Clinical Guest Contributors
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FDA’s Updated Guidance On Human Genome Editing: New Implications & Remaining Questions
2/27/2024
On Jan. 29, 2024, the FDA released the final version of the guidance document on human gene therapy products incorporating genome editing. This article shares what changed between the draft and now final version of the guidance, and what open questions remain for the industry and scientific community to help resolve.
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AI's Role In Advancing Rare Disease Research
2/27/2024
IndoUSrare experts explore the global issues in rare disease research and examine how AI is poised to revolutionize the diagnosis and treatment of these often-overlooked conditions.
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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.
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4 Things I Learned At SCOPE 2024
2/21/2024
The Summit for Clinical Ops Executives (SCOPE) ran from Feb. 11-4. Discover four things Executive Editor Abby Proch learned at the annual event.
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The FDA Speaks Up For Quality Management: Must They Beg?
2/20/2024
The FDA's quality by design (QbD) and risk-based monitoring (RBM) messaging began more than 10 years ago with their guidance on RBM. Eleven years, five total related key guidance documents (listed below), and one global pandemic later, why aren’t we moving forward at more than a snail’s pace?
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How To Improve Your Clinical Finance Function
2/16/2024
In the finale of this three-part series on clinical finance, IGM Biosciences Vice President, Financial Planning & Analysis Chris Chan discusses how to leverage the role of clinical finance for clinical trial success.
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FDA’s CBER Issues Final Guidance For CAR T Cell Products
2/15/2024
The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on January 29. This article shares a useful and thorough summary of the guidance and where it differs (or not) from the earlier draft version of the guidance.