Thani Jambulingam, Ph.D., is a professor in food, pharma and healthcare at Erivan K. Haub School of Business, Saint Joseph’s University, Philadelphia. He is a pharma and healthcare strategist and his work focuses on AI-enabled decision frameworks, emerging technologies, and commercial strategy. He can reached at tjambuli@sju.edu.
Regulators are shifting antitrust scrutiny in healthcare from market share and pricing toward how vertically integrated systems shape patient flow, access, and competitive dynamics, signaling deeper oversight of ecosystem design, strategic intent, and cumulative market influence.
CMS’s 2026 requirement for manufacturers to submit “reasonable assumptions” alongside ASP data formalizes the role of estimation in drug pricing, increasing scrutiny on how ASP is constructed and shifting reporting toward greater transparency and accountability.
Merck’s decision to establish oncology as a standalone business unit reflects a strategic response to blockbuster concentration risk, lifecycle complexity, and intensifying competitive dynamics, as the company prepares for the anticipated loss of exclusivity of Keytruda and repositions organizational design as a lever for long-term value protection and growth.
Pharmaceutical manufacturers must address the question of how exactly does value get created and destroyed inside these organizations and how will AI fundamentally shift that equation?
The first wave of Commissioner’s National Priority Vouchers signals a fundamental shift in FDA competitiveness, rewarding companies that pair breakthrough science with affordability commitments, onshore manufacturing readiness, and the operational muscle to execute ultra-accelerated reviews.
The FDA’s new Commissioner’s National Priority Voucher signals a transformative shift in U.S. drug review, tying accelerated approval to manufacturing readiness, domestic supply-chain strength, and credible affordability commitments, while redefining how companies must innovate, scale, and launch therapies in 2025 and beyond.
Novo Nordisk’s board overhaul signals a decisive return to Foundation-led scientific and operational governance, raising strategic questions about whether the company can sustain U.S. growth and consumer-market leadership in the GLP-1 era without deeper American commercial expertise.
How the Metsera deal extends Pfizer’s 25-year blueprint for growth.
As leading drugmakers launch direct-to-patient platforms with steep discounts and digital care bundles, a new channel dynamic is emerging that gives manufacturers greater control of patient engagement while redefining, but not replacing, the strategic role of traditional wholesalers.
The arrival of GLP-1 receptor agonists and dual agonists has delivered unprecedented efficacy, reframed obesity as a chronic disease, and sparked an industry gold rush.
The Regeneron litigation highlights that donations routed through independent entities are not immune from challenge, especially if the government believes they are effectively covering a patient’s co-pay for a specific product.
The 15% tariff on pharmaceutical imports from the European Union is not a short term inconvenience, it represents a structural shift in the economics of the US pharmaceutical market.
AI influencers represent the cutting edge of digital storytelling. But when applied to pharmaceutical marketing, innovation must be balanced with integrity.
Executives who treat capital allocation as a CEO-level strategic discipline are best positioned to thrive in a volatile and increasingly capital-constrained environment.
In today’s environment, aligning the Target Product Profile with the appropriate Value Evidence Archetype is not just good practice, it is a strategic imperative.
November 12th 2025
