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In this article, Aman Khera, the Global Head of Regulatory Strategy for Worldwide Clinical Trials, makes a case for regulatory involvement in drug development from start to finish and explains how the role of the regulator is changing, as well as what this means for pharma.
In this virtual roundtable, Scott Bradley (Principal Research Scientist, Eli Lilly and Company), Joan Malmstrøm (Principal Scientist, Novo Nordisk) and Kelly Sackett (Principal Scientist, Pfizer) exemplified how high-resolution nuclear magnetic resonance (NMR) is a key technology that provides critical information about protein structure and dynamics. Here, the participants offer some…
Welcome to European Pharmaceutical Review’s Guide to Data Integrity. In this edition, Ian Harrow and Thomas Liener, Consultant Project Managers at The Pistoia Alliance, explain the importance of the FAIR data principles; and Charles River Laboratories and Thermo Fisher Scientific showcase their unique data integrity services and discuss how they…
Francesco Berti, Scientific Director at GSK Vaccines - Siena, Italy, reveals how NMR spectroscopy tools are invaluable in vaccine production.
Articles in this in-depth focus discuss the development and delivery challenges associated with mRNA vaccine technology and explore how investing in the off-patent drug sector can benefit both pharma innovation and patient care.
In this in-depth focus, find out about the key points to consider when implementing new software in the pharma development space and the current positions of the EMA and FDA with regards to nitrosamine contaminants.
In this journal, features on the current regulatory positions on nitrosamine impurities, how investing in off-patent medicines can help drive innovation and why new regulations could lead to a biosimilar boom in the UK. Other articles include an exploration of the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines,…
The new ATU programme may support more efficient use of healthcare spending but could it mean fewer patients receive early access to treatments? Here, experts from Charles River Associates discuss the new ATU programme reforms and how they could impact pharma.
In this article, EPR’s Hannah Balfour explores the current usage of monoclonal antibody therapies for COVID-19, with commentary from Professor Adrian Streinu-Cercel of the Carol Davila University of Medicine and Pharmacy.
Psychedelic drugs are gaining popularity in the pharmaceutical R&D sector because of their apparent benefits for people suffering with neuropsychiatric disorders - and those which are resistant to existing therapies in particular. In this article, Imperial College London’s Professor David Nutt discusses the evidence underlying the development of psychedelic therapies…
Pharmacovigilance obligations present significant challenges for biotechs. Small companies face the same rigor as large pharma - and it does not help that there is divergence between the requirements of the FDA, the EU and its member states. Here, seasoned pharmacovigilance experts and non-executive advisors to Arriello, Eric Caugant in…
South Africa and India’s request that the World Trade Organization waive intellectually property rights for COVID-19 vaccines, treatments, diagnostics and technology has garnered extensive media coverage, particularly since the US decision to support the proposal. In a three-part series, European Pharmaceutical Review’s Assistant Editor, Hannah Balfour, will discuss the IP…
In this article, Giacomo Chiesi from Chiesi Group outlines why the company took steps to become Benefit Corporation and B Corp certified, how this status may impact business and the associated operations.
In this article, Dr Ash Ramzan, principal consultant at Woodley BioReg, discusses the five key challenges preventing biosimilars from reaching their full potential.
This ebook from Sartorius takes an in-depth look at how the quality control (QC) microbiology laboratory plays a critical role in control of the pharmaceutical manufacturing environment and product release.
