Streamlining Study Submissions for Success: An Integrated Summary of Safety Case Study

Presenters: Denise ShortinoDemi Niforos
Recorded Live: Thursday, June 10, 2021Presenters
Denise Shortino
Sr. Director, Biostats, Programming and Data Management, Urovant SciencesDenise 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
Vice President, Biostatistics and Statistical Programming, eClinical SolutionsDemi 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.
By submitting, you agree to the processing of your personal data by eClinical Solutions as described in our Privacy Policy.