05.16.25 -- Adapting To Change In The Era Of Tariffs, Tax, And Regulatory Changes

Gene therapy is complex—and so is writing about it. From viral vectors to cell types, every element demands deep understanding. Safety reporting adds further complexity: is an adverse event from chemotherapy, a procedure, or the gene therapy itself? These challenges require a thoughtful, flexible approach to document strategy and execution. Explore common hurdles and practical solutions for gene therapy document writing and submissions.

Delve into the significance of evolving clinical trial models, their potential to remove barriers to participation, and strategies for sponsors to implement hybrid and decentralized designs.

Explore the impact of extractables and leachables (E&Ls) in CGT development. Learn how to qualify single-use systems and use cell-painting assays to assess E&L effects.

Despite clinical trial awareness campaigns and site expansions, trials continue to fall short in reaching the patients who need them most, resulting in a shift toward community-rooted recruitment.

Learn how leveraging the expertise and capabilities of an experienced partner is a key factor in optimizing AAV processes using Design of Experiment (DoE), thereby reducing variability and risk.

Biotech firms often grapple with complex vendor payment processes. Discover how to streamline operations, reduce errors, and free up staff time with these four effective solutions.