Evaluate Ltd, a life science market intelligence firm, has partnered with AdverseEvents, Inc. (AEI), a leading healthcare informatics company focused on drug safety data, to fill a critical gap in commercial insight by enabling detailed FDA post-approval drug safety analysis.

Historically, pharmaceutical professionals have lacked convenient, accurate and timely access to the FDA’s Adverse Event Reporting System (FAERS), a key set of over 5 million post-approval adverse event reports for marketed drugs across all demographic groups. The FDA uses FAERS analyses to make post-marketing regulatory decisions such as the issuance of label warnings/ changes or market withdrawals.

AEI has developed a rigorous proprietary method to standardize and analyse FAERS post-marketing safety data to provide accessible, actionable, and predictive drug safety measures derived from real-world, patient populations. Its’ proprietary analytics determine a drug’s potential risk to a patient, identify future safety alerts/labelling changes by the FDA, and enable the determination of a drug’s total medical cost and the long-term economic impact of prescribing a particular drug. The integration of adverse event analyses within EvaluatePharma empowers the industry with new drug safety and healthcare economic insights to support strategic and operational decision-making.

Examples of some of the standard propriety analyses available in EvaluatePharma include: Standardized, high quality FAERS data with up-to-date reports via Freedom of Information Act (FOIA) requests;  Proprietary scores of relative safety and signals of potential future drug label risks; Inclusion of adverse event incidence rates per 100,000 patients treated; Classification of adverse events as ‘on-label’ or ‘non-label’ depending on whether they appear on the current drug label; Adverse events defined as serious or non-serious and exclusion of disease-related adverse events;  Screen for class effects across multiple drugs from similar groups;  Screen for patient demographics susceptibility to adverse event; Comparisons by Indication, Pharmacological Class, EphMRA codes; Company portfolio and product safety profiles for comparative benchmarking; Custom analytical services performed by credentialed experts.

“The AdverseEvents module in EvaluatePharma reveals the evolving adverse event profile on new FDA approved drugs. This insight can finally be leveraged in commercial assessments, licensing/M&A, competitive positioning and safety monitoring,” said Anthony Raeside, Head of Research at Evaluate.

A new series of reports by Evaluate demonstrates how the data can be applied by clinical, business development, and launch teams to gain competitive advantage:  Part I. Commercial Insights and Clinical Trial Project Teams optimising clinical trial strategy; Part II. Business Development Teams assessing in-licensing opportunities;  Part III. Product Launch Teams developing product positioning.

Evaluate is the trusted source for life science market intelligence and analysis with exclusive consensus forecasts to 2020. the company support life science and healthcare companies, financial institutions, consultancies and service providers in their strategic decision-making.

AdverseEvents is a California-based healthcare informatics company that improves patient safety and reduces systemic healthcare costs through the comprehensive analysis of post-marketing drug side effect data.