Recent FDA Oncology Initiatives

This presentation will discuss two recent FDA guidance documents issued related to oncology drug development. The first is related to dose optimization for treatment of oncologic disease as part of Project Optimus which was published as draft guidance in January 2023. In this guidance, FDA discusses the issue with Maximum Tolerated Dose (MTD) approach for oncology dose selection and offers recommendations. The second subject is Tissue Agnostic drug development, issued as draft guidance in October 2022. This opens up the opportunity to develop a single treatment for multiple tumor types if they all contain the same specific molecular alteration such as biomarker or pathway.

Clara Li, Vice President Regulatory and Strategic Development,

Clara Li has worked in regulatory affairs for over 30 years, and has expertise in US, European, Canadian, and Asia Pacific regions for Phase 1-4 studies. Her areas of therapeutic expertise include oncology, inflammation, cardiovascular, renal, endocrine, neurology, ophthalmology, infectious diseases, and dermatology. She has held numerous leadership roles in regulatory strategy for development of well-characterized biologics; small molecules; cell, tissue, and gene therapy; microbiome; vaccines; and combination products.  She has developed innovative regulatory paths leading to clinical programs and marketing approval, including successful execution of 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. Clara also has expertise in conducting due diligence for companies buying products as well as out-licensing products including single products, entire product lines, products still in clinical development, and marketed products.

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