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Filing an Investigational New Drug application with the FDA is a necessary step in advancing to clinical trials. It is frequently identified as a company milestone — but it is not a value inflection point in and of itself. What is the purpose of an IND? What does it mean to investors, and what resources does it take to be IND-enabled and to file an IND? Join us to learn from Chelsea Bahney, CEO and co-founder of UCSF spinoff Hydronovo, currently doing the work to enable an IND, and Dr. Bruce McCarthy, an expert in drug development, and formerly CEO of Afferent, acquired by Merck.

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About the Speakers

Bruce McCarthy, MD

Dr. McCarthy is a drug development and start-up company consultant. Most recently, he was the President and CEO of Afferent Pharmaceuticals, a clinical development stage company developing treatments for pain, bladder and respiratory disorders based upon P2X3 antagonism which was ultimately purchased by Merck in 2016 transaction valued at $1.25B in cash and contingent payments. His experience includes 25 years of neuroscience drug development. At Pfizer, Inc., Dr. McCarthy served as vice president, neuroscience development. Clinicians in his organization obtained approval for Chantix® for smoking cessation. Prior to joining Pfizer, he held various roles at Abbott Laboratories, including venture head, where he managed clinical development programs for neuroscience drug candidates, including ABT-594 (an NNR antagonist for pain) and Depakote. He has previously served as an industry consultant, when Dr. McCarthy served as head of development and chief medical officer for several start-up companies including Embera, developing treatments for neurological and psychiatric disorders. Dr. McCarthy received an M.B.A. from Kellogg School of Management, an M.D. from the Johns Hopkins University School of Medicine and a B.S. in biological sciences from Stanford University. He completed his residency in neurology at the University of California, San Francisco.

Chelsea Bahney, PhD

Chelsea Bahney is an associate professor of orthopedic surgery at UCSF and CEO/COO of Hydronovo, a company she co-founded with fellow UCSF faculty and CSO Sarah Knox. The company focuses on using an injectable neuromimetic hydrogel to drive tissue regeneration.

Bahney’s UCSF research focuses on developing novel stem cell based therapies for the treatment of musculoskeletal diseases and injuries. Specifically, she believes we can drive improved tissue regeneration by recapitulating the developmental and repair sequences stem cells follow. She uses a cross-disciplinary approach that combines engineering training in biologically modified synthetic polymers, cell and developmental biology, and pre-clinical models of orthopaedic injuries.

Bahney earned her PhD from Oregon Health Sciences University in a degree that combined cell and molecular biology with orthopaedics and rehabilitation. Previously, she worked for five years at Medtronic as an R&D engineer. She earned a BS in chemical engineering from the University of Colorado, where she coached the freestyle ski team.