committees and currently Chairs the ISO Genomics Informatics Committee. As part of this role, he closely coordinates with other SDOs such as the Global Alliance for Genomics & Health (GA4GH) and Health Level Seven (HL7).

Aaron Mann

aaron.mann@crdsalliance.org

Aaron Mann

SVP, Data Science

Prior to joining CRDSA, Aaron 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. He was also a member of the Clinical Trial Data Leadership Team and Platform Lead for the industry’s COVID-19 patient-level data-sharing initiative.

Recognizing the data-sharing opportunities and challenges across the landscape, Aaron led the multi-stakeholder effort behind the establishment of CRDSA.

Aaron’s experience spans global enterprises, high-growth technology companies, and early-stage startups, with a focus on developing data governance and analytics strategies for companies including Visa, SanDisk, Symantec, Capital One, and Lenovo.

Arpana Patel Headshot

arpana.patel@crdsalliance.org

Arpana Patel

Program Manager

Arpana Patel is an experienced program manager with IEEE Industry Standards and Technology Organization (IEEE-ISTO). Prior to joining IEEE-ISTO, Arpana served IEEE in Corporate Governance, specializing in the Board election process. She was also part of the International Standards team at the American National Standards Institute (ANSI) supporting working groups and standards development. Arpana graduated with a degree in Political Science from Rutgers University in New Jersey.

Board of Directors

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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.

Jules Desmond Headshot

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.

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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.

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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.

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.

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.

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.

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.

Virginia Nido

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 Headshot

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.

Sam Volchenboum Headshot

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.