Our Mission
To develop inhaled drug/biologic and device combination that will improve the standard of care for acute and critically ill patients.
About Us
Creating the first generation of inhaled drugs specifically designed for acute and critical care
Aerogen Pharma, headquartered in Galway, Ireland, with drug development and business operations in San Mateo, California, is a clinical-stage specialty pharmaceutical company developing proprietary, inhaled medications for improved care of patients receiving oxygen and ventilatory support in acute and critical care. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high-performance aerosol delivery system. For our initial product programs, we have selected tried and trusted drugs and repurposed them for inhalation, with the aim of improving their safety and efficacy via targeting to the lung. Our approach is optimized for quick, efficient, consistent and user-friendly delivery of liquid medications to patients on a broad range of oxygen and ventilator support equipment.
Brian Noga
Chief Executive Officer
Brian is an experienced global matrix leader with over 30 years in the industry and a proven track record of success in MDI/DPI drug product development and commercialization. He possesses a strong understanding of the COPD and asthma competitive landscape. His core expertise lies in pharmaceutical product and device technical development and delivery, as well as particle engineering/formation technology and physical properties testing techniques. Brian has demonstrated a consistent ability to build and sustain strong functional teams. His specialties include product development, physical properties and analysis, and MDI/DPI science.
Andy Clark, PhD
President & General Manager
Andy is a recognized leader in the field of respiratory drug development, with over 35 years’ experience and recipient of multiple industry awards. He played key roles in the creation of Pulmozyme® (the first inhaled protein), Exubera® (the first inhaled insulin) and Tobi Podhaler® (the first inhaled dry powder antibiotic). Prior to joining Aerogen Pharma, Andy was Site Head of Novartis Pharmaceuticals’ pulmonary development and manufacturing group in San Carlos, CA. Earlier in his career he held senior management positions including CTO at Nektar Therapeutics (San Carlos, CA), General Manager at Bradford Particle Design (Bradford, UK) and Head of the Pulmonary Group at Genentech (So. San Francisco, CA). Andy has received multiple awards for major contribution to pharmaceutical aerosol Science, including the Young Investigator Award from the International Society of Aerosols in Medicine, The TT Mercer Award from the American Association for Aerosol Research and the RDD Charles G. Thiel Award.
Vidya Joshi, PhD
Chief Development Officer
Vidya has more than 25 years
of extensive end to end, pulmonary product development experience including
pMDIs and DPIs for both respiratory and systemic delivery. She has led multiple
global inhaled product development programs from proof of concept through
commercialization, including successful product approvals of Breztri®, Bevespi®,
Airsupra®, Symbicort Aerosphere® and Exubera®.
Vidya was most recently the Global Program Lead, driving the transition
of AstraZeneca’s entire pMDI portfolio to the greener ‘Next Generation
Propellant’ platform. In this role,
Vidya engineered a creative regulatory strategy, significantly reducing the
clinical program through strong collaboration and science-based discussions
with the FDA. In addition, she led the
establishment of a robust propellant supply chain by building strong
partnerships with Honeywell and overcoming a number of logistical challenges. Vidya has a BS in
Pharmaceutical Sciences from University of Bombay and a PhD in Industrial
Pharmacy from Purdue University.
Jim Fink, PhD, RRT, FAARC, FCCP
Chief Scientific Officer
Jim is an accomplished clinician and researcher of more than 40 years’ standing, with a three-decade focus on the design and application of aerosol devices. Prominent industry roles have included Sr. Fellow of Aerosol Device Development at Dance Biopharm (Brisbane, CA), Chief Clinical Officer at Aerogen (Galway, Ireland), Fellow of Aerosol Science at Nektar Therapeutics (San Carlos, CA) and many years as consultant on inhalation technology to the drug development industry. Jim holds more than 40 patents and 180 peer reviewed papers.
David Durand MD
Chief Medical Officer
David is a neonatologist with over 35 years’ experience in clinical research. He has spent most of his career at UCSF Benioff Children’s Hospital Oakland, where he was the Director of Neonatology, then the Chief Medical Officer. He has been Principal Investigator, steering committee member, DSMB member and/or Site Investigator on multiple clinical trials evaluating surfactant treatment and ventilator strategies in neonatal care, as well as the use of inhaled nitric oxide and neuro-protective treatments. He is a former President of the California Association of Neonatologists, was a long-standing member of the research arm of the California Perinatal Quality Care Collaborative (CPQCC), and a founding member of the Children’s Hospitals Neonatal Consortium (CHNC). He has lectured extensively nationally and internationally, particularly regarding respiratory support and lung-protective strategies for care of critically ill infants, and is an author on numerous papers and textbook chapters on these topics. Although no longer practicing clinical medicine, he remains a member of the Division of Neonatology at UCSF Benioff Children’s Hospital Oakland where he is actively involved with the quality improvement and research programs.
Plamena Entcheva-Dimitrov, PhD, RAC
Acting Chief Regulatory and Quality Officer
Plamena is a seasoned Regulatory Affairs executive with over 15 years of experience in advancing drug/device combination products, such as XIENCE V Drug eluting stent for Abbott Vascular (Santa Clara, CA) and Blowfish Transbronchial Micro-Infusion Device for Mercator MedSystems (Emeryville, CA), from concept to marketing approval. She is the Founder of Preferred Regulatory Consulting and Preferred Clinical Research, boutique firms specializing in supporting start-up companies to develop disruptive medical products such as Zenflow Spring Implant and MIDASVu Arthroscope. Plamena’s industry experience includes leadership roles in regulatory, medical and clinical affairs and quality assurance for devices and drugs at Neuraltus (San Bruno, CA), Mercator MedSystems, and IntraVu Medical (Redwood City, CA).
Judy Doto, RN, BSN
Vice President of Clinical Operations
Judy has over 25 years’ experience in Clinical Operations within the pharma industry, encompassing drug and device product programs across all phases of development. She was formerly Director of Clinical Operations for Panacos Pharma (Watertown, MA), and clinical operations consultant to Becton Dickinson (NYSE: BDX) and Afferent Pharma (San Mateo, CA; acquired June 2016 by Merck & Co.). In addition, Judy has served as Project Manager on more than 30 clinical programs for clients of the CROs Theorem Clinical Research, Premier Research, PAREXEL International, PRA Health Sciences and MTRA/AAI.
Jeanette Asselin, MS, RRT-NPS, FAARC
Clinical Director, Neonatal Programs
Jeanette has over 30 years’ experience of clinical practice in the NICU, primarily focused on studies to better treat, and decrease the incidence of, bronchopulmonary dysplasia. She has been responsible for, or a collaborator on, multiple multicenter clinical studies in the NICU and PICU, including trials focused on inhaled nitric oxide, surfactant delivery, liquid ventilation and high frequency ventilation. Prior to joining Aerogen Pharma, Jeanette was for over 20 years a Member of the UCSF Benioff Children’s Hospital Oakland Research Committee and Institutional Review Board, serving as IRB Chair from 2015 to 2018.
