Reducing white space in early development: Four regulatory pitfalls to avoid pre-IND
In a clinical development world divided by phases, transitions are critical at every step. The transition from nonclinical testing to…
All articles by Miranda Mclaren
Miranda Mclaren
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How better protocol design can reduce white space in clinical development
From the start of Phase I to the completion of Phase III, the average clinical trial cycle has been increasing…
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The resurgence of mesenchymal stem cell therapies
Dr. Zamilpa is the Executive Director of Biomanufacturing and Collaborative Programs at BBG Advanced Therapies, a subsidiary of BioBridge Global…
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The changing dynamics of eClinical: Why configurability is king
Clinical trial sponsors are navigating a landscape of increasing complexity. A team of researchers recently set out to explore this…
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What causes white space in early-stage drug development?
White space refers to unproductive gaps in drug development, when progress stalls due to scientific barriers or because of process,…
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Sharp Services invests $100 million in US and European facilities to increase capacity and service offerings
Sharp Services, a leader in pharmaceutical packaging, clinical trial services and sterile manufacturing has announced a $100 million investment across its…
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Forced degradation studies: A critical lens into pharmaceutical stability
Forced degradation studies simulate harsh conditions to accelerate degradation, helping us uncover potential vulnerabilities in a molecule’s structure and predict…
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Could AI help avoid unpredictable and high placebo response rates in pain trials?
According to the CDC, an estimated 20.9% of the US adult population experienced chronic pain in 2021, while 6.9% were…
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The story of IRT: What does the next chapter have in store?
The Interactive Response Technology (IRT) market continues to grow from its humble origins, with one report valuing the IRT market…
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Wearables and AI in Parkinson’s trials: Enriching endpoints for accurate, holistic assessments
Parkinson’s Disease is a complex, progressive neurological condition which requires challenging, multi-modal endpoint assessment across both motor and non-motor symptoms.…