Our leading subject matter experts share their insightful analysis and points of view to help you stay abreast of industry trends
Biomarker testing is a cornerstone of modern oncology, transforming how clinicians diagnose, stratify, and treat cancer. By identifying particular genetic, molecular, or protein characteristics in a patient’s tumor or blood sample, biomarker tests provide invaluable insights into disease behavior and a patient’s potential response to various therapies.
In recent years, advances in next-generation sequencing (NGS) have dramatically shortened turnaround times without sacrificing accuracy. Rapid NGS tests scan multiple genes at once and can be used with even limited sample material to…
This article was originally published on Norstella’s website.
As real-world data (RWD) evolves, the rise of unstructured data—from clinical notes to lab reports—is transforming how life sciences teams identify, understand, and engage with patients and providers. These data sources offer rich, contextual insights into patient experiences, disease progression, and physician decision-making that traditional structured datasets often miss.
At a recent industry event, I sat down with Joanne Tsai, director and team lead for Oncology at Pfizer, Lance Wolkenbrod, senior principal, RWD Solutions at Norstella,…
For many manufacturers, the period between FDA submission and the PDUFA date feels deceptively quiet. Clinical work is largely complete, pricing assumptions have already been modeled, and commercial teams are waiting for the green light. But in reality, this pre-launch window is one of the most consequential phases of a brand’s lifecycle—and one of the riskiest.
As discussed in our recent on-demand webinar, Reducing Risk: Five Steps for a Fearless Launch, the decisions made (or deferred) during this pivotal period often…
When the Inflation Reduction Act (IRA) first passed in late 2022, payers rushed to respond. On paper, the bill’s intentions were clear: this legislation sought to lower drug costs, reduce patients’ out‑of‑pocket burden, and empower Medicare to negotiate prices for the first time. In practice, however, the ripple effects have been far more complex for manufacturers, prescribers, and payers.
Roughly three years later, payers are now reassessing their strategies for navigating this shifting landscape and determining what changes to make for…
Portfolio contracting is quietly rewriting the rules of pharmaceutical market access. What began as a way to bundle a handful of related products has evolved into a defining access strategy that influences pricing, formulary positioning and competitive dynamics across therapeutic areas (TAs). Today, market success depends less on a single blockbuster drug than on how well manufacturers can leverage their portfolios at the negotiating table.
Before we dive into what’s happening in portfolio contracting today, let’s take a look at the…
To better understand what 2026 might bring, we asked three MMIT market access experts to share their perspectives on upcoming market shifts. Read on for key insights into the year ahead (and don’t miss the first post in this two-part series.)
1. Patients are increasingly gravitating to direct-to-consumer platforms. What effects do you think these platforms will have on the PBM industry next year? Steve Callahan, Senior Director, Advisory & Insights: Direct-to-consumer (DTC) programs offer patients access to specific drugs without…
To better understand what 2026 might bring, we asked three MMIT market access experts to share their perspectives on upcoming market shifts. Read the first of this two-part series for key insights into the year ahead.
1. What’s the biggest challenge for manufacturers launching new products this year? Steve Callahan, Senior Director, Advisory & Insights: We’ve observed a tightening of payer access which will continue into 2026. New-to-market blocks are one of the key controls payers use to manage access for…
Copay accumulator and maximizer programs are now firmly embedded in the commercial market, and their influence on patient access and manufacturer strategy is becoming impossible to overlook. In the first installment of our two-part series on copay accumulators and maximizers, we shared recent Indices research on how payers are deploying and measuring these programs.
In this follow-up blog post, we look at the downstream effects of copay adjustment programs and suggest a few strategies for manufacturers trying to protect patient access…
As payers continue to refine their cost-containment strategies, copay accumulator and copay maximizer programs have quietly become standard tools in their playbook. As of March 2025, 21 states have enacted laws banning payer/PBM use of copay accumulator programs for state-regulated health plans, including the individual, fully insured large-group, and small-group markets.
Yet despite this legislation, the majority of payers are still using copay accumulators, not to mention copay maximizer programs. These copay adjustment programs limit the amount of money that payers…
As artificial intelligence (AI) transforms how life sciences organizations access and analyze real-world data (RWD), one challenge looms large: ensuring that these powerful tools are used appropriately.
RWD can illuminate patient outcomes, accelerate research, and guide better decision-making—but only when it’s handled ethically, transparently, and within the boundaries of contractual and regulatory use. Here are some ways to avoid the misuse of RWD with AI.
The Stakes of Responsible RWD Use Historically, RWD analysis was controlled by trained data specialists who knew how to…
