Archives: Agenda

• Why phase‑appropriate logistics matters: Contrast early‑phase needs (speed, flexibility, limited batches) with later‑phase demands (cost efficiency, scale, partnerships).
• Defining scope + managing complexity: Clarify what logistics covers (R&D, CMC, clinical, cold chain, inventory, vendor management) and avoid “boiling the ocean” by right‑sizing processes.
• Building reliable systems: Align on cold‑chain qualification/validation, understand regulatory implications, and evolve tools from spreadsheets to integrated supply chain software.
• People & partners as drivers of success: Leverage SME expertise, combine AI with human intelligence, and manage vendors intentionally to support each clinical phase transition

• Valuation of clinical items moving through borders
• HS/HTS codes for blinded clinical shipments versus clinical supplies moving to distribution sites
• VAT expenses: how they apply, when and how they can be recovered
• Sanctions and exemptions in the pharmaceutical industry
• Overall best practices to approach your clinical studies from a customs perspective

• Multidisciplinary scientific evidence demonstrating high manufacturing quality, consistent product performance, shelf-life stability, and toxicological profiles that are substantially lower compared with those of combustible cigarettes and at or below those of FDA-authorized ENDS products.
• In a six-week study using a single, randomly assigned Breeze Pro flavor, approximately 10% of adults with no prior intent to quit smoking fully discontinued cigarette use, while close to 40% reduced daily cigarette consumption by at least 50%

An exclusive invitation only yacht experience bringing together industry colleagues for an evening of refined networking and relaxation against the stunning backdrop of Miami.

Private Luxury Yacht: Venetian Lady

We close by focusing on the choices institutions can no longer defer, and the consequences of getting them wrong

• Where firms are overinvesting, underinvesting or moving too slowly
• The trade-offs between speed, control and competitive position
• What to stop, what to scale and what to redesign
• What will define winners and laggards over the next 24 months

We move from theory to failure, examining what actually happens when AI systems hit real infrastructure, real customers and real controls

• Where production systems fail under pressure
• Integration challenges with legacy architecture and workflows
• Human oversight, escalation and intervention in practice