The Yin and Yang of Regulatory Science in the Post-COVID Big Data Era

When: May 11, 2021

Venue: Online

Time: 5pm to 6pm (Singapore Time)

Event Description:

Regulatory science has always been the cornerstone of Translational Medicine (TM) and clinical development. It warrants safety, conformity with ethical and moral issues, and a balance between the need for innovation and the duty to preserve the patients’ integrity and safety. 

However, many tensions are generated when the forces that shape clinical development and TM get into attrition. On the one hand, there is an interest from Pharma and those who develop new technologies in moving as fast as possible towards access to the market for financially apparent reasons. On the other hand, patients and patients’ organisations often complain about the speed of development and clamour for more testing before market access.

Regulatory science stands as the gatekeeper against these pressures. The landscape is, however, rapidly changing. The introduction of precision medicine and artificial intelligence in creating large datasets and mining them has provided new opportunities to develop new targets for therapies and develop new tools to speed up the clinical development process and, with these, regulatory sciences.

A dramatic example provided by circumstances has been significantly shaping many of the dogmas of regulatory sciences in response to the need for a rapid COVID vaccine.