Archives: Agenda

• Evolution of masking technology to achieve protease-mediated, tumor-specific drug activation
• Applications of masking technology in oncology and immunology, including the ubiquitous macrophage checkpoint, CD47, and cytokines
• Development of a China-inclusive early development path, including considerations of IITs, China IND, and US IND.

• Exploring the capability of Digital Display Labels (DDLs) and the benefits for Clinical Trial Supplies
• A demonstration of the functionality of DDLs; just in time labelling, lot and expiry update, multiple page count.
• Understanding the operational ability to securely & remotely update content and language.
• Integrating across IMP profiles, vials, bottles, blisters etc.

• How pharma can move digital health and digital diagnostics from pilots to scalable real-world solutions
• Key building blocks for adoption, including data, clinical evidence, technology development, and clinical workflow integration
• Practical lessons from real programs across screening, monitoring, and patient-centric digital tools

Visit our exhibitors’ booths throughout the 2 days and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

• Overcoming financial constraints when budgets are limited and resources tight
• Building flexibility into outsourcing partnerships for scalability
• Fierce site competition: How start-ups can compete with established companies for sites
• Utilizing effective planning to improve study and program efficiency without compromising patient safety
• Agile and adaptable: Being prepared to adjust your strategy and approach as needed

Moderator: Keya Watkins, President – Oncology, Worldwide Clinical Trials

As oncology development grows more complex, CRO partnerships have become central to how programs scale, execute, and deliver. Yet in practice, these relationships are often more nuanced than the traditional value proposition suggests.

In this candid discussion, we’ll explore CRO partnerships from a biotech perspective – examining where they fall short, and what it takes to make them work in real-world settings.

• The strategic upside of CRO partnerships, including scaling with specialized operational and regulatory expertise
• Where partnerships break down, from misaligned expectations to gaps in execution, communication, and accountability
• When a single, integrated CRO model is most effective — and when a more tailored, multi-CRO approach better supports program needs
• What stronger partnerships look like in practice, with a focus on alignment, transparency, and shared ownership of outcomes

• Managing increasing regulatory divergence across the US, Europe, and emerging global trial regions
• Understanding the operational impact of evolving FDA expectations and Project Optimus requirements on oncology development programs
• Do sponsors know where the gaps are in the latest ICH-GCP E6(R3) and how can AI help conduct gap analyses across SOPs and study documents
• Assessing the current state of European harmonization, including ongoing challenges around submissions, approvals, and operational consistency across markets

Moderator: Keya Watkins, President – Oncology, Worldwide Clinical Trials