I recently sat down with Oliver Overheu – oncologist and senior associate at Duke Capital Partners – to discuss where oncology is heading and what's standing in the way.
1. The clinical trial landscape is transforming – new modalities like CAR-Ts, bispecifics, and radiopharmaceuticals offer hope, but implementation challenges persist, especially beyond academic centers.
2. Accelerated approvals and surrogate endpoints, while controversial, remain essential for faster patient access, but post-approval evidence and real-world outcomes are now a must.
3. Regulatory turbulence, particularly around FDA oversight, is driving uncertainty in biotech investment and innovation. Consistency and reliability in policy are needed to restore industry confidence.
4. Financing shifts: Royalty financing has become a lifeline for late-stage oncology, but early-stage innovation still relies heavily on traditional venture capital. (Be on the lookout for my recent interview with Anis Fahandej-Sadi - to be published soon!)
5. The patient access gap is widening - decentralized trials, telehealth, and wearables provide promise, but equity in access must be prioritized, especially for rural communities.6. The sector is moving toward personalized oncology, but greater focus on economics, patient experience, and medical affairs is key to closing the innovation-access divide.
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