This is the first of three blog posts discussing best practices for developing oligonucleotides. Interest in oligonucleotide therapies, which are composed of short strands of DNA or RNA, is growing rapidly; there are at least 135 of them currently in development.1 Underscoring their proliferation, a PubMed search for “oligonucleotide therapeutics” generated more than 35,000 hits. … Continued
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250 Label claims using PBPK without the need for additional clinical studies “Clinical Studies and Model-Informed Approaches.” This is the language typically used by the US FDA on drug labels to describe how clinical pharmacology decisions have been reached. Much more detail can be found in the Office of Clinical Pharmacology (OCP) review that supports … Continued
By: James Zoshak The COVID-19 pandemic has added increased risk and uncertainty to gene therapy supply chains. To mitigate this risk, it is critical for biopharmaceutical manufacturers to properly maintain the documentation governing their continuity of operations. It’s complicated: Gene therapy products supply chains and manufacturing While many people working in the pharmaceutical industry can … Continued
This blog discusses the challenges that drug developers face in getting patients access to cell and gene therapies as well as some potential solutions.
“You would not be able to tell 40 different writers were authoring these. It looked as though one person was writing them! The writers wrote a streamlined and visually-cohesive and consistent story that made reviewing the large set by only a few reviewers extremely efficient. This software is extremely valuable.” — Associate Director, Medical Writing … Continued
By Eva Gil Berglund and Nathalie H Gosselin Oligonucleotide therapeutics are a validated class of drugs that can modulate a multitude of genetic targets with gene silencing to prevent expression of encoded “disease-related” proteins. Developing drugs in this class is challenging. That’s why we’ve put together this list of 8 clinical pharmacology and pharmacokinetic considerations … Continued
This blog explains how using the Gene Therapy Virtual Twin™ Platform can help optimize dosing for patients.
One of the most exciting things about working in the pharmaceutical industry is the ability to meet and work with colleagues all over the world. In particular, China is one of the fast-growing centers for drug development. Indeed, a report from McKinsey last year estimated the Chinese biopharma market to be worth $130B. I recently … Continued
