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The ‘failure’ of clinical trials in the search for COVID-19 treatments

pharmaphorum

It may not be appropriate to use the word ‘failure’ when summarising the utility of clinical trials in the search for a curative or preventative treatment for disease. Most of the trials are underpowered to demonstrate efficacy on mortality and long-term consequences of the disease.

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Receptor Occupancy Assays by Flow Cytometry: Benefits for Clinical Trials

XTalks

Flow cytometric receptor occupancy assays are being increasingly used in preclinical and clinical studies. Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. What is Flow Cytometry?

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The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

Liquid biopsies have demonstrated promising activity in multiple clinical settings, but the great enthusiasm and expectations around them can be harmful if not adequately managed,” said Dr. El Mustapha Bahassi, PhD, Director, Clinical Laboratory Sciences, at the global clinical research organization (CRO) Medpace.

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Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Recombinant therapeutic proteins. Fusion proteins. Gene and cellular therapies. Growth factors. Interferons. Monoclonal antibodies (mAbs).

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Osimertinib Resistance and EGFR Mutations in NSCLC Treatment

Bioengineer

This mutation hinders the drug’s binding to the mutant EGFR protein. Osimertinib, however, can covalently bind to the T790M and cysteine-797 (C797) residue at the protein’s ATP binding site, overcoming resistance mechanisms. In the same study, those with T790M loss had a shorter treatment duration (6.1 months vs. 15.2

Genome 119
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A protein-based COVID-19 vaccine that mimics the shape of the virus

The Pharma Data

Food and Drug Administration were based on mRNA, more conventional protein-based vaccines have also shown promise in clinical trials. Most train the immune system to recognize the RBD, a peptide that is the portion of the SARS-CoV-2 spike protein that binds to the ACE-2 receptor on host cell surfaces. bioRxiv [Preprint].

Protein 52
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Lab to jab in 100 days: manufacturing flexibility for future rapid responses

Pharmaceutical Technology

Messenger RNA vaccines contain nucleic acids that code for a specific protein, or target antigen, related to a virus or disease. When an mRNA vaccine is administered, a patient’s body produces that protein to prompt a desired immune response. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed.