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Life Sciences organizations need to bring new high-quality therapeutics to market fast to respond to patient needs specific to different diseases and geographies. But development time and costs for new therapeutics are gigantic with an average accrual of $2.6B and 12 years from ideation to market. Reasons for the struggle include (1) the long “time to fail” in new target identification, (2) increasing global and regional regulations and
scrutiny, and (3) the major efforts required to ensure that therapeutics are safe, efficacious and compliant with specifications. Personalized Medicine and Patient Centricity add complexity to Development and Manufacturing. Testing is required to confirm therapeutic characteristics discovered during Research, to identify and optimize formulations for production and scale-up, and to release active ingredients and products.
