On-Demand: The Importance of Biopharmaceutics in Early Drug Development

Hear strategies being used by biotech and pharmaceutical companies to overcome biopharmaceutic challenges for small molecules in today's drug development pipeline.

Chris Roe, Principal Research Fellow at Quotient Sciences, discusses effective strategies to overcome biopharmaceutic challenges for small molecules and alternative approaches for accelerating your early development plan. He presents case studies related to poorly soluble molecules, drugs with short half-lives, and preclinical to clinical translation.

Nominated candidates entering clinical development often have sub-optimal physicochemical, biopharmaceutic or DMPK properties for oral delivery. Development teams are challenged with how to understand the properties of new drug candidates, how to design the appropriate formulation strategy, and how to move quickly and successfully into early-phase clinical trials. Along the way, it is important to identify developability risks and take steps to mitigate these factors, balanced carefully against time and cost investments.

What we'll help answer:

• How do BCS or DCS classification frameworks inform formulation strategies for poorly soluble molecules?
• What role does PBPK modeling and simulation play in rational formulation design?
• What are the key drivers of poor bioavailability?
• How can bioavailability drivers be identified through in vitro, in silico, preclinical, and clinical approaches?
• Why is salt and polymorph screening critical for prototype selection in preclinical assessment?
• How can formulation optimization be accelerated through adaptive clinical programs?
• How should the appropriate dosage form be selected for first-in-human (FIH) studies