The guest speaker of BioRN Lounge on April 25 was Cristina Grigore, Customer Proposals Professional at LONZA AG.
Cristina guided a very crowded audience through the bumpy journey of a drug product development, from its identification, through its development in clinical phase to validation and submission to authorities.
The anonymized study case she presented, convinced the audience that to develop and validate a drug product, scientists should start with the end in mind. It is not early during clinical phase I to have a clear view about patient population needs, dosing requirements, impact of changes on timeline and therefore budget and involvement of strategic partner in the process.
To face the so-called “Death Valley” at the switch between pre-clinical phase and phase I in the life sciences innovation journey, risk management is the key. This means - among others, “be prepared” to choose the right partner accordingly to the financial model and available resources by keeping the end in mind.
Impressions