Day 1 started with an engaging and detailed presentation on the importance of variability in securing an efficient supply chain. Here Robert Bottome from BioMarin Pharmaceuticals explored the current challenges we have in running clinical trials such as the high costs, global reach, unique storage and shipping conditions whilst pinpointing the struggles in the likelihood of failure and dependency on devices. However, Bottome offered concrete action plans on building a robust system early on in the clinical supply chain whilst adapting to changes during the study. Lastly, delegates left with a concrete strategy on buffering against anticipated variability.
Later on in the day, John Simons from Gilead delivered a highly anticipated and topical session on CMO management from a quality perspective. Within the session, Simons detailed the current benefits and challenges of an outsourced model. Maintaining favourable relations with third parties appears to be an industry challenge which Simons address head on by offering fundamental in relationship fundamental to build robust relationships that benefit the clinical study at hand. Additionally, certain tools such as site assessments, questionnaires, audits and various others were discussed as a means of making the most out of your CMO. All in all, the quality of the content was apparent as exemplified in the quantity and interested expressed by all delegates.
Equally invigorating day 2 included the highly appraised session delivered by Lilian Kee from Achagen. Kee outlined a case of ultilizing a global network of CMOs for phase 1 clinical trials. In a world with rapid technological advances, the logistics landscape has been no different consumers receiving goods faster than ever. Kee highlighted three principles in maximising the global network namely being addressing the API import challenges, ensuring effective self-life management and efficiently utilizing your internal team.
Ultimately, the high quality and relevant content at the 2018 event has set the pace for the developments that will become apparent in 2019.
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