PUBLICATIONS

CT Scans and Future Cancer Risk: Time to Recalibrate How We Use Imaging A major new study published in JAMA Internal Medicine estimates that computed tomography (CT) scans performed in 2023 could lead to over 100,000 future cancer cases in the US—an alarming projection that may place CT as the source of up to 5% of all new cancer diagnoses annually, if current practices continue. This updated risk Read more

Hatch-Waxman: The Underrated Power Tool in the Biotech Playbook Key Takeaways: Market exclusivity can be achieved without patents using new clinical data. Hatch-Waxman provisions provide 3-7 years of protection. Effective for drug repurposing, new formulations, and rare diseases. Align with 505(b)(2), Orphan Drug Designation, and Fast Track pathways to enhance value. Understanding and leveraging the Hatch-Waxman Act is crucial for biopharma success, particularly for Read more

Engaging Early with EMA Scientific Advice: A Strategic Advantage for Sponsors For companies planning clinical trials or pursuing marketing authorization in the European Union (EU), early engagement with the European Medicines Agency (EMA) through its Scientific Advice procedure can be a game-changing strategy. This is especially true for small to mid-sized developers and non-EU sponsors who may be less familiar with the European regulatory environment. Understanding Read more

FDA vs. EMA: Navigating Divergent Regulatory Expectations for Cell and Gene Therapies. What Biopharma Companies Need to Know Key Takeaways for cell and gene therapies (CGTs)  Stakeholders Regulatory divergence increases complexity – US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have different trial design expectations, approval pathways, and post-market requirements, making a single regulatory approach ineffective. FDA offers faster approval but with uncertainty – Expedited pathways (RMAT, Fast Track, Read more