Naoko Fujii, JD

Ms. Fujii is a pharmaceutical regulatory compliance expert with more than 20 years’ experience, and has an extensive background in international law. She has been a member of numerous global launch teams providing regulatory guidance relating to clinical trials, compassionate use programs, new drug applications, distribution, and commercial launch issues. See for example, XTANDI® (enzalutamide) for Patients With Metastatic Castration-Resistant Prostate Cancer, OMONTYS® (peginesatide) Injection for the Treatment of Anemia Due to Chronic Kidney Disease (CKD) in Adult Patients on Dialysis, and Korlym™ (mifepristone) for Cushing’s Syndrome Patients.

Ms. Fujii spent 3 years as the Executive Director of the Academic Alliance for Infectious Diseases in Africa, a philanthropic project funded by Pfizer, Genentech, Cisco Systems and other companies to build the first outpatient HIV/AIDs clinic in western Africa designed to treat patients and train African doctors on HIV treatment and prevention. Prior to that, she spent 7 years at Pfizer working on international healthcare policy initiatives in South Africa, Israel, Japan, Australia, Taiwan, EU and other countries utilizing her experience as a FDA regulatory attorney. Projects included negotiations to update Japanese clinical trial regulations to accept clinical trials in non-Japanese subjects to comply with ICH standards.

Before joining Pfizer, Ms. Fujii held positions with international responsibility in the legal departments of Merck & Co., Inc., and Schering-Plough Corporation. She was a member of the global development and launch teams for the drugs: XTANDI® (metastatic castration-resistant prostate cancer); VIBATIV® (complicated skin structure infections); VIAGRA® (erectile dysfunction); CRIXIVAN® (HIV/AIDS); PROSCAR® (benign prostatic hyperplasia); and FOSAMAX® (osteoporosis). She began her legal career as an international trade and FDA regulatory attorney at the law firm of Weil, Gotshal & Manges in Washington, DC.

Ms. Fujii holds a JD from Georgetown University Law Center and an AB from Stanford University. She is a licensed member of the New York and Washington, DC bars.

Ms. Fujii is currently providing FDA regulatory compliance services to biotech start-up companies preparing to launch their first FDA-regulated drug or device.