President & CEO
Jim has 33 years of experience in the life science industry developing both drugs and devices. Prior to co-founding Lowell Therapeutics, he served as the VP of New Enterprise Development at La Jolla Pharmaceutical Company where he identified Niyad™ for development in the US market. Prior to working at La Jolla, Jim was the COO of Pluromed, Inc. where he led the development and commercialization of two successful products in the U.S. and Europe. The first product was licensed to Boston Scientific, which fueled development of the flagship product. He was instrumental in the sale of the company to Sanofi, which provided a 6x return to seed investors and 4.7x to Series A. Jim was the head of Engineering for 3 sites at MedChem Products and helped sell the company to C.R. Bard after which he co-founded Surgical Sealants, Inc. in 1997. Jim holds 4 issued patents and several pending applications. He received a B.S. in Engineering from the University of Massachusetts in 1985.
Elaine Liong, Ph.D.
VP, Regulatory Affairs
Elaine Liong has 13 years of pharmaceutical industry experience, managing and directing regulatory intelligence and efforts from pre-IND to postmarking regulatory filings. She has written and contributed to 3 pre-INDs, 8 INDs & 1 NDA. Elaine leverages scientific and technical data with the requirements for regulatory approval, identifying and implementing regulatory strategies to innovatively advance drug discovery and development programs.
Michelle Merrigan, Ph.D.
Michelle Merrigan, Ph.D. has more than 11 years of experience in clinical development. She specializes in early clinical development, and has managed strategy, research, content creation and agency communications for multiple submissions. Michelle has developed clinical trial protocols from planning through report writing, publication and regulatory filings. Regulatory submissions include 4 NDAs, 3 MAAs, 5 INDs, 4 Pre-INDs, and 1 IDE. Michelle’s expertise spans multiple therapeutic areas, including critical care medicine, infectious diseases, gastroenterology, and oncology. Prior to entering the pharmaceutical industry, Michelle conducted basic and translational research in the academic environment for more than 10 years. Michelle earned her Ph.D. in Microbiology and Immunology from Loyola University Chicago.
Scientific Advisory Board
Stuart Goldstein, M.D.
Dr. Goldstein is an active investigator in the field of pediatric acute kidney injury (AKI) since 2000.His main research foci include AKI epidemiology and outcomes, acute renal replacement therapy provision and investigation of novel urinary AKI biomarkers in the pediatric population.He has a strong record of interdisciplinary and inter-institutional collaboration, evidenced by my establishment and directing of the Prospective Pediatric Continuous Renal Replacement Therapy (ppCRRT) Registry and its success as well as collaboration with critical care physicians, cardiologists and emergency medicine physicians to study AKI in their populations.More recently, he established the Prospective Pediatric AKI Research Group (www.ppaki.org), a 53 international research consortium with a mission of advancing the translational science for children with AKI.The ppAKI recently published an unprecedented prospective observational study, Assessment of Worldwide AKI, Renal angina and Epidemiology (AWARE – NCT01987921).AWARE enrolled 5,927 patients from 32 centers worldwide, making it the largest pediatric critical care nephrology study executed to date. He was recruited to Cincinnati Children’s Hospital in 2010 to establish and direct the Center for Acute Care Nephrology (CACN), which has as one if its aims to collaborate with investigators throughout the world to improve outcomes for children with, or at-risk for AKI.