| · Strategies for just-in-time manufacturing to reduce inventory and waste
· CMO Selection: Aligning Partner Capabilities with Evolving Clinical Supply Demands · Modernizing the Supply Chain: Evaluating and Adopting Next-Generation Manufacturing Solutions |
Archives: Agenda
Localising clinical trial supply in (J)APAC: Risk, resilience, and revenue
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
Morning refreshments and networking
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: Why Listening to Patients Matters: Redefining Clinical Development Strategies
| · Understanding how prioritizing patient care enhances trial success
· FDA guidance driving patient-centric clinical development · Real-world impact of patient input on protocol design and trial conduct |
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
How to Choose the Right Clinical CRO: A Strategic Guide for Biotech Venture
| · 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 |
Chairperson’s opening remarks
Registration and refreshments
Speaker Hosted Roundtables
Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.
Roundtable session lasts for 30 minutes and rotate
ROUNDTABLE 1: Optimized clinical development strategies and milestone planning for the enablement of long-term strategic partnerships
Hyojin Park, Business Development Manager, GlobalData Healthcare
ROUNDTABLE 2: Driving Efficiency and Results Through Strong Sponsor, CRO Partnerships
YongGwan Kim, Associate Director, Janssen
ROUNDTABLE 3: Comparator Sourcing in Small Biotech: Overcoming Limits with Strategic Outsourcing
ROUNDTABLE 4: Integrating Packaging and Labeling with Clinical Supply Chain Operations