Lansita J, Weis S. A peek into the black box—Insight from former FDA reviewers on the BLA review process. Presentation at 25th annual Charles River Biotech Symposium, Carlsbad, CA, September 8–11, 2019.
Presented in a workshop titled, “Demystifying the Late Stages of Nonclinical Development of Biotherapeutics”
Charles River workshop abstract: The workshop will focus on late stage nonclinical scientific and regulatory strategies necessary for a successful BLA filing and marketing authorization. How to plan for and execute a US and worldwide nonclinical toxicology registration strategy based on specific requirements for biologics and share insight around regulatory procedures and the FDA review processes will be discussed. The different late-stage studies and sections of a BLA including reproductive toxicity, juvenile toxicity, carcinogenicity, and comparability assessment will be discussed in more detail also. The use of a gap analysis to assess for potential scientific and regulatory issues mid-development as well as tips for drafting appropriate supportive late-stage program documents (e.g. briefing documents, annual updates, PPSR/PIP, labels, RMP) will be shared.