Our leading subject matter experts share their insightful analysis and points of view to help you stay abreast of industry trends
Launching a new therapy is one of the most consequential moments in a pharmaceutical brand’s lifecycle. As we’ve said before, you only launch once! The difference between brands that achieve their uptake goals and those that fall short often comes down to one factor: how quickly can a team identify problems and adapt their strategy accordingly?
Many manufacturers enter a brand’s launch year with carefully developed forecasts, access assumptions, and adoption targets. Yet even the best plans can—and should—change in the…
Cell and gene therapies are no longer reserved only for ultra-rare diseases. In many therapeutic areas (TAs), advances in viral vector delivery, gene editing technologies, and cell-based medicine are enabling interventions that target disease at its biological source, often through a single administration rather than lifelong treatment.
These developments should be unequivocally positive for patients. However, as gene therapies transition from scientific breakthrough to commercial reality, a more complex picture of access is emerging. Insurance companies that were built to fund…
There is no doubt that payers in the U.S. are investing heavily in AI, but there is much uncertainty about how this technology is currently deployed. While the industry’s AI conversation has focused on generative tools and administrative efficiency, payers are increasingly deploying AI in utilization management, clinical pathways and contracting. According to research from MMIT’s Indices team, nearly half of payers are planning the implementation of at least one additional AI solution in the next 12–18 months.
Although AI-driven changes…
More than 10,000 attendees visited Las Vegas last week for Asembia’s ASX26 Summit. Along with meeting with clients and hosting the Specialty Pharmacy Patient Choice Awards, MMIT representatives attended many excellent sessions on the state of the industry. In one session after another, patients’ ability to afford and access their medication was front and center.
As we know, the healthcare ecosystem is undergoing a significant policy-driven reset, with affordability, access, and transparency taking center stage. From the IRA’s negotiated Maximum Fair…
This article was originally published in Pharmaceutical Executive on April 6, 2026.
Pharmacy benefit managers (PBMs) sit at the center of an increasingly complex web of relationships among manufacturers, health insurers, pharmacies and employers. While they streamline negotiations between employers and pharmaceutical companies, increase price competition and standardize claims, formulary and utilization practices, they’ve recently faced increased scrutiny because of potential conflicts of interest and opaque sources of revenue.
As a result, the Trump administration called on the secretary of labor…
In many therapeutic areas, especially oncology, physicians have been using early screening tests for decades. Designed to identify the early signs of a disease or condition before any noticeable symptoms develop, early detection tests support timely medical intervention.
In the U.S. alone, early cancer screenings have been credited with preventing 4.75 million deaths (and counting) since 1975. According to the National Cancer Institute, the prevalence of cancer screenings have contributed significantly to a 34% drop in overall cancer mortality from 1991…
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…
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