Advanced regulatory science is needed to provide better biopharmaceutical products for people amid pandemics, such as Covid-19, former U.S. Food and Drug Administration Commissioner Margaret Hamburg said on Tuesday.

At the Global Bio Conference held by the Ministry of Food and Drug Safety, Hamburg, vice president of Nuclear Threat Initiative, noted that regulatory science can foster efficient product development by ensuring regulators have the tools that detect unsafe or ineffective therapies.

“Korea has reacted to the pandemic with speed, focus, and leadership, bringing the traditional tools of public health to gather with biomedical product innovation and the rapid development of a critical new tool, importantly including the diagnostics,” Hamburg said. “People should remember that medical product innovation only matters if it makes a difference when considering it from a patient perspective.”

The former FDA head pointed out that regulators always, but especially in emergencies, try to assure that necessary studies have been conducted to determine which biopharmaceutical products would work or not and for whom and under which circumstances.

She explained that discovering a new candidate and developing a new medical product is generally a long and arduous path, which requires a solid science and policy at every step along the way of development.

“Regulatory science is of knowledge and tool needed to evaluate a product’s safety, efficacy, quality, and performance, and it involves the development of new methods, standards, and models that can be used to speed up development, review, approval, and ongoing oversight of medical products,” she went on to say.

Hamburg emphasized that regulations are required to deliver safe, effective, and the right medicines to people.

She noted that the recent delta surge and stressed hospital system have shown that society needs new and better therapeutics to manage the acute severe disease and keep people away from the hospitals.

“If we are to advance biomedical product innovation and ensure that we can deliver the power of science, providing people what and when they need to improve health and limit disease, we must work together and enhance collaboration to promote innovative thinking and approaches,” Hamburg said.

The former FDA commissioner said that the world has seen in real-time how fast modern biomedical research and biotechnology have helped to develop a new vaccine for the Covid-19.

However, she emphasized the need for solid interpretable data to guide decision-making when millions of people are betting their lives on medical interventions amid the Covid-19, saying that people deserve better than a hunch or an empty hope.

“People will still consider regulations as a barrier for getting what they need, but truly, a world without regulation will not be good for anyone, and I believe regulations play a positive and proactive role in innovation when done right, assuring new products through the approval process and into the market,” Hamburg said.

The U.S. expert said there is a pressing need to respond to global demand for equitable and affordable timely access for a host of reasons during a worldwide pandemic because no one would be safe until everyone is.

“As we look to the future of what the new normal will mean for biopharmaceutical products and people, it is evident that advanced regulatory science, enhanced understanding of regulatory process and role, and strengthened investment in regulatory development can make a difference,” Hamburg said.