According to research, only 1 in 10 new molecules in active clinical development are readily bioavailable(1) and therefore suitable for conventional formulation development such as powder in bottle. Unless advanced formulation expertise and technologies are used for bioavailability challenged compounds, there is a risk that drug candidates will not be sufficiently absorbed to achieve dose escalation in phase 1 studies.
In addition, drug developers are under constant pressure to accelerate entry into clinical trials with limited funding and availability of API.
In order to de-risk the development process, it is important to fully characterise the molecule upfront and perform rapid screening of proven formulation approaches before proceeding to animal trials.
This event will consider the process of molecule assessment, formulation enhancement and delivery of animal PK study materials and how this approach may help speed onward development of optimal drug delivery forms.
(1) R. Lipp; The Innovator Pipeline: Bioavailability Challenges and Advanced Oral Drug Delivery Opportunities, Am. Pharm. Rev., 2013”