Recent FDA Oncology Initiatives

Speaker: Clara Li

Over thirty-one (31) years in regulatory affairs with expertise in US, European, Canadian, and Asia Pacific regions (Phases I-IV).  Strategic regulatory leadership role in development of well-characterized biologics; small molecules; cell, tissue, and gene therapy; microbiome; vaccines; and combination products.  Lead strategist with quick understanding and assessment of how to develop innovative regulatory paths leading to clinical programs and marketing approval.   Expert in integrating and leading multi-disciplinary project teams to meet aggressive timelines.  Therapeutic area expertise include oncology, inflammation, cardiovascular, renal, endocrine, neurology, ophthalmology, infectious diseases, and dermatology. 

Planned and successfully executed FDA and EU health authority negotiations, submissions, approvals of clinical trial (IND, CTA) and marketing submissions (NDA, 505(b)2 NDA, BLA, MAA) and life cycle management of dossiers.

Lead teams for submissions and approvals of Orphan, Fast Track, Breakthrough, QIDP, Pediatric Plans (PIP/PSP) and PRIME.

Expertise in assessing and defining technical and data requirements for expedited development paths and novel development programs.  Lead role in due diligence teams for companies buying products and also out licensing products including single products, entire product lines, products still in clinical development, and marketed products.

Lead team of over 20 regulatory affairs and strategy professionals across the US, Europe, and Asia Pacific.