Cristina Damatarca
Agility Clinical, USA
Biography
Dr. Damatarca has over 17 years of experience in the biopharmaceutical industry, across all stages of development and product commercialization. In her current position as Vice President of Medical Affairs and Pharmacovigilance at Agility Clinical, Dr. Damatarca provides oversight for all medical affairs and drug safety activities for Agility Clinical, which focuses on rare diseases.Before joining Agility Clinical, Dr. Damatarca was Vice President and Head of Drug Safety and Pharmacovigilance at Clovis Oncology, where she provided oversight for all safety aspects of the clinical development program for Clovis oncology molecules. Before that, Dr. Damatarca served as Executive Director and Head of Safety at Avanir Pharmaceuticals, where her responsibilities included oversight of clinical trials and postmarketing safety, pharmacovigilance, medical review, signal detection, aggregate reporting, and risk management. Previous functions included senior roles in Pharmacovigilance as Therapeutic Area Head for the Oncology Signaling Franchise at Genentech-Roche and before that, as Global Safety Officer and Global Safety Forum Chair at Amgen for various products in Oncology, Oncology–Hematology, and Inflammation-Internal Medicine. While at Amgen, she also served as the Chair of the Global Safety Forum, an internal advisory board for safety issues. Prior to Amgen, Dr. Damatarca worked in drug safety at several pharmaceutical companies. At Amylin Pharmaceuticals, she worked on products within the company’s product portfolio in the diabetes and metabolic disorders pipeline, most notably on two new molecular entities in diabetes. At Ligand Pharmaceuticals, she worked on several drugs in Oncology and Pain, and served as safety officer for various international clinical trials. During her tenure in drug safety and pharmacovigilance at various pharmaceutical companies, Dr. Damatarca participated in several Drug Advisory Committees and served on the teams who developed REMS - RiskMAP – risk management programs for various products, some of these having played a key role in optimizing the benefit-risk profile of the products.
Abstract
Abstract : Unique challenges and opportunities in conducting Pharmacovigilance for orphan drug