Archives: Agenda

• Challenges in Clinical Drug Supply Management
• New Technologies in Clinical Drug Supply Management
• Global Case Studies & Best Practices

• Understanding Data Integrity (DI) for Effective GMP Management in CMO/CDMO
• A Trend of Parametric Release Criteria for Aseptic Drug Production by MFDS (Korean Food and Drug Administration)

With JAPAC now the fastest-growing clinical trial region, sponsors need local supply strategies to de-risk programs and improve patient access. This session explains the necessity of building resilient, compliant local supply networks and the commercial upside for manufacturers and CROs across and within JAPAC

• Why JAPAC matters now: JAPAC trial activity is accelerating vs. other regions, major growth in China and parts of Asia(https://www.reuters.com/business/healthcare-pharmaceuticals/china-pharma-firms-turn-local-reagent-s…)
• Supply risk: reliance on Europe/US creates delays and vulnerability: Local sourcing reduces lead times and tariff risk (recent moves to local reagents/manufacturing)(Reuters)
• Practical actions: rapid tech-enabled cold chain, local comparator sourcing, in-region labelling/regulatory templates and contract manufacturing partnerships

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.

• 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