Türk Karaciğer Araştırmaları Derneği

Amrik SHAH

Chief Analytics Officer at Curio Therapeutics of Zydus Therapeutics
United States of America

Experience in drug development spanning Discovery thru Phase 3 clinical trials with therapeutic areas being NASH, neurology, immunology, infectious diseases, cardiovascular and most recent in Liver Diseases. FDA interactions include face-to-face meetings, teleconferences, preparation of briefing books, and responses to statistical analysis plan issues. European Regulatory experience includes preparation of Briefing Books and face-to-face scientific advice meetings with the EMA, CHMP, BfARM, and AIFA. Technical strengths and interests include sequential/adaptive designs, hypothesis testing with multiplicity control, longitudinal/mixed models including PK/PD and small sample inference.