6. What do bioanalytical labs of the future look like with the ICH M10 guidance implemented in light of recent changes in the way drugs are being developed?

Ask the Experts Regulated bioanalysis

Mark Arnold (left) and Rob Nelson (right) (Labcorp)

M10, like any guidance, is a snapshot in time of scientific approaches and regulatory expectations. Changes in new modalities of therapy, like cell and gene therapies and mRNA vaccines, have required the application of technologies not covered within M10.  Many are wondering if M10 will propose common principles that can be applied to these technologies or if we must wait for specific guidance for them.  Other changes are occurring in new therapy development that may also not be adequately covered if M10 is a rigid document.  Those changes include decentralized clinical trials, patient centric sampling, and the need for sustainability in drug development.

Some positive impacts from M10 are anticipated to improve CRO efficiency and speed, including standardization of practices, standard report templates, improved and simplified software and IT tools, and consistent expectations during regulatory inspections of labs and in review of filings.

 Kelly Dong (United-Power Pharma Tech Co., Ltd.,)

With the implementation of ICH M10, bioanalytical labs across the globe can have a common understanding and take similar approaches for method validation and sample analysis. M10 also provides clear requirements for cross-validation, which will help ensure data comparability between laboratories. The adaptation of ICH M10 would raise quality standards for bioanalytical laboratories globally.

 

The opinions expressed in this feature are those of the authors and do not necessarily reflect the views of Bioanalysis Zone or Future Science Group.