Webinar | August 14, 2013

The Cost of Failure In Pharma Development: A Risk for Everyone

The Cost of Failure In Pharma Development:  A Risk for Everyone
Date: September 10th, 2013
Time: 12:00pm ET

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Georg Blaser PhD, Group Leader, APS
Noel Smith PhD, Lead Scientist, APS
Olga Obrezanova, PhD, Lead Scientist, APS

Last year a post made by Forbes took social media platforms by storm by suggesting a new way of calculating the true cost of developing new drugs. The results were staggering; with some companies portrayed to spend, on average, between four and eleven billion US dollars for every new therapeutic treatment eventually commercialized. Approximately 90% of drug candidates will fail during their clinical development stages; over 99% if one includes preclinical stages of development. The ‘valley of death’ in pharmaceutical development spans late discovery through early clinical phase. It is substantially longer and more deadly than in other industries and, over the years, has been the end of many promising therapeutic approaches and the companies developing them. Developing new therapeutics is more than ever becoming a business for the brave.

Lonza now provides a complete Developability Assessment Toolbox that consists of a suite of in silico tools and protein structure expertise. The Platform includes Manufacturability and Safety Assessment Services applicable to customers in both discovery and early stage biological drug development. Predicting potential problems serves no purpose if it is not accompanied by adequate corrective actions or mitigation strategies to address them. This webinar will also discuss risk mitigation options for both early and late stage development programs.

      • Manufacturability Assessment Service analyzes chemical degradation pathways and post translational modifications including deamidation, oxidation and glycosylation, as well as potential physical stability issues, most notably, protein aggregation.

      • Safety Assessment Service uses our proprietary Epibase™ In silico Screening tool to identify T-cell epitopes in target proteins that may trigger potential immune reactions in human studies.

The Benefits of Early Risk Assessment Include:
      • Reduction in development costs and time
      • Acceleration of the lead candidate selection process
      • Increase the chance of a candidates success
      • Potential optimization of the process before problems arise in development
      • Improved chance of successful manufacturing scale-up

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