Pre-Conference Day

This intensive workshop will delve into the cutting-edge integration of genetic and

proteomic profiling to overcome the “one-size-fits-all” limitation of current obesity therapeutics. By leveraging high-resolution molecular data, participants will learn to transition from broad-spectrum weight loss approaches to precision-led development strategies that identify high-responders and mitigate non-response early in the pipeline. The session will focus on utilizing multi-omic insights to enhance trial predictability, minimize late-stage attrition, and deliver personalized cardiometabolic solutions with proven clinical superiority. 

This session will cover:

• Implementing multi-omic patient stratification to move beyond BMI-based enrollment, using polygenic risk scores (PRS) and proteomic signatures to identify sub-populations with the highest probability of therapeutic response
• Decoding genetic drivers of non-response by analyzing the molecular heterogeneity of obesity (such as MC4R or INHBE variants) to predict why certain cohorts remain refractory to standard GLP-1/GIP therapies
• Utilizing proteomic biomarkers for early efficacy signals to identify real-time changes in metabolic health and adipose tissue distribution, providing objective proof-of-concept data long before significant weight loss is visible on the scale
• Integrating precision medicine into trial design through the use of biomarkerenriched protocols and adaptive “basket” trials that dynamically group patients based on their specific genetic metabolic drivers
• Establishing AI-driven predictive models that link large-scale genomic data to clinical outcomes, allowing development teams to optimize drug-target pairing and justify investment in personalized “next-generation” obesity assets
• Case study with Canary Cure: Integrating large-scale human genomic data and AI to identify the specific cross-talk between the CB1R and ZFP423 genes to deliver a dual gene-silencing therapy that precisely triggers the “browning” of white fat cells within 72 hours, ultimately providing an early proteomic proof-of-concept that identifies high-responders and secures a 25% increase in lean muscle mass for superior body composition results

This intensive workshop will delve into the critical shift from traditional BMI-centric metrics to a more sophisticated regulatory framework that reflects the true biological impact of next-generation obesity therapeutics.

As the FDA moves toward evaluating “quality of weight loss” and metabolic improvement, this session provides a strategic toolkit for biotechs to align their clinical endpoints with modern regulatory expectations. Central to this evolution is the Lancet Commission’s new framework, which offers a structured 18-point system to assess tissue and organ dysfunction. By differentiating between Pre-clinical obesity (excess adiposity without dysfunction) and Clinical obesity (impaired organ function), this framework allows for more precise patient stratification and offers a method to prioritize pharmacological or surgical interventions for those with the highest biological risk.

This session will cover:

• Integrating advanced body composition metrics to move beyond the limitations of the scale, utilizing DEXA and MRI data to quantify changes in visceral adipose tissue and lean muscle mass as primary or key secondary endpoints
• Defining meaningful metabolic endpoints by establishing validated links between drug-induced weight loss and the resolution of comorbidities such as MASH, CKD, and heart failure to support “beyond weight loss” label claims
• Designing trials for functional outcomes that measure improvements in physical mobility, exercise capacity, and respiratory function, providing the FDA with clear evidence of enhanced patient quality of life
• Navigating the regulatory path for maintenance and prevention by developing trial structures that satisfy FDA requirements for long-term safety and weight-regain prevention
• Establishing collaborative regulatory strategies for novel mechanisms (such as gene therapies or non-incretins) where traditional weight-loss benchmarks may not fully capture the drug’s therapeutic value