Bellerophon Therapeutics Культура компании

Dr. Deborah A. Quinn, also known as Debbie, M.D., has been the Chief Medical Officer of Bellerophon Therapeutics, Inc. since September 2015. Dr. Quinn served as Vice President and Medical Lead for INOpulse Programs at Bellerophon Therapeutics LLC since January 2015. Prior to joining Bellerophon, from December 2006 to April 2013, Dr. Quinn was responsible for leading global clinical trials in PAH at Novartis, and from 2013 to 2015, served as a Medical Director for Novartis' heart failure programs. From 1998 to 2011, Dr. Quinn was a Practicing Physician at Massachusetts General Hospital. In addition, she served as an Instructor In Medicine at Harvard Medical School from 1998 to 2006 and as a Clinical Assistant Professor in Medicine from 2006 to 2011. She has focused on caring for patients suffering from PAH while also leading basic research in the area of pulmonary vasculature. Dr. Quinn received her M.D. from the University of Massachusetts Medical School in Worchester, Massachusetts and completed her Postdoctoral training in Medicine and Pulmonary and Critical Care Fellowship at Massachusetts General Hospital.

Mr. Peter Fernandes, M. Pharm, has been the Chief Regulatory and Safety Officer of Bellerophon Therapeutics, Inc. since May 2015. Mr. Fernandes served as Chief Regulatory Officer and Vice President of Bellerophon Therapeutics LLC since May 20, 2015. Mr. Fernandes served as Vice President of Regulatory Affairs and Quality US at OptiNose US Inc. since joining in 2011. Mr. Fernandes was responsible for the US regulatory strategy development, FDA negotiations and regulatory filing for OptiNose US' unique range of bi-directional nasal drug-delivery products. Mr. Fernandes was the Vice President of Regulatory Affairs at Ikaria, Inc. from October 2012 to May 2015. Previously, he led Regulatory Affairs for OptiNose, Inc. from 2010 to 2012 and was the Drug Regulatory Affairs Respiratory Franchise Head for Novartis Pharmaceuticals AG from 2007 to 2010. Mr. Fernandes has over 22 years of US and global pharmaceutical development experience. He has served in several senior leadership positions, as Head of the US Development Site at Nycomed, Vice President of Regulatory Affairs and Quality Assurance at Altana Pharma and Vice President of Regulatory Affairs at Novartis. In addition, he has had extensive hands on regulatory and project leadership experience at Boehringer Ingelheim, Scios-Nova and Wyeth-Ayerst. Mr. Fernandes has a proven track record with successfully leading cross-functional teams resulting in US and global approvals of products that are now well-recognized blockbusters. His first success at Boehringer Ingelheim (BI) was with FLOMAX, leading the NDA filing, one cycle approval and trade name negotiations with the US FDA in 1996. His 12 years of dedicated regulatory support for SPIRIVA HandiHaler, starting from its pre-IND phase in 1993 to its global NDA filings resulting in approvals in US, EU, Japan and 40 other countries by 2005. For this, he received three prestigious BI President's Awards for his exemplary leadership. In 2005, as part of the Altana Pharma team, Mr. Fernandes completed SPIRIVA's first eCTD for OMNARIS in allergic rhinitis resulting in a one cycle FDA approval in 2006. He was instrumental in re-designing the regulatory strategy of a previously failed Phase III program for DAXAS in COPD. This re-designed Phase III program finally resulted in the EU approval in 2010 and is now anticipating US FDA approval. Mr. Fernandes has had accountability for a diverse spectrum of products -- biologics, small molecules and drug-device combinations -- across a wide-range of therapeutic areas -- respiratory, cardiovascular, urology, gastrointestinal and oncology. He has led four FDA Advisory Committee Meetings (ACM) and delivered the opening regulatory presentations at two of these meetings. He has established an efficient working relationship with the FDA Staff at both the Division and Office levels. Mr. Fernandes holds a Masters in Pharmacy and Clinical Pharmacology from the Grant Medical College, University of Bombay. He holds a B. Pharm. from the K.M. Kundnani College of Pharmacy, at the University of Bombay in India.

Dr. Parag Suresh Shah, Ph.D. has been Vice President of Business Operations at Bellerophon Therapeutics, Inc. since May 18, 2017. Dr. Shah served as Vice President of Project Management and Distribution at Bellerophon Therapeutics, Inc. since April 2016 until May 18, 2017. Dr. Shah is responsible for project management, supply distribution, pre-clinical and business development activities. Prior to Joining Bellerophon, Dr. Shah was Principal Scientist at Pfizer from 2004 to 2010 where he was responsible for leading multiple parenteral and liquid formulation development teams. In Addition, Dr. Shah was a member of multiple limited duration teams including serving as pfizer's team lead for the nanoparticle network responsible for internal and external evaluation of nanoparticle technologies. Dr. Shah joined ikaria as parenteral development lead in 2010 and assumed additional responsibilities in 2012 as Director of Pharmaceutical Science, covering both pharmaceutical development and clinical supply management. Dr. Shah received his bachelor's degree from Carnegie Mellon and his Ph.D. in Chemical Engineering from the University of Texas at Austin.

Debbie Quinn serves as the Chief Medical Officer of Bellerophon Therapeutics. Debbie started at Bellerophon Therapeutics in Sep of 2015. Debbie currently resides in the Greater New York City Area.

Amy Edmonds serves as the Vice President Clinical Operations and Administration of Bellerophon Therapeutics. Amy started at Bellerophon Therapeutics in September of 2015. Amy currently resides in the Greater New York City Area.

Peter Fernandes serves as the Vice President / Chief Regulatory, Quality & Safety Officer of Bellerophon Therapeutics. Peter started at Bellerophon Therapeutics in October of 2012. Peter currently resides in the Greater New York City Area.

Andre Moura serves as the Director of Bellerophon Therapeutics. Andre started at Bellerophon Therapeutics in February of 2014. Andre currently resides in the Greater New York City Area.