This presentation will focus on enhancing clinical site supply strategies. This session will delve into proposed IRT features, along with external concepts that sponsors can evaluate utilizing, and which IRT vendors can potentially incorporate into their development roadmaps. Together, we aim to address existing gaps by identifying necessary features to potentially pave the way for reliable artificial intelligence use.

A look at the history of IRT, best practices, and what to expect in the future.

In the realm of clinical trial drug supply forecasting, complexity has surged and the need for fast data decision making is growing. Leveraging interconnected systems and determining right input parameters is essential. This approach optimizes end-to-end supply strategies, reduces costs beyond inventory, while bolstering environmental sustainability. It guarantees efficient clinical supply chain throughout its entire operations, aligning with an industry evolution need.

Clinical supply waste reduction and streamlined planning is achieved through a comprehensive innovation program driven by cross-functional collaboration, integration of processes, data ,and models between clinical supply, clinical operations, clinical trial analytics, innovation & digital health analytics, and IT. This program aimed to reduce clinical supply waste by 5% (valued at $15M/year) through improved demand forecasting, improved supply optimization, automated data pipelines, and model performance monitoring.

Supply managers practice more art than science when optimizing trial supply chains. They might employ a simulation or forecasting tool to predict demand, or look at dashboards for monitoring, but they ultimately use trial and error. Machine learning techniques can analyze inventory data and provide guidance around meeting supply targets. This talk will address applications of machine learning techniques on inventory data to improve supply chain efficiencies.

Forecasting software combined with machine learning empowers supply chain planners to prevent and manage future risk. Our planners supplement long-term forecasts with fit-for-purpose tools to mitigate short term risks. Harness the power of robotic process automation and micro-tools to focus resources and avoid patient impact.

At the heart of TCR-based cell therapy manufacturing lies the starting material: patient cells, which are collected at hospitals and clinical sites where patients receive their cancer treatment. To ensure the success of this critical step, it's essential to establish a strong foundation with the clinical sites. This requires upfront effort to create a seamless process that benefits both the clinical site and the company and most importantly in the end the cancer patients.

In large pharmaceutical companies, the opportunities for advancement may be limited due to the availability of leadership positions, corporate siloing, and competition. In addition, exposure to the drug development process may be limited by function. Small biotech may offer an opportunity to use large pharma drug development and functional experience to gain further knowledge and expertise across functional areas leading to enhanced development and leadership opportunities. There is risk and a transition period when taking this leap. This presentation will focus on the differences between the work experience at a large pharma vs a small biotech, what to expect during the transition, and how to plan for success. Topics will include infrastructure, choosing a CRO, relationships, technology, culture, recruitment, hiring for success, and training and development of team members.

Clinical study success depends on three “C” or core elements: communication, collaboration, and cooperation from all participating individuals. When it comes to working on rare diseases, the chances of outsourcing to a CRO or vendor with prior experience in that particular indication are often nonexistent or quite limited. This presentation will focus on how Rezolute took a more direct, hands-on approach to executing a rare pediatric pivotal Phase 3 Global Program. How we removed divisions in vendor communication lines and instead led or joined the lines which helped facilitate site and vendor relationships, ultimately delivering faster outcomes and creating stronger and more cohesive study teams.

Running trials nimbly—utilizing in-house talent and managing a trial without a CRO. How to evaluate if this is the right model for you and look at the pros and cons for your team/organization. Which vendors and consultants will you need and which resources can be used from the company? Which processes and plans will need to be developed and which lessons learned?

Today's clinical trials will almost invariably require biospecimen importation. Whether done for an assay to support trial endpoints, to develop unique cell therapy modalities, or simply for exploratory analysis or storage, the process can be complex and burdensome to navigate. In our session we will cover some of the more common topics including: 1) sample classification 2) CDC import permit portal 3) certification statements and 4) customs clearance.