CDISC Welcomes Three New Board Members

CDISC has gained three new members to its Board of Directors, each of whom will serve three-year terms: Jonathan Chainey, Dominic Labriola and Rhona O’Donnell. Existing Member Dr. Erik Pulkstenis now chairs the governing body.

“We enthusiastically welcome these new board members,” Pulkstenis said. “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.”
 
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. Before being elected to the CDISC Board of Directors, Chainey chaired the CDISC Advisory Council.
 
O’Donnell is currently vice president, 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.
 
Labriola is chief Data and Analytics officer of Madrigal Pharmaceuticals. Dr. Labriola has more than 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 an 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. 
 
“It’s a pivotal time at CDISC as we evolve organizationally to embrace governance of clinical research information standards,” CDISC President/CEO David Evans said. “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.”
 
Current CDISC board members include 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.
 
CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the U.S. Food and Drug Administration and Japan’s Pharmaceuticals and Medical Devices Agency, recommended by the China National Medical Products Administration, and adopted by the global 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.