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

RCT Recruitment Prediction: Better Statistics, Better Trials

Pharmatica image of RCT recruitment prediction showing clinical trial sites, patient enrolment pathways, statistical forecasting, and recruitment targets.

RCT recruitment prediction can improve trial planning by using Poisson and Bayesian models to estimate enrolment rates, uncertainty, and recruitment risk.

Nicole Dale

AI-Driven Digital Organisms Could Change Drug Discovery

Pharmatica image of an AI-driven digital organism concept showing a realistic human cell connected to computational data pathways for virtual biology and drug discovery.

AI-driven digital organisms could transform drug discovery by simulating biology across scales. Explore GenBio AI's AIDO vision and the virtual cell.

Nicole Dale

Ketryx and Accenture Build Regulated AI MedTech at Scale

Pharmatica image of regulated AI connecting medical device software development, validation, traceability, and regulatory compliance.

Ketryx and Accenture are combining AI-native compliance infrastructure and transformation expertise to help MedTech scale regulated AI without slowing development.

Nicole Dale

Why Formulation Development Now Starts With Manufacturing

Pharmatica image of pharmaceutical formulation development connecting drug formulation science with advanced manufacturing and process control.

Formulation development is moving beyond drug delivery to shape manufacturing, quality, scale-up, and supply resilience across modern pharmaceutical operations.

Nicole Dale

MHRA Clarifies Licensing for Microbiome-Based Medicines

Pharmatica image of abstract red microbial imagery on a soft white background, representing microbiome-based medicinal product UK regulation.

The MHRA has set out its position on microbiome-based medicinal products, confirming that a clear UK licensing route already exists for these therapies.

Nicole Dale

Enriched Clinical Trial Design: Who Gets Left Behind?

Pharmatica image representing enriched clinical trial design showing selected patient cohorts, clinical research data, and connected trial pathways.

Enriched clinical trial design can improve trial efficiency, but may exclude patients from the evidence base. Explore the implications for clinical development.

Nicole Dale

Better Predictive Modelling for Better Drug Development

Pharmatica image showing AI-powered pharmaceutical drug discovery environment showing predictive modelling, molecular research, and connected scientific data.

Discover how predictive modelling, QSP, AI, and systems biology creates better drug development by connecting biological evidence with better predictions.

Nicole Dale

BMS and NVIDIA Build Pharma’s AI Supercomputer

Pharmatica image of an AI-powered pharmaceutical supercomputing environment and pharma laboratory connecting scientific data, advanced computing, and drug discovery research.

BMS and NVIDIA are building a powerful pharma AI factory using advanced supercomputing, AI models, and scientific data to accelerate drug discovery.

Nicole Dale

Robotics and GMP: Building the Factory of Tomorrow

Pharmatica image for robotics in pharmaceutical manufacturing showing automated GMP equipment, sensors, and connected manufacturing data in a clean production environment.

Robotics in pharmaceutical manufacturing is strengthening GMP through automation, contamination control, traceability, and more consistent production processes.

Nicole Dale

FDA Oncology Trial Guidance Targets Eligibility Barriers

Pharmatica image showing new FDA oncology clinical trial guidance for clinical trial eligibility represented through connected patient assessment, clinical research data, and trial pathways.

FDA oncology clinical trial guidance targets restrictive eligibility criteria, covering performance status, washout periods, medications, and laboratory values.

Nicole Dale

EHR Patient Recruitment Gets A Reality Check

Pharmatica image representing EHR patient recruitment technology connecting electronic health records, clinical trial eligibility data, and patient-trial matching.

EHR patient recruitment could improve clinical trial matching, but workflow integration, data quality, interoperability, and AI validation remain key challenges.

Nicole Dale

Could q-CAR Redefine Drug Discovery?

Pharmatica image for q-CAR drug discovery showing dynamic protein conformations, ligand binding, and AI-driven molecular analysis.

Find out how q-CAR drug discovery moves beyond static protein structures by linking protein dynamics, ligand activity, and AI to precision drug design.

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