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Here, Origin’s Rich Quelch explores the potential benefits of basing drug prescription on pharmacogenomic data and how transitioning to such a system could impact the UK’s National Health Service.
With increasing numbers of cell and gene therapies (CGTs) entering clinical trials, Dr Dave Li and Dr Anna Baran of KCR Consulting discuss how the biological characteristics of CGTs should be taken into account with early phase trial designs.
Small biopharma companies often need to partner with larger firms to achieve their goals, but such agreements can fail if preparations are poor. Here, Diane Seimetz and Jörg Schneider at Biopharma Excellence discuss how due diligence smooths the path to collaboration.
Work is underway to create a collaborative virtual research institute (VRI) to support the fundamental research and subsequent clinical translation of precision medicine in Abu Dhabi, as well as the United Arab Emirates more broadly. Here, European Pharmaceutical Review’s Hannah Balfour discusses the project with the Head of the new…
As the face of healthcare changes and the emphasis on more-targeted remedies and preventative care increases, pharma’s traditional role in healthcare must also evolve. Here, Vintura Consultancy’s Gérard Klop looks at how pharma might carve out a new role in a more value-based healthcare market.
Here, EPR’s Hannah Balfour discusses the latest reports on pharmaceutical counterfeiting and falsification, exploring global and European crime rates, as well as recent counterfeiting incidents reported by Big Pharma.
With comment from Diane Paskiet, chair of the Product Quality Research Institute (PQRI) L&E Working Group, EPR’s Hannah Balfour outlines three key exposure-based safety thresholds and explores how the new extractables and leachables (E&Ls) strategy for parenteral drug products was established.
A recent empirical study of continuous manufacturing (CM) versus batch processing of US and non‑US pharmaceutical manufacturing facilities suggests that CM would be more economical than batch facilities, at least for the production of oral solid dosage products. This has significant consequences for policies and strategies to reduce supply chain…
Leakage, cracking and corrosion in pressure vessels present a serious risk for operators of pharmaceutical production systems. Imminent damage must be reliably identified at an early stage to enable necessary steps to be promptly taken. Oliver Großgart, Plant Safety Expert at TÜV SÜD Industrie Service GmbH, explains how TÜV SÜD…
Here, David Elder elucidates the workings of the manufacturing classification system (MCS) used to guide decision making for drug formulators.
Dr Owen Seddon, Consultant in Infectious Diseases and Medical Microbiology at University Hospital of Wales, explains how successes in the development of the coronavirus vaccine must be used in the fight against other vaccine preventable disease.
Disulphide bonds between cysteines play a critical role in the stability and activity of therapeutic antibodies. Here, Dr Ioannis Papayannopoulos, Principal Scientist at Dragonfly Therapeutics, describes the characterisation of the oxidation state of cysteines and formed disulphides in therapeutic antibody drugs.
Ayman AlSaadi and Wayne G Carter from the School of Medicine, University of Nottingham, illustrate the value of analysing the wastewater of specific populations to gain insight into levels of illegal drug usage and other health-related biomarkers.
Targeting medicines against the genetic and molecular drivers of lung, breast and other tumours has helped transform cancer care for many patients, yet precision medicine for complex chronic diseases has lagged behind. Maria Orr, Adam Platt and Ben Challis, from BioPharmaceuticals R&D at AstraZeneca, explain why this is changing for…
Novel and advanced therapies have come on in leaps and bounds over the past decade. Some cell and gene therapies have already reached the approvals stage, while others have now entered the later development stages. As a result, manufacturing process consistency, GMP standards and more must now meet more formal…
