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The power of patient engagement

80% of clinical trials are delayed due to recruitment problems. This is a well-known figure but despite its familiarity, it shouldn’t be normalised. It’s a dissatisfying number that calls for action to improve our work in clinical trials. Luckily, there’s a solution to this problem, and the even better news is that it will probably fix more than just the 80% issue. The aim of this article is to give a better understanding and overview of the challenges related to patient participation in clinical trials and providing actionable suggestions to activities that would solve these challenges and hopefully improve the drug development process all together.

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Personalised medicine – utopian future or a new healthcare norm?

Universalised healthcare may soon be outdated as advancements in genomics, bioinformatics, and related fields are changing the face of medicine. Moving from a one-size-fits-all approach to personalised care offers major benefits, like better treatment effectiveness and cost savings by tailoring interventions to individual genetic profiles. Although there are challenges, such as needing specialised infrastructure, funding, and navigating regulations, personalised medicine has the potential to improve preventive care, optimise treatments, and create a more efficient healthcare system.

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Collaboration key to delivering targeted medicines

Targeted medicines continue to make headway in the battle against chronic disease, changing the prognosis for many cancer patients, with the promise of breakthroughs in other fields. But the path to development and regulatory approval for these transformational products is complex, requiring a high degree of collaboration from the outset. This is particularly critical considering the urgent need of patients awaiting innovative treatments.
There are clear benefits in therapeutic and diagnostic teams working closely together during the development of targeted therapies. Similarly, sponsors that make the most of opportunities to engage with regulators as early as possible are better positioned to navigate the path to approval.

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Risk Assessment for Different Formulations in a Highly Potent Drug Facility: Oral Solid Dose & Liquid Dosage Formulations

Handling of highly potent active pharmaceutical ingredients (HPAPIs) within a shared multi-product GMP facility requires proactive risk assessment for both quality and occupational reasons: preventing cross-contamination means safer medicines for patients, while preventing unacceptable exposure means a safer environment for workers. Thorough risk assessment requires careful consideration of numerous factors including health-based exposure limits, the formulation and associated physical properties, the manufacturing process, batch size, and the available facility and product handling engineering controls. Personal protective equipment must always be a last resort. In this article, some important considerations are presented when assessing risks for different formulations in a highly potent drug facility for oral solid dose and liquid dosage formulations, including contrasting cross-contamination risk assessment vs occupational risk assessment.

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