Debra has more than 25 years experience in the biopharmaceutical industry. Prior to ThesIS, Debra was the Director of Clinical Data and Systems Management for Roche Global Development in Palo Alto, California, where she managed teams accountable for systems, standards, tools and services to facilitate the capture, management and quality of clinical trials data.
Debra was also the Global Head of Thesaurus Administration for Roche, responsible for the formation of Roche's worldwide coding group. In this role, she championed the replacement of study-specific coding with centralized, company-wide coding encompassing all clinical trials as well as drug safety. In addition, Debra successfully managed Roche's global implementation of MedDRA for clinical trials, including the conversion of legacy data from COSTART.
Debra started her career in the biopharmaceutical industry as a bioanalyst at Syntex Research. Since then, Debra has held management positions in bioanalysis, safety reporting, clinical systems, and clinical data management. In these positions, she provided oversight and management of support services for project teams in the areas of:
- safety software
- standards for safety data collection, management, analysis and reporting
annual progress reporting
- ad hoc safety reporting
- treatment blinding security
- laboratory data administration
Debra brings to ThesIS a wealth of biopharmaceutical experience garnered not only from her numerous management positions but also from years of extensive hands-on practice.
Henry has more than 25 years of information technology experience, with 19 of those years dedicated to providing technology services to the biopharmaceutical industry. He has spent the last 16 years working with medical dictionaries such as MedDRA, WHO Drug, ICD-9, and COSTART. Henry is one of the earliest users of MedDRA, with involvement starting from the MedDRA 1.0 Alpha version in 1995. He has pioneered sophisticated techniques and systems for the coding and versioning of terms for both MedDRA and WHO Drug.
As a principal consultant for DataPlus Corporation, a technology consulting company, Henry has managed the design, development, testing and deployment of several custom software systems specific to the biopharmaceutical industry, including:
- a clinical informatics environment for efficient aggregation, data mining, and analysis of clinical data and content to protect existing product lines from competitive threats and to gain new clinical insights by leveraging existing data
- a system to encrypt the identity of patients participating in clinical trials utilizing genetic data
- an evaluation system to improve the selection of compounds into a company’s drug development portfolio
- a document imaging and workflow routing system to process case report forms (CRFs) collected from clinical trials
- portions of the Rx/Clinical (now marketed as Oracle Clinical) study design facility
While a consultant to Roche, Henry was responsible for the creation of an extremely powerful, custom-built, global thesaurus classification system to code adverse event and drug data for clinical trials and drug safety. He successfully managed its global deployment, including the conversion of data from and the retirement of several legacy thesaurus systems. In addition, Henry worked in conjunction with the Global Head of Thesaurus Administration to lead a successful implementation of MedDRA globally for clinical trials and drug safety and the continual migration to newer MedDRA versions.
Henry has given numerous presentations on MedDRA and WHO Drug, as well as on thesaurus systems and clinical trials systems, to a wide variety of companies, conferences, and industry groups. He serves as a coding and dictionary management subject matter expert for the Society for Clinical Data Management (SCDM).
Henry has also worked with numerous biopharmaceutical companies to ensure their applications comply with the requirements for validated computer systems and 21 CFR Part 11.
Henry brings to ThesIS an intimate knowledge of the biopharmaceutical industry, combined with an innate ability to apply state-of-the-art technology to efficiently solve the problems encountered in the drug development process.