Drug Development for Cell and Gene Therapy
In this scientific journal, we review considerations for nonclinical cell and gene therapy development, including expert approaches to mitigating complex challenges, improving study efficiency, and maximizing translational opportunities from nonclinical to first-in-human trials.
• the ICH S-12 Guideline on nonclinical biodistribution studies
• species selection criteria per the FDA
• choosing the appropriate vector
• immunogenicity evaluations
• findings from two case studies
Read the issue HERE.
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You may also be interested in the following:
• Webinar: Cell and Gene Therapy―Enhanced CNS and Ocular Delivery in NHPs
• Poster: Gene Therapy Utilizing Adeno-Associated Viral (AAV) Vectors―Historical Data Review
• Webpage: Preclinical Research Services