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In this article, Karen Ooms, Head of Statistics at Quanticate, compares the rule- and model-based approaches to Phase I trial design, exploring their benefits and weaknesses in defining maximum tolerated dose for oncology products.
The impending ‘Bio Revolution’, with the microbiome at its foundation, offers ground-breaking solutions and a wealth of opportunity in data science and bioinformatics, explains Anthony Finbow of Eagle Genomics.
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.
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.
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.
Here we run down four new research collaborations in the cell and gene therapy sector, announced by Bayer, BMS, Pfizer and Moderna.
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.
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…
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.
Tim Mullane, President and COO of FUJIFILM Irvine Scientific, talks expansion, evolution and excellence.
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…
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.
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.
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…
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.
