FARE's Clinical Development Day

This year’s Clinical Development Day will explore food allergy through a longitudinal lens, emphasizing how phenotypes—observable traits—can differ among individuals and change over the course of a patient’s life. Recognizing these patterns can inform more innovative and effective disease management practices.

This exclusive event will convene key stakeholders focused on food allergy, including representatives from the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH), industry partners, translational and clinical scientists, and practicing clinicians. 

This symposium aims to foster collaboration and dialogue toward overcoming challenges in the development of innovative therapeutics and diagnostics. By bringing together diverse expertise, this event seeks to accelerate progress towards addressing the unmet needs of individuals living with food allergy and improving their quality of life. 

October 30, 2025 | 5:00 p.m.–9:00 p.m. ET

• Cocktail Reception
• Dinner with Presentation
• Dessert Reception

October 31, 2025 | 8:00 a.m.–3:30 p.m. ET

• Breakfast and lunch will be served on site

Proposed sessions include:

• “Immune Diversity in Food Allergy: Age Matters, Innovation Depends on It” - The clinical heterogeneity of food allergy—shaped by immune diversity and age-related changes—poses significant challenges for diagnosis and management. These complexities complicate the selection of appropriate regulatory and clinical development strategies. This session will examine how immune variation and age influence food allergy expression, the resulting challenges for product innovators, and potential approaches to address these issues.
   
• “Feeding the Machine: The Next Generation of Food Allergy Diagnostics” - Machine learning offers powerful tools for integrating complex datasets—ranging from omics and clinical data to environmental exposures—to better characterize immune responses and food allergy phenotypes. However, the path to accurate diagnosis is challenged by limited predictive value of current tests and challenges associated with test validation (e.g. disease heterogeneity, age-related phenotypic changes, etc.). This session will discuss both new diagnostics under development and how advanced data science can inform next-generation diagnostics, including what evidence is needed to overcome regulatory, scientific, and economic barriers to clinical adoption.
   
• “Underrecognized Food Allergies: Alpha-Gal, FPIES, EoE, and More” - As the food allergy epidemic grows, a range of underdiagnosed, food-induced immunologic disorders—including alpha-gal syndrome, food protein-induced enterocolitis syndrome (FPIES), eosinophilic esophagitis (EoE), and others—are gaining increased attention. These conditions present with distinct clinical features, immunologic mechanisms, and diagnostic challenges that fall outside traditional IgE-mediated paradigms. This session will highlight the unique barriers facing each of these syndromes, including gaps in awareness, delayed diagnosis, limited treatment options, and evolving regulatory frameworks. Through expert discussion, we will explore strategies to advance research, improve patient outcomes, and better integrate these conditions into the broader food allergy agenda.
   
• “Sourcing Allergen as a Barrier to Optimal Food Allergy Diagnosis and Treatment” - Allergen characterization and standardization are foundational considerations in the development of food allergy diagnostics and therapies, yet sourcing and characterizing food allergens for clinical and research use remains challenging due to inherent source variability in protein content and component allergen potency. While pharmaceutical-grade, well-characterized allergens may be essential in certain therapeutic contexts, they may not be necessary—or practical—for all patients in real-world practice. This session will examine the scientific, regulatory, and logistical barriers to achieving allergen standardization, and explore how to prioritize standardization efforts where they matter most. By convening experts from research, industry, and regulatory sectors, the session will seek actionable strategies to support safe, scalable, and targeted use of food allergen materials.
   
• “Immunotherapy, Biologics, and Beyond: Current Options and Future Directions in Food Allergy Treatment” - As therapeutic strategies for food allergy continue to evolve, a new generation of biologics, immunotherapies, and novel interventions is advancing through industry-sponsored development programs. This session will provide an overview of current and emerging treatments, with discussion of how these innovations may be applied across different age groups and clinical phenotypes. Panelists will explore how disease heterogeneity, patient-specific factors, and real-world implementation challenges shape the future of food allergy management, offering both near-term insights and long-term perspectives on the treatment landscape.
   
• “Right Patient, Right Treatment—Even When It’s Hard: Ethics and Access in Food Allergy Management” - As therapeutic options for food allergy expand, so too do the ethical and practical challenges of ensuring equitable, patient-centered care. This session will explore the complex intersection of access, ethics, and individualization in food allergy management. Topics will include health disparities in diagnosis and treatment access; the paradox of coverage; and the influence of financial incentives, conflicts of interest, and practice logistics on shared decision-making. Panelists will examine the real-world barriers to adopting current treatments—including the cost of biologics like omalizumab, the resource demands of oral immunotherapy, and the lack of regulatory approval for SLIT and other emerging approaches—and consider how to navigate these issues while prioritizing the right treatment for the right patient, even when it’s hard.