Preclinical and Translational Sciences
Darren Matthews, PhD
Associate Science Director
Charles River
Harlow, England, United Kingdom
Dolly Jacob, PhD
Director, Integrated Development Services, Early Development
Quotient Sciences
Nottingham, England, United Kingdom
Description: The transition from Early Discovery to the Clinic has been termed the ‘Valley of Death’ due to approximately 95% of compounds failing to make the later clinical stages. It is estimated that majority of failures in Phase 2 are due to poor efficacy because of poor exposure. By control of the drug properties and early consideration of appropriate formulation strategies during development the risks can be reduced, minimizing the challenges for the formulation scientist.
Learning Objectives include;
Understand the avoidable challenges that are met by the formulation scientist when developing the drug product for clinical studies.
Understand what can be done during the Early Discovery phase to mitigate these risks, providing a smooth transition from Early Discovery across the entire development pathway.
Gain an appreciation of the nuances of alternative dosage routes, and the impact on attrition and development.