healthŌme and GalenusRx Forge Strategic Partnership to Launch Genomics-based Personalized Medication Safety Program
Adverse drug events (ADEs) are rampant and rising worldwide, contributing to increased global spend on pharmacovigilance. Today’s inefficient, reactive technologies must observe ADE occurrences in a large volume of patients, leading to avoidable harm and increased cost.
GalenusRx flips the reactive model of pharmacovigilance with proactive, predictive medication safety technology. We streamline the process of forecasting risk of simultaneous multi-drug interactions and ADEs, using real-world data and predictive analytics.
ADE Forecasting produces actionable insights to improve the safety of investigational and post-marketed drugs
Personalized, Comprehensive Polypharmacy Engagement brings research into everyday practice
With our technology platform, pharmaceutical companies and their stakeholders can identify the potential population and individual-level impacts of a new drug using real-world data, without exposing patients to real risk.
APPRAISE ADE Forecasting uses quasi-mechanistic, predictive algorithms to derive actionable, context-specific insights to improve drug safety across the entire pre-and post-approval lifecycle. These preemptive insights are derived from our proprietary assessment of simultaneous multi-drug, drug-gene, and drug-disease interactions.
The people who are eventually prescribed post-marketed investigational drugs typically look nothing like those represented in clinical trials. Real patients often have complex polypharmacy medication regimens, and adding a new drug often results in untoward effects that were not detected in clinical trials—ultimately causing medication discontinuation.
With our proprietary APPRAISE technology, GalenusRx virtually forecasts ADE risk for complex polypharmacy patients, providing insights to help improve medication persistence and avoid regulatory actions associated with reporting previously undetected ADEs.
“ADEs have become more common and more serious, especially in vulnerable populations. Over the past decade, their occurrence has doubled, and their severity has increased by nearly 150%. Previously, basic data systems for collecting ADE reports only allowed for reactive responses to ADEs. Now [through GalenusRx], we have advanced analytics—predictive algorithms —to identify ADEs prospectively, assess their seriousness, and identify high-risk patients.”
Clinical Professor Emeritus & Founding Director, Center for Pharmacometrics and Systems Pharmacology, University of Florida College of Pharmacy. Former Director, Office of Clinical Pharmacology for the Center for Drug Evaluation and Research, FDA
Personalized, Comprehensive Polypharmacy Engagement leverages Precision Clinical Pharmacists in community settings to support the successful launch of new drug entities into the real world. By virtually adding the new drug to an individual patient’s medication regimen, the Pharmacist can counsel the patient on optimizing their medication regimen before starting therapy.
Our custom programs are implemented in communities to ensure access to novel, innovative therapies while ensuring appropriate medication monitoring, persistence, outcomes, and regulatory compliance. This patient-centric approach supports the update and safe use of new drug entities. GalenusRx can also support adherence to REMS through care coordination and medication monitoring, improving the likelihood of long-term therapy success.
Before a new or repurposed drug enters the market, ADE Forecasting produces actionable insights to help refine the risk-benefit profile and mitigate high-probability concerns, well ahead of real-world use. After a drug enters the market, Personalized Comprehensive Polypharmacy Engagement supports its uptake and safe use through one-one-one patient counseling provided by Precision Clinical Pharmacists.
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Founded in 2023 by a team of internationally recognized healthcare leaders, GalenusRx is the world’s most advanced medication safety assessment organization.
