ARTICLES BY TIM SANDLE

• FDA Finalizes Guidance On Nonclinical Evaluation Of Pharmaceutical Immunotoxicity

  7/18/2023

  The FDA has now finalized a guidance document on the immunotoxic potential of pharmaceuticals. The FDA builds on current ICH guidance and proposes a two-stage approach. Central to the guidance is using a risk framework.

• FDA Adopts ICH Guidance On Assessing Nonclinical Biodistribution Of Gene Therapy Viral Vectors

  5/23/2023

  An important step in the gene therapy development process is assembling biodistribution data in suitable animals in relation to the intended clinical population. Developing an accurate biodistribution profile is influenced by factors such as the route of administration, dose level(s), dosing regimen, and the animal immune response to the gene therapy product. The FDA adopted this ICH guidance in May 2023, and the EMA plans to adopt it in September 2023.

• 5 Characteristics Of The Automated Microbiology Lab Of The Future

  4/24/2023

  The modern microbiology laboratory is starting to look very different from the laboratory of 10 years ago, and it will continue to evolve in the next few years. There are a number of innovations being implemented now or are in progress that can signal the path that many microbiology laboratories will follow.

• 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.

• How Can Nanomedicine Innovations Combat Cancer?

  10/24/2022

  For the past two decades, nanotechnology has promised a revolution in medicine, especially in creating new ways to deliver medicines to treat cancer. This article shares an overview of nanomedicine and some of the key innovations within the field during the past year.

• 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.

• 10 Critical Validation Parameters For Microbiological Experiments

  7/26/2021

  In studying a microbiological method, different validation parameters require assessment. These are variables or factors that can be controlled, changed, or measured in the experiment. This article outlines the key parameters to consider.