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.

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.

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.

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.

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.