Integration of Pharmacy Compounding and GMP Drug Product Manufacturing for Seamless Product Supply

Proof-Of-Concept (POC) is a pivotal milestone in the drug development process and yet around 80% of drug candidates continue to fail by the end of Phase II. As a result, biotech and pharma companies are continuously seeking creative ways of re-engineering the early development process to shorten project timelines, reduce costs and improve overall R&D productivity.

Companies are intensely focused on hitting key clinical milestones to gain a competitive edge and timelines for starting clinical development are becoming shorter. Since the team working on the clinical plan is seldom involved in the overall CMC strategy, the clinical formulation, or drug product, is not always given the same level of attention and investment. As such, companies may abbreviate the CMC package and develop exploratory formulations to begin clinical trials sooner, presenting major downstream risks. Firstly given today’s challenging drug substance chemistry, a fit-for-purpose first-in-human (FIH) formulation may not provide adequate systemic exposure to allow study endpoints to be met, and secondly, such simple drug products are likely to be unsuitable for next stage patient studies if positive clinical results are obtained.

This raises some key questions for drug development teams:

• How can we therefore build in more flexibility within the FIH studies to respond to human clinical data?
• How can we exit FIH with a “patient ready” dosage form to avoid a huge time and cost penalty whilst clinical development is effectively paused whilst formulation and CMC activities are “caught up”?
• How can we achieve these important goals whilst still managing CMC investments?

This webinar will summarise how a fully integrated development plan can bring together the needs of the drug product team and the clinical development team.