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The Food and Drug Administration (FDA, the Agency), Center for Biologics Evaluation and Research, the National Institutes of Health, and the Coalition for Epidemic Preparedness Innovations are announcing the following public workshop entitled "Identification and Use of Biomarkers to Advance Development of Preventive Vaccines." 

Purpose of the workshop:

The purpose of the public workshop is to exchange information with stakeholders from industry, academia, and government about the scientific, clinical, and regulatory challenges encountered in the identification, characterization, and qualification of biomarkers for use in the development of preventive vaccines for infectious diseases indications.

Background:

FDA’s Biomarker Qualification Program was established to encourage the development of biomarkers for use in drug development, to facilitate an efficient review process, and to make information on qualified biomarkers publicly available. The 21st Century Cures Act of 2016 (Pub. L. 114-255) further highlighted the importance of biomarker qualification in accelerating the availability of safe and effective products.

Topics for Discussion at the Public Workshop:

The public workshop will bring together government agencies, academia, industry, and other stakeholders to discuss the scientific, clinical, and regulatory challenges encountered in the identification,characterization, and qualification of biomarkers for preventive vaccines for infectious diseases indications. The workshop will include discussions on exploring the use of biomarkers to inform the clinical development of preventive vaccines and in regulatory decision making.

Video Recordings

Identification and Use of Biomarkers to Advance Development of Preventive Vaccines - September 16th Video
Identification and Use of Biomarkers to Advance Development of Preventive Vaccines - September 17th Video

DATE:

September 16 - 17, 2019
8:30 AM – 4:30 PM

LOCATION:

NIAID Conference Center
5601 Fishers Lane, Rm. 1D13
Rockville, MD 20852

Entrance for public workshop participants is through the lobby, where routine security check procedures will be performed. For parking and security information, please refer to https://www.niaid.nih.gov/about/visitor-information.

REGISTRATION:

To register for the public workshop, please visit the following website: https://www.eventbrite.com/e/identification-and-use-of-biomarkers-to-advance-development-of-preventive-vaccines-public-workshop-tickets-61166762433

Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by August 28, 2019, midnight Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. There will be no onsite registration. If you need special accommodations due to a disability, please contact Loni Warren Henderson or Sherri Revell no later than August 28, 2019.

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, [email protected] (subject line: Biomarkers Workshop).

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