FDA Law Blog: Drug Discovery

JANUARY 4, 2023

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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Therapies Engineering Production FDA 59

Sygnature Discovery

FEBRUARY 11, 2022

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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Assay Development Disease Engineering Science 52

PPD

OCTOBER 18, 2023

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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Laboratories Assay Development Small Molecule Drug Development 52

Drug Target Review

JUNE 15, 2023

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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RNA Small Molecule Disease Assay Development 96

Broad Institute

JUNE 30, 2023

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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Small Molecule Cell Based Assays Disease Assay Development 105

Drug Target Review

OCTOBER 10, 2024

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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Therapies Immune Response Clinical Trials Disease 52

The Pharma Data

JANUARY 27, 2021

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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FDA Synthetic Chemistry Assay Development Treatment 52