Where did this fish come from? Securing World-Class Seafood Traceability Technology
< (From left) KAIST Ph.D. candidate Hyeontaek Hwang, Research Professor Yalew Kidane, Senior Researcher Young-jong Lee, Researcher Geon-woo Park, and (Top) Professor Daeyoung Kim >
When buying seafood at a supermarket, you may have wondered where the fish was caught and what process it went through to reach your dinner table. However, due to complex distribution processes, it has been difficult to transparently track that path. KAIST’s research team has developed a digital technology that solves this problem, allowing the movement path of seafood to be checked at a glance based on international standards recognized worldwide.
KAIST announced on December 19th that "OLIOPASS," a GS1 international standard-based digital transformation solution developed by Director Daeyoung Kim (Professor, School of Computing) of the KAIST Auto-ID Labs Busan Innovation Center, has passed the rigorous performance verification of the GDST (Global Dialogue on Seafood Traceability). It is the first in Korea to obtain the "GDST Capable Solution" certification.
< (Left) GDST Global Certification Logo, (Right) KAIST OLIOPASS Platform Logo >
Only 13 technologies worldwide have received this GDST certification. Among them, only 7 entities, including KAIST, support "Full Chain" traceability technology, which manages the entire process from production and processing to distribution and sales.
The GDST is an international organization established in 2015 at the suggestion of the World Economic Forum (WEF). It helps record and share information on all seafood movement processes digitally, according to the GS1 international standard agreed upon by the global community. This can be compared to creating a "common language for the supply chain" used worldwide.
The GDST is a global standard system that increases the reliability of seafood history information by defining Key Data Elements (KDEs) that must be recorded during the movement of seafood and Critical Tracking Events (CTEs) that define when, where, and what moved, based on international standards.
As major food distribution companies in the United States and Europe have recently begun requiring GDST compliance, this standard is becoming a de facto essential requirement for entering the global market. Since 2019, KAIST has participated as a founding member of GDST and has played a key role in designing seafood traceability models and system-to-system information interoperability.
In particular, with the U.S. Food and Drug Administration (FDA) announcing the mandatory enforcement of food traceability (FSMA 204) starting in July 2028, this certification is significant as it secures a technical solution for domestic companies to meet global market regulations.
OLIOPASS, which received certification on November 5th, is a digital traceability platform that combines KAIST's IoT technology with international standards (GS1 EPCIS 2.0, GS1 Digital Link). It records and shares movement information of various products and assets in a standardized language and utilizes blockchain technology to fundamentally prevent forgery or alteration. Even if systems differ between companies, history data is seamlessly linked.
Furthermore, OLIOPASS is designed as an "AI-ready data" infrastructure, allowing for the easy application of next-generation AI technologies such as Large Multimodal Models (LMM), AI agents, knowledge graphs, and ontologies. This allows it to serve as a platform that supports both digital and AI transformation beyond simple history management.
Daeyoung Kim, Director of the KAIST Auto-ID Labs Busan Innovation Center, stated, "This certification is an international recognition of our capability in reliable data technology across the global supply chain. We will expand OLIOPASS beyond seafood and food into various fields such as pharmaceuticals, logistics, defense, and smart cities, ensuring KAIST’s technology grows into a platform used by the world."
※ Related Link: https://thegdst.org/verified-gdst-capable-solutions/
< List of Certified Organizations >
Scientists re-writes FDA-recommended equation to improve estimation of drug-drug interaction
Drugs absorbed into the body are metabolized and thus removed by enzymes from several organs like the liver. How fast a drug is cleared out of the system can be affected by other drugs that are taken together because added substance can increase the amount of enzyme secretion in the body. This dramatically decreases the concentration of a drug, reducing its efficacy, often leading to the failure of having any effect at all. Therefore, accurately predicting the clearance rate in the presence of drug-drug interaction* is critical in the process of drug prescription and development of a new drug in order to ensure its efficacy and/or to avoid unwanted side-effects.
*Drug-drug interaction: In terms of metabolism, drug-drug interaction is a phenomenon in which one drug changes the metabolism of another drug to promote or inhibit its excretion from the body when two or more drugs are taken together. As a result, it increases the toxicity of medicines or causes loss of efficacy.
Since it is practically impossible to evaluate all interactions between new drug candidates and all marketed drugs during the development process, the FDA recommends indirect evaluation of drug interactions using a formula suggested in their guidance, first published in 1997, revised in January of 2020, in order to evaluate drug interactions and minimize side effects of having to use more than one type of drugs at once.
The formula relies on the 110-year-old Michaelis-Menten (MM) model, which has a fundamental limit of making a very broad and groundless assumption on the part of the presence of the enzymes that metabolizes the drug. While MM equation has been one of the most widely known equations in biochemistry used in more than 220,000 published papers, the MM equation is accurate only when the concentration of the enzyme that metabolizes the drug is almost non-existent, causing the accuracy of the equation highly unsatisfactory – only 38 percent of the predictions had less than two-fold errors.
“To make up for the gap, researcher resorted to plugging in scientifically unjustified constants into the equation,” Professor Jung-woo Chae of Chungnam National University College of Pharmacy said. “This is comparable to having to have the epicyclic orbits introduced to explain the motion of the planets back in the days in order to explain the now-defunct Ptolemaic theory, because it was 'THE' theory back then.”
< (From left) Ph.D. student Yun Min Song (KAIST, co-first authors), Professor Sang Kyum Kim (Chungnam National University, co-corresponding author), Jae Kyoung Kim, CI (KAIST, co-corresponding author), Professor Jung-woo Chae (Chungnam National University, co-corresponding author), Ph.D. students Quyen Thi Tran and Ngoc-Anh Thi Vu (Chungnam National University, co-first authors) >
A joint research team composed of mathematicians from the Biomedical Mathematics Group within the Institute for Basic Science (IBS) and the Korea Advanced Institute of Science and Technology (KAIST) and pharmacological scientists from the Chungnam National University reported that they identified the major causes of the FDA-recommended equation’s inaccuracies and presented a solution.
When estimating the gut bioavailability (Fg), which is the key parameter of the equation, the fraction absorbed from the gut lumen (Fa) is usually assumed to be 1. However, many experiments have shown that Fa is less than 1, obviously since it can’t be expected that all of the orally taken drugs to be completely absorbed by the intestines. To solve this problem, the research team used an “estimated Fa” value based on factors such as the drug’s transit time, intestine radius, and permeability values and used it to re-calculate Fg.
Also, taking a different approach from the MM equation, the team used an alternative model they derived in a previous study back in 2020, which can more accurately predict the drug metabolism rate regardless of the enzyme concentration. Combining these changes, the modified equation with re-calculated Fg had a dramatically increased accuracy of the resulting estimate. The existing FDA formula predicted drug interactions within a 2-fold margin of error at the rate of 38%, whereas the accuracy rate of the revised formula reached 80%.
“Such drastic improvement in drug-drug interaction prediction accuracy is expected to make great contribution to increasing the success rate of new drug development and drug efficacy in clinical trials. As the results of this study were published in one of the top clinical pharmacology journal, it is expected that the FDA guidance will be revised according to the results of this study.” said Professor Sang Kyum Kim from Chungnam National University College of Pharmacy.
Furthermore, this study highlights the importance of collaborative research between research groups in vastly different disciplines, in a field that is as dynamic as drug interactions.
“Thanks to the collaborative research between mathematics and pharmacy, we were able to recify the formula that we have accepted to be the right answer for so long to finally grasp on the leads toward healthier life for mankind.,” said Professor Jae Kyung Kim. He continued, “I hope seeing a ‘K-formula’ entered into the US FDA guidance one day.”
The results of this study were published in the online edition of Clinical Pharmacology and Therapeutics (IF 7.051), an authoritative journal in the field of clinical pharmacology, on December 15, 2022 (Korean time).
Thesis Title: Beyond the Michaelis-Menten: Accurate Prediction of Drug Interactions through Cytochrome P450 3A4 Induction (doi: 10.1002/cpt.2824)
< Figure 1. The formula proposed by the FDA guidance for predicting drug-drug interactions (top) and the formula newly derived by the researchers (bottom). AUCR (the ratio of substrate area under the plasma concentration-time curve) represents the rate of change in drug concentration due to drug interactions. The research team more than doubled the accuracy of drug interaction prediction compared to the existing formula. >
< Figure 2. Existing FDA formulas tend to underestimate the extent of drug-drug interactions (gray dots) than the actual measured values. On the other hand, the newly derived equation (red dot) has a prediction rate that is within the error range of 2 times (0.5 to 2 times) of the measured value, and is more than twice as high as the existing equation. The solid line in the figure represents the predicted value that matches the measured value. The dotted line represents the predicted value with an error of 0.5 to 2 times. >
For further information or to request media assistance, please contact Jae Kyoung Kim at Biomedical Mathematics Group, Institute for Basic Science (IBS) (jaekkim@ibs.re.kr) or William I. Suh at the IBS Communications Team (willisuh@ibs.re.kr).
- About the Institute for Basic Science (IBS)
IBS was founded in 2011 by the government of the Republic of Korea with the sole purpose of driving forward the development of basic science in South Korea. IBS has 4 research institutes and 33 research centers as of January 2023. There are eleven physics, three mathematics, five chemistry, nine life science, two earth science, and three interdisciplinary research centers.