Emerald Lake Safety (“ELS”) harnesses advances in science to identify, test, and ultimately eliminate the drug-drug, drug-disease, and drug-genomic interactions responsible for causing Serious Adverse Events.
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.