Marken successfully delivered the time-critical intravenous therapy, Legalon, from its GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning. The company’s dedicated 24/7 response team in Philadelphia had documentation readily available for emergency use authorization and prepared the drug for transport within the required 2-hour window, successfully delivering the therapy to 17 patients at 13 different sites within 24 hours or less.
Supporting the authorization of individual expanded access for emergency use to expedite distribution to poisoned patients.
To successfully deliver time-critical intravenous therapy, Legalon, from our GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.
- The longer it takes for the intravenous therapy to be delivered after consumption of the lethal death cap mushroom, the higher the rate of patient mortality
- FDA must first authorize Individual Patient Expanded Access for emergency use of the therapy then Marken is required to deliver treatment to the site within 24 hours
- Regulatory hurdles for national transport of the therapy, which is approved for use in Italy, but not in the USA
Significantly reducing turn-around-time, Marken’s dedicated 24/7 response team in Philadelphia, PA, had documentation readily available to ensure hospitals and sites can immediately begin regulatory emergency use authorization. Once approved, our cross-functional team prepared the drug for transport within the required 2-hour window.
All the proper procedures were taken with a list of escalations for each department including Direct-to/from-Patient, packaging, operations, quality and regulatory to ensure streamlined delivery to anywhere in the USA within 24 hours.
Last year, Marken successfully delivered the Legalon therapy to 17 patients at 13 different sites in the USA. Marken’s agile ready-to-use network and collaborative teams deliver these critical treatments in many cases under 12 hours, saving patients’ lives.
Marken is a wholly owned subsidiary of UPS and is the essential clinical part of UPS Healthcare. With Marken, BOMI Group and Polar Speed included, the UPS Healthcare network staffs 199 locations with 10,000+ employees worldwide. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution in 59 locations worldwide, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production. Marken’s dedicated 2,500+ staff members manage 154,000 drug product and biological sample shipments every month at all temperature ranges in more than 220 countries and territories and have orchestrated 14,000+ home healthcare visits. Additional services such as cell and gene supply chain services, ancillary material sourcing, storage and distribution, shipment lane verification and qualifications, as well as GDP, regulatory and compliance consultancy add to Marken’s unique position in the pharma and logistics industry.