Christopher Cole

In a poster presentation at AAPS PharmSci 360, by Dineli Ranathunga, PhD, indicates that AI/ML in-silico modeling can accelerate poorly soluble drug development.

AI is transforming pharma R&D, bioanalysis, and manufacturing. The industry faces intense competition (obesity wars) and FDA regulatory instability.

Analysis of FDA 505(b)(2) data (2024–2025) shows 69 drug reformulations, with a focus on enhancing stability and patient comfort, utilizing new dosage forms, and innovative strategies.

With pharmaceutical tariffs fundamentally impacting costs, global supply chains, and more, it’s important for industry professionals to understand the basics.

Maggie Saykali reviews the key points of her CPHI Frankfurt presentation on the potential game-changing opportunities of the Critical Medicines Act.

J.D. Mowery, Bora, says global sustainability standards are good, AI implementation demands data cleansing, and outsourcing must mature.

J.D. Mowery discusses boosting pharma supply resilience through localized manufacturing, AI innovation, and critical regulatory standardization.

J.D. Mowery, Bora, says tariffs localize biopharma supply chains, the "biotech freeze" mandates robust data, and AI rapidly optimizes operations.

Maggie Saykali, Cefic, explains that Western pharma vulnerability stems from market loss to Asia, caused largely by short-sighted offshoring due to environmental costs.

Gustavo Ferrer, MD, explains how AI accelerates drug development and manufacturing, streamlining clinical data into actionable pharma insights.

A panel at CPHI Frankfurt discussed how AI is transforming pharma talent, necessitating rapid upskilling, bias mitigation, and regulatory changes.

Nigel Langley of gChem stresses excipient innovation, safer solvents, and supply chain resilience for pharma’s future in part 2 of a 2-part interview related to his presentation at CPHI Europe 2025.

Eva-Maria Hempe, NVIDIA, says AI collaboration optimizes life science research via routine automation, freeing human experts for complex strategy, ethics, and exploring scarce data.

Eva-Maria Hempe, NVIDIA, says AI platforms must integrate R&D data, overcoming silos, with adoption demanding a centralized strategy and change management.

Maggie Saykali, Cefic, emphasizes the importance of competitiveness and innovation for European manufacturers to create added value and maintain environmental standards.

Nigel Langley of gChem discusses the company’s DMSO, proactive pharma strategies, and more in part 1 of a 2-part interview related to his presentation at CPHI Europe 2025.

Eva-Maria Hempe, NVIDIA, says bio/pharma must centralize AI strategy, tackle silos, prioritize process integrity, and balance quick wins with long-term drug design goals.

Maggie Saykali, Cefic, reviews how the EU’s proposed Critical Medicines Act aims to curb supply dependence and shortages by reforming drug procurement.

Eva-Maria Hempe, NVIDIA, explains that accelerated computing, data governance, and “lab in the loop” are key to bio/pharma’s AI strategy for transforming drug discovery and R&D.

The 100% tariff on imported drugs will pressure pharma companies to build manufacturing sites in the US or face significant costs.

In the first-ever “Two-Minute Mysteries: BioPharma Stories,” Agilent’s Ken Boda shares the mystery of a low reading.

The week's pharma news includes FDA warnings for Lilly and Novo, new drug approvals for MASH and edema, and a look ahead at CPHI Europe.

This potential shift has profound implications for regulatory strategy, transparency, and internal quality systems, directly impacting the core concerns of industry professionals.

Pharma embraces AI for quality, supply chain, and training; navigates FDA compliance; and develops new treatments like an epinephrine nasal spray.

FDA experts at PDA 2025 urges pharma to adopt holistic quality systems, strengthening 483 responses & post-warning letter remediation for compliance excellence.

Glenn Wright previews the 34th PDA Regulatory Conference, spotlighting AI, quality culture, FDA trends, and collaboration shaping industry progress.

The PDA Regulatory Conference convenes more than 30 FDA experts to discuss cGMP excellence, compliance trends, and regulatory outlook, offering crucial insights for pharma manufacturing professionals.

Aficamten beat metoprolol for oHCM, EMA/WHO hit 10 yrs, Oxford and EIT collaborated on AI vaccine, Offit's FDA exit stirred policy, and Pistoia set agentic AI rule.