Pharma Articles
Articles are written by renowned pharmaceutical company executives and other professionals from across the world on important topics relating to the business. The part of articles on the pharmaceutical industry focuses on current and developing concerns in fields such as pharmaceutical R&D, drug discovery, clinical trials, pharmaceutical production, biopharmaceuticals, and information technology.
Beyond Manual Literature Screening: From AI Automation to Decision Preparation in Pharmacovigilance in Europe
As of August the EU AI Act is generally applicable although some obligations for highrisk AI systems apply at later dates For pharmacovigilance organisations a key consideration is to determine the role and classification of each AI system under the Act rather than assuming that AI used in PV is au...
Business Transformation Strategies for the Pharmaceutical Industry
The pharmaceutical industry is at a crossroads Drug development timelines remain long regulatory scrutiny keeps intensifying and patients now expect the same seamless digital experiences they get from banking apps or online retailers Against this backdrop pharma business transformation has moved fro...
Risk Management in Pharmaceutical Manufacturing
The pharmaceutical industry operates under strict regulatory oversight because medicines directly affect patient health and safety Manufacturers must consistently produce products that meet predefined standards of quality safety efficacy identity strength and purity Achieving these objectives requir...
Pharmaceutical Business Strategy: Transformation, Regulation, Outsourcing and Growth
The pharmaceutical industry is standing at an unusual crossroads Patent cliffs are steeper regulators are tougher patients expect more transparency and payers are pushing back harder on price In this environment a strong Pharma Business Strategy is no longer a slide deck exercise for the boardroom...
The Next Growth Strategy: Scaling GLP-1 Manufacturing and Global Market Expansion
For most of the past four years the strategic conversation around GLP receptor agonists was a demand story Prescriptions outran forecasts waiting lists formed pharmacy shelves emptied and the commercial debate centred on reimbursement prescriber behaviour and how far the obesity indication could str...
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 r...
AI Governance in Pharma: Managing Trust, Transparency, and Regulatory Expectations
Most large pharmaceutical organisations no longer have an AI strategy problem They have an AI accountability problem Models now sit inside pharmacovigilance case intake deviation triage visual inspection trial feasibility medical information and commercial targeting deployed by different functions...
Digital Twins in Pharmaceutical R&D: Simulating Biology for Faster Innovation
For most of its modern history pharmaceutical research has been an experimental science with a statistical conscience Build the molecule dose the animal run the trial count the failures and let the survivors pay for everything that did not make it That arrangement has become progressively harder to...
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 podc...
Global CDMO Expansion: Supporting the Growing Advanced Therapy Pipeline
The European advanced therapy sector has spent the better part of two decades proving a scientific point that engineered cells corrected genes and reprogrammed immune systems can deliver durable clinical benefit That argument is now largely settled The question facing pharmaceutical and biotech lead...
