Optimizing Early-Stage Drug Development - Pharmaceutical Technology

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Optimizing Early-Stage Drug Development
Pharmaceutical companies and contract service providers adapt strategies and capabilities to reduce costs and accelerate drug-development timelines.


Pharmaceutical Technology
Volume 36, Issue 11, pp. 32-37

GlaxoSmithKline. In 2010, GlaxoSmithKline (GSK) said it became the first major pharmaceutical company to publish an internal R&D ROI to measure the investment choices within its R&D organization. In early 2010, the company estimated the ROI it made on its recently launched products and late-stage pipeline at 11%. This ROI increased to 12% in 2011, and the company has a long-term goal to improve returns to approximately 14%.

GSK changed its R&D business model in 2008, moving away from industrial-sized therapy groups to smaller, more agile and focused discovery performance units (DPUs) consisting of 5–70 scientists. Each DPU works on a particular disease or pathway and is responsible for potential new medicines through early-stage clinical trials (up to the completion of Phase IIa). As part of this new model, DPUs were given their own budgets and a three-year window to complete specific tasks, which included opportunities for collaboration with external organizations. The three-year mark for most DPUs was reached in 2011, and progress of all 38 DPUs was reviewed by GSK's discovery investment board (DIB), a panel consisting of senior management from R&D and commercial operations and external experts. Based on this review, in 2011, four new DPUs were created, and three were closed. Of the remaining DPUs, six received increased investment, and five had investment decreased. Based on this review, GSK believes that it can progress up to 30 medicines into late-stage development during the next three years.

External partnerships are an important component of GSK's R&D model In 2011, GSK had more than 50 external discovery alliances, compared to 17 in 2007, and it has been active again in 2012. In August 2012, GSK completed its $3.6-billion acquisition of Human Genome Sciences and in September 2012, increased its share to 15.2% in Response Genetics, which performs companion diagnostic tests and other related activities for GSK's immunotherapies and oncology pipeline candidates. Earlier this year, GSK increased its ownership in the biopharmaceutical company Theravance from 18.3% to 26.8%; the companies are developing compounds for respiratory disease.

In academia, in May 2012, GSK and Yale University established a research collaboration that combines GSK's expertise in medicinal chemistry with Yale's work on proteolysis targeting chimeric molecules or PROTACs. Under the agreement, a joint research team will work to show that PROTACs can be turned into future medicines. GSK will have the right to use this technology for multiple disease-causing proteins, and for each protein-degrading drug that is discovered and developed, Yale will be eligible for milestone and royalty payments. GSK also has several collaborations with UK-based universities that also entail such joint working toward common milestones combined with an element of risk sharing by the parties.


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