Clinical trial trends – what will 2022 bring?
Here, EPR’s Hannah Balfour examines the trends that look set to shape clinical research in 2022, with comment from Aman Khera, VP and Global Head of Regulatory Strategy at Worldwide Clinical Trials.
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Articles
Understanding the new EU Clinical Trial Regulation: seven things sponsors should know
In this article, Sarah Bly and Aman Khera of Worldwide Clinical Trials break down the seven key differences between the EU Clinical Trial Directive and new EU Clinical Trial Regulation, discussing when and how sponsors should begin submitting their trials through the new CTIS portal system.
Key challenges for bio/pharmaceutical manufacturing 2022
What are the top six challenges facing pharmaceutical and biopharmaceutical manufacturers in 2022? We spoke to representatives from four contract manufacturing and development organisations (CDMOs) – Samsung Biologics, Lonza, MedPharm and Genezen – to find out.
New year, new cell and gene therapy collaborations
Here we run down four new research collaborations in the cell and gene therapy sector, announced by Bayer, BMS, Pfizer and Moderna.
Microneedle patch with precise vancomycin drug dose against MRSA skin infections
Effective vancomycin concentrations can be delivered locally to methicillin-resistant Staphylococcus aureus (MRSA)-infected sites of the skin with the use of miniaturised needles. This presents opportunities for targeted delivery of medication for focal skin diseases. Here, Georgios A Sotiriou and Liv Eidsmo of the Karolinska Institutet discuss some of them.
Nearly two years on, how are European pharma supply chains coping with COVID-19?
When the pandemic broke out in 2020, pharmaceutical supply chains showed signs of potential failure across the continent. Now, with COVID-19 cases rising once more, and an end to the problem not yet in sight, we discuss with Medicines for Europe how these supply chains are faring, almost two years…
Enabling impactful breakthroughs and therapies
Linda De Jesus, Senior Vice President and Chief Commercial Officer at Azenta Life Sciences highlights the benefits of uniting and focusing efforts solely for the life sciences sector.
The culmination of knowledge and experience equals a prized partner
Tim Mullane, President and COO of FUJIFILM Irvine Scientific, talks expansion, evolution and excellence.
Event review: The Future of QA/QC for Complex Biologics
On 30 November and 1 December 2021, European Pharmaceutical Review hosted its first ever event – The Future of QA/QC for Complex Biologics Online Summit. Bringing together more than 600 attendees, 15 expert speakers and Thermo Fisher Scientific and Merck as sponsors, the summit gave industry experts the chance to…
United efforts to accelerate drug development
From the Cancer Drug Development Forum (CDDF), John Smyth (Chairman), Axel Glasmacher (Treasurer) and Jaap Verweij (Managing Director) clarify the importance of a collaborative industry approach to cancer therapy development and highlight the most pressing challenges for discussion in their meetings and workshops.
New developments in the pharmaceutical stress testing industry
A team of American scientists report on some recent developments in the realm of pharmaceutical stress testing, or forced degradation, practices relating to solid dosage forms, bringing some valuable clarity for drug developers.
Enhancing rapid microbiology methods: how AI is shaping microbiology
Rapid microbiological methods are being enhanced by artificial intelligence (machine learning in particular). The aim is to speed up analysis; increase accuracy; avoid error and introduce a level of automation. Examples include microscopy, colony counting, and microbial characterisation and matching – each of which is based on improvements in image…
Counterfeit classifications using Raman spectroscopy and visible near-infrared (VNIR) hyperspectral imaging
Colleagues Jeremy Peters, Brittany Handzo, Shan Xiao, PhD and Ravi Kalyanaraman, PhD from the Forensics and Innovative Technologies (FIT) group within Global Quality Analytical Science and Technology (GQAS&T) at Bristol-Myers Squibb, present two methods of counterfeit drug determination.
Critical steps when validating an assay or analytical method for cell and gene therapy products
Dr Kiren Baines, Analytics Lead at eXmoor Pharma, details some of the critical steps when validating an assay or analytical method, including key considerations for developing an experimental plan aligned with ICH guidelines.
The weakest link – biopharma workforce development
Killian O’Driscoll, Director of Projects at the National Institute for Bioprocessing Research and Training (NIBRT), highlights the plight of a future skills shortage in the global biopharma industry as state-of-the-art therapy production evolves at a rapid pace.
