2021 Pre-Conference Workshops - Tuesday, July 20


Effectively Translating Immunotherapies into the Clinic: Key Considerations

In the context of the first drug being approved to treat peanut allergies by the FDA just last year, there are several companies and institutions following that path and looking to begin first-in-human trials. It’s vital to understand the translational pathway to set up for long-term success, from a thorough understanding of the regulatory processes to identifying the correct dose to translate into humans. This workshop will address these translational challenges to ensure a robust, comprehensive strategy to entering the clinic.

Attend this workshop to learn about:

  • Determining dose from animal models/cell models
  • Which pre-clinical models are appropriate to use?
  • Understanding the regulatory timeline and requirements at the IND stage
  • Understanding the underlying mechanisms responsible for allergies
  • How do the first steps made in peanut allergy therapies translate to other allergens?

Workshop Leader


Samir Patel

Samir Patel
Moonlight Therapeutics

Mike Kulis b+w

Mike Kulis
Associate Professor
University of North Carolina, Chapel Hill

Soheila Maleki b+w

Soheila Maleki
Lead Scientist in Food Allergy Research


Incorporating Learnings from Peanut Allergy Drug Development in Bringing Next-Generation Therapies to Market

Peanut allergies are the most prevalent and potentially life-threatening of all allergies that affect the worldwide population, and particularly in the US and Europe. This is why there are several efforts across different therapeutic areas  (immunotherapies, antibody, and microbiome-based approaches e.g.) to meet this significant unmet need in treatment. However, there are several other allergens, including milk, egg, and shellfish, which can also have devastating impacts on patients and their families and where currently the go-to treatment is ‘avoidance’. This workshop will explore the transferrable insights from the work going into peanut allergy to develop novel therapeutic approaches for several food allergy targets.

Attend this workshop to learn about:

  • Identifying key technologies, including different types of immunotherapy, that could be amenable beyond peanut allergies
  • How would marketing campaigns differ between different allergens?
  • Exploring non-allergen specific approaches which could treat multiple allergens at once
  • What are the specific needs of different patient populations?

Workshop Leader

Erin Malawer

Erin Malawer
Executive Director