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World’s Largest Commercial Human Challenge Trials Unit Launched To Keep Up With Growing Demand

 
• By Vibha Sharma

A UK-based CRO specializing in human challenge trials says there is a big shift in industry sentiment towards such studies. Companies targeting infectious diseases are now actively accommodating challenge trials in their development plans instead of needing persuasion.

Medicine Development Laboratory: Asian Female Scientist Using Microscope, Analyzes Petri Dish Sample. Big Pharmaceutical Lab with Specialists Conducting Biotechnology Research, Developing New Drugs.
Challenge trials can help generate efficacy data earlier • Source: Shutterstock

More and more companies developing treatments and vaccines for infectious diseases are seeing the value of incorporating human challenge trials in their development programs, given their potential to speed up product development, enable faster regulatory approval, and help with research and finance.

Human challenge trials, also known as controlled human infection studies (CHIS), involve deliberately infecting volunteers with a pathogen in a...

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• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

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UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
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LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

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MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 
• By Eliza Slawther

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Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos For Breast Cancer

 
• By Natasha Barrow

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