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(919) 657-0660

Expertise: Strategic Planning & Program Leadership

Ph.D. in Biochemistry

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.

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