When Dompé, an Italian bio-pharmaceutical company sought to launch Oxervate™ - a specialized vision product, in the USA market, the need for collaboration, visibility, the utmost attention to precision, and commitment to safety was evident. Dompé Oxervate™ (Cenegermin) is the first-ever application of a human nerve growth factor as a drug or treatment and is the first-ever topical biologic medication approved in ophthalmology.
Dompé explored logistics providers that could provide specialized and reliable cold chain service packages that would both support a commercial strategy and most importantly, respect and maintain the stringent characteristics of the product. Oxervate™ requires very specific temperature controls. It must be deep-frozen for transport purposes and there is zero-tolerance for any temperature variations for this very high-value product.
The BDP Solution
Dompé engaged in an RFP for the primary distribution from Italy to the USA, along with warehousing and a secondary distribution in the USA to hospitals and patients. Ultimately, Dompé selected BDP International from a pool of several other providers. BDP’s service offering provided a solution that was inclusive of project milestones, critical customs aspects, FDA processes to be considered, transportation services, and the opportunity to benchmark routing options and services to meet market requirements.
The process for Food and Drug Administration (FDA) approval is very stringent – the shipper is required to map out the lifecycle of the shipment, which of course would follow the specific protocols involved to maintain the quality of the product. Before launching the product to the market, the transportation solution and routing was tested with a minimum of 3 different shipments to simulate a real order, but without the actual product inside.
“Dompé needed to collaborate with an expertly qualified logistics partner who would be able to put into place a reliable cold chain service package that would respect the product characteristics and support our overall commercial strategy.”
BDP’s local airfreight export manager and country manager were brought in to assist with coordinating the shipments for beta testing for the first rounds of product. After a very successful testing phase, the product was ready for pre-launch to the USA, and eventually, the official launch to the USA market.
With a product like Oxervate™ that requires the highest quality maintenance, there is no room for errors or delays that can be both costly and devastating to the end customer. Thanks to BDP’s industry-leading visibility technology, BDP Smart®, Dompé was able to monitor the entire scope of the product through the lifecycle of the supply chain, and with BDP Smart Life Sciences, critical alerts like FDA approvals and customs clearance were easily configurable.
“With BDP, we have put proven processes in place, and we have our supply chain firmly under control.”
Dompé is a company that is rooted in the core values of passion, product integrity, and innovation, and wanted a partner that shared this commitment to excellence. BDP’s expertise, proven history of quality, service excellence, coupled with ability to develop and design unique cold chain solutions made for an obvious choice.
By working with BDP, Dompé is able to deliver a product that changes lives. Thanks to the success of this initial project and continued partnership, Dompé received the Industry Innovation Award from the National Organization for Rare Disorders for the Development of Oxervate™ eye drops for neurotrophic keratitis.
Cold chain & temperature control
Supply chain visibility platform
“BDP is a reliable and agile partner, really committed to delivering on its promise, and keen to meet our requirements. Flexibility and ethical values are what make BDP the right partner for Dompé.”