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Small Biotech Company Running a Phase II Study with Limited Drug Availability

Our client, a US-based biotech company with less than 10 staff was conducting a phase II, multicenter, double-blinded, randomised, comparator controlled study to investigate the use of a new treatment for Ulcerative Colitis, a disease affecting a large population of middle-aged adults.

The sponsor of the clinical trial had limited internal clinical supply expertise and had initially outlined a manufacturing, packaging and labelling schedule for clinical trial material that was closely aligned with the study start date and site ramp-up period with full release of initial batches expected just days prior to the First Patient Screened (FPS) target date. Realising the clinical trial material challenges, the sponsor reached out to Almac’s Supply Chain Management (SCM) team to develop an understanding of the clinical protocol requirements and drug supply variable.

The SCM overseeing the study faced a number of challenges, considering initial discussions commenced seven weeks from the planned date for FPS. Some of the challenges faced were limited drug availability, management of drug supply with a customised and costly Interactive Response Technology (IRT) and sponsors manufacturing capacity.

Based on the challenges the Almac’s SCM team formulated a new kit design and drug assignment schedule that would overcome the drug supply vs. demand challenges.

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