CDISC Executive Operations Team

 

 

Rebecca Kush, PhD

CDISC President and CEO

Rebecca Daniels Kush, PhD 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.

 

 

 

 

Nicole Harmon, PhD

Chief Operating Officer

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.

 

 

 

 

Rhonda Facile, MS

Vice President, Standards Development

Rhonda Facile 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. Ms. Facile 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. She holds a BA degree from the University of Texas at Austin and an MS in Organization Leadership and Ethics from St. Edwards University.

 

 

 

 

 

 

 

 

Michael Ibara, Pharm.D.

Head of Digital Healthcare

 

Michael Ibara works at the interface of digital health, standards and industry, overseeing the FDA eSource project and several Healthcare Link efforts with registries, clinical trials and mobile health. Dr. Ibara has over 20 years’ technology and healthcare experience, pioneering research on the implications of digitized healthcare data on pharmacovigilance practice and drug safety with the goal of developing a new business model for pharmacovigilance to improve public health. He was Head of Business Development Coordination and Innovation at Pfizer, where he served in various roles, leading implementations of global systems and large-scale technologies. Dr. Ibara received his Pharm.D. degree from the University of Michigan and completed a Fellowship in Drug Research and Development with Burroughs Wellcome, Inc. and the University of North Carolina.

Bron Kisler

Vice President, Strategic Initiatives

Bron Kisler is a Co-Founder of CDISC and currently serves as Vice President, Strategic Initiatives. In 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. Mr. Kisler 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. Mr. Kisler 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 three Bachelor of Science degrees in Mathematics, Computer Science and Statistics.

 

 

 

 

 

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.

 

 

 

 

Marine Laurent

Vice President, Finance

Marine Laurent guides CDISC’s financial strategy and sustainability, working with the Leadership Team in achieving the CDISC mission, vision, and strategic goals. Ms. Laurent is a seasoned professional with over 10 years’ operational finance, treasury and purchasing experience and a strong track record in supervising complete financial processes, including designing and executing financial and management reporting, structuring operations, and strategic business planning. Prior to joining CDISC, Ms. Laurent served as CEO/CFO of France Alter Eco, a French market organic and fair-trade food distributor. Earlier in her career, she was CFO of Australia-based Boost Media International. From 2005 to 2007, Ms. Laurent was an Internal Auditor for Sanofi-Aventis.

 

 

 

 

 

 

 

 

 

Barrie Nelson

Vice President, Standards, Terminology and Technical Services

Barrie Nelson works with CDISC leadership and volunteer teams to guide the future of standard development. He has over 18 years’ experience in biostatistical programming and clinical data management, managing and implementing data standards functions, and leading a governance body to oversee the use of standards.

Working for such CDISC member organizations as GSK, Amgen and Onyx, Mr. Nelson led and contributed to many process improvement initiatives where standards were at the heart of these projects, with specific goals of cycle-time reduction, reduced operational costs and increased quality. He has been a volunteer and leader for CDISC teams since 2003, and spearheaded the development of the Oncology domains for SDTM.  

 

 

Lauren Becnel, PhD

Senior Director of Biomedical Informatics and Alliances

Lauren Becnel, PhD, focuses on informatics technologies at CDISC, including our metadata repository, SHARE, which houses all CDISC standards. Dr. Becnel works at the intersections of clinical research, translational research and healthcare, ensuring the standards remain relevant for regulated research, academic research centers and precision medicine. She has over 10 years’ experience in biomedical informatics and research IT, with seven years’ experience leading large, diverse technical teams and a high-performance research computing center at Baylor School of Medicine where she served as Assistant Professor in the Departments of Medicine, Hematology/Oncology Section, and Molecular and Cellular Biology. For the past four years, she has served on the Steering Committee of the collaborative BRIDG Translational Research Domain Analysis Model (CDISC, HL7 and ISO, NCI and FDA), which harmonizes the CDISC Foundational Standards.

 

 

Diane Wold, PhD

Senior Director, Standards Development and Modeling

 

Diane Wold, PhD, brings over 30 years’ clinical research experience as a standards expert and statistician to CDISC. Dr. Wold provides process development expertise to the Coalition for Accelerating Standards and Therapies (CFAST) project and modeling consultation to CFAST teams. As a member of the Submission Data Standards (SDS) leadership team, she coordinates development of the Study Data Tabulation Model (SDTM) and its implementation guide to meet requirements that arise from the CFAST project. Dr. Wold also serves on the CDISC Standards Review Council, which reviews proposed standards for quality and cross-standard consistency before they are sent out for public review and publication. Additionally, she contributes Biomedical Research Integrated Domain Group (BRIDG) and SDTM modeling expertise to the CDISC SHARE metadata repository. Dr. Wold has been involved with CDISC teams since 2002, and played a significant role in developing the SDTM standard. Before joining CDISC, she served as Director of Data Standards at GSK for 14 years.