Maximizing The Value Of Early Phase Material: Match Your Development And Manufacturing Path To Your IND Milestones

By Dr. Raymond Donninger, Senior Director Commercial Development, Early Development Services, Lonza Biologics

Reaching IND stage is a major milestone for biopharmaceutical companies. The drug development journey is long, expensive, resource straining, and risky due to high attrition rates. A large amount of data must be generated, collected, interpreted and correctly integrated for the First-in-Human (FIH)-enabling data package. Many of these steps are carried out in parallel but rely on the results from previous steps for an optimal outcome. For example, not performing an optimal molecule de-risking and optimization program early in drug development can result in safety, efficacy, and/or manufacturability issues later in development, resulting in higher development costs to go back and rectify these issues and development time that is likely to be significantly longer.

Discover how to maximize the value of early phase material and match your development path to your IND milestones.