Archives: Agenda

The master protocol approach is transforming the landscape of drug development by allowing multiple treatments to be evaluated across different disease states or patient populations within a single trial structure. An approach like this can offer significant advantages, including increased efficiencies, faster decision-making and improved coordination but poses challenges to operationalization without the proper planning and support. ​In this session, explore the key aspects of master protocols, it’s benefits and challenges, and provide practical insights into implementation and operationalization.

Whether you are a researcher, clinician, or part of the pharma industry, this session will equip you with the knowledge to leverage master protocols effectively in your clinical research. ​

Key Takeaways: ​

• Understand the benefits, optimal use cases and best scenarios for master protocols. ​
• Maximize trial operations with improved coordination and more sub-study opportunities. ​
• Enhance data collection and sharing, broadening patient access to new therapies. ​
• Navigate strategic relationships for safe and successful master protocol research.

• Identifying and creating criteria that addresses exactly what your study needs to make the selection process easier
• Strengthening relationships with CROs by communicating effectively throughout your study
• Understanding and assessing CROs capabilities tailored to your specific trial needs to avoid running into roadblocks

• A key digital transformation currently in live trials is the shift from traditional paper-based relabeling to the use of digital display labels in clinical trial settings.
• The integration of digital display labels marks a significant advancement in clinical trial operations, offering enhanced efficiency and flexibility.
• As this technology evolves and gains broader adoption, it is poised to transform clinical trial management—particularly in remote monitoring, adaptive trial design, and patient engagement.
• This session will examine the limitations of traditional relabeling methods, highlight the benefits of digital display labels, and discuss their potential to reshape the future of clinical research and healthcare innovation.

• Optimize employ effort
• Minimize waste and risk
• Appreciate significant savings
• Sustainably friendly

• Maintaining patient centricity in your trial to positively impact recruitment and engagement
• Working with patients, caregivers and advocacy groups to establish better patient support systems throughout trial participation
• Best practice in prioritizing patient needs in clinical trial design

• Evaluating new initiatives to speed up study start up and site activation
• Streamlining trial start up and site activation by establishing strong communication
• Implementing and executing new processes across your company for easy and effective study start up

• Lessons from working in a resource-constrained biotech environment conducting sponsored trials.
• How a strategically structured and collaborative Investigator-Sponsored Trial (IST) program helped generate valuable data to support and expand the pipeline.
• The role of strong relationships with KOLs and a responsive clinical development team in motivating high-quality IST proposals.

Examples of ISTs used to:

• Explore new indications (within and beyond oncology)
• Test novel combinations involving our investigational product

Operational models:

• Company-funded ISTs as a cost-effective alternative to sponsored trials
• Fully externally funded ISTs supported by institutional or government grants

• The importance of alignment between Clinical Development and Clinical Operations to support and oversee ISTs effectively.
• How ISTs enabled continuous data generation and scientific momentum, even while internal resources were focused on a single lead program.

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