Free webinar - Drug Product Strategies to Accelerate from Candidate Selection to Proof-of-Concept
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.
Drug companies are intensely focused on hitting key clinical milestones. 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 as the clinical strategy. As such, companies may abbreviate the CMC package and develop exploratory formulations to begin clinical trials sooner, presenting major downstream risks. For example, a fit-for-purpose first-in-human (FIH) formulation may not provide adequate systemic exposure to allow study endpoints to be met, and also, such simple drug products may have inadequate stability or shelf-life to be suitable for next stage global patient studies.
As the longer-term goal is to advance the molecule into Phase II patient trials, drug companies will inevitably have to bridge to a patient-friendly solid oral GMP drug product. The challenge is how this “product bridging” can be achieved efficiently in a compressed timeline, without incurring any delays to the start of POC trials.
Join Quotient's Dr Nutan Gangrade and Dr Andrew Lewis, for this webinar which will summarise how a fully integrated development plan can bring together the needs of the drug product team and the clinical development team.
- Learn how flexibility in dosage form design can be achieved to maximize speed, managing costs and decrease risks, particularly for challenging compounds.
- See how adaptive clinical protocols empower real-time dose and formulation changes within the first-in-human program.
- Learn how pharmacy compounding and GMP manufacturing integration can help bridge from first-in-human formulations to patient friendly dosage forms.
- Understand the strategies that can be deployed for challenging molecules such as poorly soluble compounds or highly potent drugs which require special handling and containment.