New medicines no longer need to be tested in animals to receive U.S. Food and Drug Administration (FDA) approval, according to legislation signed by President Joe Biden in late December 2022.

Some people say it's a win for the industry; others say it's too early to expect any prominent changes.

Regardless, it seems the revised Federal Food, Drug, and Cosmetic Act foreshadows many changes to come, signaling a major shift away from animal use after more than 80 years of drug safety regulation.

At BIX 2023, experts from industry, academia, and clinical medicine are gathered to discuss Alternative Drug Test Platforms.

"Technical Session 21: Emerging Advanced Alternative Drug Test Platforms: Microphysiological Systems and Organoids" was chaired and led by Dr. YongTae Kim (CEO of MEPSGEN), with Dr. Nak-Won Choi (Principal Researcher of KIST), Dr. Young-Jae Cho (Professor of Seoul National University Bundang Hospital Pulmonology Clinical), and Ms. Woo-Hee Choi (Director of ORGANOIDSCIENCES) as panelists.

Drug discovery is an expensive, slow, and risky business. 90% of developed drugs are unsuccessful in clinical trials due to inaccurate drug screening caused by physiological differences between species, meaning animal models fail to predict what will happen in humans when they're treated with a particular drug.

The experts agreed that the advent of Advanced Alternative Drug Test Platforms is inevitable. We need to find another way.

A number of global pharmaceutical companies and institutions are collaborating with MPS companies because they recognized this undeniable transition early on through government initiatives and were willing to adopt the new technology to blaze a trail to success.

Korean regulatory science has been quick to recognize the importance of animal alternatives and willing to keep pace with the global trend. However, the emergence of this new platform is still new to people and the Korean industry. Not many of them are willing to take the risk of adopting unprecedented technology that can waste time and money.

To accelerate the development of Advanced Alternative Drug tests in Korea, regulatory science needs to come up with a practical long-term plan and regulatory action that can benefit and affect both industry and academia.

Non-animal technologies are still in their infancy, but they are rapidly evolving worldwide.

These technologies, such as MPS, organoids, cell-based assays, computer modeling, bioprinting, etc., have their own pros and cons.

Experts of each technology should remember that our goal is to replace animal testing as much as possible for the people and for the sake of the 50 million animals used in animal testing each year, not prove whose tech is superior to the other. To achieve our goal, we should always be open to new ideas and collaborations.

Together, we can make a difference.