ADDS 2022 Speakers
Principal Executive Officer / Chief Regulatory, Safety and Quality Officer
Mr. Fernandes has over 30 years of global drug development experience within the pharmaceutical industry. He currently serves as the Principal Executive Officer and Chief Regulatory, Safety & Quality Officer of Bellerophon, a company that focuses on developing drug-device combination products to treat patients with cardiopulmonary diseases. He is also instrumental in the ongoing negotiations with FDA on the use of Actigraphy as a primary regulatory endpoint for phase 3 studies in cardiopulmonary diseases and currently is serving as Co-Chair of the Pulmonary Vascular Research Institute (PVRI) and an NIH task force to help streamline future development of this digital health technology (DHT). Prior to joining Bellerophon, he held senior leadership positions at both large and mid-size pharmaceutical companies, serving as Head of US Development Site at Altana-Nycomed, VP Regulatory and US DRA Respiratory Franchise Head at Novartis, VP Regulatory at Ikaria, VP Regulatory & Quality Optinose and Director Regulatory Affairs at Boehringer Ingelheim. Peter has a proven track record of leading cross functional development teams covering respiratory and cardiovascular diseases with successful US and Global regulatory submissions and approvals obtained for a number of block buster drug-device combination products. He holds a Masters in Clinical Pharmacology from the Grand Medical College and a Bachelors in Pharmacy from the University of Mumbai India.