Focus On Safety And Efficacy And Prove Quickly That Your Product Works

This episode of the De-risking Drug Development series examines essential decisions in the drug development process, focusing on reducing risk while enhancing commercial viability. Episode two centers on early-phase development (phases I to IIa), where safety, tolerability, and efficacy play critical roles in determining a drug’s success. Failures at this stage often stem from insufficient planning and misaligned priorities, making risk mitigation crucial.

This session emphasizes the value of integrated clinical development planning, offering expert insights into regulatory, feasibility, and early-phase requirements. By addressing these areas, biotech leaders can better navigate the complex landscape, minimizing safety risks and enhancing the likelihood of positive outcomes.