Getting it Right Early: 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.

Summary

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.

Key Points:

• The importance of salt and polymorph screening and prototype selection for pre-clinical assessment
• BCS or DCS assignment and developing a formulation strategy for poorly soluble molecules
• The role of physiologically based pharmacokinetic (PBPK) modelling and simulation (M&S) for rational formulation design
• Teasing apart the drivers of poor bioavailability - In-vitro testing / in-silico techniques / in-vivo preclinical studies / clinical assessment
• Choosing the appropriate dosage form for first-in-human trials
• Formulation optimization using adaptive clinical programs