Regulatory Affairs Principal Consultant
LuCore Regulatory Services LLC
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 LLC, 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, PIND-EOP2 meetings, and pediatric agreements.
Ann brings clients a strong understanding of global regulations, guidelines, regulatory environment; effective use of knowledge to develop and implement sound regulatory strategies. Ann's experience has included roles at Exelixis, Inc., as Vice President, Regulatory Affairs; and Group Director, Regulatory Affairs at Roche/Genentech. Early in her career, Ann held positions in Analytical Chemistry, while at Genentech and Scios. She is currently an active member of the Chief, RAPs and HBA organizations.
Solutions Circle (A): Regulatory Consulting-Ins and Outs
Thursday, October 9, 2025
10:35 AM - 11:05 AM EST