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The Food and Drug Administration (FDA) is announcing a 1-day public workshop, regarding development and use of biomarkers in the regulation of allergenics to treat respiratory and food allergies. 

Purpose of Workshop:

This public workshop is intended to be a forum for the exchange of information and perspectives among regulators and academic investigators on the use of biomarkers to monitor, predict efficacy, and evaluate responses to novel therapeutics for allergic diseases. The input from this public workshop will facilitate decisions by regulatory agencies, industry, and clinical investigators on the use of biomarkers in clinical trials for allergenics, biologics and drugs used to treat respiratory allergic disease and food allergy in children and adults.

Goals of the Workshop:

1. To inform stakeholders of FDA’s biomarker qualification program and requirements for biomarkers to be accepted for use in clinical trials.
2. To inform FDA regulators of the status of diagnostic biomarkers and endotypes in respiratory allergic disease.
3. To inform FDA regulators of the status of potential prognostic biomarkers in respiratory allergic disease and food allergy.
4. To inform FDA regulators of the status of potential cellular and serologic predictive biomarkers that may arise before the measured clinical response to allergen immunotherapy.
5. To inform FDA regulators of the status of monitoring/response biomarkers that may act as a surrogate for current clinical endpoints.

Background:

Clinical trials to prove efficacy of immunotherapeutics for allergic diseases are often prolonged and difficult to execute. For example, phase 3 studies for seasonal allergic rhinoconjunctivitis require two pollen seasons and are based on clinical scores, which are highly subjective and may vary from year to year depending on pollen counts. Similarly, the “gold standard” for evaluating efficacy for food allergy is a double-blinded food challenge in which the amount of food that triggers an allergic reaction is determined before and after therapy, a time-intensive and unappealing procedure that may hinder recruitment of study subjects. Furthermore, none of these endpoints inform clinical investigators about possible disease modifying activity of the investigated intervention. For example, clinical scores over two pollen seasons cannot predict whether a therapeutic for allergic rhinoconjunctivitis will modify the immune response to prevent sensitivity to additional environmental allergens or progression to asthma. Similarly, decreases in asthma exacerbations over one year cannot definitively predict whether a novel biologic prevents airway remodeling and fibrosis that characterize irreversible end-stage asthma. Considering the current requirements that are necessary to bring allergy therapeutics to phase 3 clinical trials, biomarkers that indicate their efficacy and whether they can truly modify disease outcome at time of licensure would be a major advance in clinical and regulatory science.

Topics for Discussion:

1. Discussion of the FDA’s biomarker program, including application of “omics” and the role of translational science towards biomarker development
2. Discussion of the state of art of biomarkers that may be applied towards development of therapeutics for allergic rhinoconjuctivitis and asthma
3. Discussion of the state of art of biomarkers that may be applied towards development of therapeutics for food allergy

Date:

February 22, 2024
8:00 AM – 5:00 PM EST

Location:

This is an in-person/virtual hybrid event. For those who wish to attend in person, the workshop will take place in the Great Room, Building 31, FDA White Oak Campus at 10903 New Hampshire Avenue, Silver Spring, MD. 

Shuttle transportation will be provided to and from the Walter Washington Convention Center for out-of-town registrants who will be attending the AAAAI Annual Meeting in Washington DC the following day. Visitor parking is also available on the FDA campus (Visitor Parking and Campus Map | FDA). For virtual attendees, the link for viewing/participation will be provided within your Eventbrite confirmation upon registration.

REGISTRATION:

To register for the public workshop, please visit the following website: https://www.eventbrite.com/e/biomarker-driven-drug-development-for-allergic-diseases-and-asthma-workshop-tickets-719280466237. Registration is free and based on space availability. If you need special accommodations due to a disability, please contact Loni Warren Henderson or Sherri Revell no later than February 8, 2024, at the contact information provided below.

FOR FURTHER INFORMATION CONTACT:

Loni Warren Henderson or Sherri Revell, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1118, Silver Spring, MD 20993, 240-402-8010, or 240- 402-8180, or [email protected] (subject line: Biomarkers for Allergic Diseases Workshop).

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