Process R&D under the magnifying glass: organization, business model, challenges, and scientific context

Bioorganic & Medicinal Chemistry
Hans-Jurgen Federsel

Abstract

Initially, the aim is to provide the big picture illustrating the as is situation in the pharmaceutical industry: a lack of productivity resulting in too few products reaching the market; a loss of billions in revenue over the next few years as some of the major megabrands go off patent; a spiraling cost for developing new drugs and taking them through clinical and safety studies. Following on, a look deeper into the organization will offer an insight into the state-of-the-art in a technical function accountable for chemical Process R&D (with a remit to develop scalable, robust, and cost efficient processes for small molecules). The vast majority of compounds already launched in the form of drug products on the market or still being pursued through the phases of discovery and development, fall within the category of small molecules (as opposed to biopharmaceuticals, e.g., proteins, monoclonal antibodies). This typically means molecular weights of <1000Da and puts organic synthesis in the widest sense of the word at the forefront of technologies needed to support R&D programs in the pharma industry. Understandably, the demands on Medicinal Chemistry are quite different to what applies in a Process R&D (PR&D) organization. In the...Continue Reading

References

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Citations

Sep 1, 2012·Journal of Neurology·Peter RieckmannSven Schippling
Nov 30, 2010·Drug Discovery Today·Michael K O'BrienKaren Sutherland
Mar 1, 2013·Angewandte Chemie·Jacques-Alexis Funel, Stefan Abele

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