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

Good Laboratory Practice Always Sets the R&D Standard

Good Laboratory Practice strengthens data integrity, reproducibility, and regulatory confidence across pharma non-clinical R&D and preclinical research.

Nicole Dale

AlphaGenome Atlas: Mapping Every Possible DNA Variant

Google DeepMind’s AlphaGenome Atlas maps all nine billion possible DNA variants, helping researchers rapidly prioritise disease-linked mutations.

Nicole Dale

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

The FDA’s Expedited IND Pilot introduces rolling review and sponsor-QRI partnerships to accelerate Phase I first-in-human trials while retaining regulatory oversight.

Nicole Dale

CDRH Rare Disease Impact Initiative Sets New FDA Focus

The CDRH Rare Disease Impact Initiative puts greater focus on rare disease devices, patient engagement, evidence strategy, and closer FDA coordination.

Nicole Dale

More Than Conjugation: ADC Manufacturing

ADC manufacturing is becoming more complex as payloads, conjugation, lyophilisation, containment, and scale-up reshape CMC strategy and commercial readiness.

Nicole Dale

GLP-1 Obesity Evidence Is Changing Clinical Development

GLP-1 obesity clinical evidence is reshaping drug development as efficacy, safety, cardiovascular outcomes, and treatment durability become critical.

Nicole Dale

Libre Duo FDA Authorisation Through De Novo Pathway

Abbott’s Libre Duo FDA authorisation creates a new Class II device category, combining glucose and ketone monitoring while setting a regulatory path for future devices.

Nicole Dale

Liver-Chip Supported Drug Discovery Moves to FDA Qualification

Pharmatica image of a human liver-chip platform used for liver-chip drug discovery and preclinical drug toxicity assessment in a pharmaceutical laboratory.

Liver-chip supported drug discovery is moving closer to regulatory acceptance as Emulate advances FDA ISTAND qualification for human-relevant DILI assessment.

Nicole Dale

AI Bioweapons Risk: What Anthropic’s Report Means for Pharma

Pharmatica image representing a pharmaceutical AI research environment that uses AI biosecurity, biological research governance, and emerging bioweapons risk.

The Anthropic 2026 threat report documents a significant bioweapons risk. See what this means for pharma biosecurity, research, and AI controls.

Nicole Dale

Mitigation of PFAS Contamination in Pharma Manufacturing

Pharmatica image of pharmaceutical manufacturing water treatment and PFAS contamination monitoring.

PFAS contamination is a growing manufacturing risk. Explore the latest on the research, wastewater challenges, monitoring, remediation, and pharma implications.

Nicole Dale

FDA 10 Guiding Principles of Good AI Practice in Drug Development

Pharmatica image to represent the FDA’s 10 Guiding Principles of Good AI Practice in Drug Development showing AI evidence analysis within a pharmaceutical regulatory setting.

Get to know the FDA 10 Guiding Principles of Good AI Practice in Drug Development and what they mean for AI governance, validation, and regulatory risk.

Nicole Dale