US trade tariffs and the potential impact on pharma supply chains
When Donald Trump was elected the 47th president of the United States of America, the outlook for pharmaceuticals was unclear,…
All articles by Miranda Mclaren
Miranda Mclaren
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Overcoming technical challenges in gene therapy product fill-finish operations
Gene therapy holds transformative potential in treating a wide range of diseases—from cancer and genetic disorders to infectious diseases. While…
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Orphan drug market access in Europe: HTA challenges and the growing potential of RWE
Europe has witnessed strong growth in orphan drug approvals over the past decade, yet for pharmaceutical innovators, securing market access…
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Beyond oncology: The expanding potential of cell and gene therapies
Cell and gene therapies (CGTs) have established themselves as revolutionary treatment methods in the world of oncology, where they have…
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Clinical trial challenges in China: How a Sharp and ClinsChain pairing is breaking down barriers
The market for clinical trials in China is currently experiencing significant growth, driven by increasing activity from both Chinese sponsors…
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Project Optimus: The evolution of dose optimisation in oncology
In 2021, the Project Optimus initiative was launched by the US Food and Drug Administration’s (FDA) Oncology Center of Excellence,…
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Beyond compliance: The strategic role of PASS in rare disease therapy success
By taking a more strategic approach to PASS, you can secure long-term market access, gain regulatory trust, and provide critical…
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Realising the opportunities for growth in the European orphan drug market
The European orphan drug market is growing and is already comparable in size and scope to the US market. The…
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Orphan drugs: How to avoid costly stock losses in Europe
Estimates suggest that there could be around 300 million people worldwide living with a rare disease. A disease is classed as…
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Antibody drug conjugates: Tackling the unsolved challenges with novel technologies
Antibody drug conjugates (ADCs) represent a promising new generation of cancer therapeutics and a significant advance in targeted drug delivery.…