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Choosing the Right Indirect Treatment Comparison When Navigating Cross-Trial Heterogeneity
Navigate the Complexity of Modern Evidence Synthesis In modern health economics and outcomes research (HEOR), selecting the right Indirect Treatment Comparison (ITC) is no longer just a technical detail but a critical driver of regulatory success, HTA submissions,…
The Industry Doesn’t Have an Access Collaboration Problem. It Has an Accountability Problem.
Who should own market access? Today, market access is no longer a solo responsibility. Access outcomes are shaped by decisions made across nearly every corporate function—from R&D to regulatory to trade and channel to field reimbursement. Yet many organizations still operate in silos, acquiring “access debt.” Every decision can create reimbursement, affordability, or distribution…
Rethinking Quality Systems Compliance in the Age of AI
For pharmaceutical and medical device organizations, the baseline for regulatory trust has fundamentally shifted. Compliance is no longer proved by a shelf of well-written procedures or confident explanations during an inspection. Rather, it is demonstrated by a system’s ability…
What Happens When AI Doesn’t Just Speed Up Agency Work, but Redefines It?
Pharma organizations are investing heavily in AI, yet many are still operating within agency models built for a different era. As AI becomes more embedded across pharmaceutical commercialization, a new question is emerging: Are today’s agency…
Comparing CDK4/6 Inhibitors in Real-World Practice: What the Evidence Reveals
Palbociclib, ribociclib, and abemaciclib, the three approved CDK4/6 inhibitors, are established first-line treatment options for HR+/HER2− advanced or metastatic breast cancer (a/mBC). Yet no randomized, head-to-head trial has compared the three agents directly. In the absence…
What Does a Pharma Media Agency Look Like in an Agentic AI World?
Artificial intelligence (AI) is rapidly transforming how life sciences organizations approach commercialization. From content creation and analytics to media planning and audience development, AI-powered tools are becoming increasingly embedded across the pharmaceutical marketing ecosystem. But as…
Understanding Scientific Exchange Following the FDA’s 2025 SIUU Guidance
Medical Science Liaisons (MSLs) play a crucial role in exchanging scientific information compliantly. To clarify recent regulatory shifts, Susan Giacalone, SVP, Medical Deployment of EVERSANA, Beth Giblin, Head, Field Medical Affairs for PRECIGEN and Amber Svardal Director, Medical Excellence & Sr. MSL…
How IRA, MFN, and HTA are rewriting oncology launch strategy
For years, oncology launch planning followed a relatively familiar playbook. Companies prioritized indication sequencing, evaluated market opportunities, and built evidence strategies around anticipated pricing and reimbursement requirements. Today, that’s all changing. New policies, evolving Health Technology Assessment (HTA) requirements, and growing scrutiny around pricing are…
Is AI the Secret to Saving the Human Touch in Oncology Nursing?
Recently, ASCO held its Annual Meeting in Chicago unveiling clinical breakthroughs from new bispecifics to the latest CAR-T therapies. However, beneath the loud buzz of groundbreaking science, there was a quieter, more anxious question echoing in the hallways: Who is…
What’s Really Driving the Direct-to-Patient Boom?
Once viewed as an emerging channel, Direct-to-Patient (DTP) models are increasingly becoming a core component of commercial strategy as life sciences manufacturers look for new ways to improve patient access, reduce friction, and create more direct relationships with…