Biopharmaceutical product development is a costly and risky undertaking with an overall failure rate of over 96%, including a 90% failure rate during clinical development. Delivering new drugs to the patients, that need them, requires a holistic approach keeping focused on the end goal and includes ensuring a seamless integration of the various functional activities needed for efficient and successful development. This session will discuss examples of pitfalls and challenges often encountered in drug development and how to potentially avoid these or reduce their impact.
An expert in global drug development Mark has over 30 years of experience in life sciences. His product development experience spans small molecules, biologics, biosimilars and medical devices across multiple therapy areas. Understanding what it takes to deliver new drugs to the market his expertise includes clinical and regulatory strategy, regulatory agency meetings, and program, project and portfolio management.