Challenge

A small biotech company had undertaken several projects in clinical development and needed focused CMC consultancy support in progressing to the next phases of these ventures.

Solution

Our CMC consultant worked with the client, providing the necessary expertise at key points of the development of two projects. Our support included:

• assessing the CMC package available for an oral compound (novel small molecule) in late stage Phase II clinical trials and writing a report to establish key requirements for a US and European product license submission
• helping assess formulation characteristics and substance characterization — for an oral compound that showed batch to batch variability in dissolution profiles
• developing a new particle size method for both milled and unmilled drug substance
• managing the transfer of product manufacture between sites in the UK and France, and the scaling up and manufacture of Phase III supplies
• providing significant input into a regulatory document seeking scientific advice from the FDA prior to Phase III studies