The rise of biologics has introduced manufacturing complexity that didn't exist a decade ago. Monoclonal antibodies, stem cell therapies, and mRNA platforms all demand specialist capability. This session explores how manufacturing is moving from a back-office function to a strategic differentiator.

• The biologics manufacturing challenge: what's required for mAbs, stem cells, and mRNA, and who can deliver it
• API sourcing and supply chain resilience: where ingredient-level decisions create downstream risk
• Manufacturing strategy for start-ups: why your CDMO relationship is a founding decision, not an operational one
• COGS and commercial viability: how unit economics at the manufacturing stage determine whether a product can reach market
• Manufacturing as a diligence factor: what acquirers and investors look for in your CMC package

Livestock technology has never been more capable. Yet a consistent pattern repeats: innovations that succeed in controlled settings fail in commercial production. The challenge is not innovation. It is translating data into simple, actionable decisions that deliver visible ROI within the real constraints of commercial livestock environments, where labor is scarce and untrained, infrastructure is hostile, genetics and climate vary enormously, and workflows leave no room for complexity. This session explores what designing for actual operational reality requires. This session will explore:

• Why turning data into decisions is the defining ROI question, and what tools that genuinely change producer behavior look like
• How workflow fit, simplicity, and the variability of real production environments determine whether technology delivers on its promise or fails at deployment
• How data quality, fragmentation, and interoperability determine whether technology scales within a single operation and across a diverse producer base
• What a commercially credible validation pathway looks like and where the roadblocks are

Expectations around care delivery and the veterinary value proposition are shifting, and both uncertainty and opportunity live in the spaces between. Contextualized care / spectrum of care recognize that the evolving needs of pet families will rely on a diverse set of veterinary and pet health offerings. Grasping the opportunities that sit outside the highest levels of care is a largely unmet opportunity for animal health organizations. 

• Understand the commercial opportunity in broadening care delivery
• Identify where the evidence base is strong and where further research is needed
• Assess the opportunities in new care delivery models and in evolving current models
• Outline how value might be communicated in the most client-centric manner (e.g., health outcome data)

More products were approved in 2025 than in any year since 2021, expedited pathways are being used more creatively, and a growing wave of biologics submissions is testing frameworks built for small molecules. This session explores how the landscape is shifting and what that means for companies with assets in development.

• What a best-in-class pre-submission strategy looks like in the current environment
• The 2025 approval surge: what's driving it and whether it's sustainable
• Regulatory strategy for biologics, mAbs, stem cells, and gene therapies: what's different and what's still being figured out
• IP positioning, pathway choices, and how regulatory strategy shapes launch timing and competitive positioning
• Expedited pathways: where the real opportunities are and how to qualify for them