Survive the Valley of Death and De-risk Your Pipeline

The pharmaceutical industry is facing a growing number of challenges including escalating R&D costs, lower approval rates of new therapeutics and more stringent regulatory scrutiny.  Screening of potential candidates in the discovery process will help reduce costs, risk (attrition) and overall development time.  Being able to assess the manufacturability and safety at the pre-clinical stage, before large investments are made, allows companies to focus on the most probable candidate and maximize R&D spending.

Knowing about these potential risks at the start of product development can enable you to select the best candidate, optimize the development process, ensuring a rapid and cost effective drug development strategy.

 

Figure 1. Drug development cycle and the ‘valley of death’. Schematics of the drug development lifecycle, duration of each one of the stages, capitalized costs and probability of failure. Adapted from {Paul, 2010 #886} and Michael J. Fox Foundation.

 

For more information on Developability, please visit the links below for recent publications from our Applied Protein Services Scientists.

Zurdo, J. et al (2015). Early Implementation of QbD in Biopharmaceutical Development:  A Practical Example. BioMed Research International. Article ID 605427.

Obrezanova, O. et al (2015). Aggregation Risk Prediction for Antibodies and its Application to Biotherapeutic Development. mAbs, Vol. 7, Iss. 2.

Zurdo, J. (2013). Surviving the Valley of Death. European Pharmaceutical Review, 195, 50-54.

Zurdo, J. (2013). Developability Assessment as an Early De-risking Tool for Biopharmaceutical Development. Pharmaceutical Bioprocessing, 1(1), 29-50.

GEN. Optimizing Cells Lines Improves Production – Really! By Angelo DePalma. Reviews the use of developability mentioning Lonza’s approach.