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AGENDA

October 6-8, 2025

SAN DIEGO, CA

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DAY 1

Defining the Future  

Explore how regulatory transformation, clinical & scientific innovation, and digital disruption will reshape the future of clinical development.

  • 12pm: Registration Opens
  • 1pm to 5pm: Programming
  • 6:30pm: Rooftop Reception
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DAY 2

Scaling Innovation & Leadership in Clinical Development

Focusing on scaling innovation, operational excellence, leadership, and regulatory alignment to translate vision into execution.

  • 9am to 5pm: Programming
  • 6:30pm: Offsite dinner
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DAY 3

Industry Alignment & Action Planning

Deepening peer connections, aligning next steps, and engaging with sponsors through showcases, demos and facilitated discussions. 

8:30am to 11am:

  • Build deeper peer connections in a small group setting
  • Explore solutions with sponsor showcases and live demos
  • Align priorities define next steps to sustain momentum beyond CORE 2025

This year’s agenda has three primary themes:

Regulatory Transformation
  • Global regulatory frameworks evolving to keep pace with AI, DCTs, and RWE
  • Adaptive regulatory strategies, regulatory intelligence, and agile submission models
  • Harmonization efforts to rethink risk, quality, and oversight
  • Future-proofing regulatory strategies: digitizing submissions, managing global divergence, aligning innovation with compliance
Clinical & Scientific Innovation
  • Precision medicine, cell and gene therapies, and rare disease programs driving new trial designs and scientific models
  • Innovation in decentralized/hybrid trials, platform studies, and adaptive protocols reshaping development
  • Growing demand for cross-functional expertise integrating science, operations, and data
  • Advancing scientific program leadership, advisory boards, innovative trial strategies, and integrated development planning
Digital Disruption
  • AI/ML, automation, and digital biomarkers transforming trial design and operations
  • Cloud-based platforms, digital health, and real-world data revolutionizing evidence generation
  • Tech adoption outpacing governance: urgent need for data strategies, tech evaluation, and digital readiness
  • Developing digital transformation roadmaps, tech enablement strategies, and aligning innovation with regulatory and operational frameworks
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JOIN US

CORE is designed to be a small, intimate retreat where attendees can openly discuss, debate, and question the hottest topics across the life science industry. Registration is capped at 100 attendees.

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BECOME A SPONSOR

If you are interested in being a CORE 2025 sponsor, please email Sheila Gwizdak, VP/Head of Consulting, Halloran Consulting Group, sgwizdak@hallorancg.com.

 

SIGN UP AS A SPONSOR