This presentation will highlight the journey a rapidly growing biopharma company has been on to accurately forecast resource needs to operationalize a robust portfolio of clinical trials. It will include challenges faced with introducing the concept of capacity planning, developing role-based algorithms, understanding needs based on trial complexity and sourcing models, introducing new tools and dashboards, and using the data to drive decision making.

Understanding how many resources are needed to fully execute clinical trials is critical to delivering the portfolio within required timelines. Credible and accurate algorithms are necessary to ensure functional areas are appropriately staffed and resources are on-board prior to study start. This talk will share best practices on how to leverage data visualization tools to effectively collaborate with stakeholders while building algorithms (and build trust in the final calculations).

With the consistent need for speed and “doing more with less,” the establishment of Master Protocols offers a way to ease those with capacity limitations. This talk will highlight the advantages of Master Protocols and the ways in which they reduce overall cost and time, freeing up resources for other tasks.

Patient enrollment and engagement remain the most challenging aspect of the clinical research process. You will learn: 1) How to engage with large geographically diverse healthcare institutions 2) What processes will need to be in place to ensure a successful engagement 3) What roles and responsibilities are altered, shared, or maintained by all individuals involved. And you will receive take-away material to assist in your ability to do the same.

Key stakeholder alignment is critical in optimizing strategic enrollment. Collaborative resource planning can improve enrollment forecasting and management plans. This presentation will provide an overview on leveraging country operations expertise to drive strategic enrollment planning and management. Examples scenarios will showcase opportunities for applying country operations expertise and translating expert feedback into study enrollment plans.   

Communication and strong partnerships are critical to ensuring a reliable supply chain. The pandemic has tested and stretched all partnerships across the supply chain and Bayer, through its External Manufacturing LatAm lead, will shed light on how teams became more agile to ensure a reliable supply. Adequate communication pacing, the sharing of the customer´s focus and the building of trust are keys to anticipate potential problems and to keep a reliable compliant cost effective and steady supply from CMOs and third-party suppliers.

The COVID-19 pandemic has created a variety of challenges across the clinical trial conduct space, and CTM supply is one of the areas impacted. To mitigate risk of infection associated with patients receiving CTM at clinical sites and hospitals, Daiichi Sankyo developed several approaches to maintain CTM supply in close collaboration with both internal and external stakeholders.