Anita Knott

Company: Astellas

Job title: Senior Director - Regulatory Affairs Chemistry, Manufacturing & Controls

Seminars:

Enhancing Gene Therapy Comparability through Statistical Solutions 11:00 am - 1:00 pm

Learn from the experts as they provide insights, practical solutions, and real-world examples to enhance the comparability of gene therapy products. Learn how statistical considerations can help overcome challenges in gene therapy comparability studies and ultimately contribute to the success of these groundbreaking therapies. Get involved and delve into: Navigating limited batches and statistical significance…Read more

day: Pre-Conference Workshop Day

Round Table Discussions: Analyzing the Latest Update from the FDA Review on the Comparability Guidelines 1:30 pm

Join us for an enlightening session as we delve into the recent update from the FDA on comparability guidelines and its potential implications for the evolving landscape of gene therapy development. In this session, we will explore diverse viewpoints from experts in the field, shedding light on the key facets of the FDA’s latest guidelines…Read more

day: Conference Day One