Ms. Lee is a healthcare leader and recognized expert in accelerating drug development pipelines from preclinical to commercialization. Over the past 25 years, Ms. Lee successfully launched NDA efforts for Celebrex®, Bextra®, Myrbetriq®, Betmiga®, Xtandi®, among others. She has held senior positions in small, mid-, and large pharma and biotech companies and has managed more >50 clinical product candidates for oncology, CNS, infectious, rare disease, and immuno gene/cell therapies. Her experience includes leading clinical development efforts, initiating INDs, accelerating clinical developments, filing NDAs, launching new products, developing external partnerships, building clinical development teams, generating and executing inspection-readiness programs, and leading global inspections as a Subject Matter Expert. With senior-level experience at Pfizer, Gilead, and Astellas, Ms. Lee conducted numerous inspections for FDA, EMA, MHRA, China, Japan, South Korea, and other countries. Through a deep diligence process, Ms. Lee translates life sciences research discoveries into business opportunities, developing clinical development strategies into new products.
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