OBJECTIVE:
“I am interested in licensing a drug currently in development and need to perform due diligence to establish if the risks and challenges involved in the manufacturing could be surmountable within an achievable budget.”
SCOPE FOR CEREBRO CMC:
> Review CMC-related files held in licensor’s on-line data room
> Identify key risks either to usability of existing drug or to future manufacturing
> Prepare a list of questions seeking further information from licensor
> Challenge licensor’s CMC team on key risks to try to uncover gaps or solutions
> Prepare a risk analysis assigning risk priority and risk mitigation options
> Contribute to overall due diligence presentation
> Optional: develop a high-level plan for taking the CMC activities to the next development milestone
TIMELINE:
A due diligence package typically spans a period of up to 1 month to complete the scope once access to the data room is established.