Chief Executive Officer
Dan was the founder and president of Emerge Life Sciences, a consulting company focused on new and emerging technologies in the life science space with significant work in translational medicine and devices over the last decade. Prior to this, he focused on commercialization of respiratory products for asthma and COPD with GSK.
Carolyn Durham, PhD
Chief Scientific Officer
Carolyn received a PhD in Mucosal Immunology from UAB and was a Howard Hughes Fellow in Translational Medicine. After a post-doc at UNC, she was the Scientific Advisor of Montague Capital, focusing on scientific strategy and collaboration. She has spearheaded the transition of ARINA-1 from 15 years of research to product commercialization.
Marilyn has over 25 years of experience as a business development executive in the biotech, pharma, medical device, software and 3D scanning sectors. She has served as a Controller, Director of Finance and Chief Financial Officer with oversight of Accounting, Finance and Administrative areas of business. She and has extensive experience in new business and federal grant reporting and auditing. She has also served as a consultant to over 100 start-up companies.
CMC Strategy and Operations
Hal is the founder of Trout Creek Consulting, LLC, a strategy and life science supply chain consultancy focused on solving CMC, strategic and technical challenges. As as experienced operating executive with over 30 years in FDA-regulated industries, he has held multiple roles with responsibilities including global business units, supply chain, quality and regulatory, engineering and maintenance, capital projects, and commercial real estate. His expertise includes manufacturing, product / process development and strategic planning.
Matt Cowlen, PhD, DABT
Inhalational Toxicology Strategy and Operations
Matt is the founder of Cowlen Consulting, LLC. He is a board-certified toxicologist with a PhD in pharmacology and 24 years of drug development experience. He was the Dir. of Toxicology at Inspire Pharmaceuticals (acquired by Merck, 2011) with responsibility for nonclinical safety assessment, including the evaluation of an inhaled investigational drug for CF. As a consultant for over 9 years, Matt has designed / managed nonclinical safety assessment programs and authored relevant sections of US and international regulatory applications for inhaled, oral, ocular and parenteral therapeutics.
Michelle Gruver, RN, BSN, MS, CCRA
Michelle is the founder of Advanced Research Solutions, Inc. and has over 29 years of experience in the healthcare industry, including as a registered critical care / ICU nurse. She specializes in pharmaceutical and biotech companies to develop well-designed clinical programs to bring safe, effective and innovative treatment solutions to patients in need. She is a UNC-Chapel Hill graduate and has a MS in Clinical Research from Campbell University.
Uyen has over 19 years of clinical research experience , including 5 years as a R&D scientist and over 14 years as an NDA/MAA Project Manager, Director Clinical Research, Clinical Study Manager and Lead CRA/CRA. She previously held key roles in clinical operations for Prometheus, Spectrum Pharmaceuticals and Pfizer, as well as in R&D project management at Valeant Pharmaceuticals. She managed a critical Phase 2 study with positive outcomes and was promoted to director for clinical programs (4 US and global Phase 3 trials).