“Extensive expertise that we could never just have on staff”
Interview with Anthony Flammia, Vice President Global Manufacturing & Supply at The Medicines Company, on gaining market access for Europe.
Diapharm: Why does the European market appeal to The Medicines Company?
Flammia: Our drug bivalirudin, marketed under the trade name Angiox® (Europe), and Angiomax® (United States), is used in hospitals. We identified the types of hospitals where our product would best fit, and a large proportion of them are in Europe. Therefore, the European marketplace has a particular focus for The Medicines Company.
Flammia: In Europe, we chose the centralized filing approach for the marketing authorization application (MAA). Although there was a centralized filing approach, we still had rapporteurs and co-rapporteurs from different European countries. It proved to be okay, but it was different from what you would expect. In addition, setting up the infrastructure to be able to conduct business proved challenging with the different licensing requirements beyond the MAA; the ability to import, wholesale dealer’s license, the pharmaceutical licenses for each country, manufacturing licenses, and so on. That is when we came to Diapharm, who then took on the manufacturing license part of it.
Having experience in both consulting and
executive leadership in directly managing supply chains under a variety
of challenging situations, Anthony Flammia offers a unique perspective
on the industry’s opportunities for growth & profit optimization Diapharm: Why did The Medicines Company decide on Diapharm?
Flammia: We have the infrastructure for sales and marketing with several offices in Europe. On the manufacturing supply chain side, our model is not to build our own infrastructure, but rather to outsource with strategic partners. In the course of our implementation, we came across Diapharm as a group of people that has the extensive expertise that we could never just have on staff. It is really a highly competent and skilled partner and advisor that has solved problems for us. Not just in the initial days, but also as we go through this journey together.
Diapharm: What changes do you want to see in the regulatory system in Europe?
Flammia: I think a continuation of the centralized MAA approach down to pricing/reimbursement and licensing would be very helpful. It would be nice to say ‘I have one wholesaler dealer’s license for Europe, I have one pharmaceutical license, et cetera. I can operate. I don’t need individual licenses for every country.’ When we get to the packaging side and languages, I think that will probably always remain with a number of different languages spoken. That is fine to adapt to, as long as the regulatory procedures and processes are aligned, which is probably not easy to do, but it is aspirational, of course.
