Michelle Higgin

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 currently holds leadership roles in several other biotech companies too.