Archives: Agenda

Exploring New Frontiers in Radiopharma: Global Strategies for Clinical Success

• Following recent shifts in the FDA landscape, radiophama developers are increasingly exploring alternative regions and pathways to advance early-stage programs more efficiently
• Global interest in radiopharma including Korea’s rapidly growing focus, reflects a strategic move toward more flexible, collaborative, and regionally diversified development models
• Novotech’s multi-country radiopharma studies demonstrate an agile and integrated approach, showing how a CRO can deliver end-to-end support from preclinical planning to late-phase execution

Building Resilient Clinical Supply Chains: From Seamless Comparator Sourcing, Labeling, Packaging to Last-Leg Delivery in Global Clinical Trials

This session, will provide an insightful overview of how Jupiter Research Services’ bespoke service model enables Sponsors, CROs, and CDMOs to leverage a truly global and resilient clinical supply chain – encompassing Seamless Comparator Sourcing, Regulatory-Compliant Labeling & Packaging, and Efficient Last-Leg Delivery across multi-regional clinical trials

  • Identifying, Mapping & Mitigating Risks in a Volatile Supply Chain
    – Understanding how global shortages, parallel trade shifts, customs complexities, and cold-chain vulnerabilities impact study timelines—and how to proactively mitigate them.
  • Resilient & “Glocal” Comparator Sourcing Strategies
    – Approaches that combine global reach with local execution to reduce bottlenecks, prevent study interruptions, and secure critical US/EU comparator products for global trials.
  • Overcoming Regulatory Challenges for Uninterrupted Study Operations
    – Navigating FDA, EMA, MHRA, MFDS, PMDA, CDSCO, DSCSA/EPCIS, and QP release requirements to maintain continuity and compliance across regions.
  • Integrated Labeling, Packaging & Blinding for OTD (On-Time Delivery)
    – A coordinated, risk-based approach to labeling, packaging, kitting, and blinding that ensures accuracy, compliance, version control, and timely delivery.
  • Application of JIT, DTP & Innovative Supply Models
    – Deploying Just-in-Time (JIT) packaging, Direct-to-Patient (DTP) distribution, and flexible logistics models that support decentralized and hybrid trials.
  • Case Studies: Successful End-to-End Execution
    – Real-world examples demonstrating rapid comparator procurement, seamless global-to-local execution, proactive QA oversight, and uninterrupted delivery to sites and patients.

KEY NOTE: Driving CRO Performance in Clinical Trial

  • Determining the optimal stage for CRO engagement to maximize efficiency
  • Engaging CROs in protocol development to inform strategic decisions, including country selection and trial design considerations
  • Leveraging CRO expertise by fostering a collaborative, partnership-driven relationship

CASE STUDY: Optimizing T Cell Engaging Therapies from Preclinical Study to Human Clinical Trial: Conditional Activation of T Cell in the Tumor Microenvironment by a Novel 4-1BB T Cell Engaging BsAb (Grabody T)

·       The Grabody T platform: A Clinically Validated 4-1BB Bispecific Antibody Approach to Overcome Liver Toxicity

·       Grabody T Exhibits TAA-Dependent 4-1BB Activation and Strong in vivo Efficacy

·       Promising Clinical Activity and Favourable Safety Profile Across the Grabody T Pipeline (Givastomig, Ragistomig, and YH32367)