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8:20 am Chair’s Opening Remarks

REVIEWING THE LATEST PROGRESS IN FOOD ALLERGY DRUG DEVELOPMENT: PROMISING STRATEGIES

8:30 am Clinical Considerations for Food Allergy Therapeutics Development

Synopsis

  • Understanding the key safety and efficacy endpoints used in clinical development programs
  • Exploring key hurdles in development of novel food allergy therapeutics
  • How can we learn from the experiences of the first approved therapeutic to inform future therapeutic development?

9:00 am Utilizing Microbiome-Based Medicines for the Prevention and Treatment of Food Allergy

Synopsis

  • What we know about the microbiome’s role in food allergy
  • Multiple windows of opportunity for intervention utilizing microbiome-based approaches (primary prevention, secondary prevention, treatment)
  • Developing diagnostic tools to support clinical development

9:30 am Using Kinase Inhibitors to Prevent Food-Induced Anaphylaxis

Synopsis

  • Overview of potential kinase targets in the IgE pathway
  • Review of preclinical and clinical data using kinase inhibitors to prevent anaphylaxis
  • Understanding applicability of this technology in food allergy and beyond

10:00 am New Biomarkers in Food Allergy to Accelerate Drug Discovery & Improve Diagnosis

Synopsis

      • Diagnosis:  “Food allergy management is complicated by the lack of highly predictive biomarkers for diagnosis and prediction of disease course.”
      • Drug Discovery: Discovery of new drugs for the treatment of food allergy and clinical research can evolve with highly predictive biomarkers

10:10 am Morning Break & Speed Networking

Synopsis

Grab a cup of coffee from the comfort of your own kitchen and jump straight into this exclusive virtual speed networking! This session is the ideal opportunity to meet face-to-face (albeit 2D faces) with many of the brightest minds in the industry to establish meaningful business relationships.

11:00 am Developing Proof of Concept for a Virus-Like Particle Single Allergen Approach

  • Matthew Heath Principal Scientist, Innovation & Product Development , Allergy Therapeutics

Synopsis

  • Genetic fusion design of a peanut allergen-VLP vaccine
  • Displaying peanut allergens on VLPs reduces its reactogenicity
  • Single allergen combined with VLPs protects against a complex peanut extract
  • First clinical study using novel VLPs against peanut allergy now planned

11:30 am Food Immunotherapy Outcomes

  • Mimi Tang CEO/Head of Allergy Immunology Research Group, Prota Therapeutics/Murdoch Children’s Research Institute

Synopsis

  • Understand the different clinical outcomes that food immunotherapy can achieve
  • How to evaluate for the different clinical outcomes in a clinical trial
  • Discuss the benefits that patients gain from the different outcomes

12:00 pm PANEL DISCUSSION: Desensitization vs. Tolerance: Striving Towards Disease-Modifying Food Allergy Treatments

Synopsis

As prevalence of food allergies continues to rise, increased investment is being made to develop novel therapies that target the underlying mechanisms associated with food allergy, rather than simply treating the symptoms. This panel will address the move in industry towards developing disease-modifying treatments, including:

  • How can we define desensitization compared to tolerance?
  • Are any current treatments classed as ‘disease-modifying’?
  • Promising treatment strategies to evoke more durable, safer responses

12:30 pm Lunch Break & Networking

DEVELOPING A CLINICAL TRIAL TO TREAT FOOD ALLERGY: WHAT ARE THE KEY CONSIDERATIONS?

1:30 pm Novel Bioparticle – Synthetic VLP to Treat food and Other IgEMediated Allergies

Synopsis

  • Protein-based desensitization vs vector-based immunotherapy
  • Bioparticle-Potentiated Immunotherapy
    – Design
    – Production platform
  • Pre-clinical results
  • Implications / Applications

2:00 pm Discussing Sublingual Immunotherapy in Clinical Development: Key Considerations

  • Edwin Kim Associate Professor of Medicine & Pediatrics, University of North Carolina School of Medicine

Synopsis

  • Sublingual immunotherapy as a safe and tolerable approach for long-term food
    allergy therapy
  • How to approach defining and meeting clinical endpoints
  • Taking into considerations variability within and across patient populations
  • How could this approach be extended beyond peanuts to other allergens?

2:30 pm Integrated Phase I Study Design for a Novel Peanut Allergy Vaccine

  • Kemi Oluwayi Head of Clinical Science, Allergy Therapeutics

Synopsis

  • Integrated Phase I Study Design for a Novel Peanut Allergy Vaccine
  • Study design overview
  • Subject selection criteria and associated challenges
  • Identifying the starting dose
  • Study endpoints

3:00 pm Afternoon Break & Networking

PREPARING FOR THE CLINIC & SUPPORTING PATIENT-CENTRIC APPROACHES

3:20 pm Addressing the Unmet Need in Food Allergy Diagnostics

  • Maria Suprun Assistant Professor, Icahn School of Medicine at Mount Sinai

Synopsis

  • The double-blind placebo-controlled oral food challenge is the “gold standard” for diagnosing food allergy, but it is time and resource intensive and carries risk for the patient
  • Prick skin testing is highly sensitive, but non-specific for diagnosing IgE-mediated food allergy
  • In vitro assays to quantitate IgE to food proteins and especially some food component proteins have improved specificity for diagnosing some food allergies
  • Novel diagnostic tests such as basophil activation tests and bead-based epitope assays may not only provide more accurate diagnostic tests but also provide information on potential food allergen eliciting doses and reaction severity following ingestion

 

3:50 pm Precision Diagnostics in Food Allergy Drug Development and Commercialization

  • Thomas Vollmers Head of Strategic Partnerships and Commercial Strategy, AllerGenis

Synopsis

  • Biomarkers as surrogate endpoints in food allergy drug development
  • Biomarkers to support the commercialization of food allergy therapeutics
  • AllerGenis’ platform capability

4:00 pm Utilizing the FARE Clinical Network to Advance Food Allergy Therapies

  • Thomas Casale Chief Medical Advisor for Operations/Professor, Medicine and Pediatrics, FARE/University of South Florida, Tampa

Synopsis

  • Demonstrating the role of the FARE Clinical Network in facilitating the development of novel therapies for food allergy:
  • Accelerating and increasing accessibility of next-generation therapeutics
  • Improving standardization across trials
  • Understanding the role regulators play in clinical trial design and implementation

4:30 pm Food 101: Why the Oral Cavity is the Best Classroom for Educating the Immune System

  • William Reisacher Senior Medical Advisor/ Associate Professor, Intrommune Therapeutics/Weill Cornell Medical College

Synopsis

  • The oral cavity mucosa has a tolerogenic function for the immune system
  • Different mucosal areas within the oral cavity have different properties
  • There are several methods available to deliver allergens and other agents to the oral cavity mucosa
  • Exposure of food and airborne allergens to the oral mucosa has been shown to produce robust desensitization over time

5:00 pm Chair’s Closing Remarks

5:10 pm Close of Day One