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Five Promising Treatment Areas in Early-Phase DrugDevelopment in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drugdevelopment is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.
The current landscape of proteindrugdevelopment is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.
This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drugdevelopment strategy and optimal study designs. The shared placebo design is another approach to accelerating drugdevelopment in ALS research.
The oncology drugdevelopment landscape is evolving rapidly, driven by the deployment of targeted therapies in precision medicine and regulatory initiatives like the FDAs Project Optimus. It also covers strategies for drugdevelopers who have yet to identify a biomarker, helping them advance their programs effectively.
Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. Where vector presence is detected, transgene mRNA and/or proteinexpression levels should also be measured. Tobolowsky & Charles G. Raver & James E.
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