- What is really stopping us today: Lack of internal training, Limited digital integration, Scalability pressures, Other operational or regulatory barriers. What next practical steps can we take to overcome these hurdles?
- Live polls or short Q&A to capture attendee perspectives
Archives: Agenda
PATIENT ADVOCACY INTERVIEW: Beyond the Supply Chain: How every operational decision impacts the patient experience
Explore how patient-centric supply planning can reduce burden, improve retention, and build trust through advocacy partnerships, flexible logistics, and aligned operations
Interviewer: Christine von Raesfeld, Patient Advocate, The Light Collective
Speaker: Paul Gater, Advocate for patients with multiple myeloma, Member of the Patient Advocate Committee SWOG Cancer Research Network (former Genentech)
Interactive Breakfast Speaker – Hosted Roundtable Discussions
🗣️ ROUNDTABLE SESSIONS offer a valuable opportunity to connect with peers, share best practices, and collaborate on solutions to key industry challenges. These interactive discussions also help you expand your network and learn from others’ experience and expertise.
1.How to Prepare for U.S. Biological Material Importation: Navigating Regulatory Requirements, Operational Challenges, and Best PracticesÂ
Moderators: Carmin Cerullo, Agriculture Operations Manager, San Francisco and Portland Field Office, U.S. Customs and Border Protection; Jolien Wychules, Biological Threat Operations Specialist, San Francisco and Portland Field Office, U.S. Customs and Border Protection
2. Small vs. Large CDMOs/CMOs: How to choose the right partner for agility, scale, and clinical supply success
Moderator: Umar Hayat, VP, CMC and Supply Chain, Union Therapeutics; Rabindra Shivnaraine, Director, Clinical Supply Pharmacology, Aerys Biosciences
3.How to meet big pharma standards on a startup budget: Scaling compliance with limited staff and high regulatory burdens
Moderator: Charisse Eary, Head of Quality, Aligos Therapeutics
4.How to accelerate clinical decision-making through system integrity: Moving beyond manual data reconciliation to gain instant, cross-functional visibility
5. Integrated Program Planning: Syncing CMC, Manufacturing, and Clinical Supply for Accelerated Timelines
Moderator: Joerg Wania, Head of Clinical Trial Supply / Export, Stadpharm
6. How to manage costs efficiently by producing smaller, on-demand batches strategically timed to patient enrollment, avoiding overproduction and waste
7. How to leverage consultants to fill expertise gaps, optimize QP resources, and stay audit-ready without scaling internal teams
Chair’s opening remarks and early birds prize draw – 🏆 Top 3 LinkedIn posts with hashtags 🏆
Registration and refreshments
Chair’s summary and close of day 1
Don’t forget to leave us your feedback through our app! Your insights help us make future sessions even better.
Afternoon refreshments and networking
Afternoon refreshments and networking
INTERACTIVE CUSTOMER CHAT: How to leverage just-in-time labeling with late-stage customization to reduce timelines and drug waste
- How to design flexible packaging strategies that can adapt to protocol amendments and regional requirements
- How to align JIT labeling with IRT and forecasting systems to enable demand driven labeling based on real-time enrolment and dose data
- How to make JIT work with limited resources by partnering with the right CDMOs and packaging vendors
CUSTOMER VOICE CASE STUDY: How to secure global comparator supply: Direct vs. Open Market Sourcing
- How to ensure product authenticity, quality, and traceability when sourcing from the open market
- How to build relationships with manufacturers and qualified suppliers to improve access & reliability
- How to secure supply continuity for high-value trials with limited comparator availability
- How to navigate regulatory and documentation requirements across regions for comparator sourcing