Sasan Sabrdaran

Dr. Sabrdaran is a physician and scientist with over 16 years of experience in the pharmaceutical industry and over 13 years of experience in the world of drug safety, pharmacovigilance and risk management. He has been involved with over 70 clinical trials at various stages of product development from pre-clinical concepts and phase 1-3 of product development all the way through the rigorous process of product approval by the Health Authorities around the world and post approval monitoring of the drugs on the market. During his career, he has provided clinical monitoring and drug safety expertise and leadership to numerous companies including GSK, Sepracor, Peregrine Pharmaceuticals, Pfizer, Genentech, InterMune, J&J and many more. His contributions to the science of medicine in general and safety of drugs has resulted in the approval of many drugs, most notably Avastin (the world best-selling anti-cancer treatment), Xolair (the first-in-class treatment for Allergic Asthma) and Esbriet (the first treatment for the fatal disease of Idiopathic Pulmonary Fibrosis). Dr. Sabrdaran is a subject matter expert on drug safety analyses and global risk management strategies. He has been the primary architect of the global risk management strategy and the primary author of the Post Authorization Safety Study (PASS) for Esbriet, which received marketing approval in European countries and ultimately in the United States. Dr. Sabrdaran has authored, reviewed and/or approved over 10,000 Individual Case Safety Reports from clinical trial and post marketing sources and over 50 aggregate safety analyses and plan including PSURs, ASRs, Risk Management Plans, IND Annual Reports and DSURs and had written numerous responses to Health Authority inquiries on various drug safety issues.

Areas of expertise:

Medical Review of ICSRs, AEs, SAEs

Design, Execution, Monitoring and Data Analysis of Clinical Trials

Post Marketing Safety Surveillance

Aggregate Safety Data Analysis

Signal Detection, Signal Analysis and Signal Management

Developing, Maintaining, Managing and Optimizing Benefit-Risk Profile

Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans

Authorship/Review of PSURs, DSURs and Annual Reports

Domestic and International Labeling

Company Core Data Sheet, Company Core Safety Information, Investigator Brochures

MedDRA Coding

US-NDA and EU-MAA approval process

Strategic Planning, Team Building, Staffing, Budgeting and Operational Excellence

Transition from Product Development to Product Approval

Drug Safety and Pharmacovigilance Regulations

Cross-functional and Strategic Leadership

FDA Advisory Committee Expertise