Clinical Trials
Top Life Science Resources for Fall 2024
There’s a lot of life science content out there, so for your convenience, we’ve curated a selection of expert insights, tips, case studies, and scientific and regulatory information. Catch up on what you might have missed below!
BioPharma Dive: Pharmaceutical Research on mRNA and CAR T-Cell Therapy in Cancer — Pioneering the Future of Oncology
ISSUE NO. 41 — Immunomodulation Assessments for Clinical Trials: Sophisticated Bioanalytical Approaches to Support Complex Modalities
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).
Case Study: How to Evaluate Human Abuse Potential (HAP) for CNS Drugs
How Improving Diversity Can Benefit Clinical Trials
In June 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.
Top 10 Life Science Resources for Summer 2024
There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for your convenience. Catch up on what you might have missed below!
Development of the Subject-Rated Comprehensive Drug Withdrawal Scale (CDWS) to Evaluate the Physical Dependence Potential of Investigational Drugs
Pragmatic Considerations for the Application of Physical Withdrawal Assessments in Patient Studies
Optimizing for Success: How Sponsors Can Overcome the Challenges in Early-Phase Drug Development
The Challenges With Outsourcing Drug Development
In a Biopharma Dive survey, 45% of the over 143 biopharmaceutical executives surveyed cited the inability to adhere to tight deadlines as a common challenge in preclinical and Phase I clinical development.