AHNTI US Agenda at a Glance

8:15am-8:35am: Meeting Timeslot 14

8:40am-9:00am: Meeting Timeslot 15

9:05am-9:25am: Meeting Timeslot 16

9:30am-9:50am: Meeting Timeslot 17

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

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

The technology available to veterinary practices has never been more capable. But capability does not always directly correspond to performance. Open API access remains inconsistent, integrations break quietly after go-live, and the real cost of connecting systems is rarely what anyone discussed. The gap is not just adoption. It is the absence of a true orchestration layer that makes the pieces work reliably in a clinical environment.

This session will address the real performance and interoperability challenge head on: what it actually costs to connect systems, why integrations fail in practice rather than in demos, and what measurable value looks like across different practice types and workflows.

• The Integration Reality: Why does API access remain inconsistent, and what does the absence of a true orchestration layer cost practices operationally and financially?
• Who Pays: What are the real economic costs of integration in markup, staff time, and implementation burden?
• Performance Over Capability: How do practices evaluate technology against clinical outcomes rather than feature lists?
• Proving Value: What are the concrete metrics, documentation time, charge capture rate, staff retention, and revenue balance, that define success and hold partners accountable?

Great science doesn't guarantee investment. Funding decisions happen based on factors that rarely make it onto slides: market validation, team composition, regulatory strategy, and business models that actually work. This panel explores what investors are really evaluating when they assess animal health opportunities.

• What separates fundable companies from well-pitched ones
• Market validation: what investors need to see before they believe the opportunity is real
• Regulatory strategy as an investment signal: how pathway choices affect risk and return
• Team composition and what investors are actually backing
• Business model scrutiny: the unit economics and revenue assumptions that get stress-tested hardest

HPAI costs hundreds of millions per outbreak. PRRS circulates persistently through the most biosecure swine systems in the world. The science to prevent both exists. Yet delivering solutions at a commercial scale is limited by challenges in demonstrating ROI and operational capacity.  

• How the economics of prevention need to be reframed around visible, near-term financial return rather than disease avoidance alone
• How data, diagnostics, and early detection are shifting biosecurity from reactive to preventive, and what tools are genuinely changing producer behavior
• The role of vaccination and emerging biological tools in building more resilient production systems at commercial scale
• What designing prevention systems for real operational conditions, consolidating herds, untrained workforces, and hostile environments, actually requires
• What collaboration across producers, industry, and regulators needs to look like to make progress at scale