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Target-directed cancer: protein-ligand interactions  

Drug Target Review

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.

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The hidden risks of over-reliance on healthy donor material

Drug Target Review

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.

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BetterLife Engages Eurofins Discovery for its Next Generation Psychedelics 2-bromo-LSD FDA IND-enabling Pharmacology Studies

The Pharma Data

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.

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The essential role of recombinant phage display antibody libraries

Drug Target Review

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.

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Tech Transfer Tools: The Requirements and Uses of Manufacturing Process Descriptions

The Premier Consulting Blog

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.

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Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Agency IQ

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.

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Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

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.