Streamlining Study Submissions for Success: An Integrated Summary of Safety Case Study
Clinical development has more partnerships and collaborations than ever before with many companies acquiring assets from others and building centers of excellence and expertise through late-stage development and submission preparation. This webinar will present a case study on the submission planning process including data analysis, collaboration process, and technology platforms leveraged to deliver the Integrated Summary of Safety (ISS) deliverable for the Urovant Gemtesa (Vibegron) FDA submission. Urovant acquired the Vibegron asset mid-way through development and worked with eClinical Solutions on the submission deliverables and utilized the elluminate® clinical data platform as a core centralized repository.
The topics presented will include why Urovant selected eClinical as their ISS partner and how Urovant and eClinical collaborated to surpass their target timelines and produce a final deliverable to the FDA. The webinar will cover these topics from both the Urovant and the eClinical perspectives including the development and review of the Statistical Analysis Plan, the mapping and up-versioning to current SDTM standards and practices utilized. The talk will highlight how eClinical and Urovant worked collaboratively for more than a year and how data was centralized across numerous legacy studies for faster access.
The webinar will also highlight how to structure, coordinate and manage an effective team with various dependencies utilizing a combination of both internal and external resources to collectively work on submission deliverables. Lessons learned across planning, process, execution, team structure, collaboration, dry runs and the final submission will be analyzed.
Register for this webinar to hear expert speakers with years of statistical analysis, programming and submission experience share the knowledge and skills needed by submission preparation team members to ensure success and manage risk associated with submission deliverables.
The presentation and case study will cover the following topics:
- Submission preparation and planning processes
- ISS/ISE partner evaluation
- Team organization, roles and responsibilities to ensure success
- Data preparation including SDTM up-versioning
- Best practices and lessons learned
- Technology infrastructure utilized
- Results and future directions
Denise Shortino is Senior Director of Biostatistics, Programming and Data Management at Urovant Sciences. She is an experienced biostatistician in pharmaceutical clinical research and development with more than 20 years of experience. Prior to joining Urovant Sciences, she held leadership roles in biostatistics and programming at GlaxoSmithKline and Parexel.. She has successfully supported regulatory submissions for cardiovascular, infectious diseases and urology medicines.. At Urovant, Denise leads all data related activities and oversaw the submission of the Gemtesa (Vibegron) which received FDA approval in late 2020. Denise has a MS in Biostatistics from UNC Chapel Hill and a B.S. in Statistics from Virginia Polytechnic University.
Demi Niforos is VP, Biostatistics and Statistical Programming for eClinical Solutions and has more than 20 years of drug development experience in both the CRO and Pharmaceutical/Biotech environments. Prior to joining eClinical Solutions she held leadership roles in biostatistics and data management across multiple companies including YM Biosciences, Viventia Biotech and AAIPharma. She has extensive expertise in the clinical development process from study planning to agency submission. Prior to joining eClinical Solutions, Demi led Biostatistics and Data Management for Arbutus BioPharma. Demi holds an M.S. in Applied Statistics from Worcester Polytechnic Institute and a B.S. in Mathematics and Science from Worcester State College.