Drug Target Review

NOVEMBER 1, 2023

The mission of the CCDD is to discover novel small-molecule therapeutics for the treatment of cancer and progress them to hypothesis testing phase 1 clinical trials. We support the drug discovery projects of the CCDD with assay development and screening, biophysics, structural biology and recombinant protein production.

Fragment Screening 96

Fragment Screening Biochemical Assays Small Molecule Biophysical Assays 96

Drug Target Review

OCTOBER 10, 2024

What are the risks of over-reliance on healthy donor material in early-stage research, and how can decision-makers ensure a balanced integration of diseased material to avoid potential gaps when transitioning to clinical trials? Healthy cells may also serve as a valuable control in experiments.

Therapies 52

Therapies Immune Response Clinical Trials Disease 52

The Pharma Data

JANUARY 27, 2021

We look forward to working with Eurofins Discovery to bring this treatment to patients as quickly as possible as we prepare for our IND and trials,” said BetterLife’s Chief Executive Officer, Dr. Ahmad Doroudian.

FDA 52

FDA Synthetic Chemistry Assay Development Treatment 52

Drug Target Review

OCTOBER 3, 2024

This comprehensive toolbox of Type 1, Type 2, Type 3 and Type 4 anti-idiotypic antibodies provides PK and ADA assay developers with enhanced flexibility for a thorough analysis of antibody candidates. FDA no longer needs to require animal tests before human drug trials [Internet]. Adapted from Harth S et al. (8) www.science.org.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

The Premier Consulting Blog

OCTOBER 26, 2022

Development of the manufacturing process description The development of the MPD is an iterative process. The MPD is best created and controlled by a sponsor, rather than by a contract development and manufacturing organization (CDMO) assigned to perform the process and assay development.

Production 40

Production Assay Development Clinical Supply Engineering 40

Agency IQ

JULY 21, 2023

The assessment of this benefit typically relies upon the use of specific endpoints to measure this clinical benefit, generally within the context of a clinical trial. [ OS is an outcome-related endpoint that is defined as the time from trial randomization until death from any cause in the intent-to-treat population.

FDA 40

FDA Clinical Trials Treatment Trials 40

Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. This enables patient selection, stratification and other adjustment in clinical trial design planning.

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40