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Process chemistry development – Fast, lean and green

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SUSANA LUCAS
Group Leader, R&D – Process Chemistry Development, Hovione Farmaciência SA, Portugal

Pharmaceutical development is prone to challenges over drug launch pathway. For decades, the average development timeframe from bench to market was set as high as 12 years with rates of success as low as 1 to 5000. While the success rate may remain low as will be always nature dependent, the paradigm of approval timelines has suffered important breakthrough. From early 80’s to now several mechanisms emerged to accelerate drug launch, a major driving force was Acquired Immune Deficiency Syndrome but others like flu have made their impact. Currently FDA has set successful mechanisms to speed up the availability of drugs that treat serious diseases: Priority Review, Breakthrough Therapy, Accelerated Approval and Fast Track. FDA figures from 2019 show that from the 48 novel drugs approved 35 % were designated Fast Track (process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need) and a total of 60% were designated in one or more expedited categories.

We live unprecedent times due to Covid-19 and it is our duty as scientists to make it clear for the sake of public awareness, tha ...




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