Biotech Regulatory Solutions chaired a session at the ARCS Sydney Annual Conference 2017 “A Case Study Using Novel Scientific Technologies to Mitigate Risk in Drug Development” with Speaker Daina Vanags PhD. “…With the advancement of technologies such as induced pluripotent stem cells (iPSCs) regulators are highlighting concepts such as “Clinical trials in a dish” whereby iPSCs from peripheral blood can be reprogrammed into large numbers of various cell types including neurons, hepatocytes or cardiomyocytes.
In vitro clinical trials with specific cell or tissue specimens enable the assessment of how oncology treatment may react with particular types of cancer or other diseases, importantly provide the ability to predict how individual patients will respond in advance of therapy. Other examples were discussed included the ability to identify patients who will benefit and those that may suffer harm from particular therapies with off target cardiotoxicity will significantly contribute to the safety assessment of new therapies in the early phases of drug development.
The potential for iPSCs and “clinical trials in a dish” to greatly improve safety outcome in patients is an exciting aspect to a new horizon in precision medicine that is very close to implementation and underlines the necessity of an up-to-date and resilient regulatory strategy.” It was a very interesting session and certainly an area that should be explored further at future conferences.