Emerald Lake Safety (ELS) conducts research into the mechanisms behind Serious Adverse Events associated with marketed pharmaceuticals. We conduct clinical and genomic research both on our own and in conjunction with leading academics and scientists from around the world.
The Problem
- Adverse Drug Reactions – particularly drug-drug interactions – are a top killer and source of patient danger in the United States.
- Researchers at Yale University found that out of the 222 novel therapeutics approved for sale between 2001 to 2010, 123 (55%) have had what the investigators called major post-market safety events, including three withdrawals, 61 boxed warnings, and 59 FDA safety communications.
The Solution
- ELS conducts high quality clinical and genomic research that can clearly establish the potential causes of Serious Adverse Events.
- The quantitative data coming out of this research gives drug makers and regulators a clear roadmap for how to update medical practice and remove the danger. For example, a drug’s use may have to be restricted in patients with certain genes or a specific disease; or a change in dosage may be required for certain subpopulations or during co-administration of another medicine.
- When implemented, these changes mean fewer Adverse Events, allowing doctors to deliver more benefit with less risk.