Workshop Report: FDA Workshop on Improving Cardiotoxicity Assessment With Human-Relevant Platforms.

08:00 EDT 11th October 2019 | BioPortfolio

Summary of "Workshop Report: FDA Workshop on Improving Cardiotoxicity Assessment With Human-Relevant Platforms."

Given that cardiovascular safety concerns remain the leading cause of drug attrition at the preclinical drug development stage, the National Center for Toxicological Research of the US Food and Drug Administration hosted a workshop to discuss current gaps and challenges in translating preclinical cardiovascular safety data to humans. This white paper summarizes the topics presented by speakers from academia, industry, and government intended to address the theme of improving cardiotoxicity assessment in drug development. The main conclusion is that to reduce cardiovascular safety liabilities of new therapeutic agents, there is an urgent need to integrate human-relevant platforms/approaches into drug development. Potential regulatory applications of human-derived cardiomyocytes and future directions in employing human-relevant platforms to fill the gaps and overcome barriers and challenges in preclinical cardiovascular safety assessment were discussed. This paper is intended to serve as an initial step in a public-private collaborative development program for human-relevant cardiotoxicity tools, particularly for cardiotoxicities characterized by contractile dysfunction or structural injury.


Journal Details

This article was published in the following journal.

Name: Circulation research
ISSN: 1524-4571
Pages: 855-867


DeepDyve research library

PubMed Articles [24846 Associated PubMed Articles listed on BioPortfolio]

Before and after assessment of a sexuality workshop in high-school students.

To assess different aspects of the perception of sexuality among students before and after a workshop.

Impact of the 2011 International Workshop on Meibomian Gland Dysfunction on clinical trial attributes for meibomian gland dysfunction.

The 2011 International Workshop on Meibomian Gland Dysfunction was organized to build consensus on various disease aspects of MGD. The purpose of this review was to examine the influence of the MGD Wo...

ESCMID/ESGMD postgraduate technical workshop on diagnostic microbiology.

The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) workshop on diagnostic microbiology was held in Lausanne from 25 to 28 September 2018. A total of 87 participants from 31...

High incidence of early onset preeclampsia is probably the rule and not the exception worldwide. 20th anniversary of the reunion workshop. A summary.

The 11th workshop on Immunology of preeclampsia in Reunion 2018 celebrated its 20th candle In this paper we try to summarize the main tracks of reflections during these two decades. First, of course, ...

Report from the Eleventh Killer Immunoglobulin-like Receptor (KIR) Workshop: novel insights on KIR polymorphism, ligand recognition, expression and function.

The Eleventh Killer Immunoglobulin-like Receptor (KIR) Workshop was held in Camogli (Genoa, Italy) in October 2018. This congress brought together 113 participants working on KIR field. Fifty-eight st...

Clinical Trials [9420 Associated Clinical Trials listed on BioPortfolio]

Influence of the "Atelier du rêve" (Dream Workshop) on the Quality of Falling Asleep in the Operating Room.

A "dream workshop" is organized for the children by nurses specialized in anesthesia in the CHI Creteil. During this workshop, the anesthesia process is explained to the children using gam...

Student Wellness Workshop Study

While efficacy of Sudarshan Kriya Yoga (SKY) has been demonstrated in a number of prior studies, little is known about the effects of SKY taught as part of the Your Enlightened Side (YESpl...

Improving Clinical Decision Making Skills for Myanmar Physical Therapists by Series of Workshop

This study aims to improve the Clinical Decision Making (CDM) skills of a group of Myanmar physical therapists by series of educational workshops that will introduce them to and guide them...

Effect of Short Laparoscopic Skills Workshop on Residents' Knowledge and Skills

There is no objective data on the outcome of a daylong workshop as commonly offered to the surgical residents by various institutions. Hence we planned a study with the objectives to deter...

Hepatitis C Self-Management

The objective of this study is to compare the efficacy of a 6-session hepatitis C self-management workshop to a hepatitis C self-management self-study program. Both interventions are desig...

Medical and Biotech [MESH] Definitions

Inflammation and loss of connective tissues supporting or surrounding the teeth. This may involve any part of the PERIODONTIUM. Periodontitis is currently classified by disease progression (CHRONIC PERIODONTITIS; AGGRESSIVE PERIODONTITIS) instead of age of onset. (From 1999 International Workshop for a Classification of Periodontal Diseases and Conditions, American Academy of Periodontology)

Systematic identification of a population's needs or the assessment of individuals to determine the proper level of services needed.

Evaluation procedures that focus on both the outcome or status (OUTCOMES ASSESSMENT) of the patient at the end of an episode of care - presence of symptoms, level of activity, and mortality; and the process (ASSESSMENT, PROCESS) - what is done for the patient diagnostically and therapeutically.

A constituent organization of the DEPARTMENT OF HEALTH AND HUMAN SERVICES concerned with protecting and improving the health of the nation.

Damage to the heart or its function secondary to exposure to toxic substances such as drugs used in CHEMOTHERAPY; IMMUNOTHERAPY; or RADIATION.

Quick Search

DeepDyve research library

Relevant Topics

Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Searches Linking to this Article