In this podcast interview, Ramin Farhood hosts Dr. Thomas Lönngren, an expert in drug regulation, approval, and market access. Thomas has an impressive career spanning over three decades, including a transformative tenure as the executive director of the European Medicines Agency (EMA). He currently serves as a strategic advisor, leveraging his experience to guide pharmaceutical companies and biotech through the complex landscape of regulatory approval and market access in the US and Europe.

A central piece of advice is the critical importance of early engagement with regulators, as he states, "Lesson number one, talk with the regulators first, and then you could start to build your regulatory strategy." This is especially important for novel modalities or complex products, allowing companies to shape their approach from the outset, understand the development path, and anticipate associated costs.

However, Thomas emphasizes that regulatory approval alone is insufficient for commercial success in today's landscape. Companies must also consider health technology assessment (HTA) and payer requirements, which can be more stringent than regulatory approval. Designing clinical trials with comparative data and incorporating real-world evidence from the start is essential to demonstrate meaningful value for patients and secure reimbursement.

Many biotech boards, particularly those dominated by US members, often overlook the global nature of the industry. Thomas advocates for boards to maintain a worldwide perspective, considering regulatory and access hurdles beyond just the US market. Failure to do so can result in costly delays and potential failure to commercialize a product successfully.

Looking ahead, he highlights emerging trends such as increased use of real-world data, remote monitoring of clinical trials, and joint HTA evaluations in Europe for oncology and advanced therapy products. Companies must stay informed of these developments and adapt their strategies accordingly.

Key takeaways:

1. Develop a regulatory strategy early, engaging with regulators for novel modalities.
2. Consider HTA and payer requirements from the outset, not just regulatory approval.
3. Design trials with comparative data and explore real-world evidence opportunities.
4. Boards must have a global perspective and understand requirements beyond the US.
5. Attract experienced biotech talent for leadership roles and functional experts.

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