PPD

OCTOBER 18, 2023

With the depth of knowledge to support all types of pharmaceutical products across all phases of development, we provide services ranging from end-to-end assay development to platform expansion, designed with the client’s timeline and budget in mind. Stay ahead of the curve with a great GMP/CMC contract laboratory partner.

Laboratories 52

Laboratories Assay Development Small Molecule Drug Development 52

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.

Small Molecule 105

Small Molecule Cell Based Assays Disease Assay Development 105

Drug Target Review

OCTOBER 10, 2024

By promoting partnerships between biobanks, research institutions, regulators, and industry, we can create networks for information sharing, streamline access to diseased donor material, and facilitate joint research initiatives. Furthermore, fostering cross-industry collaboration is essential.

Therapies 52

Therapies Immune Response Clinical Trials Disease 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

The Pharma Data

JANUARY 27, 2021

These include in-vitro assays, cell-based phenotypic assays, safety pharmacology and efficacy, ADME toxicology, medicinal chemistry design, synthetic chemistry, and custom proteins and assay development capabilities.

FDA 52

FDA Synthetic Chemistry Assay Development Treatment 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)

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

The Premier Consulting Blog

OCTOBER 26, 2022

During the development cycle of a regulated therapeutic, the transfer of the manufacturing process is inevitable. The process will be transferred from the development lab to a pilot or small-scale manufacturing facility and, if the program is successful, to a facility for commercial manufacturing.

Production 40

Production Assay Development Clinical Supply Clinical Development 40