| The Second Pandemic: Key to New Drug Development through Rapid Clinical Trials"
| Low DCT in Korea: Many Obstacles, Including Ownership of Clinical Trial Data
| The Use of AI in New Drug Development - Positive; Great Potential of Generative AI in Clinical Fields"
▲ SeEun Kim, the Project Owner of JNPMEDI, stated, 'If DCT becomes widespread, the time required for clinical trials could be reduced.' / Reporter DongWon Kim.
The COVID-19 pandemic is still having an impact. Numerous negative effects have been left in the wake of the disaster. Businesses and offices have shut down, and the disturbance to students' education hasn't stopped. Sadly, a few people have lost their lives.
The problem is that the pandemic is not over. Infectious diseases like COVID-19 can emerge unexpectedly at any time. The frequency of outbreaks is becoming shorter. In fact, since the "Spanish Flu" of 1918, there have been several threats to humanity, including SARS in 2002, MERS in 2012, and COVID-19 in 2019, with the intervals between infectious diseases decreasing. We cannot predict when a new infectious disease will strike. The World Health Organization has already mentioned a novel influenza virus as a likely candidate for the next pandemic.
On a positive note, regardless of what the next pandemic candidate is, the speed of vaccine development to combat new viruses has accelerated. The vaccine development speed for COVID-19 was faster compared to previous outbreaks. A vaccine was developed within the same year as the pandemic and was subsequently supplied worldwide, significantly reducing the threat of infection. Future advancements in artificial intelligence (AI) technologies have also greatly increased the speed of discovering candidate substances by extracting necessary information from numerous research papers. Techniques for virtually mixing these substances and predicting results have also progressed. In line with this trend, the regulatory agency has announced plans to develop a vaccine within 100 days if a novel influenza, identified as a candidate for the next pandemic, emerges and to expand the number of surveillance medical institutions to 1,000.
However, there is a problem: data ownership. In the clinical trial phase of new drug development, the ownership of the data used does not belong to the clinical research organization (CRO) but to the sponsor of the new drug development. While CROs continuously collect data, the ownership remains with the sponsor, making it difficult to utilize effectively. This issue slows down the speed of new drug development, as the clinical research phase is the most time- and cost-intensive stage.
SeEun Kim, Project Owner of JNPMEDI, pointed out that decentralized clinical trials (DCT), widely used overseas, are not well utilized in Korea, citing the issue of clinical data ownership. DCT refers to trials conducted digitally, allowing patients to participate from home. According to the global data organization Clinical Trial Arena, Korea's DCT rate stands at 4%, which is half of the rates in the U.S., U.K., Australia, Canada, and Poland.
Project Owner Kim emphasized that to increase the speed of new drug development and the use of DCT in Korea, the issue of clinical data ownership needs to be addressed. She noted that there is already a lot of data that can be utilized in the clinical trial phase, but ownership issues often prevent its use. I had the opportunity to discuss this in detail with her.
Project Owner Kim graduated from Ewha Womans University with a degree in Nursing and obtained a master's in Health Policy from Seoul National University’s Graduate School of Public Health. She began her career at the Clinical Trial Center of Samsung Medical Center and then gained practical experience in various areas, including clinical trial operations, data management, and quality control, at the CRO LSK Global PS. As a Business Development Director, she proposed optimal solutions to clinical trial sponsors through interactions with domestic and international pharmaceutical, biotech companies, and CROs. In July, she moved to JNPMEDI, where she is promoting digital transformation (DX) in the clinical stage.
▲SeEun Kim, Project Owner of JNPMEDI, expressed her ambition to “secure DM technology in Korea on a global scale and establish a global clinical trial service center.” / Reporter DongWon Kim
Q. COVID-19 reminded us, the importance of the speed of new drug development. However, many people still point out that the time required for clinical trials in the drug development process remains long.
“COVID-19 has highlighted the role of decentralized clinical trials, or DCT. In the past, there were limitations in trial sites and institutions, but with the use of DCT, those constraints are breaking down. If there are subjects available anywhere, there are ways to collect data, and with the development of wearable devices and applications, I expect that the time required for clinical trials will be reduced compared to before. When new diseases emerge, vaccines and new drugs need to be developed quickly. This is something everyone agrees on, so I believe methods like DCT will become more common, and related technologies will continue to evolve.”
Q. The cycle of zoonotic infections transmitted from animals to humans is speeding up. Are there changes you would like to see in the current clinical trial phase to prepare for this?
“Data ownership is a major issue. There is a lot of data available for use in clinical trials, but due to ownership issues, CROs find it difficult to utilize it. While CROs collect data, they are not free from ownership issues. In reality, the ownership belongs to the sponsors of vaccine development. This is one reason why DCT has not been actively implemented in Korea. The issue of data ownership is also important when integrating AI. Given that clinical trials are a regulated industry, they tend to be more conservative. I believe that if these issues are improved, there will be significant advancements in technology and speed.”
Q. In countries like the U.S. and Europe, not only DCT but also advanced digital devices are being utilized more freely in clinical trials. It seems that Korea, despite its technological advancements, has a more conservative mindset.
“Of course, the government is making efforts. The Ministry of Health and Welfare and the Ministry of Food and Drug Safety are aware of these issues and are engaging in discussions. There were efforts during COVID-19, such as rapid testing. It has been pointed out that DCT is still difficult to implement due to regulations in Korea, but I understand that the government has begun various support projects to change this. If these efforts continue, I believe that areas like DCT and the use of digital devices will improve rapidly. JNPMEDI is also actively voicing its opinions in related consortiums. We are currently developing areas that can be utilized within the regulatory framework while also sharing our views on what is needed.”
Q. You recently joined JNPMEDI. What was your reason for making this switch?
“I had been involved in various tasks related to clinical trials, but I found the Data Management (DM) aspect particularly appealing. While working in DM, I had many ideas about what could be supported to make clinical trials easier. When I learned that JNPMEDI is open to digital transformation, cloud computing, and blockchain, and has its own developed systems, I saw an opportunity. Additionally, while conducting DM, I was impressed by the comprehensive services offered, from strategy to commercialization and clinical trials in the drug development cycle. I joined JNPMEDI with the expectation that we could gradually achieve digital transformation in clinical trials by exploring areas for improvement with the development team.”
Q. Recently, AI technologies related to new drug development have advanced significantly. As someone with extensive experience in this field, what are your thoughts?
“I find it very attractive. While continuing my work in clinical trials, I became very interested in innovations for data acquisition. In particular, I see great potential in AI due to its ability to handle vast amounts of data. However, I believe that AI's advancement will not reduce the role of humans. Rather, the role of DM in managing clinical data will become even more important. If AI learns from incorrect data, it will produce flawed results. Therefore, data reliability and validation will become increasingly critical. The biggest challenge in implementing AI in clinical trials will be securing high-quality data.”
Q. Is there a role for generative AI in the digital transformation of clinical trials?
“I believe there are many possibilities. Generative AI is a high-potential technology, and if safety measures are in place, it can be quite effective. Initially, it could help with smaller tasks like document creation. Utilizing generative AI to generate reports from document data could significantly alleviate the workload of responsible personnel. While it may seem like a small aspect, automating these smaller tasks can lead to significant value.”
Q. From an external perspective, what do you think are the advantages of JNPMEDI's Maven solution?
“I think the user interface (UI) is very good. The service is designed to make it easier for users to perform their tasks. Its flexibility is also a strength, as it responds well to requests like ‘What do we need?’ or ‘What would be better?’ This adaptability is advantageous in providing optimized services tailored to client needs.”
Q. Having joined JNPMEDI, do you have specific goals you wish to achieve?
“Korea's DM and statistical expertise is globally competitive. In particular, JNPMEDI's Maven solution holds significant value even overseas. I want to enhance the competitiveness of the DM aspect of this solution. I aim to continuously upgrade technology to adapt to various environments and client requirements, creating a setting in Korea where global clinical trials can be conducted. Ultimately, I aspire to secure Korea’s DM technology on a global scale and establish a global service center. I believe this is entirely achievable.”
▶View Original Article
https://digitalchosun.dizzo.com/site/data/html_dir/2024/09/14/2024091480003.html
https://www.newstheai.com/news/articleView.html?idxno=6361
| The Second Pandemic: Key to New Drug Development through Rapid Clinical Trials"
| Low DCT in Korea: Many Obstacles, Including Ownership of Clinical Trial Data
| The Use of AI in New Drug Development - Positive; Great Potential of Generative AI in Clinical Fields"
▲ SeEun Kim, the Project Owner of JNPMEDI, stated, 'If DCT becomes widespread, the time required for clinical trials could be reduced.' / Reporter DongWon Kim.
The COVID-19 pandemic is still having an impact. Numerous negative effects have been left in the wake of the disaster. Businesses and offices have shut down, and the disturbance to students' education hasn't stopped. Sadly, a few people have lost their lives.
The problem is that the pandemic is not over. Infectious diseases like COVID-19 can emerge unexpectedly at any time. The frequency of outbreaks is becoming shorter. In fact, since the "Spanish Flu" of 1918, there have been several threats to humanity, including SARS in 2002, MERS in 2012, and COVID-19 in 2019, with the intervals between infectious diseases decreasing. We cannot predict when a new infectious disease will strike. The World Health Organization has already mentioned a novel influenza virus as a likely candidate for the next pandemic.
On a positive note, regardless of what the next pandemic candidate is, the speed of vaccine development to combat new viruses has accelerated. The vaccine development speed for COVID-19 was faster compared to previous outbreaks. A vaccine was developed within the same year as the pandemic and was subsequently supplied worldwide, significantly reducing the threat of infection. Future advancements in artificial intelligence (AI) technologies have also greatly increased the speed of discovering candidate substances by extracting necessary information from numerous research papers. Techniques for virtually mixing these substances and predicting results have also progressed. In line with this trend, the regulatory agency has announced plans to develop a vaccine within 100 days if a novel influenza, identified as a candidate for the next pandemic, emerges and to expand the number of surveillance medical institutions to 1,000.
However, there is a problem: data ownership. In the clinical trial phase of new drug development, the ownership of the data used does not belong to the clinical research organization (CRO) but to the sponsor of the new drug development. While CROs continuously collect data, the ownership remains with the sponsor, making it difficult to utilize effectively. This issue slows down the speed of new drug development, as the clinical research phase is the most time- and cost-intensive stage.
SeEun Kim, Project Owner of JNPMEDI, pointed out that decentralized clinical trials (DCT), widely used overseas, are not well utilized in Korea, citing the issue of clinical data ownership. DCT refers to trials conducted digitally, allowing patients to participate from home. According to the global data organization Clinical Trial Arena, Korea's DCT rate stands at 4%, which is half of the rates in the U.S., U.K., Australia, Canada, and Poland.
Project Owner Kim emphasized that to increase the speed of new drug development and the use of DCT in Korea, the issue of clinical data ownership needs to be addressed. She noted that there is already a lot of data that can be utilized in the clinical trial phase, but ownership issues often prevent its use. I had the opportunity to discuss this in detail with her.
Project Owner Kim graduated from Ewha Womans University with a degree in Nursing and obtained a master's in Health Policy from Seoul National University’s Graduate School of Public Health. She began her career at the Clinical Trial Center of Samsung Medical Center and then gained practical experience in various areas, including clinical trial operations, data management, and quality control, at the CRO LSK Global PS. As a Business Development Director, she proposed optimal solutions to clinical trial sponsors through interactions with domestic and international pharmaceutical, biotech companies, and CROs. In July, she moved to JNPMEDI, where she is promoting digital transformation (DX) in the clinical stage.
▲SeEun Kim, Project Owner of JNPMEDI, expressed her ambition to “secure DM technology in Korea on a global scale and establish a global clinical trial service center.” / Reporter DongWon Kim
Q. COVID-19 reminded us, the importance of the speed of new drug development. However, many people still point out that the time required for clinical trials in the drug development process remains long.
“COVID-19 has highlighted the role of decentralized clinical trials, or DCT. In the past, there were limitations in trial sites and institutions, but with the use of DCT, those constraints are breaking down. If there are subjects available anywhere, there are ways to collect data, and with the development of wearable devices and applications, I expect that the time required for clinical trials will be reduced compared to before. When new diseases emerge, vaccines and new drugs need to be developed quickly. This is something everyone agrees on, so I believe methods like DCT will become more common, and related technologies will continue to evolve.”
Q. The cycle of zoonotic infections transmitted from animals to humans is speeding up. Are there changes you would like to see in the current clinical trial phase to prepare for this?
“Data ownership is a major issue. There is a lot of data available for use in clinical trials, but due to ownership issues, CROs find it difficult to utilize it. While CROs collect data, they are not free from ownership issues. In reality, the ownership belongs to the sponsors of vaccine development. This is one reason why DCT has not been actively implemented in Korea. The issue of data ownership is also important when integrating AI. Given that clinical trials are a regulated industry, they tend to be more conservative. I believe that if these issues are improved, there will be significant advancements in technology and speed.”
Q. In countries like the U.S. and Europe, not only DCT but also advanced digital devices are being utilized more freely in clinical trials. It seems that Korea, despite its technological advancements, has a more conservative mindset.
“Of course, the government is making efforts. The Ministry of Health and Welfare and the Ministry of Food and Drug Safety are aware of these issues and are engaging in discussions. There were efforts during COVID-19, such as rapid testing. It has been pointed out that DCT is still difficult to implement due to regulations in Korea, but I understand that the government has begun various support projects to change this. If these efforts continue, I believe that areas like DCT and the use of digital devices will improve rapidly. JNPMEDI is also actively voicing its opinions in related consortiums. We are currently developing areas that can be utilized within the regulatory framework while also sharing our views on what is needed.”
Q. You recently joined JNPMEDI. What was your reason for making this switch?
“I had been involved in various tasks related to clinical trials, but I found the Data Management (DM) aspect particularly appealing. While working in DM, I had many ideas about what could be supported to make clinical trials easier. When I learned that JNPMEDI is open to digital transformation, cloud computing, and blockchain, and has its own developed systems, I saw an opportunity. Additionally, while conducting DM, I was impressed by the comprehensive services offered, from strategy to commercialization and clinical trials in the drug development cycle. I joined JNPMEDI with the expectation that we could gradually achieve digital transformation in clinical trials by exploring areas for improvement with the development team.”
Q. Recently, AI technologies related to new drug development have advanced significantly. As someone with extensive experience in this field, what are your thoughts?
“I find it very attractive. While continuing my work in clinical trials, I became very interested in innovations for data acquisition. In particular, I see great potential in AI due to its ability to handle vast amounts of data. However, I believe that AI's advancement will not reduce the role of humans. Rather, the role of DM in managing clinical data will become even more important. If AI learns from incorrect data, it will produce flawed results. Therefore, data reliability and validation will become increasingly critical. The biggest challenge in implementing AI in clinical trials will be securing high-quality data.”
Q. Is there a role for generative AI in the digital transformation of clinical trials?
“I believe there are many possibilities. Generative AI is a high-potential technology, and if safety measures are in place, it can be quite effective. Initially, it could help with smaller tasks like document creation. Utilizing generative AI to generate reports from document data could significantly alleviate the workload of responsible personnel. While it may seem like a small aspect, automating these smaller tasks can lead to significant value.”
Q. From an external perspective, what do you think are the advantages of JNPMEDI's Maven solution?
“I think the user interface (UI) is very good. The service is designed to make it easier for users to perform their tasks. Its flexibility is also a strength, as it responds well to requests like ‘What do we need?’ or ‘What would be better?’ This adaptability is advantageous in providing optimized services tailored to client needs.”
Q. Having joined JNPMEDI, do you have specific goals you wish to achieve?
“Korea's DM and statistical expertise is globally competitive. In particular, JNPMEDI's Maven solution holds significant value even overseas. I want to enhance the competitiveness of the DM aspect of this solution. I aim to continuously upgrade technology to adapt to various environments and client requirements, creating a setting in Korea where global clinical trials can be conducted. Ultimately, I aspire to secure Korea’s DM technology on a global scale and establish a global service center. I believe this is entirely achievable.”
▶View Original Article
https://digitalchosun.dizzo.com/site/data/html_dir/2024/09/14/2024091480003.html
https://www.newstheai.com/news/articleView.html?idxno=6361