Archives: Agenda

ASK THE EXPERT PANEL: How to choose CDMOs as a true extension of your team to enable flexible, and stage-specific clinical supply needs đź“Š LIVE POLL

  • How to align CDMO partnerships with phase-specific needs while staying agile
  • How to collaborate across CDMOs and ensure smooth tech transitions, especially for biologics therapies
  • How to build transparent CDMO partnerships from Day 1 to overcome challenges and save costs

Moderator: Amanda Murphy, Head of Digital Product Management, GlobalData

  • Panelist 1: Aimee Hogue, Director Supply Chain, Sutro Biopharma
  • Panelist 2: Amber Bill, Associate Director, Sangamo Therapeutics  

Panelist 3: Burkard Kolb, Former Executive Director, CMC Operations, 89bio  (Genentech) 

CASE STUDY: Streamlining E2E Supply Complexity: Implementing Robust S&OP Governance Across the Value Chain

  • Aligning Supply Chain, CMC, Clinical Operations, Regulatory, Quality, and Finance to evaluate options, trade-offs, risk, and cost and align on an integrated path forward
  • Establishing S&OP governance, ownership, and decision rights linking supply execution with financial planning to drive transparency, accountability, and aligned decisions
  • Creating end-to-end visibility to identify constraints early, improve agility, mitigate risk, and maintain supply continuity across clinical and commercial programs

INTERACTIVE KEYNOTE: The Forecast Is Dead: Clinical Supply’s Shift from Prediction to Continuous Orchestration

  • From forecasting to continuous supply intelligence: why the real metric is decision latency, the time between a supply signal and a supply action, and how leading sponsors are collapsing it from weeks to hours
  • The connected ecosystem in practice: how event-driven supply orchestration (IRT working in concert with eCOA, depots, couriers, and temperature data) turns thousands of small, automated decisions into fewer shipments, leaner stock, and uninterrupted patient dosing.
  • You vs. the algorithm (live)

 

OPENING REGULATORY KEYNOTE: Ensuring Clinical Trial Continuity – Navigating the Importation of Pharmaceuticals, Biologics, Medical Devices & Combination Products

  • Understand current importation requirements and regulatory considerations for pharmaceuticals, biologics, medical devices, and combination products used in clinical research.
  • Learn practical strategies and best practices to prevent shipment delays, mitigate compliance risks, and maintain continuity of clinical trial supplies across global supply chains.
  • Explore how to navigate the FDA imports process from entry submission to compliance determination

 

Drinks reception

🍷 Drinks reception – Unwind and network while enjoying some of California’s finest wines

🏆 PRIZE DRAW: Visit our exhibitors’ booths throughout the day and collect stamps to enter our Prize Draw and be in for a chance of winning Apple prizes or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

CASE STUDY: Moving away from audit nightmares to real-time accountability and audit readiness approach

  • How to make sure you are building accountability and reconciliation practices into the study planning up front, before the first shipment is dispatched
  • How to clearly define the accountability process and primary system of record to ensure sites and CROs understand expectations for documentation, reconciliation and destruction
  • How to standardize site-level data capture while accommodating local practices to prevent mismatches and delays at study closeout
  • How to leverage electronic systems to embed audit-ready accountability into daily workflows, shifting from reactive clean-up to real-time documentation
  • How to ensure a controlled IRT closure that eliminates discrepancies and supports complete, audit-ready records that helps you to save money in the long run