Key Considerations for the Successful Development of a Biologic: Seven Steps to Success

Understanding the biology of your therapeutic is key to effectively and efficiently progressing it from first principles, through safety assessment studies, and into clinical trials. The unique characteristics and specific biology of each large molecule therapeutic make it impossible to design a “one size fits all” approach to non-clinical development, requiring instead a design tailored to each molecule.  For efficient development strategies, this should include a thorough understanding of the disease and therapeutic biology as well as ensuring that the most appropriate studies are conducted to progress each molecule. Despite the need for unique approaches for each novel biologic, there are seven key steps that should be considered when developing biologics through non-clinical development in order to ensure effective and efficient progress.