8:00 am

Coffee & Networking

9:00 am Chairman’s Opening Remarks

DELVING DEEPER INTO CLINICAL DEVELOPMENT CONSIDERATIONS FOR NOVEL FOOD ALLERGY THERAPEUTICS

Synopsis

Many companies are trying to start the first in-human studies considering the FDA’s recent approval of the first medicine to treat peanut allergies. To set up for long-term success, it is crucial to comprehend the translational route, from a complete grasp of the regulatory mechanisms to finding the appropriate dose to translate into people. These translational difficulties will be addressed in this section to guarantee a strong, thorough approach to entering the clinic.

9:15 am Choosing Appropriate Functional as Well as Translational Disease Models to Gain Better Understanding of the Disease Pathophysiology

  • Kari Brown Senior Medical Director, Aimmune Therapeutics

Synopsis

  • The journey from animal/cell models to humans
  • Understanding the molecular mechanisms responsible for allergies
  • Determining the intended use of the assay/biomarker development and how to incorporate that into disease planning

9:45 am Panel Discussion: Overcoming the Barrier of Securing Funding to Skyrocket Pre-Clinical & Clinical Studies

Synopsis

  • Challenges in securing funding for start ups
  • Understanding the key qualifications to secure funding
  • Tackling funding challenges for different phases of research and trials
  • Drawbacks in funding due to low/no support from government policies

10:45 am

Morning Refreshments & Networking

12:00 pm A Treatment for Peanut Allergy That Induces Remission of Allergy & Leads to Meaningful Improvement in Patient Quality of Life

  • Mimi Tang Chief Executive Officer, Prota Therapeutics

Synopsis

  • Looking at long-term limitations of desensitization
  • Sharing the long-term benefits of remission
  • Understanding the unique benefits of combining probiotics and oral immunotherapy
  • Pointing out regulatory challenges to develop a therapy that achieves clinical remission

12:30 pm Understanding Patient Perspective & Education to Enhance Their Quality of Life

Synopsis

  • Psycho-social impact of food allergy on patients
  • Incorporating patient views early in research to guide clinical and commercial decisions
  • 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

1:00 pm

Lunch & Networking

2:00 pm Panel Discussion: How to Aid Patient Recruitment & Avoid Dropout: Patient Representative vs. Clinician vs. Pharmaceutical Representative

  • Erin Malawer Chief Executive Officer, AllergyHealth
  • Mimi Tang Chief Executive Officer, Prota Therapeutics
  • William Reisacher Professor of Otolaryngology & Director of Allergy Services, Intrommune and Weill Cornell, Cornell University

Synopsis

  • Whom to enroll: patient enrolment criteria and external validity
  • Financial consequences of patient dropout
  • Ways to invest in services that will support patient retention
  • Analyzing methods to deal with poor compliance, dropout and missing patient data

3:00 pm Developing Microbiome Modulating Therapeutics for Food Allergy & Colitis

Synopsis

  • Novel biopolymers for targeted delivery of microbial metabolites to treat allergic and inflammatory disease
  • Synbiotic approaches to early life disease prevention

3:30 pm

Afternoon Break & Refreshments

ASSESSING THE REGULATORY LANDSCAPE & MARKETING REQUIREMENTS TO GUARANTEE CONTROL & COMMUNICATION

Synopsis

It is crucial from a safety and effectiveness standpoint that variables are accounted for to ensure consistency within and across batches when dealing with food allergies, and essentially turning a natural product into a drug product. The response of a patient to immunotherapy and its concept might be greatly affected by even a little difference from batch to batch. This section will address some of the important regulatory factors, along with an overview of the food market, that every company in the field needs to be aware of.

4:00 pm Overcoming Challenges in Marketing Novel Therapies, Diagnostics & Food Products

  • Nurry Hong Chief Executive Officer, Pareto Bio, Inc.

Synopsis

  • Understanding the consumer acceptance and food market of a product
  • Effect of novel microbiome therapy marketing on patient recruitment
  • Solving the problem of adults stuck out of the ‘age window’

4:30 pm Highlighting the Regulatory Pathway & Timelines: Working Towards an IND

  • Abhit Singh Vice President, Innovation, Intrommune Therapeutics

Synopsis

  • Understanding ethical challenges of early implementation and overcoming the lack of reliable existing data
  • Allergen stability demonstration challenges over varying lifecycles timepoints and how to obviate these facets
  • Mitigating risk of anaphylaxis at every stage of the clinical trial protocol according to best scientific and empirical practices
  • Navigation of FDA Combination Product Regulatory Categorization in order to ensure comprehensive patient-safety

5:30 pm Chairman’s Closing Remarks

5:45 pm Close of Summit