Advantages of an integrated development model.

As outlined in the case studies, solving challenges in early stages is critical to a success product launch. Characterizing the target drug product profile before the clinical stage will help choose enabling technologies and drug delivery platforms among other elements. Pharmaceutical companies and their CDMO partners must work closely to define key problem statements early on to design robust processes for the entire development program, beyond the first stages. Thoughtful processes cut inefficiencies from the bud and prevent them from snowballing to later phases of development. This can potentially save months, if not years, in manufacturing, saving millions of dollars along the way and potentially getting the medicine to the patients who need them sooner.

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