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Controlled Terminology

 

Instructor: Bron KislerInstructor: Bron Kisler

Company: CDISC

Courses Taught: Controlled Terminology

 

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.

 

 

 

 

Instructor: Erin MuhlbradtInstructor: Erin Muhlbradt, PhD

Company: Medical Science and Computing, Inc.

Courses Taught: Controlled Terminology


Dr. Erin Muhlbradt is a contractor for the National Cancer Institute’s Enterprise Vocabulary Services (NCI EVS) and is the NCI EVS project lead for the Clinical Data Interchange Standards Consortium (CDISC) terminologies. Erin has over 5 years’ experience in the bioinformatics and pharmaceutical industries, including data standardization, database and metadata repository development, and terminology development. She manages a team at EVS that is responsible for the development and maintenance of CDISC controlled vocabularies in use by the pharmaceutical industry and the US Food and Drug Administration (FDA). Her duties include project management, biomedical and clinical trial subject matter expertise, terminology development, quarterly terminology publications, managing the CDISC terminology change request mechanism, and developing the content around the CDISC metadata repository. Previously, Erin was a doctoral candidate at Georgetown University in the Tumor Biology department and she performed her thesis work in laboratories at Georgetown University and Columbia University.

 

Erin holds a Bachelor of Science Degree (Honors) in Molecular and Cellular Biology from the University of Glasgow (Glasgow, Scotland) and a Doctoral Degree in Tumor Biology from Georgetown University (Washington DC).

 

Erin is active on all CDISC controlled terminology teams, a member of the management team for the CDISC SHARE project and active on therapeutic area standards development teams.

 

 

 

Instructor: Bernice YostInstructor: Bernice Yost

Company: CDISC

Courses Taught: Controlled Terminology

 

Bernice Yost currently serves as Manager, Standards Development in CDISC.  She coordinates the global development and harmonization of controlled terminology standards for medical research, supporting the CDISC standards, including SDTM (Study Data Tabulation Model), ADaM (Analysis Data Model), and SEND (Standards for the Exchange of Non-clinical Data) all for regulatory submissions, and CDASH (Clinical Data Acquisition Standards Harmonization) for data collection. These controlled terminology standards have been widely adopted and implemented throughout the world. 

 

She is currently involved in developing standard terminology for multiple global therapeutic area standards projects and is active with the CDISC SHARE project.

 

Bernice has worked in the pharmaceutical industry for more than 20 years.  Her past experience as Therapeutic Area Data Standards Specialist gives her the pharmaceutical industry prospective in the development of global standards across multiple disease areas. This work included successfully bringing together diverse global views to satisfy the needs for submission to many different regulatory bodies while developing global standards that all departments and users could implement including regulatory, clinical (for data collection), statisticians and data managers.

 

Bernice holds a Bachelor’s degree in Biology from the University of Pennsylvania (Philadelphia, PA) and a Master’s degree in Computer Science from Villanova University (Villanova, PA).