Going from discovery to first in human studies as fast as possible is a clear objective for most biotech companies and accelerating timelines has always been a focus for the biopharmaceutical industry. Financial pressures, competition and current global healthcare events are further driving the emphasis to move as quickly as possible into the clinic.
At the same time, with increased speed drug developers may expose their program to additional costs, timeline and regulatory risks. Companies need to wisely select which activities can be accelerated and to carefully plan how to reduce not only time into the clinic, but to also equip the drug candidate from day one with a robust CMC-package that will add value as they advance from one clinical phase to the next, and as they are looking for investors and partners.
In this webinar we talk about how Lonza’s advanced platform can achieve speed whilst minimizing risks to achieve the optimal program profile for a seamless transition from gene to IND and beyond. To help companies navigate through this uncertainty, de-risk and accelerate their path to IND, Lonza has created the IbexTM Design solution. The program not only guarantees* timelines to supply tox drug product material in 9 month and GMP drug product for phase 1 trials in 12 months, but also delivers a scalable, commercially viable process. Our subject matter experts in cell line, process and drug product development will walk you through the details and supporting data about how the convergence of technological innovations and 30 years of track record can deliver speed without compromise.