CARLSBAD, Calif., June 21, 2016 /PRNewswire/ -- Agility Clinical, Inc. a specialty consulting and contract research organization announced today the appointment of Cristina Damatarca, MD to Vice President of Medical Affairs and Pharmacovigilance. Dr. Damatarca is a physician with 20 years of global experience in the biopharmaceutical industry across all stages of development and product commercialization in oncology, hematology, neurosciences, metabolism, pain, as well as other therapeutic areas.
"We are pleased to announce that Dr. Damatarca, a seasoned professional in global pharmacovigilance, has joined our team to help biopharmaceutical companies overcome the challenges they face in bringing much needed treatments to patients suffering from rare and ultra‑rare diseases and disorders," says Marilyn Carlson, D.M.D., M.D., RAC, Executive Vice President of Medical, Regulatory and Scientific Affairs at Agility. Dr. Damatarca will provide leadership for global safety programs and supplement our expertise in study design and project feasibility.
Prior to joining Agility Clinical, Dr. Damatarca served as Vice President, Head of Drug Safety and Pharmacovigilance at Clovis Oncology, Executive Director and Head of Drug Safety at Avanir Pharmaceuticals, and held senior leadership roles in the Industry including Therapeutic Area Head for the Oncology Signaling Franchise at Genentech-Roche, Global Safety Officer at Amgen for various products in the Oncology, Hematology, and Inflammation-Internal Medicine and Chair of the Global Safety Forum, an internal advisory board for safety issues. She participated in several regulatory submissions (NDA, BLA, and MAA), Drug Advisory Committees, successful regulatory audits, and served on teams that developed REMS - RiskMAP - risk management programs for various products. She is also an experienced "hands on" medical monitor and drug safety physician.
Agility is a niche CRO focused on the needs of pre-clinical and clinical stage companies and specializes in complex trials and rare diseases. The Agility team has an extensive track record conducting trials and preparing data for regulatory submissions leading to product approval. Founded in 2012 by an experienced executive team and employee-owned, Agility won the ROAR (Rare and Orphan Advocacy and Research) award for best CRO for two consecutive years against several well‑known CROs. Our team is experienced, efficient and dependable, yet creative and committed to our clients and the patients they are trying to help. Agility has established operations in Carlsbad, CA.
For more information, visit www.agility-clinical.com.
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SOURCE Agility Clinical, Inc.