PPD

OCTOBER 18, 2023

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

Laboratories 52

Laboratories Assay Development Small Molecule Packaging 52

Drug Target Review

OCTOBER 3, 2024

3 This change signals a major shift away from animal use in drug safety regulation and encourages the use of alternative methods like organ-on-chip or other animal-free technologies. Recently, the FDA announced that new medicines need not be tested in animals to receive regulatory approval. Adapted from Harth S et al. (8) 2024 Jan 5;16(1).

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development.

Therapies 59

Therapies Engineering Production FDA 59

Agency IQ

JULY 21, 2023

BY RACHEL COE, MSC JUL 18, 2023 11:14 PM CDT Oncology endpoints: The growing pains of an evolving field FDA approval of a drug or biologic relies on whether there is “substantial evidence” of safety and effectiveness derived from “adequate and well-controlled clinical investigations” according to the Federal Food, Drug, and Cosmetic (FD&C) Act.

FDA 40

FDA Clinical Trials Treatment DNA 40

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. Cell Genomics. DOI: 10.1016/j.xgen.2023.100346

Small Molecule 105

Small Molecule Cell Based Assays Disease Assay Development 105

Drug Discovery World

MAY 11, 2023

This high level of quality control is also demanded and regulated by regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which consider HCPs a critical quality attribute (CQA). LC-MS can prove valuable not only in quality control, but also in early development phases.

Production 130

Production Vaccine Immune Response Therapies 130

Drug Discovery World

FEBRUARY 15, 2023

However, over the last few decades, it has been widely accepted that interaction between the tumour and host immune response plays a critical role in regulating tumour biology and hence its progression. DDW Volume 24 – Issue 1, Winter 2022/2023 References Cancer Research UK. This continues to be the standard of care.

Research 130

Research Therapies Immune Response Clinical Trials 130