An interview with:

Robert W. Lee, Ph.D., SVP, Business Development
Shamim Ahmed, Ph.D., EVP, Pharmaceutical Development
Jane Meyer, VP, Business Development
Bruno Cuypers, VP, Business Development

Europe continues to attract pharmaceutical companies for manufacturing and production. It’s uniquely positioned to deliver on client needs and demands, establishing itself as a global leader in this market.

The team at Agno Pharmaceuticals gathered together for a conversation exploring the nuances, appeal, and advantages of the European pharmaceutical market. We’ve recorded their insights below.

The European Market Landscape

From your perspective, what makes the European pharmaceutical market unique or challenging compared to the U.S.?

Bruno Cuypers: Europe has a comparable population to the US, but the market is totally different. Europe’s market is more complex, with more than 40 countries, each with unique national legislations. There are, of course, centralized procedures and inspections, etc., for pharmaceutical products, but there are also country-specific regulations that we must consider, adding to the market’s complexity.

The European pharmaceutical market has unique links to other pharma markets, too. For example, many countries and companies in Africa and the Middle East rely on European companies for inspections, certificates, raw material supplies, and various other factors that drive their own pharmaceutical productions. If supplies and products are registered in Europe, that makes it easier to enter into African and Middle Eastern markets.

Europe’s government support for pharmaceutical companies is also a standout feature compared to the US and other markets, both on a national level and across the continent. The support/reimbursement system and price structure are also unique, and it’s a reason why many companies choose to build and operate facilities in Europe.

How does the regulatory framework in Europe (EMA, national authorities) affect how companies plan product launches or development?

Shamim Ahmed, Ph.D.: European regulatory requirements are a little different than those in the US, primarily seen in their dual process for regulatory frameworks: centralized and decentralized.

In European pharmaceutical regulation, centralized authorization allows for EU-wide marketing authorization of certain medicines. Decentralized authorization facilitates universal marketing authorization in multiple EU countries via a single application. The centralized procedure offers a streamlined, efficient route for EU-wide access, particularly for innovative drugs. The decentralized procedure, on the other hand, provides flexibility for companies to target specific markets and is often favored for generic products.

One appealing aspect of EU regulatory bodies is that they’re systemic. They provide exact timelines for responses as well as feedback from the regulatory authority in each state. Unlike in the US, where the FDA provides yes or no answers with little nuance or feedback, Europe’s regulatory bodies provide ample feedback under clear timelines that can help streamline your project development.

Bruno Cuypers: A unique regulatory framework of European pharma production is the requirement of a QP (qualified person) on site. The qualified person is the only authorized person in a pharmaceutical company who can release batches before they go on the market. They also serve as the responsible pharmacist for the company. They provide the official signature for documents that go to regulatory authorities. Much of Agno’s client base consists of smaller companies and start-ups, and most don’t have a QP, especially in the development phase. Because we have a dedicated and authorized QP, we can support those companies from the very beginning phases of their projects.

How do European timelines and documentation expectations differ from FDA-regulated processes?

Bruno Cuypers: Like Shamim mentioned, European and national agencies are prompt with feedback and specific about timelines. In the US, the FDA is usually slower with less clarity regarding project timelines. European development is very predictable –– an appealing quality for pharma companies looking to develop their products.

Logistics, Scalability, and Supply Chain

What advantages do companies gain when choosing Europe for their manufacturing and/or production site?

Shamim Ahmed, Ph.D.: One good thing about working with a European company is the location. Logistically, Europe is in a good situation, especially for supply chain, material sourcing, etc., which is why a lot of companies try to set up something in Europe. When we talk about European expansion, it’s cost-effective, good for supply chains, and good for the global market, which is why companies from the US go to Europe to get the job done.

Jane Meyer: Depending on their clinical strategy, some clients like to know they have dual supply with a European and US supplier. Maintaining a global imprint on both of those regions is an important factor in ensuring you can be a long-term supplier for those clients.

Collaborating Across Borders 

What are the keys to a successful transatlantic partnership with a European manufacturing site?

Bruno Cuypers: The keys to a successful partnership of any kind come down to good communication and being present in the region, being able to be face-to-face with your clients. At Agno, we aren’t just a CDMO partner; we take ownership of client projects. Their success is our success. It’s important for us to have a presence that allows us to be hands-on with projects to ensure every stage meets our standards.

Jane Meyer: From a manufacturing perspective, you’ve got to ensure equipment consistency. If you’re going to have equipment trains and sets in one country, you want consistency if you’re going to be transferring, or likewise have representative material if you’re going to be working intercontinentally. Also, timelines: making sure you communicate the same timeline requirements across all parties. Staff availability – everyone has different holidays, vacations, and shutdown timeframes. Being successful in this global industry means proactively working around those.

Robert W. Lee, Ph.D.: You also have to consider communication and time zones and make sure you can work around those time restraints.

How does Agno ensure consistency and quality in European facilities?

Jane Meyer: As we seek to expand, we look to use the same equipment manufacturers both internally at the same site, so you don’t have inconsistencies when you scale at a particular site, and likewise cross-site, to have the consistency of the manufacturing as it’s transferred. Equipment consistency also helps with staff training and quality. You can have representative training across the company versus having independent training on five different equipment sets. Because we have a QP, we can ensure every element of production lines up with EU requirements and expectations.

Robert W. Lee, Ph.D.: There is a lot of talk surrounding redundancy, risk mitigation, and secondary sourcing or manufacturing sites. Many companies are adopting secondary sites to protect against supply chain disruptions. If you have the luxury of multiple sites with the same equipment, that’s extremely advantageous, as Jane said.

Looking Ahead: Global Strategy 

Do you see more U.S.-based companies looking toward Europe for manufacturing support or market entry?

Jane Meyer: It’s always been a trend to look globally. Today, more and more companies see the value of having dual sites in both Europe and the US, especially for derisking, continuity of supply, commercialization, and transportation.

Shamim Ahmed, Ph.D.: If you can select a cost-effective country within the EU, it’s much more economically advantageous to manufacture in Europe. The employee costs in many EU countries are half those in the US. For this reason, most global companies have a big footprint in Europe or are taking steps to build one.

How does Agno support dual-market/multi-market product strategies?

Shamim Ahmed, Ph.D.: This is the exact reason we’re looking to expand into Europe. We’re already positioned to manufacture in the US and Asia. If we go into Europe, that gives the client even more flexibility and the power of choice, which are top priorities for us here at Agno.

Any final thoughts on where the European pharma market is headed in the next 3–5 years?

Bruno Cuypers: This is a big question. It depends on the global geoeconomic situation and each client’s global supply requests as they grow. Will Europe have the same disposition as the US? Will there be a movement to bring API manufacturing and support back to Europe? Time will tell.

How is Agno positioned to serve clients in this evolving market?

Jane Meyer: Agno Pharma does whatever it takes to meet client needs across the spectrum, from clinical to commercial. As we grow into a global footprint with the intent to broaden into Europe and other markets, we’re prioritizing our ability to backward and forward integrate, derisking projects to allow clients to get the best of manufacturing and cost considerations as we pull in different sites. In other words, if a client uses China to make their intermediates and raw materials, and they want to make their API in the US, and for whatever reason they want the final drug product in Europe, we can integrate all three perspectives to give them one continuity of a supplier without having to manage all of that as they go through their pipeline and requirements for the patient.

Robert W. Lee, Ph.D.: Bruno mentioned this earlier, but local representation is key, and it’s something we provide here at Agno. We want to maintain a local presence to ensure quality and consistency with client projects and, of course, to facilitate trust among our clients.

Shamim Ahmed, Ph.D.: Agno believes in flexibility and delivering flexible options to our clients. It’s one of our core values. We want to be a global company. That’s why we already have a presence in Asia and Europe and are expanding our capabilities in the US and Asia. We want to be a truly global CDMO for our clients so they can manufacture their products where they want, faster and more cost-efficiently while maintaining the absolute highest quality.

Conclusion

Agno Pharmaceuticals is your end-to-end drug development partner. We’re with you from conceptualization to commercial, adopting your project as our own across the US, Asia, and Europe. Contact us  today to explore how our seasoned team can facilitate and guide your journey to success.