DIA: Driving Insights to Action

Regulators Promote Reliance as 21st Century Best Practice

“How do you do the process of regulation? Not the science of regulation, but how do you do the process of regulation more flexibly and agilely?” asks Murray Lumpkin, Deputy Director Integrated Development and Lead for Global Regulatory Systems Initiatives, Bill & Melinda Gates Foundation. “We certainly hope that the openness that regulators around the world have to this concept of reliance, of referencing, will evolve and strengthen because of what we're all going through now,” says John Lim, founding Executive Director of the Center of Regulatory Excellence at Duke-NUS Medical School in Singapore. (Listen to our previous Pandemic Vaccine Preparedness podcast with Dr. Lumpkin.)

Regulatory and Clinical Science Align to Fight COVID-19

The focus on clinical trials to discover therapies that alleviate suffering caused by COVID-19 also spotlights the regulators responsible for monitoring patient safety and scientific rigor in these trials. “The common goal is to define better therapies for patients and needs. At the same time, we are driven by science, so we need to do what is right on a scientific perspective in order to not create additional burden for patients, for physicians, for communities, for payers, but to really deliver innovative products and medicines,” explains Dr. Max Wegner, Senior Vice President of Regulatory Affairs at Bayer. “What is the desire of the pharmaceutical industry? I think the desire is to have new products reaching patients. What is the desire of the regulators? I think it's the same.”