Case Study V: Hands on Support Enables Fast-Track Approval During the Pandemic
Situation: A pharmaceutical company with a pipeline of first-in-class small-molecule and antibody therapeutics had just been awarded fast-track approval by the FDA and European Medical Agencies on a breakthrough drug. The company had only six months to complete the marketing applications for the FDA and European Medicines Agency, just as the coronavirus was disrupting clinical, laboratory, and manufacturing supply chains. Attention to sample logistics, on-time data review, and auditing were identified gaps. Waiting to fill openings under such a tight timeframe was not an option. To bring its first-of-its-kind treatment option to patients, the company turned to Spannerwerks for help.
Insight: For many companies, completing a marketing application requires a surge of expertise. There's no time to hire, train, or on-board. Engaging a proven partner with a track record of supporting successful filings is a must to capitalize on the fast-track approval opportunity.
Solution: At the outset, Spannerwerks brought in much-needed CMC expertise that functioned in two capacities. The first conducted quality reviews for manufacturing, process, and assay validation results, identifying and addressing any deviations as they arose. The second was embedded within the company, providing the hour-by-hour project management, communications, and tracking of patient samples and biological materials being shipped around the world amid the uncertainties and disruptions of the coronavirus pandemic.
Results: With Spannerwerks' support, the company had the quality oversight expertise and capacity they lacked when fast-track approval was first awarded. Relying on Spannerwerks, the company also managed complex biologic supply chain logistics across suppliers, vendors, and laboratories during a global health crisis. BLA filing occurred with the FDA and the European Medical Agencies on schedule in a cost-effective and agile manner when the world was facing uncertainty.