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Decoding FDA Gene Therapy Guidances Part Three: Long-term Follow-ups
In Part Three of our Decoding FDA Gene Therapy Guidances series, we discuss the need for thorough long-term follow-up studies for these products, as…
Featured Insights
Ask the Experts: Understanding Juvenile Idiopathic Arthritis
In light of JIA Awareness Month, its treatments, its stigma, and more, we spoke with Dr. Johnny Peppers, Executive Director of Drug Development for…
PRA Teams with Microsoft to Enhance COVID-19 Monitoring
Over the past several months, participants in PRA Health Sciences’ Health Harmony COVID-19 Monitoring Program have had vital information about…
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Blog
Decoding FDA Gene Therapy Guidances Part Two: Rare Disease
In Part Two of Decoding FDA Gene Therapy Guidances, we discuss three separate guidances that provide further insight into how sponsors can safely and…
Blog
Decoding FDA Gene Therapy Guidances Part One: Chemistry, Manufacturing, and Control
In Part One of our Decoding FDA Gene Therapy Guidances series, we discuss the significance of several new FDA guidances regarding human gene therapy…
Blog
COVID-19 Kicks Healthcare Technology Adaptation into High Gear
From telemedicine to decentralized clinical trials to artificial intelligence and beyond, the COVID-19 crisis has kicked the use of technology in the…
Fact Sheet
Pharmacogenomics (PGx) Fact Sheet
Pharmacogenomics aims to develop rational means to optimize drug therapy with respect to the patient’s genotype, ensuring maximum drug efficiency…
White Paper
Glaucoma: Under Pressure to Treat
Glaucoma remains a chronic and visually debilitating disease that has vast public health implications, as well as pronounced effects on individual…
Newsletter
Industry Watch
In our first issue of Industry Watch for 2021, we’re bringing our readers insights from a founding member of the Human Genome Project, looking at…
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Ask the Experts: What Does the Future Hold for CRISPR Gene Editing Technology?
Changing a living organism’s DNA sounds like something out of science fiction, but recent strides in genome (gene) editing have given scientists…
Fact Sheet
The Center for Vaccine Research Fact Sheet
PRA Health Sciences’ Center for Vaccine Research is a cross-divisional, highly experienced team dedicated to providing customized solutions and…
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Ask the Experts: Why Do Rare Disease Clinical Trials Require a Unique Approach?
According to the National Organization for Rare Disorders (NORD), 90% of rare disorders do not have an FDA-approved treatment. We spoke with Juliane…