Spotlight on China: A Dominant Player in the Clinical Trial Landscape
In a series exploring trends across the APAC region, Norstella’s subject matter experts from key biopharma hubs delve into this year’s standout developments and share their outlook for 2025. China’s booming clinical trial landscape continues to grow and diversify with greater investment from Big Pharma in addition to new promising modalities at play. In our […]
2024 FDA Diversity Guidance: What It Means and How It Could Impact Future Clinical Trial Outcomes
The US Food and Drug Administration (FDA) released a diversity-focused draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” on June 26, 2024. I sat down with Lya Rebelo, commercial enablement manager at Citeline, to discuss the future impact of this long-awaited guidance, how it differs from […]
Why Are Clinical Development Success Rates Falling?
Likelihood Of Approval For New Phase I Drugs Is Now Just 6.7% Phase transition data from Citeline for the 10-year period between 2014ؘ and 2023 show that the average likelihood of approval (LOA) for a new Phase I drug is now just 6.7%. This has steadily fallen in each analysis to an all-time low. The […]
Eight Routes to Patient Diversity
Norstella helps clients achieve diversity in clinical trials while committing to it in its own practices. Andrew Warmington, manufacturing editor at Norstella, spoke to Fenwick Eckhardt, senior manager of clinical new product development at Norstella Diversity is a widely used term in many contexts and clinical trials are no exception. But what does the word […]
A New Era for Patient Recruitment and Retention in Rare Disease
Pharma and biotech organizations continue to prioritize the diversification of their pipelines to innovate more in areas of high and rare unmet need. In addition to delivering life-saving treatments to patients who have had historically limited therapeutic options, addressing high and rare unmet needs can lead to faster routes to market with accelerated regulatory pathways […]
