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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog: Drug Discovery

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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Taking a 3D view of heart failure with River BioMedics

Sygnature Discovery

This exciting partnership combines our novel assay development and hit identification expertise with River BioMedics unique, state-of-the-art technology: advanced human-predictive in vitro 3D heart models, plus their deep knowledge of cardiac biology.

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Six Factors for Biotech Companies to Consider When Choosing Next-Generation Contract GMP/CMC Laboratories

PPD

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. 1 With this growth comes increased demands for laboratory services at all steps across the development process. Stay ahead of the curve with a great GMP/CMC contract laboratory partner.

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RNA processing in health and disease: challenges and opportunities of the field

Drug Target Review

His current research aims to develop small molecular modulators of RNA processing, expanding on his previous drug discovery efforts in therapeutic manipulation of pre-mRNA splicing. Sam focuses on the application of innovative assay development strategies to enable to interrogation of complex targets.

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New image-based cellular profiling tool peers deeply into metabolic biology

Broad Institute

LipocyteProfiler builds on the concept of image-based profiling that was first introduced in the context of morphology mapping by Cell Painting, a high-content imaging assay developed by Broad institute scientist and Imaging Platform senior director Anne Carpenter.

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The hidden risks of over-reliance on healthy donor material

Drug Target Review

Developing cell therapies exclusively with healthy donor material introduces substantial risks that can hinder clinical translation and jeopardise the entire program. These risks stem from the fundamental biological differences between healthy and diseased cells, impacting various stages of development.

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BetterLife Engages Eurofins Discovery for its Next Generation Psychedelics 2-bromo-LSD FDA IND-enabling Pharmacology Studies

The Pharma Data

TD-0148A is a potential novel new therapy to treat debilitating psychiatric disorders with high unmet need, such as treatment resistant severe depression and post-traumatic stress disorder.

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