Tag: Biopharmaceutical Development

Risk management in pharma is often treated as a reactive compliance box-ticking exercise. This article argues for reframing risk as a strategic competitive advantage. It details proactive frameworks like the "Excipient Exclusion Filter," Decision Quality (DQ) matrices, and "pre-mortem" analyses that allow development teams to anticipate failure modes and engineer them out of the pipeline before they occur.

The "Valley of Death" in pharma is no longer just about scientific failure; it is about commercial irrelevance. This article examines the critical need to align R&D ambition with market reality early in development. It explores the evolution of the Target Product Profile (TPP) into the Target Value Profile (TVP), the role of the "commercial scientist," and strategies for integrated evidence generation that satisfy both regulators and payers.

The era of "gut feeling" in pharmaceutical portfolio management is ending. This article explores how advanced analytics, machine learning, and predictive modeling are revolutionizing project prioritization. It details the shift to Monte Carlo simulations, integrated data lakes, and AI-driven decision support, enabling companies to objectively rank programs and optimize R&D return on investment.

The traditional reliance on risk-adjusted Net Present Value (rNPV) and peak sales forecasts is failing to capture the true potential of modern pharmaceutical assets, particularly platform technologies. This article introduces holistic valuation frameworks like Real Options Analysis (ROA) and the Platform VISTA model, arguing for a shift toward valuing "strategic fit," "lifecycle potential," and the intangible equity of innovation engines.

Pharmaceutical companies are radically redesigning portfolio strategies to survive a "triple threat" environment of scientific complexity, regulatory upheaval like the IRA, and capital scarcity. This analysis explores the shift from efficiency-driven models to resilience-first frameworks, detailing how leaders are embedding optionality into pipelines, embracing modality agnosticism, and using dynamic resource allocation to thrive amidst volatility.

Thermo Fisher Scientific has gone on to announce quite a major expansion of its Bioprocess Design Centers in Asia, hence deepening its investment within...

IQVIA, known across the life sciences industry for its clinical research operations, commercial analytics, and health-data expertise, has entered a strategic collaboration with Amazon...