Regulatory Affairs Principal Consultant, LUCORE Regulatory Consulting
Ann Lucchesi is a regulatory affairs professional with more than 20 years of experience in the pharma biotech space. Currently with LUCORE Regulatory Affairs Consulting, Ann uses her expertise to assist clients to overcome challenges in drug development. Ann’s accomplishments include: IND/NDA planning, successful team preparations for FDA meetings, multiple IND clearances, pre-IND and end-of-Phase 2 meetings, and pediatric agreements. Ann brings clients a strong understanding of global regulations and guidelines, using that knowledge to develop and implement sound regulatory strategies. Ann’s experience includes roles at Exelixis as vice president of regulatory affairs and at Roche/Genentech as group director of regulatory affairs. Early in her career, Ann held positions in analytical chemistry at Genentech and Scios. She is currently an active member of the Chief, RAPS and HBA organizations.