ARTICLES BY TIM SANDLE
Tackling Safety Issues Of Adjuvanted Vaccines3/8/2023
An adjuvant is a substance added to some vaccines to enhance the immune response and/or to reduce the number of doses required to achieve a protective effect. This article discusses the emerging use of adjuvants and assessing safety issues.
FDA Releases Final Guidance On Early-Phase Cell & Gene Therapy Trials1/18/2023
The cell and gene therapy development process involves screening different variants of a product type. To aid this process and to ensure that suitable evidence is gathered so that effective variants of the product are taken through to later-stage trials, the FDA has produced a final guidance, Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial.
FDA Adopts ICH Final Guidance On Bioanalytical Method Validation1/11/2023
The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.
Can AI/ML Help Solve Underrepresentation In Clinical Trials?4/26/2022
Too often, there is an underrepresentation of women in clinical trial subject populations, leading to erroneous data since women differ in presentation, clinical manifestations, and outcomes in comparison to men. This article shares tips for how to use AI for better representative trial outcomes, including using it in patient recruitment, trial design, patient monitoring, and postmarket surveillance.
The Current Landscape Of mRNA Vaccines In Clinical Research3/17/2022
With the Pfizer-BioNTech and Moderna products, mRNA vaccines made global headlines in 2021 in the fight against COVID-19. As we recognize National Immunization Awareness Month, this article shares how mRNA vaccines currently in clinical research and clinical trials may be soon used to fight HIV-1, herpes, cancer, and more.