All Article articles – Page 7
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ArticleBig potential for small molecule drugs in cancer treatment
With recent recommendation of Takeda’s fruquintinib by the European Medicines Agency (EMA), EPR spoke to Dr Sebastian Stintzing, Professor of Medicine, Head of the Department of Hematology, Oncology, and Tumor Immunology (CCM) of The Charité University Hospital in Berlin and investigator on the FRESCO-2 trial, to find out more about ...
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ArticleSFC-MS: advancements and applications in pharmaceutical quality control
Modern supercritical fluid chromatography systems coupled with mass spectrometry are empowering pharmaceutical QC laboratories. Here, analytical experts from the University of Liège discuss applications from impurity and nitrosamines detection to purity analysis.
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ArticleModifier gene therapy - clinical development and manufacturing considerations
Expanding on his earlier podcast discussion with EPR, Dr Arun Upadhyay, Chief Scientific Officer and Head of Research & Development at Ocugen, discusses the company’s promising modifier gene therapy candidates for ophthalmic disorders.
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ArticleDeveloping the EU’s first intestinal microbiota-based biologic
In this final installment of EPR's Microbiome therapeutics: microscope to medicine, Dr Olaia Aurtenetxe, Head of Clinical Research at Mikrobiomik, reveals study data demonstrating why MBK-01, an investigational drug based on faecal microbiota transplantation, presents a promising alternative to the current standard of care for Clostridioides difficile infections (CDI), potentially ...
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ArticleDelivering long-acting oral treatments
In this interview, Kyle Haraldsen, Chief Technology Officer of Lyndra Therapeutics, explores how the drug delivery landscape is evolving to increase focus on patient centricity and sustainability through development of long-acting, oral-delivery technologies.
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ArticleRegulation and legislation in the era of automation and digitalisation
Experts at IP firm Finnegan discuss if the pharmaceutical industry is ready for the innovation and technologies that digitalisation and automation will bring, and whether these advances are a threat or ally to intellectual property rights in the sector.
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ArticleAdvancing targeted treatments for multiple myeloma
Edmond Chan, Senior Director, EMEA Therapeutic Area Lead, Haemato-Oncology, Johnson & Johnson Innovative Medicines, offers insight into the promising evidence of cell therapies and biologic-based treatments for patients with multiple myeloma.
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ArticleFresh or frozen? Navigating the cryopreservation dilemma for CGT
Cell and gene therapy development grapples with a paradox: fresh starting material is often equated with higher-quality drug products, but cryopreservation is crucial for scale-up. In fact, every approved autologous cell-based therapy relies on freezing cells. Reconciling these truths can be key for the success of any commercial therapy based ...
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ArticlePioneering AAV gene therapy for Krabbe disease
Dr Maria Escolar, Chief Medical Officer, Forge Biologics, explores the advantages of the company’s novel AAV gene therapy for Krabbe disease, which could help to overcome some of the immune and safety challenges the gene therapy sector is facing.
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ArticleHarnessing small molecules to treat chronic inflammatory diseases
Dr Sheldon Sloan, MBE, Chief Medical Officer, Abivax, shares why the company’s microRNA small molecule treatment could provide long-term efficacy for ulcerative colitis patients, as well as the outlook for using small molecule-based drugs in autoimmune and chronic diseases.
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ArticleProgressing personalised cell therapies in oncology
Dr Imran Khan, PhD, Vice President, Medical Affairs, Hematology, Johnson & Johnson Innovative Medicine discusses the major benefits and current challenges of CAR-T cell therapies, as well as the potential of the company’s novel BCMA-targeted treatment for multiple myeloma.
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ArticleICH Q14 – latest guideline on analytical procedure development
Here, Dave Elder delves into the newly issued ICH Q14 guidance on analytical procedure development, discussing its impact during commercial phases as well as clinical development.
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ArticleWhy patient-centricity is essential to accelerate rare disease clinical research
There is an urgent need for novel treatment options for people living with rare diseases, but carrying out clinical research in this field is notoriously difficult. As Clinical Trials Day approaches, Cezary Statuch, Head of Medical Affairs International and Japan at Alexion Pharmaceuticals, highlights how adopting patient-centric approaches can help ...
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ArticleEffective data quality governance: challenging five common myths
It is a well-established expectation that regulatory processes will become increasingly data focused, which places a new urgency on data quality governance in the pharmaceutical industry. In this Q&A Steve Gens and Preeya Beczek present a pragmatic view of what is involved.
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ArticleInsights into AstraZeneca’s MANDARA Phase III data
In this Q&A, Dr Michael Wechsler, Professor of Medicine, Director of the National Jewish Health (NJH)/Cohen Family Asthma Institute, reveals details of the data from the MANDARA Phase III trial, showing remission is achievable in EGPA with Fasenra.
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ArticleAdvancements and knowledge gaps in ICH Q2(R2)
In this article, experts from USP’s Analytical Procedure Lifecycle Joint Subcommittee explore the latest advancements in ICH Q2(R2) guidelines on validation of analytical procedures and their implications for industry. They highlight areas that would benefit from additional guidance and compare how the latest ICH Q14/Q2(R2) guidelines align with US pharmacopeial approaches.
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ArticleAdvancing pharmaceutical technology: trends and innovations at ACHEMA 2024
Taking place in Frankfurt, Germany on 10-14 June, ACHEMA 2024 is expected to bring together chemists, engineers and process technicians from across the pharmaceutical and other industries.
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ArticleDissolution of capsule with cross-linking
In this article, Jigar Shah, Senior Group Leader in Analytical Development at Baroque Pharmaceuticals, explores the intricacies of capsule dissolution testing.
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ArticlePioneering the next wave of LBP-based therapeutics
Christopher Weidenmaier, PhD, Chief Scientific Officer, and Johannes B. Woehrstein, PhD, Chief Technology Officer at mbiomics share with EPR about the challenges and considerations of manufacturing microbiome-based therapeutics.
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ArticleWhat is the future of biologic medicines?
Sigma Mostafa, PhD, Chief Scientific Officer at KBI Biopharma, discusses the current trends in biologics and how technologies such as automation are advancing the field.