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CDISC Executive Operations Team

 

 

Rebecca Kush, PhD

CDISC President and CEO

Rebecca Daniels Kush, Ph.D. is a Founder and the current President and CEO of CDISC. Dr. Kush has over 25 years of experience in the area of clinical research. She has worked for the U.S. National Institutes of Health, academia, a global contract research organization and pharmaceutical companies in the U.S. and Japan. Among numerous publications, Dr. Kush is lead author of the book, eClinical Trials: Planning and Implementation. Dr. Kush has given invited presentations (including keynotes) and tutorials at industry conferences, FDA and other venues in the U.S., Europe, and Japan for over 20 years. She earned a Ph.D. in Physiology and Pharmacology from the University of California (UCSD) School of Medicine in La Jolla, CA and has a B.S. in Chemistry and Biology from the University of New Mexico.

 

 

 

 

Wayne Kubick

Chief Technology Officer

Wayne Kubick is the CTO for CDISC. He holds an MBA degree and has over 25 years of experience in clinical research and drug safety, including executive management and strategy development. He has most recently worked for Oracle Health Sciences as Sr. Director of Product Strategy, and previously as Sr. Vice President for Lincoln Technologies/Phase Forward. Mr. Kubick has held several leadership positions with CDISC since 1999, as an original and current Board member, CDISC Technical Director and team leader; he led the development of the CDISC Study Data Tabulation Model (SDTM) for regulatory submissions and other standards efforts.

 

 

 

 

 

 

Nicole Harmon, PhD

Executive Director

Nicole Harmon, PhD, is a seasoned non-profit executive professional with 15 years of leadership experience, offering a full-circle perspective due to her unique background in strategic planning, capacity building, fiscal management, fund-raising, program and policy development, educational outreach, advocacy, market analysis, grants management, public relations and marketing. Dr. Harmon worked previously with the National Kidney Foundation, the Texas Hospital Association/Healthcare Trustees, the American Cancer Society, and in the field of mental health and brain injury research and rehabilitation, which relate directly to the CDISC development of standards for specific therapeutic areas.

 

 

 

 

 

Bron Kisler

Vice President, Strategic Initiatives

Bron Kisler is a Co-Founder of CDISC and currently serves as Vice President, Strategic Initiatives. Within this role, he is responsible for identifying new growth opportunities for CDISC, steering the  organization into new clinical and geographic markets, and managing key strategic alliances. Bron has 25 years of technical and business experience from both the public and private sectors, and has worked in the pharmaceutical industry for 15 years, developing innovative clinical research solutions. He spearheaded the CDISC Terminology Program in 2005, and has been successful in launching CDISC Therapeutic Area projects. Bron is currently Chair of the Joint Initiative Council for global standards harmonization and serves on the BRIDG Board of Directors. He is a graduate of the University of Central Florida and holds 3 Bachelor of Science degrees in Mathematics, Computer Science and Statistics.

 

 

 

 

 

Sam Hume

Vice President, SHARE Technology and Services

Sam Hume, MS, has over 20 years experience in clinical research informatics, eight of these specializing in the development of global clinical information standards. At CDISC, he leads the CDISC SHARE project and co-leads the XML Technologies team. Previously, he worked as Director of IS Architecture at AstraZeneca, where, amongst his many varied functions, he was instrumental as the IS leader of a team charged with creating a standards metadata repository to drive interoperability, and developed a global CDISC implementation strategy and roadmap for AZ. Prior to this, Mr. Hume held the position of VP of Technical Operations at Phoenix Data Systems and Chief Technology Officer at CB Technologies. Sam has an MS in Information Science, MS in Telecommunications, and is completing his doctorate in Healthcare Informatics.

 

 

 

 

 

 

Shannon Labout, CCDM

Vice President, Education

Shannon Labout, CCDM, has over 20 years experience working in healthcare technology and clinical research organizations in the US and EU. She is a clinical data management and standards leader with a career reputation of pursuing and achieving excellence through affirmative team leadership. During her career, she has developed expert knowledge of ICH clinical development processes, and implementation of industry standards (CDISC, GCDMP and ICH GCP). Prior to her current position at CDISC, Ms. Labout held the positions of Senior Director of Education at CDISC, Director of Data Management at Statistics & Data Corporation, and Manager of Clinical Data Management at both Astellas Pharma Europe and Tyco Healthcare Mallinckrodt. She currently serves on the Board of Trustees for the Society for Clinical Data Management. Ms. Labout is a Certified Clinical Data Manager (CCDM), and received her BA in Organizational Leadership from Maryville University.

 

 

 

 

Rhonda Facile, MS

Vice President, Standards Development

Rhonda brings over 25 years of clinical development experience and has worked in a global CRO, as well as pharmaceutical and biotechnology companies in the United States and abroad. She has worked with CDISC for over eight years developing and contributing to the CDASH (CRF) standards program and the CDISC SHARE project. Rhonda currently manages the CFAST therapeutic area standards program as well as facilitating and ensuring that all CDISC standards projects progress and comply with CDISC development processes and policies. Rhonda holds a BA degree from the University of Texas at Austin and an MS in Organization Leadership and Ethics from St. Edwards University.

 

 

Shirley Williams

Vice President, Finance Administration

Shirley Williams was privileged to be the first CDISC employee and has been a part of its growth and success since its inception. She has over 20 years' experience in the clinical research industry and was instrumental in the start up of two different organizations, including CDISC. Her extensive experience is in the areas of financials, metrics, reengineering and process improvement and project coordination. She has been responsible for CDISC’s financial and legal viability, ensuring that CDISC has always used its funds appropriately to establish and support the CDISC standards. In 2008, Shirley was promoted to Executive VP, Finance & Events Administration for CDISC. In addition to her legal, financial and human resource responsibilities, she is now responsible for overseeing the successful Events and Education program that CDISC offers, including the CDISC Interchanges around the globe, training courses/workshops and ensuring CDISC’s presence at worldwide events.