Broad experience in biostatistics, clinical development, and regulatory process in the US and EU.Developed and implemented novel efficacy evaluation methodologies for proof of concept clinical studies with small sample size leading to substantial clinical development risk reduction;Implemented and negotiated with the FDA (US) and EMA (EU) primary efficacy evaluation approach based on the various recurrent event analysis methods; demonstrated substantially greater treatment effect size comparing to traditional time to first event analysis (applicable to repeated heart failure hospitalizations, cancer relapses, opportunistic infections, etc.);Was responsible for/participated in numerous FDA/EMA submissions in multiple therapeutic areas. Multiple successful communications with FDA and EMA reviewers (advisory, pre-IND, end of Phase 2, pre NDA/BLA and other meetings, special protocol assessment negotiations).Experience in heart failure, gene therapy, dermatology, HIV, cancer, pain management, cartilage repair and other therapeutic areas.Multiple publications in the leading peer-reviewed journals.