SpeakerSeminar: Dr. Linda Narhi, Scientific Executive Director at Amgen, Host: Jacob Israelachvili
Date and LocationWednesday November 09, 2016 11:00am to 12:00pm
With an increasingly competitive landscape and the spiraling cost of clinical trials, coupled with increased understanding of protein therapeutics, there is a trend in biotechnology to incorporate pre-clinical developability filters to differentiate large numbers of biological candidates as part of a Quality-by-Design (QbD) strategy. This is especially important as we move towards patient-centric therapeutic design. We want to choose the candidate that has the best chance of being a commercial molecule, and also delivers to the needs of the patient population and the desired route of administration while at the same time being safe and efficacious. While biology is still the determining factor in candidate progression, pre-clinical developability assessment is critical to identify opportunities for additional engineering efforts or to help in the selection of candidates for further pre-clinical development. It is also a critical component in understanding the critical quality attributes (CQA) of therapeutics, the parts of the molecule that must remain unchanged in order to preserve safety and efficacy.