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

Digital Measures in Clinical Trials: FDA vs EMA Pathways

Clinician reviewing digital measures in clinical trials on a tablet, illustrating regulatory acceptance of digital health technologies, digital biomarkers, and FDA and EMA qualification pathways for modern clinical research.

Explore how novel digital measures gain regulatory acceptance in clinical trials, comparing FDA-structured pathways with EMA engagement-led frameworks.

Nicole Dale

FDA Draft Guidance on Gene Editing Safety (2026)

DNA double helix illustrating the FDA gene editing draft guidance 2026, highlighting next-generation sequencing (NGS) safety assessment, off-target editing analysis, genomic integrity testing, and regulatory requirements for cell and gene therapy development.

The FDA’s 2026 gene editing draft guidance could change your regulatory strategy. Explore the new NGS requirements for cell and gene editing therapies.

Nicole Dale

Next-Generation Sequencing for Cell Line Development in Biologics Manufacturing

Laboratory illustrating next-generation sequencing cell line development for biologics manufacturing, highlighting DNA analysis, genomic characterisation, bioprocess development, Quality by Design, and pharmaceutical manufacturing innovation.

Discover how next-generation sequencing in cell line development is improving biologics manufacturing, quality control, and regulatory confidence.

Nicole Dale

Real-Time Clinical Trials Are a Huge Competitive Advantage

Clinical researcher analysing live clinical trial dashboards and digital analytics, illustrating real-time clinical trials, continuous clinical trial data monitoring, adaptive trial management, and data-driven decision-making in pharmaceutical research.

Real-time clinical trials enable continuous data capture and faster decisions, improving how data is used in clinical trials. Here is what pharma leaders need to know.

Nicole Dale

Optimising Preclinical Pharmacology for Oncology NMEs

Oncology researcher performing preclinical pharmacology testing for new molecular entities (NMEs), illustrating oncology drug development, translational research, biomarker discovery, and advanced preclinical model optimisation.

Over 90% of oncology NMEs that succeed in animal studies fail in clinical trials. This analysis examines how to optimise preclinical pharmacology models to improve translational success.

Nicole Dale

Could Biological Age Become Pharma's Most Important Biomarker?

Biomarkers biological age illustration showing a human silhouette, DNA strands and AI-powered health analysis representing precision medicine and longevity research.

New research shows biomarkers of biological age predict mortality and hospitalisation better than chronological age, opening new opportunities for pharma innovation.

Nicole Dale

FDA 2026 Draft Guidance on Alternatives to Animal Testing

Illustration representing FDA alternatives to animal testing, featuring laboratory research, organ-on-chip technology, genetic science, AI-enabled drug discovery and next-generation pharmaceutical testing methods.

The FDA's March 2026 draft guidance on alternatives to animal testing marks a pivotal shift in preclinical drug development. Here's what pharma R&D teams need to know.

Nicole Dale

Why Europe's Heatwave Is an Important Pharma Cold Chain Risk

Visual representation of pharmaceutical cold chain risk showing refrigerated medicine storage exposed to extreme heat conditions, highlighting temperature-sensitive pharmaceutical supply chain challenges during climate-related disruptions.

Europe's 2026 heatwave is pushing pharmaceutical cold chain risk to the limit. Here is what supply chain leaders must do to protect drug integrity now.

Nicole Dale

Midjourney Medical: The AI Image Pioneer’s Unexpected Healthcare Play

Digital human body visualisation representing Midjourney Medical, showcasing AI-powered whole-body imaging, preventative healthcare technology, advanced medical scanning, and personalised health intelligence.

Midjourney Medical is bringing AI, full-body imaging, and preventative care together. Could this unexpected move reshape healthcare delivery?

Nicole Dale

How Low Can They Go? Clinical Trial Success Rates

Clinical laboratory automation platform used in drug development research, illustrating factors that influence Clinical Trial Success Rates, including advanced manufacturing technologies, precision workflows, and pharmaceutical innovation.

Clinical trial success rates have declined sharply over the past 20 years. This analysis examines what the data reveals about the drug approval rate and phase-by-phase attrition.

Nicole Dale

The AI Bioweapons Risk: We Cannot Afford to Look Away

Abstract visualisation of AI bioweapons risk showing a connected hexagonal network and glowing AI hub, symbolising biosecurity challenges, gene synthesis screening vulnerabilities, biotechnology innovation, and governance in the pharmaceutical industry.

The risk of AI being used to create a bioweapon is a serious concern for pharma biosecurity after researchers found AI-designed toxins can evade DNA screening. Here’s what you need to know about the AI and bioweapons risk.

Nicole Dale

CRO and Vendor Oversight in Clinical Trials

Clinical research professional reviewing operational data and regulatory documents on dual-monitor workstations, illustrating CRO vendor oversight in clinical trials, vendor performance monitoring, compliance management, and quality assurance across outsourced clinical research operations.

ICH E6(R3) raises the governance bar for CRO and vendor oversight in clinical trials. Here's what sponsors must build into outsourcing relationships to protect trial quality and timelines.

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