Why Most RWE Fails Payer Scrutiny (and What Actually Passes)
Real-world evidence is no longer optional in market access discussions. Payers expect it. HTA bodies ask for it. Internal teams invest heavily in generating it. And yet, a quiet reality persists: most ...
The Hidden Gap Between Phase III Success and Market Access: When Evidence Misalignment Delays Commercial Readiness
For many biopharma teams, Phase III is treated as the final mountain to climb. Once efficacy and safety are proven, commercial readiness is assumed to follow naturally. In reality, that assumption is ...
Designing an Early Access Pathway for a CNS Therapy Using Real-World and Claims Insights
Background: A mid-stage biopharma company was advancing a novel CNS therapy into late Phase II, with early clinical signals suggesting meaningful benefit for patients with progressive neurological de ...
The IRA Phase 2: What 2026 Price Negotiations Mean for Innovators, Biosimilars, and Global Launch Strategy
The Inflation Reduction Act (IRA) continues to reshape the U.S. pharmaceutical market. After the first list of 10 Medicare Part D drugs entered negotiations in 2023, the clock is now ticking toward Ph ...
The Collapse & Comeback of Digital Therapeutics: What the Industry Learned and Where It’s Going Next
For a few years, digital therapeutics were treated as inevitable. Prescription apps would scale like software, improve outcomes like medicines, and disrupt chronic care economics along the way. Ventur ...
CGT Commercialisation 2.0: Ranking Markets by Regulatory, Infrastructure & Reimbursement Readiness
Cell and gene therapies are no longer a niche category. With more approvals coming through, payers pushing back harder, and health systems struggling to keep up operationally, CGT commercialisation ha ...
Building a Global Patient Funnel to Predict Uptake for a Gene Therapy Across 15 Countries
Context: A global biotech developing an ex-vivo gene therapy for a rare neuromuscular disorder engaged Thelansis to build a cross-market patient funnel and uptake forecast. The therapy was approachin ...
Beyond the Drug: Why Ecosystem Based Commercial Models Are Becoming Critical in Rare Diseases
The quiet truth about rare disease medicines is that a brilliant molecule or a one-time gene therapy is only the opening act. Getting the drug from a lab bench miracle into durable, equitable patient ...
How Thelansis helped a Pharma company mitigate LOE impact through Forecast Modelling & Market Analytics
Background: In 2024, a mid-size specialty pharma company approached Thelansis with a clear challenge: its hero product, a second-line therapy in a tightly contested market, was set to enter Loss of E ...
Japan’s Evolving HTA Landscape: What Global Launch Teams Must Know
Japan has quietly turned its HTA framework into one of the most influential, but often misunderstood, pricing systems in major markets. Since formal cost-effectiveness evaluation became part of the NH ...