*All times are shown in EDT
NAVIGATING THE REGULATORY LANDSCAPE FOR FOOD ALLERGY THERAPEUTICS
8:50 am Chair’s Opening Remarks
9:00 am Highlighting the Regulatory Pathway & Timelines: Working Towards an IND
- Abhit Singh VP, Medical Affairs, Intrommune
- Allergen Stability Demonstration Challenges in INT 301 over varying lifecycle timepoints and how to obviate these facets
- Mitigating risk of Anaphylaxis at every stage of the Clinical Trial Protocol by careful calculation of loading dose and calibration of updosing in successive cohorts according to best scientific and empirical practices
- Navigation of FDA Combinatorial Product Regulatory Categorization bundling Metered Dose Device Actuator and INT 301 Allergenic Toothpaste to demonstrate accuracy of potential dispensed dose in order to ensure comprehensive patient-safety
INCORPORATING PATIENT PERSPECTIVES IN THERAPEUTIC DEVELOPMENT
9:30 am Understanding & Incorporating the Needs and Wants of the Patient Community
- Erin Malawer Executive Director, AllergyStrong
- Developing food allergy treatments successfully need to incorporate the patient voice
- Exploring which treatments/therapeutics types appeal most to patient communities & the best ways to collect this information
- Highlighting the role of education on food allergy and where this responsibility could and should lie across different stakeholders
- Discussing patient eligibility for trials in the context of understanding and defining the criteria and how this can influence perceptions of different therapies
10:00 am PANEL DISCUSSION: Incorporating Patient Views Early in Research to Guide Clinical & Commercial Decisions
- Erin Malawer Executive Director, AllergyStrong
- Anita Roach VP, Education & Voice of the Patient, FARE
- Marietta Krebs Head of Clinical Operations, Allergy Therapeutics
There is little point in developing any therapeutic without understanding the specific needs and wants of the potential end user. This is particularly important when working in the food allergy space, where many patients are young children where the caregiver will be making the key decisions around participating in clinical trials, or using a specific therapy when it becomes commerically available. Therefore, these sessions will cover key aspects of this dynamic, including:
- How to incorporate the patient voice into drug development
- Understanding patient views on risk vs benefit
- Managing expectations with relation to both existing treatments and potential options coming through the pipeline
10:30 am Morning Break & Networking
ASSESSING THE CMC & MANUFACTURING REQUIREMENTS TO GUARANTEE STABILITY & STANDARDIZATION
11:00 am Virtual Roundtables: Investigating CMC & Manufacturing Challenges in Developing a Safe & Stable Food Allergy Drug Product
When working with food allergens and essentially transforming a natural product into a drug product, it’s vital from both a safety and efficacy perspective that variables are controlled for to guarantee nconsistency within and across batches. Even a minor change from batch to batch could significantly impact a patient’s reaction to immunotherapy for example. Therefore, reliable and high-quality manufacturing and analytics are essential for any product using allergen proteins. This roundtable will explore key topics, including:
12:00 pm Lunch Break & Networking
Take this opportunity to connect with colleagues using our ‘People’ Tab and organize individual or group calls to build relationships and share insights with like-minded individuals.
REVIEWING COMBINATION THERAPIES & MULTIPLE ALLERGEN TARGETING: THE FUTURE OF FOOD ALLERGY TREATMENT?
1:00 pm Identifying Relevant Biomarkers to Personalize Immunotherapy for Individual Patients
- Mohamed Shamji Reader in Immunology & Allergy, Imperial College London
- Developing biomarkers to monitor allergen immunotherapy
- How can biomarker selection be more standardized?
- Understanding underlying biological mechanisms is key
1:30 pm Regulating & Remodeling the Immune System: A Microbiome & Immunotherapy Approach
- Rose Szabady Director, Immunology, Vedanta Biosciences
- Can combination approaches lead to more durable food allergy treatments?
- Defining parameters for clinical trials – who is eligible, and for who will treatment have most impact?
- How to treat food allergic individuals with microbiome therapy
2:00 pm Towards Short-Course and Long-Lasting Allergen Immunotherapy by Oromucosal Patch Based Presentation of Allergens in Combination with Tolerogenic Bacterial Particles
- Poul Sørensen Co-Founder & CSO, Allero Therapeutics
- There is a large unmet need for developing more efficacious next-generation AIT approaches with simplified short-course treatment regimens but with an equally safe profile
- Specific Oromucosal Immunotherapy (SOMIT) represents an improved shortcourse AIT approach by prolonged food allergen delivery using a mucoadhesive patch technology combined with proper stimulation of a tolerogenic immune privilege with probiotic bacterial particles
- SOMIT is a short-course, safe and non-invasive technology and offers a more patient friendly solution than current approaches
2:30 pm Afternoon Break & Networking
3:00 pm Addressing Cow’s Milk Allergy by using Extensively Hydrolysed Formula (EHF): Safety, Efficacy & Manufacturability
- Sophie Nutten Science Lead, Allergy, Nestle
- The role of EHF as first-line treatment in non-breastfed infants with cow’s milk allergy
- EHF are a heterogenous group of products
- Challenges in design, production, and safety assessment of EHF
- Do EHF have a role in promoting later tolerance of cow’s milk?
UNDERSTANDING THE BROADER COMMERCIAL PERSPECTIVE
3:30 pm OPEN DISCUSSION: What Criteria are Big Pharma Using to Assess Regulated Food Allergy Therapies?
Without an understanding of the commercial angles that play into food allergy drug development, it is challenging to develop a successful therapy which is not only safe and efficacious, but also makes good business sense. This panel will look to incorporate:
- Trends towards big pharma making significant investments in the food allergy space
- Key considerations for investment: what are they looking for?
- Understanding long-term commercial potential and how that plays into overall program development