Aurinia Pharmaceuticals, MyMeds&Me
MyMeds&Me, a leading provider of drug safety software to transform the end-to-end pharmacovigilance process, have today announced that Aurinia Pharmaceuticals Inc. (Aurinia) has selected the Reportum QuickStart platform to streamline the capture, processing and management of safety data for the investigational drug voclosporin, following recent positive Phase 3 results.
Aurinia is a late-stage clinical biopharmaceutical company focused on developing and commercializing innovative therapies which have the potential to change the lives of people with rare autoimmune and inflammatory diseases. Aurinia has filed a New Drug Application (NDA) for voclosporin under Priority Review and is working towards launch readiness with a potential commercial launch in the first quarter of 2021.
Aurinia will implement the Reportum QuickStart platform to support the launch of voclosporin, enabling adverse event, product quality complaint, and medical information requests to be captured by field-based representatives, medical science liaisons and speciality pharmacy providers, as well as direct from healthcare professionals and consumers.
Offering the full safety data capture functionality of the Reportum platform, which is already in high volume use by top 10 pharma companies, QuickStart is a preconfigured and validated solution to facilitate rapid set-up and cost-effective deployment. Utilising MyMeds&Me’s extensive industry experience, QuickStart enables pharmacovigilance teams of all sizes to benefit from a robust and scalable drug safety system that can be implemented within a matter of weeks.
“We are excited to work with MyMeds&Me to streamline our pharmacovigilance processes with the Reportum QuickStart platform” commented Dr. Neil Solomons, Chief Medical Officer of Aurinia. “We are advancing voclosporin as a potential first-in-class therapy for the treatment of lupus nephritis. Implementing an efficient method to capture robust product safety data in a timely manner is an essential step along that journey.”
“Reportum QuickStart provides Aurinia with a centralised solution to capture data, including direct from consumers and healthcare professionals” said Dr Andrew Rut, founder and CEO of MyMeds&Me. “By harmonizing the capture of adverse events across intake routes and making the data available for prompt analysis, Aurinia are able to analyse their data rapidly and potentially accelerate safety insights.”
Aurinia Pharmaceuticals Inc. is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. Aurinia is currently seeking FDA approval of voclosporin for the potential treatment of lupus nephritis (Anticipated PDUFA date: January 22, 2021) and evaluating voclosporin ophthalmic solution (VOS) in a Phase 2/3 study for the treatment of dry eye syndrome. Aurinia’s corporate headquarters is in Victoria, British Columbia, Canada and the U.S. commercial hub is situated in Rockville, Maryland.
Find out more at auriniapharma.com
MyMeds&Me provides an end-to-end pharmacovigilance solution to simplify adverse event and product quality data capture and accelerate safety insights.
Founded in 2011 by Senior Pharma executives who have direct experience of managing pharmacovigilance systems, MyMeds&Me’s goal is to accelerate safety insights through digital transformation. They created the Reportum platform, a proven, scalable drug safety platform for the capture, management & processing of adverse events & product quality complaints. Currently in high volume use by Pharma & CROs around the world, Reportum is a centralised solution that provides standardised data across all intake routes, increases efficiencies, and accelerates safety insights
Find out more at mymedsandme.com