Summary:

In this episode, host Kim Kushner is joined by Dr. Chantal van Gils, a leading expert in evidence and value strategy at SSI Strategy. Building on the previous podcast discussion with Christian Howell of Cognito, this episode delves into three key themes:1) differing evidentiary requirements for medical devices versus pharmaceuticals, 2) the critical importance of patient-focused drug development, and 3) strategies for getting buy-in to invest in real-world evidence generation.

Chantal explains the historical divide between the evidentiary burdens for drugs versus devices is narrowing as innovative companies push the boundaries. The role of real-world evidence is becoming increasingly vital - not just for post-market surveillance, but to help define the problem that needs solving and guide the entire clinical development journey.

Chantal emphasizes that RWE data is critical not just for regulatory approvals, but for convincing payers and patients of a product's value in the real world. She shares insights on how leading companies are building the business case and narrative around building real-world evidence as this strategic imperative.

Overall, this conversation offers a nuanced, forward-looking perspective on the evolving evidence standards shaping the biotech and medtech industries. Chantal's expert insights and the relatable style make this a must-listen episode for anyone seeking to understand the changing landscape and stay ahead of the curve.

If you'd like to discuss how you might apply these learnings to your own context, contact us now.

This episode features an interview with Christian Howell, Chief Commercial Officer at Cognito Therapeutics, a biotech company pioneering a neurotechnology approach to treat Alzheimer's disease. Christian draws on his diverse background spanning the military, medical device giant Medtronic, and now the biotech industry.

The conversation covers Cognito's evidence generation strategy to demonstrate the value of their non-invasive neural stimulation therapy. As Christian states, "It's critical to bring all the key players to the table early and be fully transparent about your data - that's how you build trust and alignment around value."

Key takeaways include:

• The importance of cross-sector partnerships and stakeholder engagement from day one

• Fostering a culture of innovation through mission-driven leadership

• Promoting employee accountability to take smart risks

• Learning quickly from failures versus avoiding them

With experience implementing value-based healthcare models at Medtronic, Christian also shares unique perspectives on driving innovation while developing novel therapies.

Learn from Christian’s approach spanning evidence generation, collaborative value demonstration, and creating an environment primed for breakthrough thinking. Listen in and get inspired!

Are you leading a biotech and would like to share your experience with our podcast audience? We'd love to hear from you! Please reach out to us.

Episode Overview:

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.

If you’re facing similar challenges to those discussed in our podcasts, contact us now.