FDA Public Workshop: Leveraging Human-Relevant Cardiomyocytes in Nonclinical Studies to Provide Mechanistic Insights into Cardiovascular Safety Liabilities

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Colleagues,

You are invited to attend an FDA public workshop planned for March 29, 2019 titled Leveraging Human-Relevant Cardiomyocytes in Nonclinical Studies to Provide Mechanistic Insights into Cardiovascular Safety Liabilities. The event will be held at the FDA White Oak Campus in Silver Spring, MD.

The goal of the workshop is to discuss the assessment of cardiotoxicity (with an emphasis on contractile dysfunction) using human relevant in vitro models.  While contractility will be a primary focus, translational biomarkers of cardiotoxicity would also be discussed.

The registration link is here and final agenda and will be available soon. Persons interested in attending this public workshop must register online by 5 p.m. on March 27, 2019

 

Workshop Objectives

  • To seek feedback from industry, academia, and other stakeholders on using human-relevant cardiomyocytes in nonclinical studies for cardiovascular safety assessment.
  • Accelerate the development of high throughput assays and translational biomarkers in reducing drug-induced cardiotoxicity with novel therapeutics
  • Map out priorities for appropriate “fit for purpose” applications to be used by industry and regulators to ensure drug safety for patients

Date: March 29, 2019

Time: 8:30 am to 4:30 pm

Location: FDA White Oak Campus
Building 31, Room 1503 – Great Room
10903 New Hampshire Avenue
Silver Spring, MD 20993
FDA Campus Information, (e.g., local airports, directions, and local hotels)

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