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Articles

Smart Quality Management: AI-Powered GMP Compliance and Release by Exception

European pharmaceutical manufacturing has rarely faced this many simultaneous pressures Tightened sterile expectations have raised the bar across the continents fillfinish capacity biosimilar competition is compressing biologics margins and procurement authorities are pushing

Rethinking Make-or-Buy: Strategic Manufacturing Decisions in Pharma

Few strategic decisions in pharmaceutical operations carry as much longterm consequence as the choice of what to make and what to buy and few are revisited as rarely Network footprints agreed a decade ago partners selected during a capacity crunch technology transfers completed under launch pressure these choices harden into architecture They stop looking like decisions and start looking like the...

Genetic Testing in Mainstream Medicine: Driving Precision, Prevention, and Population Health

Healthcare systems globally are shifting toward valuebased care where reimbursement is tied to outcomes not procedures Genetic testingparticularly multigene panels and polygenic risk scores is emerging as a highimpact enabler of early intervention and targeted prevention reducing longterm costs and improving clinical outcomes

Achieving Full Digital Maturity in Pharma Manufacturing: A Paperless Transformation Guide

The pharmaceutical sector is changing radically as manufacturers do not rely on the past and dataintensive processes The vision of paperless pharma manufacturing is not a dream anymore it is a strategy based on the pressure of the regulators the complexity of operations and the need to accomplish faster and with accuracy production The center of this change is the digital pharma manufacturing and...

Why AI Is Changing What Good Validation Looks Like

The comprehensive landmark report and framework set out seven principles for using AI safely in pharmacovigilance together advocating a riskbased approach to governance validation and more Here ArisGlobals Jason Bryant highlights some of the guidances main assumptions as recently distilled in a podcast with Denny Lorenz a core member of the CIOMS XIV working group

The Future of Oncology Clinical Trials: Adaptive, Biomarker-Led, and AI-Enabled

Oncology now absorbs close to a third of the industrys active development pipeline and a comparable share of its research budget It also carries the worst odds in medicine A molecule entering firstinhuman cancer studies has historically had a midsingledigit probability of reaching approval against roughly double that across other therapy areas For a European chief executive allocating capital acro...

Techno Trends

Alume Biosciences Secures FDA Breakthrough Therapy Designation for Bevonescein

Alume Biosciences has received Breakthrough Therapy Designation BTD from the US Food and Drug Administration FDA for bevonescein an investigational fluorescent drug being developed to support realtime nerve visualisation during head and neck surgery in adults Bevonescein is an intravenous fluorescent peptidedye conjugate that binds to nerve tissue

Projects

SK pharmteco Plans More Than US$200 Million Investment in Small Molecule and Peptide Manufacturing

SK pharmteco is planning a fiveyear investment of more than US million to expand and modernise its pharmaceutical development and manufacturing operations in the United States The programme will strengthen capabilities for small molecules and peptides while supporting a more

Research Insights

A drug repurposing screen reveals dopamine signaling as a candidate therapeutic pathway for PIGA-CDG

PIGACDG is a congenital disorder of glycosylation caused by pathogenic partial lossoffunction variants in the PIGA gene PIGA encodes an enzyme responsible for the catalytic transfer of Nacetylglucosamine

whitepaper

Post-Translational Modifications in Drug Discovery: From Molecular Regulation to Clinical Impact

For decades the central dogma of molecular biology has anchored our understanding of cellular function DNA to RNA to protein But this linear view is incomplete A growing body of evidence shows that much of biologys