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,…
All articles by Miranda Mclaren
Miranda Mclaren
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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.…
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Oncology and eClinical solutions: How one company is adapting to the challenges
Meticulous planning is central to building an effective clinical trial, powered by well-designed Interactive Response Technology (IRT) which provides not…
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Will European PFAS ban disrupt pharma supply chains?
Used in consumer products since the 1950s, perfluoroalkyl and polyfluoroalkyl substances (PFAS) are synthetic chemicals with strong fluorine-carbon bonds, earning…
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Enhancing patient engagement and outcomes in the NHS
Medication non-adherence is an enduring issue in the UK healthcare system, costing the NHS a staggering £930 million annually.[i] Despite…
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The future of third-party logistics in an evolving biopharmaceutical world
Despite inflationary pressures and ongoing challenges in the geopolitical landscape, expectations are high regarding the biopharmaceutical industry’s growth prospects. A…
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Meet the company on a mission to reengineer drug development
We’ve all seen the statistics. Drug development has a scarily high attrition rate, with approximately 90% of candidates falling short.…