This session examines where the inefficiencies are, what's actually changing, and what a best-in-class development program looks like today. The adoption gap is just as important: designing a trial without thinking about how the product will be used in practice builds in a commercialization problem from day one.

• Where the biggest time and cost sinks in trial design are structural versus fixable
• Real-world evidence and PIMS data as a supplement to traditional clinical trials
• What regulators, acquirers, and licensees actually need from your data package
• Designing for adoption: building clinical utility and practice-readiness from the start
• The CRO landscape: what's available, what's missing, and where the bottlenecks are

Novel was built on a simple bet: that the industry's usual trade-off between accessible care and a sustainable business doesn't have to exist. No exam fee, a subscription model, and a doctor-to-support-staff ratio that puts far more of the client relationship in the hands of trained, well-paid support staff, freeing doctors to focus on medicine rather than the business of the visit. Co-founders Emma Harris and Brendon Laing talk through the thinking behind that model, why removing cost as a barrier to care doesn't have to mean thinner margins, and what it actually takes to build team-based medicine around the human-animal bond rather than around the doctor's calendar.

AnimalBiome’s early growth was driven by products that genuinely improved the health of cats and dogs through microbiome science. But the company’s biggest acceleration came later—when it began deeply understanding how customers make decisions, build trust, and engage with pet health products. In this talk, Carlton Osborne shares the lessons AnimalBiome learned about branding, subscriptions, channel strategy, pricing, and customer behavior—and how those insights transformed a science-driven startup into a faster-growing, more customer-centric business.

Animal health is advancing on two fronts: new modalities including mAbs, mRNA, CGT, vaccines, long-acting injectables, tides, conjugates etc. and new care models built on telehealth, remote monitoring and at-home treatment. Both change what a product must deliver, and both raise the CMC bar.

This session unpacks the five decisions that make or break commercial success: manufacturability, scalability, stability and distribution, regulatory reproducibility, and supply chain readiness with a practical lens on why cost-of-goods is uniquely decisive in animal health, and why most failures happen after proof-of-concept, not before it.

Great science earns attention. Great CMC earns the market.