Current and future development of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or simply GLP-1s, involves complexities not only in formulation but in all areas of early-phase drug development. Developing and refining preclinical models for early efficacy signals, developing and validating the bioanalytical assays necessary for quantitation, and designing the clinical studies that deliver the most robust data in this innovative therapeutic area are all key elements of a drug development program.

In Issue 42 of The Altascientist, we review the requirements for successful GLP-1 drug development, including:

• preclinical approaches
• early-phase clinical study design
• bioanalytical techniques
• manufacturing

Two case studies are also included. 

Immunomodulatory drugs are at the forefront for the treatment of various types of cancer, infectious diseases, and numerous autoimmune diseases, including rheumatoid arthritis, type I diabetes, lupus, and multiple sclerosis. As the complexity of these therapeutics increases, so must the sophistication of the bioanalytical assays designed to either quantify them or measure their impact on the patient.

In Issue 41 of The Altascientist, we explore common classes of immunomodulators, bioanalytical methods used to quantify them, and their associated biomarkers. Featuring two scenarios that explore the complexities of bioanalysis for immunomodulators, The Altascientist offers practical considerations for ensuring accurate bioanalysis, as well as pharmacokinetic, pharmacodynamic, and safety data in clinical trials.

This issue also covers: 
•    classes of immunomodulators, including monoclonal antibodies, CAR-T cells, and vaccines;
•    immunotherapy trials, focusing on complex study designs and diverse patient populations; and
•    bioanalytical methods and assays, including pharmacokinetics and anti-drug antibodies (ADA).