Challenges in CV Tox

The current cardiac safety paradigm is costly and time consuming. Despite this, compounds still continue to fail at the in vivo dog study or early clinical phases. This is costly and inefficient for pharmaceutical and biotech companies. The established way of obtaining traditional measurements of cardiotoxicity doesn’t capture all the right metrics.

“I would do a voltage sensitive dye study on the myocyte” – Major Pharma, Global Head of Safety
“A reasonable approach” – FDA Physician

Measuring voltage alone is not an accurate predictor of toxicity
Measuring intracellular calcium alone is not an accurate predictor of toxicity
Measuring contractility alone is not an accurate predictor of toxicity

Current in vitro assays have poor predictability and it can be difficulty to elucidate multiple ion channel effects alongside effects on contractility. Only one assay has the ability to measure effects on voltage, calcium and contractility simultaneously in a whole cell environment.

The Challenge for Pharma

Large pharma companies have the challenge of choosing from a selection of imperfect assays:

  • Multiple assays – multiple sets of data
  • Different experimental conditions
  • Frequently conflicting results
  • Low levels of confidence in final data

The Challenge for Biotech

  • Affordability of multiple assays
  • Uncertainty over outcomes

The Consequences for Industry

  • Increased time in drug discovery
  • Greater requirement for animal studies
  • Complex data sets, with conflicting results
  • Compounds fail later, and more expensively, than necessary
  • Increased cost

Only one assay has the ability to measure effects on voltage, calcium and contractility simultaneously in a whole cell environment.

Get the Complete Picture with the Power of 3

Get the Complete Picture with the Power of 3