Agenda Archive

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

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

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

Unlocking FDA Strategies for Speedy Approval and Smart Dosing in Oncology Trials

Exploring recent US FDA updates on expedited approval pathways and dosing strategies in oncology
Designing clinical trials that meet FDA expectations for surrogate endpoints and biomarker use
Developing regulatory-aligned strategies for oncology drug development under new FDA guidance

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