Insights

In-depth articles and expert analysis from pharmaceutical leaders, exploring advances in life sciences, drug development and the trends shaping healthcare innovation.

Pharmatica image of a Pharmaceutical research laboratory illustrating Good Laboratory Practice, controlled experiments, documentation, and data integrity in preclinical R&D.

Preclinical Development Biomedical R&D Pharma Policy

Good Laboratory Practice Always Sets the R&D Standard

Nicole Dale

Pharmatica image representing the AlphaGenome Atlas genomic AI map with single-nucleotide variant prediction across the human genome.

AI Drug Discovery AI & Machine Learning Research Informatics

AlphaGenome Atlas: Mapping Every Possible DNA Variant

Nicole Dale

Pharmatica image showing planning for FDA Expedited IND Pilot application to support faster preparation for first-in-human clinical trials.

Regulatory Pathways Regulatory Strategy Clinical Trial Regulation

FDA Expedited IND Pilot Targets Faster First-In-Human Trials

Nicole Dale

Pharmatica close-up image of a young child wearing a white T-shirt with a Rare Disease Day badge, seated in a bright clinical home environment with red medical devices in the background, representing rare disease care, patient independence, and humanitarian medical technology.

CDRH Rare Disease Impact Initiative Sets New FDA Focus

Pharmatica image of an ADC manufacturing facility showing antibody-drug conjugate drug product production and pharmaceutical processing equipment.

More Than Conjugation: ADC Manufacturing

Pharmatica GLP-1 obesity clinical development visual showing metabolic therapy, clinical research, and evidence generation.

GLP-1 Obesity Evidence Is Changing Clinical Development

Pharmatica editorial close‑up of FDA regulatory submission materials for diabetes devices, featuring a Libre glucose sensor, red insulin pen, and red office stamps and pens on a beige folder labeled, ‘U.S. Food & Drug Administration (FDA) – Regulatory Submission Diabetes Division,’ representing medical‑device approval and diabetes‑management technology.

Libre Duo FDA Authorisation Through De Novo Pathway

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Browse our complete library of expert articles and analysis. Explore content across science, policy and life sciences innovation.

Nicole Dale

Can Large Language Models Solve More Rare Disease Genomes?

Pharmatica image showing a clinical geneticist using LLM-assisted rare disease diagnosis tools to analyse genome sequencing data and generate evidence-based diagnostic hypotheses for precision medicine.

LLM-assisted rare disease re-assessment improves genomic analysis, increasing diagnostic yield and supporting clinician-led precision medicine and possibly drug development.

Nicole Dale

Modular Pharma Factories: The Next Step for Continuous Manufacturing?

Pharmatica image showing modular pharmaceutical manufacturing using continuous pharmaceutical manufacturing processes, interconnected production modules, and Process Analytical Technology to improve flexible drug manufacturing.

Discover how modular pharmaceutical manufacturing and continuous production could improve flexibility, resilience, and efficiency across modern pharmaceutical operations.

Nicole Dale

FAST-EU Pilot: Can Europe Finally Accelerate Multinational Clinical Trials?

Pharmatica image representing the FAST-EU Pilot supporting multinational clinical trials through coordinated European regulatory collaboration, accelerating clinical trial approvals under the EU Clinical Trials Regulation (CTR).

The FAST-EU Pilot aims to accelerate multinational clinical trials through faster coordinated assessments, supporting Europe’s 2030 clinical research ambitions.

Nicole Dale

Foundational AI In Cell and Gene Therapy Development Success

Pharmatica image representing AI in cell and gene therapy development success through improving drug discovery, viral vector engineering, manufacturing, and predictive quality control.

Discover why AI in cell and gene therapy is necessary for successful development by improving drug discovery, viral vector engineering, manufacturing, and quality control.

Nicole Dale

Success for Non-Animal Testing of Preclinical Toxicity?

Pharmatica hyper-realistic image of a human organ-on-chip platform with cultured cells used for non-animal testing in drug discovery in order to determine preclinical toxicity in a pharmaceutical research laboratory.

Can non-animal testing methods be used in preclinical drug discovery? Here is what the evidence is for their accuracy and limits assessing preclinical toxicity.

Nicole Dale

Eli Lilly and AtaiBeckley: AI and Psychedelic Biotech Converge

Pharmatica image showing an anatomically accurate human brain with subtle neural activation inspired by functional MRI imaging, representing psychedelic biotech, mental health therapeutics, CNS drug discovery, and AI-enabled pharmaceutical innovation.

Eli Lilly's acquisition of Peter Thiel’s backed AtaiBeckley highlights growing investment in psychedelic biotech and the future of CNS drug discovery.

Nicole Dale

Why CMC Strategy Defines Cell and Gene Therapy Success

Pharmatica image of a modern cell and gene therapy manufacturing facility supporting advanced CMC strategy through GMP production, digital process monitoring, pharmaceutical quality systems, and bioprocess innovation.

Cell and gene therapy CMC strategies, quality systems, and manufacturing innovation are critical to advanced therapy development and determine scalability.

Nicole Dale

One Pivotal Trial for FDA Approval? Success Depends on Trial Design

Pharmatica image of a modern pharmaceutical regulatory affairs workspace representing documentation, compliance, and submission processes essential for FDA drug approval. The scene shows three binders labeled “Regulatory Affairs,” “Submissions,” and “Compliance” on a clean office desk with documents and a pen in the foreground, while a blurred meeting of professionals is visible through a glass wall in the background. The composition conveys administrative precision and regulatory science underpinning.

One pivotal trial for FDA approval could accelerate drug development, reshape clinical trial strategy, and change the pharmaceutical regulatory landscape.

Nicole Dale

Great Drug Discovery Starts with Great Scientists

Pharmatica image of a modern pharmaceutical research laboratory representing drug discovery scientists using computational biology, structural biology, medicinal chemistry, and AI-assisted therapeutic research.

Learn how drug discovery scientists are evolving alongside AI, computational biology, and multidisciplinary research to accelerate therapeutic innovation.

Nicole Dale

Claude Science: An Operating System for AI-Driven Pharma R&D

Pharmatica photo‑realistic representation of scientists collaborating in a unified AI‑driven pharmaceutical research environment using Claude Science, integrating genomics, structural biology, cheminformatics, and AI-assisted pharmaceutical research

Claude Science is a new AI R&D tool for drug discovery, integrating 60-plus scientific databases into one place. Here is what pharma R&D teams need to know.

Nicole Dale

Europe’s Life Sciences Strategy. A New Era of Innovation?

Pharmatica picture of European pharmaceutical innovation showing biotechnology research, advanced manufacturing, artificial intelligence, and regulatory collaboration supporting the European Life Sciences Strategy.

The new European Life Sciences Strategy aims to accelerate pharmaceutical innovation through investment, regulatory reform, biotechnology, and AI capabilities.

Nicole Dale

One Global CMC Dossier? Digital Regulatory Submissions

Pharmatica photo‑realistic representation of CMC regulatory submissions showing global data networks, secure digital dossier exchange, and pharmaceutical manufacturing integration — document binders, connected globe, red padlock cybersecurity icon, and industrial equipment with red‑capped vials illustrate digital CMC submissions, regulatory reliance, and manufacturing quality.

Discover how digital CMC regulatory submissions, cloud collaboration, and AI accelerate the modernisation of manufacturing approvals and global pharma operations.

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