Michael Buckley (Mike) has served as CRIT’s Associate Director of Product Management since October 2022. In this role, he leads diverse teams who translate user needs into transformative digital products that improve the quality, cost, and experience of healthcare for MSK clinical research customers.

Michael joined MSK in 2008. He served as the Manager of Enterprise Clinical Research Innovation (2014-2022) and, earlier, as Manager of the Department of Medicine Clinical Trials Office. Prior to joining MSK, Michael was Associate Research Scientist and Manager of the Clinical Core Laboratories of The NYU School of Medicine’s Cancer Institute, which included the radiochemistry, pharmacokinetics, and pharmacodynamics core facilities.

Michael holds a BS in Chemistry from Allegheny College, an MS in Biology from NYU, and an MBA, with a specialization in high technology, from Northeastern University. With more than 20 years of experience in oncology research; he is also the Co-Founder and Co-Chair, of the Society for Clinical Data Management’s eSource Implementation Consortium.

Anne Moen is full professor at the Faculty of Medicine, University of Oslo, Oslo, Norway, and adjunct Professor, Norwegian Center for eHealth Research, Tromsø, Norway. She is Director of UiO:eColab, a research lab supporting technology mediated complex, patient focused interventions, and multidisciplinary teamwork to sustain health and wellbeing. Her program of research seeks to understand digital citizens centered services, based on opportunities to “collect, curate and control” all relevant, personal health information, emphasizing citizen empowerment, digital health literacy and overall engagement for health and wellness.

Professor Moen is the Academic Coordinator of “Gravitate – Health: Empowering and Equipping Europeans with Health Information from trusted sources for active, safe, secure personal health management and adherence to treatment” (project 945334, IMI2 JU, 2020-2026). Gravitate-Health’s mission is to prepare and test innovative, easy-to-use, elegant digital services that actively engage and empower citizens and their support network with access to and understanding of health information from trusted sources. More information is available at www.gravitatehealth.eu. Collaboration within VULCAN accelerated the creation of the Global Medicinal Product Information (ePI) IG through balloting by HL7 and active use in Gravitate-Health.

Professor Moen was President of EFMI (European Federation for Medical Informatics) (2014 – 2016), representative in EU eHealth stakeholder group (2015 – 2019) and rapporteur for exploration of “Citizens – health data”. She served as Board Chair, HL7 Europe (2023-2024), member of the HL7 Europe Board of Directors (2022-2024) and member of the HL7 Vulcan Accelerator Steering Committee (2022 – 2024). She is fellow of ACMI (American College of Medical Informatics) 2015, founding fellow of IAHSI (International Academy for Health Sciences Informatics) 2017, and elected Honorary Fellow of EFMI from 2019.

Dr. Garza is an Associate Professor and Clinical Research Informaticist at the University of Texas Health Science Center at San Antonio (UTHealth San Antonio) with 12+ years of experience in clinical research and public health informatics.

Throughout her career, she has managed several national and international projects, providing informatics and operational support in the areas of workflow and data flow analysis, systems development, data standards development and implementation, and data management for both single- and multi-site clinical trials. She has extensive experience in healthcare data and messaging standards, secondary use of EHR data for clinical and public health research, data quality, and interoperability and healthcare information exchange; and has been heavily involved in the
optimization of real-world data systems for clinical research. She has worked closely with Pharmaceutical Companies, Technology Vendors, Federal Agencies, and other Standards Development Organizations over the course of her career.

She has been an active, voting member of HL7 since 2012, participating in several working groups: Biomedical Research and Regulation (BR&R), Clinical Interoperability Council, and Public Health. She has been an active Co-Chair for BR&R and Co-Chair of the Vulcan Operations Committee, both since 2022.

Health data and informatics educator for Duke School of Medicine, MMCi program.

Mohammad Adibuzzaman, PhD, is an Assistant Professor at Oregon Health & Science University and Director of Informatics at the Oregon Clinical and Translational Research Institute (OCTRI). He leads the Informatics program, supporting clinical and translational research through data infrastructure, governance, and innovative software development.

His research centers on clinical research informatics, ethical artificial intelligence, and digital health tools to advance equity, patient empowerment, and transparency in healthcare. Previously, he served at Purdue’s Regenstrief Center for Healthcare Engineering and as an ORISE Fellow at the U.S. Food and Drug Administration. Dr. Adibuzzaman earned his PhD and MS in Computational Sciences from Marquette University and his BS in Computer Science and Engineering from the Bangladesh University of Engineering and Technology (BUET), the nation’s premier engineering institution.

Anita Walden is an Associate Professor and Associate Director of Translational and Integrative Initiatives at the University of North Carolina at Chapel Hill. A national and international leader in Clinical Research Informatics, she specializes in the integration of real-world data (RWD), digital health technologies, and the implementation of clinical research standards to advance interoperable, data-driven research ecosystems.

She has led multiple national RWD platform development and data accessibility initiatives, bringing extensive experience from both pharma and academia, where she has directed data operations for over 20 global clinical trials across 15 countries. Her career has centered on developing and implementing data and exchange standards across clinical and community domains to create scalable, interoperable infrastructures that support both research and patient care. She currently serves as the operational lead for a large national RWD data linkage initiative focused on enriching existing research repositories and advancing methods for integrating diverse real-world data sources.

A dedicated advocate for standards-based collaboration, she has worked closely with the FDA, WHO, CDISC, professional organizations, and HL7 to advance methodologies that enable the use of RWD in regulated research. She is a founding member of HL7 Vulcan and has held multiple leadership roles within HL7, including current member of the Vulcan Operations Committee, founding member and past co-chair of the Clinical Interoperability Council (CIC), and publication facilitator.

Throughout her career, she has been deeply committed to engaging a range of stakeholders in building an infrastructure that accelerates data integration, strengthens interoperability, and ultimately improves population health.

Stephen Konya serves as the Chief, Innovation and Strategic Partnerships for the Assistant Secretary for Technology Policy (ASTP), U.S. Department of Health and Human Services (HHS). In addition to shaping the Agency’s long-term innovation strategy, he also serves as the primary liaison to the White House Office of Science and Technology Policy (OSTP), the Networking and Information Technology Research and Development (NITRD) Program, and manages the agency’s relationship with the external healthcare start-up and investor community.

Furthermore, Mr. Konya also leads the Digital Health Innovation Workgroup under the Federal Health IT Coordinating Council, an interagency collaboration community comprised of innovation representatives from 40 other federal agencies. In addition to currently serving as the primary Federal Govt lead and Co-Founder for CancerX, Mr. Konya has previously led several other key federal projects and public private partnerships, including the HHS PandemicX Innovation Accelerator, the national Health IT Playbook, the ONC Patient Engagement Playbook for Providers, the SMART App Gallery, the FHIR at Scale Taskforce (FAST) Initiative, and is a founding Co-Chair of the Together.Health Collaborative.

Mitra Rocca joined the U.S. Food and Drug Administration (FDA) in 2009 as a Senior Medical Informatician, where she led the development of the health information architecture for the Sentinel System. She currently serves as the lead for the Center for Drug Evaluation and Research (CDER) Health Information Technology (Health IT) Board, advancing the use of health IT to support regulatory decision-making. In this role, she also leads multiple initiatives that leverage electronic health records (EHRs) for clinical research.

In addition, Mitra serves as the CDER liaison to the HHS Assistant Secretary for Technology Policy (ASTP), reviews draft regulations and is a member of the Federal Health IT Coordinating Council.
Mitra represents FDA CDER at Health Level Seven International (HL7), where she reviews draft standards. From 2012 to 2018, she served as co-chair of the HL7 Clinical Interoperability Council (CIC). She has been a member of the HL7 Vulcan since its inception and has served on both the Vulcan Steering and Operations Committees. She was also an active member of the Vulcan Adverse Events Workgroup.

Prior to joining the FDA, Mitra was Associate Director of Healthcare Informatics at Novartis Pharmaceuticals Corporation, where she focused on the secondary use of EHR data for clinical research.

She earned her advanced degree in Medical Informatics from the University of Heidelberg in Germany.

Lukasz Kaczmarek is a Senior Principal Medical Informaticist at Roche and a seasoned Technology, Data, and AI Leader. With over 15 years of experience spanning software development and solution architecture, Lukasz has a proven track record of delivering strategic technology roadmaps across Clinical Operations, Medical Affairs, and Personalized Healthcare.

Currently, he leads Roche’s real-world data (RWD) standardization and harmonization efforts, with a particular focus on federated learning ecosystems. A dedicated advocate for interoperability, Lukasz co-leads the industry-wide FHIR to OMOP initiative and is an active contributor to the FHIR, OMOP, and Vulcan communities.

His career is defined by a mission to transform healthcare data into actionable insights. By bridging the gap between clinical care and research, Lukasz is committed to building the "learning health systems" of the future-driving better outcomes for patients, clinicians, and society.

Don Jennings currently serves as Senior Director in Eli Lilly’s clinical research organization responsible for driving transformational initiatives that accelerate, scale and improve the reach of Lilly’s clinical research pipeline through use of innovative technologies. Don also participates in the Transcelerate Digital Data Flow (DDF) workstream as Vendor Engagement subteam lead where he advocates for USDM adoption to realize the promise of industry-scale data system interoperability.

Previously, Don was Senior Architect in Eli Lilly’s technical organization responsible for defining, evolving and driving innovation in Lilly’s clinical trial design and operations capabilities (2023-2025). He also led engineering teams in developing SaMD medical device software (2018-2023), eSource technologies, automated clinical information exchange, PK/PD simulation and genomic analytics (2007-2018). Prior to his roles at Lilly, Don participated in the original sequencing of the human and rat genomes at Celera Genomics (2000-2007) and delivered science ground segments for several NASA and ESA high energy astrophysics missions (1989-2000).

Don holds an MBA from Butler University, an M.S. in Physics from Iowa State University, and bachelor’s degrees in Physics and Computer Science from the University of Missouri.

Dr. Beverly Buckta is a distinguished Health IT leader and strategist with over two decades of experience bridging the gap between clinical research, data science, and global healthcare technology. Currently serving in a leadership capacity within Pfizer’s Global Chief Medical Office, Beverly focuses on Real World Data (RWD) activation, standards, and interoperability—pivotal areas that drive modern evidence generation and clinical decision-making.

Throughout her tenure at Pfizer and previous leadership roles at AstraZeneca and Bristol Myers Squibb, Beverly has established a reputation for delivering scalable, complex digital platforms and interoperable architectures. Her expertise spans the entire drug lifecycle, from R&D and Medical Affairs to Commercial and Digital Health.

Beyond her corporate leadership, Dr. Buckta is a dedicated educator. For over a decade, she served as an Adjunct Professor at Drexel University’s College of Computing and Informatics, where she instructed graduate students on the foundations of Health Information Systems, EHRs, and Biomedical Informatics. She holds a Doctorate (Sc.D.) in Management Information Systems from the University of New Haven (in collaboration with Yale) and an MLS in Scientific Medical Informatics from Rutgers University.

Beverly is a prominent voice in the standards community, contributing to high-impact initiatives including Argonaut, DaVinci, and Vulcan. Her unique blend of clinical roots (starting as a Cytogenetic Technologist) and enterprise architecture allows her to translate complex scientific requirements into technical reality.

Simon Walsh is a seasoned global leader in clinical data strategy with over two decades of experience driving transformation across data management, statistical programming, and data standards in the pharmaceutical industry. As a Senior Director of Data Management and Central Monitoring at Johnson & Johnson, he leads global groups responsible for clinical data acquisition, medical coding, and central monitoring analytics, shaping strategy and stewarding capabilities that span the entire Innovative Medicine portfolio. He serves as a key member of the senior leadership team, partnering with enterprise stakeholders to align data practices, strengthen cross-functional interoperability, and advance organizational readiness for emerging data paradigms.

Previously, Simon held multiple global head roles at Novartis, where he directed the development, governance, and modernization of enterprise-level clinical data standards, reporting standards, and statistical programming technologies. Across these positions, he chaired enterprise data standards governance boards and led global teams implementing industry data standards, end-to-end data collection frameworks, and reporting methodologies supporting regulatory submissions worldwide.

Simon’s career is marked by his ability to guide strategy for large-scale process and technology transformations, and champion data quality, consistency, and interoperability across complex organizational landscapes. His early foundation in clinical programming and data management, combined with extensive leadership in strategy, governance, and innovation, positions him uniquely to contribute to Vulcan HL7 FHIR’s mission of advancing clinical research data exchange.

He brings a strong commitment to shaping the future of clinical data ecosystems and fostering harmonized, standards-based approaches that promote true end-to-end interoperability.

Chris Decker brings more than two decades of leadership at the intersection of clinical research, data standards, and digital transformation, making him a strong representative for the HL7 Vulcan Steering Committee.
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Relevant roles and leadership: President and CEO of CDISC, the global standards organization whose models are required or recommended by multiple major regulatory authorities, giving him a broad view across sponsors, regulators, and technology providers.

Leader and spokesperson for the TransCelerate/CDISC Digital Data Flow initiative and its alignment with ICH M11 and the HL7 Unified Digital Protocol (UDP), directly connecting protocol standards, CDISC models, and HL7 FHIR. He is also a frequent panelist and presenter on Vulcan UDP and digital protocol topics, working side by side with Vulcan technical and clinical leaders.​

Why he would be a strong representative: Career-long focus on applying technology and standards to clinical research, including early experience as a statistician and later as a leader in technology and consulting organizations serving life sciences.

Bridges key stakeholders: As CDISC CEO, he can articulate and balance the needs of sponsors, regulators, standards bodies, and technology vendors, supporting Vulcan’s role as a cross‑ecosystem accelerator.

Strategic alignment with Vulcan goals: His work on Digital Data Flow, ICH M11, and UDP directly advances Vulcan’s mission to enable interoperable digital protocols and FHIR‑based clinical research data exchange.

Proven collaborator and advocate: His participation in Vulcan‑related webinars and panels shows a strong commitment to collaborative governance, transparent decision‑making, and practical, implementable standards that drive patient and trial efficiency benefits.

Nersey Rastan is Chief Technology Officer at The Synergist, a membership-funded non-profit with 10+ years of experience in sustainable funding models for digital health infrastructure. The Synergist serves as an infrastructure provider and co-creation catalyst—developing shared resources (algorithms, frameworks & contributing to standards) that enable ecosystem partners. Its flagship initiatives include the Synapse platform and Clinical Trial Data Network (CTDN), creating interoperable infrastructure that multiple partners leverage without competing with trial finders, recruitment vendors, or pharma digital teams.

Major engagements include co-leading Work Package 2 the Digital Platform of IHI-READI - a €66.8M, 6-year European Commission initiative spanning 80 partners across 18 countries. Nersey serves on the Executive Committee of IHI-READI providing technology leadership.

The Synergist became a voting member of HL7 Vulcan Accelerator in January 2026. Nersey leads work on structuring clinical trial eligibility criteria using FHIR standards. At the January 2026 HL7 FHIR Connectathon, his team structured eligibility criteria using the FEvIR platform, revealing insights about AI limitations in medical language interpretation—work continuing through May 2026 Rotterdam Connectathon.

With 30+ years of executive technology leadership, Nersey held Director positions at Deloitte NSE leading transformation for 800+ colleagues, and senior director roles at global manufacturers including KONE (Head of Application Center, 125 members, €31M budget across APAC/Europe/Americas) and ETEX (Head of Applications, 85 members, €16M budget). Achievements include enterprise SAP consolidations serving 2,500-3,500 daily users, mobile migrations for 9,000+ devices, and M&A integrations.

Nersey serves on the Governing Board of Tod'Aérs Global Network supporting UN SDGs. A Chartered Engineer, he has driven turnarounds across China, USA, UK, Italy, Netherlands, Belgium. Based in Brussels.

Rob DiCicco is the Vice President of Portfolio Management at TransCelerate Biopharma Inc. There Rob is accountable for the delivery of initiatives related to digital transformation, electronic health record data interoperability and pragmatic trials. He also heads up the company’s Health Authority and External Engagement efforts. Prior to taking on his current responsibilities he was the Deputy Chief health Officer for Life Sciences at IBM Watson Health.

He has had a long career in Pharmaceutical R&D spanning nearly 30 years; 25 with GlaxoSmithKline where he served in a variety of leadership positions.

Rob received his Doctor of Pharmacy Degree from the University of the Sciences in Philadelphia. His areas of expertise and interest include clinical trial design, clinical operations, protocol quality and ethics in research.

Steve Heard began his career in his own backyard of San Francisco during the early internet days. Sparked by a summer internship while still attending Hampshire College, he found himself in the thick of things working alongside the very developers that created the iconic AOL “You got mail!” experience and Disney’s first internet presence. From there he was instrumental in media, gaming, and internet startups, burgeoning in Silicon Valley and Boston. One of his most impactful, early roles was “Chief Nerd” at NPR’s Car Talk. But he gave up all the glamour when he joined old friends to become employee #1 at J2 Interactive, a then nascent professional health IT services organization.

Steve and his colleagues grew J2 into a company of 300 software and integration specialists spanning three continents, building the interoperability infrastructure of some of the most trusted and familiar names in healthcare. He has more than 20 years of work and leadership in the space of clinical data, Health Information Exchanges, labs, and public health research. In his words, he is “fluent in FHIR, but still dreams in HL7 v2.” Steve’s portfolio of technical architecture leadership includes some of the largest health data hubs in the United States - including the U.S. Department of Veterans Affairs - laboratories like Quest Diagnostics, and Partner's AIDS Research Center. Outside of the United States, he has been instrumental in J2’s work at the NHS and Dubai Health Authority, and he was one of the original architects behind Sweden’s National Patient Overview.

As J2’s CIO, Steve is able to dive deep on both the technical and business operations of healthcare data, while explaining these topics in ways that everyone can understand. Steve is instrumental in curating J2’s internal talent, and creating new technical resources for healthcare. He has been the driving force behind J2’s involvement in the Vulcan Interoperability Bridge program, and an advocate for emerging data standards.

David Champeaux has held founder, leadership, and advisory roles at more than a dozen digital health and AI startups since the late 1990s, complemented by Partner roles focusing on Data and AI-enabled transformation in Health and Life Sciences at McKinsey, Accenture, Alvarez & Marsal, and Infosys. This deep cross-industry experience spanning pharma, biotech, medtech, payers, and providers gives him unique insight into both the technical requirements and organizational change management necessary for successful FHIR adoption at scale.

David is currently CEO of Evidentli, an AI-enabled platform that normalizes healthcare data to international standards including OMOP, enabling collaboration on evidence generation across the research-to-care continuum. At Evidentli, he leads development of composite AI solutions that rapidly normalize large healthcare datasets—hands-on implementation experience that directly supports Vulcan's goal of developing FHIR Implementation Guides deployable at international scale. His expertise in leveraging AI for entity resolution to join siloed datasets and generate real-world insights from EHR data supports Vulcan's Real-World Data priority workstream.

As an Industry & Implementation Representative, David would bring practical implementation expertise in normalizing healthcare data at production scale, strategic vision for integrating AI with FHIR-based interoperability, and global perspective from real-world advisory engagements with health and life sciences organizations worldwide. His career-long mission of converting healthcare data into actionable insights through standardized, interoperable systems aligns with Vulcan's vision of bridging clinical care and clinical research, and he is committed to collaboration across the research-to-care continuum to achieve learning health systems that benefit patients, clinicians, researchers, and society.

I have been a member of Vulcan since its inception. Throughout my academic and professional career I have participated in multiple interoperability initiatives. As an MD Pathology Informatician at UC Davis, I worked on several NCI‑funded caBIG projects supporting cancer interoperability using the BRIDG model.

After leaving UC Davis, I joined the NCI and directly supported BRIDG. I then served as Deputy Director in CDER at the FDA, where I helped the agency become a founding member of Vulcan. At the FDA I supported and actively encouraged a multiplicative approach to our standards program, drawing on the strengths of both HL7 and CDISC standards.

Now in private industry, directly supporting clinical trial interoperability using Vulcan standards, I see firsthand the impact these standards have on the industry’s ability to manage high‑quality data and make that data available to regulatory agencies for review. Vulcan plays a critical role in increasing interoperability and advancing high‑quality standards for research.

My years of experience driving interoperability in academia and across my federal career at the NCI and FDA make me well suited to continue serving as a board member and ensuring Vulcan continues to support the research community.