Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

Drug Development 64

Drug Development Clinical Supply Production FDA 64

Conversations in Drug Development Trends

MAY 30, 2024

This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. The shared placebo design is another approach to accelerating drug development in ALS research.

Treatment 81

Treatment Clinical Trials Small Molecule Therapies 81

Sygnature Discovery

APRIL 26, 2022

Integrated protein production in drug discovery Peak Proteins’s core technologies include protein expression and purification, alongside protein crystallography, structure determination and mass spectrometry services.

Fragment Screening 40

Fragment Screening Protein Production Protein Expression Production 40

The Pharma Data

DECEMBER 8, 2020

AbCellera’s AI-powered antibody discovery platform speeds the otherwise lengthy and grueling process by analyzing the database of natural immune systems to find antibodies that can be developed into drugs. Tackle the toughest problems in drug development.” The promise to partners is to “move quickly. Reduce cost.

RNA 52

RNA Therapies Disease Protein Expression 52

The Pharma Data

OCTOBER 28, 2020

In almost all cases of Angelman syndrome, the maternal UBE3A allele is either missing or mutated, resulting in limited to no protein expression. Angelman syndrome is not a degenerative disorder, but the loss of the UBE3A protein expression in neurons results in abnormal communications between neurons.

Protein Expression 40

Protein Expression Therapies Treatment Disease 40

The Pharma Data

OCTOBER 26, 2020

Christophe Le Tourneau, MD, Head of the Department of Drug Development and Innovation (D3i) at the Curie Institute, and Principal Investigator of the trial , added: “We have seen very encouraging efficacy results in this hard-to-treat patient population, as well as a satisfying safety profile. Christophe Le Tourneau, M.D.,

Vaccine 40

Vaccine Trials Treatment Virus 40

Drug Target Review

JANUARY 20, 2025

The oncology drug development landscape is evolving rapidly, driven by the deployment of targeted therapies in precision medicine and regulatory initiatives like the FDAs Project Optimus. It also covers strategies for drug developers who have yet to identify a biomarker, helping them advance their programs effectively.

Clinical Trials 52

Clinical Trials Trials Drugs Drug Development 52

Conversations in Drug Development Trends

APRIL 7, 2025

Making strategic decisions when designing the protocol, such as including biomarkers like programmed death ligand-1 protein expression to guide the use of immune checkpoint inhibitors during treatment, can better assure safety and efficacy.

Research 40

Research Clinical Trials Trials Clinical Research 40

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Where vector presence is detected, transgene mRNA and/or protein expression levels should also be measured. For cell therapy products, the draft guidance notes that in vivo imaging techniques provide certain advantages. For gene therapy products, the use of quantitative and sensitive assays such as qPCR are recommended.

Therapies 59

Therapies FDA Production Disease 59