All Article articles – Page 4
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ArticleInnovating bioanalysis to advance oligonucleotide therapeutics
Here, Dr Jinpeng Li at WuXi AppTec reveals the analytical challenges that are hindering advancement of oligonucleotide therapeutics, medicines which have demonstrated clinical promise in the gene therapy space, and discusses promising analytical innovations.
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ArticleUnlocking intellectual property potential in European pharma
Joshua Harris, Director, Burford Capital, discusses how patent monetisation, including systems like the Unified Patent Court (UPC), enables European pharmaceutical companies to remain competitive and ensure R&D investment and innovation.
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ArticleHarnessing industry advancements to accelerate upstream process development
Here, Shidong Shi, Head of Upstream Process Development, and Li Yang, Vice President of CMC Development at Altruist Biologics, discuss the key trends in upstream processing and highlight their approach for overcoming challenges in the field.
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ArticleBiosimilar medicines: the intersection of access, affordability, and innovation
In this article, Julie Maréchal-Jamil, Director, Biosimilar Policy & Science, Medicines for Europe, explores the strategies needed at European and national levels to secure the benefits of biosimilar medicines in an evolving landscape to deliver a pipeline for these drugs by 2030.
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ArticleConsiderations for a successful tech transfer of a biologics upstream process
Bioprocess experts from Lonza discuss how molecular format and the product lifecycle phase impact the process, risks and outcomes of upstream technology transfer of biologics.
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ArticleM&A outlook for pharma in 2025
For a strong 2025, dealmaking should be central to the life sciences strategy, says EY’s annual M&A report.
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Transitioning to digital product information to ensure a sustainable future
Sarah Moores, Global Sustainability Director at AstraZeneca, discusses the potential scope for establishing electronic product information (ePI) in the pharmaceutical industry to support its endeavours in environmental sustainability.
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ArticleEmbracing green innovation in life sciences
Shishir Patel, Medical Director at Chiesi UK and Ireland, explores the efforts made to develop sustainable healthcare solutions in life sciences. Alongside examining low global warming potential (GWP) propellants and the need for investment in sustainable R&D infrastructures, he highlights the urgency for action on climate change and the importance ...
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ArticlePotential blockbuster drugs to watch in 2025
Eleven drugs are poised to make waves in the pharmaceutical industry in 2025, according to the annual report.
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ArticleHydrogel encapsulation: unlocking the potential of cell therapies for targeted treatments
In this article, Dr Stephen Harrington, Director of Cell and Hydrogel Formulation and Francis Karanu, Vice President of Cell Therapy R&D, Likarda, discuss the benefits of hydrogel encapsulation in drug delivery and enhancing the bioavailability and functionality of cell therapies.
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The year ahead for RNA therapeutic development and manufacturing
As the industry prepares for a new year, Dr Kate Broderick, PhD, Chief Innovation Officer of Maravai Life Sciences and TriLink Biotechnologies, shares her thoughts on what the RNA therapeutics landscape of 2024 can tell us about what may be on the horizon in 2025.
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ArticleHow automation and digital technologies will unlock the full potential of advanced therapies
Automation and digital technologies, combined with workforce training and regulatory advancements, hold the key to transforming the production of advanced therapies. Dr Stephen Ward, Executive Director at CGT Catapult, shares how leveraging these innovations can facilitate the delivery of life-changing therapies to patients at scale, opening new possibilities for treating ...
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ArticleICH Q6(R1): test criteria and specifications
Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
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ArticleAdopting AI for R&D in 2025 – what needs to be addressed?
Dr Vladimir Makarov, AI Community lead, The Pistoia Alliance, explains that despite the willingness of the life sciences R&D industry to adopt artificial intelligence (AI), data integrity is a key area that must be addressed to ensure successful integration of this fast-evolving technology.
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ArticleTargeting ovarian cancer with a novel antibody therapeutic
Christina Pelizon, International Medical Affairs Head for Oncology at AbbVie discusses the significance and impact of the European Commission’s approval last month of Elahere® (mirvetuximab soravtansine) to treat ovarian cancer.
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ArticleInvesting in the future of pharmaceutical microbiology QC
Troy Wright, Senior Vice President and Global Head of Quality at Abzena, shares an overview of current major challenges within pharmaceutical microbiology quality control, including the lack of staff knowledge in advanced technologies and how the sector’s importance can be overlooked, despite its key role in bringing safe, quality products ...
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ArticleThe EU AI Act: will regulation drive life science innovation away from Europe?
Mike King, Senior Director, Product & Strategy (Quality, Regulatory, Safety & Detect), Digital Products & Solutions at IQVIA and Alex Denoon, Partner at Bristows Law Firm, explore the challenges of implementing the EU AI Act and the impact of GDPR requirements in life sciences.
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ArticleEasing the mental health burden with psychedelic therapies – what’s next for the regulatory and clinical landscape?
In this article, Steffanie Wilson, Vice President and Neuroscience Therapeutic Area Lead, Emmes Group, discusses the future of psychedelic research and highlights the impact of the FDA’s decision on Lykos Therapeutics’ NDA for its MDMA therapy to treat PTSD.
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Modernising drug delivery through gel-based technology
Julie Huynh, Research and Development Manager, Gelteq, explores the potential of gel-based oral drug formulations for alleviating dysphagia and highlights the company’s approach to overcoming key challenges in this area, like administration.
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ArticleCurated and customised outsourcing
As the outsourcing market evolves, pharmaceutical businesses are reassessing their strategies to better insulate themselves against the pressure of compounding macroeconomic constraints, including a looming patent cliff, rising costs and developmental risks. Sponsors are adopting more intelligent, blended models that seamlessly integrate functional service provision (FSP), full-service outsourcing (FSO), standalone ...