ARTICLES BY TIM SANDLE

• The FDA’s Final Guidance On Early-Phase Cell & Gene Therapy Trials

  4/3/2023

  The objective of the guidance is to outline the important safety aspects and data verifications to support efficacy claims for studies of multiple versions of a cellular or gene therapy product in an early-phase clinical trial for a single disease within a single clinical trial.

• FDA Releases Guidance On Drug Products Containing Nanomaterials

  11/18/2022

  In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.

• Can AI/ML Help Solve Sex Bias In Clinical Trials?

  7/1/2022

  To assess medicines for safety and efficacy it is important that clinical trials are representative of biological sex. Too often, though, women are underrepresented in clinical trials.

• 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.

• Complying With Batch Release: Auditing Electronic Batch Records

  3/26/2021

  This article presents some advice for auditing electronic batch records to assess their current good manufacturing practice (cGMP) status. This is useful in the qualification stage and essential once the electronic record system is in operation.