ARTICLES BY TIM SANDLE

• AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance

  4/8/2024

  The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.

• Tackling Safety Issues Of Adjuvanted Vaccines

  3/8/2023

  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 Trials

  1/18/2023

  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 Validation

  1/11/2023

  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 Research

  3/17/2022

  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.