Chief Regulatory & Development Officer
Michelle Higgin, Ph.D. joins APIE-Therapeutics to manage the development and regulatory path to further advance the Idiopathic Pulmonary Fibrosis (IPF) and Heart Failure (HF) therapies through the commercialization path. Michelle is a versatile Development & Regulatory Strategist in all phases of drug development. She has supported the virtual biotech model for the past 15 years and has conducted numerous health authority meetings (eg. Pre-IND Meetings) and successfully opened 40+ INDs/IMPDs/CTAs/NDAs in US, Europe, and Australia in many therapeutic areas (neuroscience, psychiatry, oncology, GI and cell/gene therapies). Her primary competencies are in aggressive program management of: Discovery, DMPK, CMC, preclinical pharmacology, nonclinical, regulatory, and early phase clinical trials. She has played leadership roles in a number of biotech companies including but not limited to: Complexa, Cavion (now Jazz), Cortendo (now Strongbridge).
Michelle holds a Ph.D. from the University of Wisconsin-Madison and is the Principal Partner at PharmaDirections.