FDA 2.0: Advancing Preclinical Development
with Real Patient Samples and Cell-Based Assays
The FDA Modernization Act 2.0 is changing the scope of research allowing the use of other alternative methods to the use of animals in your non-clinical drug development, such as ex vivo cell-based assays, to investigate the safety and efficacy of your drugs
Vivia Biotech have access to real patient samples derived from individuals with hematological malignancies, providing a more clinically relevant and ethically sound methodology for evaluating drug efficacy and safety in contrast to traditional animal models. This approach can expedite drug development and enhance the overall success rate of new therapies in these challenging diseases.
Vivia Biotech ex vivo assays
- Proprietary functional Native Environment assays with whole peripheral blood (PB) and bone marrow (BM) patient samples
- Our ex vivo assays have attained translational pharmacology that exhibits a remarkable 92% clinical predictability for identifying sensitive AML patients, demonstrating an unprecedented correlation with clinical outcomes (published article doi: 10.1016/j.leukres.2018.11.006)
- Patient selection and stratification: access to sample patients with complete clinical information
- High quality sample supply and logistics with a well-established network of collaborating hospitals across Europe
- Sample collection is performed in accordance with GCP guidelines and after Patient Declaration of Consent