-

CDISC Welcomes New Chair and Members to Board of Directors

AUSTIN, Texas--(BUSINESS WIRE)--CDISC today announced three members have joined its Board of Directors: Jonathan Chainey, Dominic Labriola and Rhona O’Donnell each began serving a three-year term at the beginning of the year. Existing Member, Dr. Erik Pulkstenis, now leads the Board as Chair.

Jonathan Chainey is an Executive Director and Global Head, Data Standards & Governance within Data Sciences, Product Development at Roche. He leads a global team accountable for the cross-functional governance and adoption of Roche’s CDISC-aligned global data standards across all Roche sponsored early and late phase clinical trials. Prior to his election to the CDISC Board of Directors, Jonathan served as chair of the CDISC Advisory Council.

Rhona O’Donnell is currently VP, Data Management Systems and Standards at Novo Nordisk, overseeing clinical data standards, clinical data systems and data transformation across the Novo Nordisk value chain. Her experience spans global data management project delivery, EDC/clinical database and data transformation strategy and management, delivery model design, departmental financial and commercial management, clinical risk management, technical system selection and implementation as well as extensive experience in change control and process improvement projects.

Dominic Labriola is Chief Data and Analytics Officer of Madrigal Pharmaceuticals. Dr. Labriola has over 35 years’ experience as a drug developer, overseeing and contributing to the global registration of 20 medicines in multiple therapeutic and more than 20 years serving in executive leadership roles at Bristol Meyers Squibb. His interactions with global regulatory agencies have given him a unique understanding of the drug approval process and the importance of quality data to support those filings. An expert in trial designs and leveraging innovative approaches, he possesses a particular appreciation for the importance of data standards to support clinical research.

“We enthusiastically welcome these new board members,” said Erik Pulkstenis, CDISC board Chair. “Their strategic leadership, coupled with decades of experience, will be invaluable as we interact with the talented and engaged CDISC executive leadership driving this important and impactful organization forward.”

“It’s a pivotal time at CDISC as we evolve organizationally to embrace governance of clinical research information standards,” said David Evans, President and CEO, CDISC. “I am delighted to welcome these seasoned leaders who join an active and engaged Board that will deftly guide CDISC on the next stage of our journey.”

Continuing CDISC Board Members include Chair Dr. Erik Pulkstenis, AbbVie; Chair-Elect Chris Decker, d-Wise, Past Chair Pam Howard, ICON; Dr. Wenjun Bao, JMP Life Sciences of SAS Institute Inc.; Dr. David Hardison; Dr. Pandu Kulkarni, Eli Lilly; Dr. Hiroshi Masumoto, Daiichi Sankyo; Dr. Mihoko Okada, Institute of Health Data Infrastructure for All; Dr. Christina Reith, University of Oxford’s Nuffield Department of Population Health (NDPH); non-voting CDISC Advisory Council Chair Dan Crawford, Veeva System; and ex-officio, David Evans, CDISC.

For more information on the CDISC Board of Directors, please visit www.cdisc.org/about/board.

ABOUT CDISC

CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization and is headquartered in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world. www.cdisc.org.

Contacts

Ann P. White
+1.512.363.5826
awhite@cdisc.org

CDISC


Release Summary
CDISC welcomes new Chair and Members to Board of Directors at pivotal time.
Release Versions

Contacts

Ann P. White
+1.512.363.5826
awhite@cdisc.org

Social Media Profiles
More News From CDISC

ICH and CDISC Collaborate to Support the Maintenance and Governance Process for ICH M11 Controlled Terminology

AUSTIN, Texas & GENEVA--(BUSINESS WIRE)--The International Council for Harmonisation (ICH) M11 Expert Working Group (EWG) (Clinical electronic Structured Harmonized Protocol (CeSHarP) has developed a clinical protocol template and technical specification to ensure clinical study protocols are prepared in a consistent manner and provided to users in a harmonised data exchange format acceptable to all regulatory authorities of the ICH regions. This protocol and electronic exchange format will fac...

Patient Safety Set to Gain as CDISC and UMC Partner to Improve Interoperability of CDISC Standards and WHODrug Global

AUSTIN, Texas & UPPSALA, Sweden--(BUSINESS WIRE)--A new collaboration between two leading organizations in global medical data has been announced to bring greater efficiency and certainty to regulatory bodies, industry, and the healthcare community, ultimately aiming to improve patient safety worldwide. Historically, lack of interoperability has been a significant stumbling block to the effective sharing and use of medicinal product safety data. The strategic partnership announced today takes a...

CDISC is Proud to Announce a Research Collaboration to Incorporate FDA Business Rules into CDISC’s Open Rules Engine (CORE)

AUSTIN, Texas--(BUSINESS WIRE)--CDISC is proud to announce a research collaboration with the U.S. Food and Drug Administration’s Office of Translational Sciences in the Center for Drug Evaluation and Research and Office of Regulatory Operations in the Center for Biologics Evaluation and Research to incorporate FDA Business Rules into CDISC’s Open Rules Engine (CORE). CDISC’s CORE project provides an open-source version of the CDISC Conformance Rules in a machine-executable format. These rules,...
Back to Newsroom