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 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.

Rare Diseases Medical Devices Pharma Policy

CDRH Rare Disease Impact Initiative Sets New FDA Focus

Nicole Dale

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

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 Moves to FDA Qualification

Explore All Insights

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

Nicole Dale

Co-ordinated EU GMP Inspection Guidelines: What You Need to Know

Pharmatica image for co-ordinated EU GMP inspection guidelines showing pharmaceutical inspectors reviewing GMP compliance data in a modern manufacturing facility.

New EU GMP inspection guidelines take effect in September 2026. Here is what you need to know about joint inspections, planning, and reporting.

Nicole Dale

World’s First Live AI-Assisted Brain Surgery

Pharmatica photo‑realistic image of an operating theatre showing surgeons performing AI‑assisted brain surgery under bright ambient light, with monitors displaying glowing yellow neural pathways and blue data overlays, representing real‑time computer vision guidance and surgical precision.

In the world’s first, London surgeons have used real-time AI to protect a patient's sight during live brain surgery. See what the trial’s AI framework means for MedTech.

Nicole Dale

AI in Healthcare: OpenAI and Epic Integration Connects EHRs

Pharmatica image showing a healthcare professional using AI in healthcare connecting OpenAI and Epic electronic health records through an integrated clinical data platform.

OpenAI and Epic integration brings AI healthcare into EHR workflows, connecting patient records with ChatGPT for Healthcare to advance research and patient care.

Nicole Dale

The Strategic Role of CDMOs in Pharma Manufacturing

Pharmatica image of a CDMO pharmaceutical manufacturing facility with connected bioprocessing personnel and equipment.

CDMOs in pharmaceutical manufacturing are becoming strategic partners, providing technical expertise, capacity, technology, and quality oversight.

Nicole Dale

Endpoints in Gynaecological Oncology Clinical Trials

Pharmatica photo‑realistic editorial image of a healthcare professional discussing clinical data with a patient in a modern hospital setting, symbolising compassionate care and digital innovation in gynaecological oncology trials and clinical development.

Gynaecological oncology clinical trials reveal that survival gains and trial design do not always align. Here is what clinical development teams should learn.

Nicole Dale

FDA Clinical Trial Oversight Tightens Globally

FDA clinical trial oversight is intensifying globally as the agency raises expectations for GCP, foreign site inspections, data integrity, and patient protection.

Nicole Dale

Digital Health Technologies in Clinical Drug Development

Pharmatica image of digital health technologies collecting clinical trial data for drug development.

Digital health technologies in clinical drug development need more than data. Explore validation, standards, digital endpoints, patient value, and regulation.

Nicole Dale

Why Does the True Impact of AI in Drug Discovery Lag?

Pharmatica image showing dense green data nodes that converge on one illuminated point, symbolising AI in drug discovery.

AI in drug discovery keeps making headlines, but clinical success rates barely move. A new Nature Reviews Perspective explains why, and what pharma should do next.

Nicole Dale

Synthetic Genetic Codes Move Closer to Programmable Biology

Pharmatica image of the AGENTEX automated cell-free biotechnology platform illustrating synthetic genetic code engineering and programmable biology.

Synthetic genetic codes are moving closer to programmable biology as automated cell-free systems enable faster testing of new protein chemistries in R&D.

Nicole Dale

Bioprocessing Is Becoming a Smarter Manufacturing System

Pharmatica image of a pharmaceutical bioprocessing facility with stainless-steel bioreactors, process sensors, and connected digital manufacturing systems.

Bioprocessing is becoming more connected, automated, and data-driven. Here is what smarter process control means for biopharma manufacturing.

Nicole Dale

What Sponsors Need to Know About UK Combined Review 2026

Pharmatica image for UK Combined Review clinical trial approval showing coordinated MHRA and ethics assessment through a unified CTIMP regulatory pathway.

UK Combined Review unifies MHRA and ethics review for CTIMPs, reshaping approval timelines, submissions, and sponsor planning under UK trial reform.

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.

Topic