Monthly Archives: May 2018

Between navigating relatively uncharted territory and the practical limitations of most gene therapy delivery systems, ensuring successful clinical trials of these products is a serious challenge for even the most experienced researchers. Compounding this is the long-term nature of most gene therapy trials — it’s not unusual to have follow-up periods of a decade or more.Read more

Your compound holds great promise, and your investors are banking on a breakthrough. Which do you pick to run your clinical trial — a CRO that will share the risks and work with you to reach a common goal or a vendor who’s waiting on you to have all the answers? Any capable CRO can provideRead more

Like any new medical product, gene therapies must undergo rigorous approval processes. However, there are a number of additional regulations for gene therapies that don’t apply to conventional pharmaceuticals. This is especially true within the European Union. (It’s important to note that while most gene therapy studies are based in the U.S. and Europe — whichRead more

Gene therapy is a hot topic in clinical research today — and for good reason! These technologies have the potential to treat — and in some cases even cure — a wide range of conditions, including rare genetic disorders that previously had no effective therapies. What Is Gene Therapy? Gene therapies are a diverse group ofRead more

Nostalgia. Irritable heart. Shell shock. No, this isn’t a word-association game. These are among the many terms applied over the years to the highly amorphous condition we now call post-traumatic stress disorder. While people have experienced shocking, scary, and dangerous events since the dawn of mankind, the study of the cause and treatment of PTSDRead more

It’s already been three years since the FDA issued its “Guidance on Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” This guidance established a mandatory requirement for electronic submission of certain applications, amendments, supplements, and reports to the FDA’s Center for Biologics Evaluation and Research (CBER)Read more

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