Protocol Design Featured Articles
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Why The ‘Illusion’ Of Speed In Clinical Trials Unravels As Contracting Demands Scale
3/19/2024
Discover four mistakes biotechs often make in haste (and how to avoid them) as they hurry through clinical trial contracting on the path to commercilization.
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How Takeda Leverages Cultural Competency Training To Improve Diversity
3/14/2024
Karen Correa, VP, head global clinical operations at Takeda, details some uncommon ways the pharma is tackling the problem of diversity in clinical trials.
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4 Takeaways From Building A Differentiated Franchise In Clinical Immunology
3/12/2024
Immunovant CEO Pete Salzmann, MD, MBA, shares what he and his young company have learned about developing the right workforce, selecting viable targets, listening to patient needs, and trying alternative trial designs.
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Seema Verma On Huge Opportunities In Healthcare And Life Sciences
3/7/2024
The former industry regulator and now Oracle EVP and GM for health and life sciences discusses the most promising solutions to the industries’ biggest challenges.
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2 Ways To Encourage Clinical Trial Investor Funding
3/6/2024
Consider these two promising funding models that balance risk with reward: trial-specific fundraising and staged funding release.
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The Key Differences Between Expanded Access Programs And Investigator Sponsored Trials
3/6/2024
Expanded access programs (EAPs) and investigator sponsored trials (ISTs) play significant roles. While both aim to provide patients with access to investigational therapies, they operate under distinct frameworks and serve different purposes. Understanding their differences from traditional clinical trials is crucial from an investigational medicine product and supply chain perspective.
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Advancing Alzheimer's Treatment Means Using The Best Biomarker(s) — But Which?
2/26/2024
As the Alzheimer's disease community grapples with the intricacies of biomarkers, trial outcomes, and the need for more precise diagnostic tools, the path forward requires a significant shift, redefining expectations and embracing a more comprehensive understanding of the disease.
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4 Drug Development Strategies To Accelerate Commercialization
2/24/2024
Given the extenuated clinical trial timelines, every chance to shave off time, save money, and obtain regulatory approval is one worth taking. Discover four ways to accelerate your therapy’s path to commercialization.
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Post-Pandemic Planning: Using Direct-To-Patient Deliveries For Supply Chain Management
2/23/2024
UCB Vice President – Head of Global Clinical Science and Operations Tero Laulajainen gets us up to speed on direct-to-patient (DTP) trials and how UCB is leveraging it today.
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Site Feasibility Tips For Cell And Gene Therapy Clinical Trials
2/22/2024
Site feasibility assessment can be challenging. Therefore, it’s essential to have a solid understanding of the regulatory obligations for investigators and sites when it comes to choosing each.