Day 2 - October 15, 2025 - EST/EDT (Eastern Daylight, GMT-4)
- Paul Hughes - Director, Randomization & Trial Supply Management, Johnson and Johnson Innovative Medicine
- Kaylee Kloppenburg - IRT Senior Manager, Alexion
- Connor Whitaker - IRT Senior Manager, Alexion
- Katie Sheehan - IRT Senior Manager, Alexion
Site perspectives on RTSM navigation
Identifying opportunities for IRT enhancement and improving patient care
Understanding general pain points and how IRT can improve them.
Priorities are seemingly in conflict between trial sponsors and clinical sites. Both clinical sites and sponsors seek to meet their own regulatory requirements and need to efficiently and consistently manage IMP but are often taking divergent paths. While many sponsors would like to mandate the use of their IRT systems to manage all IMP returns and destructions, sites increasingly choose to utilize their own standardized processes instead and may use third party drug management systems instead of IRTs. In this panel, we will discuss diverse perspectives on the challenges and opportunities in investigational drug accountability management.
- Bjoern Rosner, PhD - Global Lead, Clinical IRT and GSC Digital Operations, Biogen
- Sarosh Anjum - Associate Director and Lead, Astellas
Address the critical issue of cost transparency in IRT services for clinical studies as we explore strategies to enhance financial clarity while balancing the needs of sponsors and vendors
Understand the importance of cost transparency in IRT services
Gain insights into potential standardized pricing models for protocol amendments
Learn strategies for balancing transparency with protection of proprietary information
Contribute to a broader discussion on improving financial clarity in clinical trial technologies
- Derek Thornton - Associate Director, Clinical Systems (IRT), Amgen
Navigate the complexities of embedding device information into pharmaceutical products including privacy and regulatory concerns and selections of digital tools
Discuss potential advantages and disadvantages of DHTs in clinical drug development
Understand how digital resources can minimize environmental impacts and greenhouse gas emissions
- Jia Huang, PhD., RAC - Associate Director, Global Regulatory Affairs & Clinical Safety Operations, Process & Systems, Merck
Identify and establish different metrics taking into consideration
Navigate the complexity of contract management between sponsor companies and multiple vendors
Discuss legal roadblocks in IRT in relation to artificial intelligence
Develop practical timelines in building RTSM study systems
Determine the most suitable sample types for remote participants
Explore efficient, patient-friendly collection strategies tailored for decentralized clinical trials
Ensure participants receive essential supplies and clear instructions for smooth sample collection
Establish reliable courier logistics to preserve sample integrity from collection to analysis