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Clinical Complexities

ICT: What are the main challenges faced by pharmaceutical companies when moving a candidate compound from the discovery lab through to first-inhuman (FIH) studies?

Torkel Gren and Anders Millerhovf: Moving a promising compound from the laboratory to the clinic is a complex, multistage challenge. You need to coordinate API production with formulation development and trial planning. The only way to do this effectively is for the teams involved in each of these processes to communicate properly.

Specific challenges include the limited quantities of API that are available, the need to develop formulations appropriate for FIH studies and for later-stage trials in parallel, and the ability to adapt to clinical protocol revisions. Effective communication between supply, formulation, and trial teams is vital, and achieving this can be a challenge, particularly if several different contractors are involved.

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Torkel Gren is Senior Director, and Science and Technology Officer at Recipharm. He holds degrees in pharmacy and business administration, as well a PhD in pharmaceutics from Uppsala University, Sweden. Torkel has worked in the pharma industry since 1988 and has held a number of scientist and manager positions in Europe and the US. He was lead formulator and co-inventor of Detrol OD/Detrusitol SR. Torkel is Vice Chairman of the board of the Swedish Pharmaceutical Society.

Anders Millerhovf is Chief Executive Officer at Clinical Trial Consultants. He holds a degree in medical biology from Linkoping University, Sweden. Anders has worked in the life sciences industry since 2002 and has focussed on Phase 0 to Phase 2a projects in various project management and director positions. He has been a partner at Clinical Trial Consultants since 2012.
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Torkel Gren
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Anders Millerhovf
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