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. Continued expansion of the biotech industry is occurring in parallel, with an estimated compound annual growth rate of 13.96% from 2023-2030.

Laboratories 52

Laboratories Assay Development Small Molecule Packaging 52

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).

Therapies 59

Therapies Engineering Production FDA 59

Agency IQ

JULY 21, 2023

subsequent superior/inferior supportive care, lifestyle changes, and/or use of additional therapies). In fact, the FDA estimates that the accelerated approval program is responsible for access to life-saving anti-cancer therapies a median of 3.4 years before they would have been available otherwise.

FDA 40

FDA Clinical Trials Treatment DNA 40

Drug Discovery World

MAY 11, 2023

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. LC-MS can prove valuable not only in quality control, but also in early development phases. coli, and Pichia cells. S SARS-CoV-2 vector vaccines.”

Production 130

Production Vaccine Immune Response Therapies 130

Drug Discovery World

FEBRUARY 15, 2023

Existing therapies have been focused on eliminating the cancer cells and/or on preventing its progression by using a combination of chemotherapy, radiotherapy, and surgical approaches. Genetically modified T cells stimulated with IL2 are now administered as cell therapy for multiple cancer cell types with beneficial results 3,4.

Research 130

Research Therapies Immune Response Clinical Trials 130

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. Online June 20, 2023. Papers cited Laber S, Strobel SM, et al.

Small Molecule 105

Small Molecule Cell Based Assays Disease Medical Schools 105

Agency IQ

FEBRUARY 2, 2024

Additionally, the plan aims to improve the quality of life for the over 12 million cancer survivors who benefited from earlier detection, effective therapies and supportive care. Briefly addressing companion diagnostics, the guideline advises that sponsors consider co-development of a companion diagnostic and the medicinal product.

Clinical Trials 40

Clinical Trials Trials Treatment Production 40