| Clinical standards have advanced, but CMC capabilities remain a concern
| “Standardized data sets must meet regulatory expectations”
🧑💻 By DaeHyun Shin, KUKINEWS
The criteria for determining the success of drug development are shifting. Innovative drug candidates and strong clinical outcomes alone are no longer sufficient. Experts now emphasize that companies must demonstrate capabilities across manufacturing and quality processes, data management, and global regulatory strategy to successfully compete in the global market.
Yumi Kim, Advisor at JNPMEDI, said in a recent interview with KUKINEWS, “We are no longer in an era where strong clinical performance alone guarantees success,” adding, “True global competitiveness can only be achieved when business strategy, data management, and regulatory readiness are closely aligned.”
Kim is a regulatory science expert who has held key positions at the Ministry of Food and Drug Safety (MFDS), including Director of the Biopharmaceutical Policy Division, Pharmaceutical Management Division, and Medical Device Policy Division. After serving as Vice Minister of the MFDS until 2024, she currently serves as Advisor for Regulatory Affairs and External Relations at JNPMEDI and Of Counsel at Jipyong LLC.
Kim identified Chemistry, Manufacturing, and Controls (CMC) capabilities as a critical factor for building a successful biopharmaceutical company. “While safety and efficacy have long been emphasized—leading to a significant advancement in clinical standards—there are still concerns as to whether CMC capabilities, which follow the clinical phase, have been sufficiently advanced to match the level of global pharmaceutical companies,” she noted.
She added that this concern is also reflected in recent movements by the U.S. Food and Drug Administration (FDA). “Between 2020 and 2024, the FDA disclosed more than 200 cases, allowing analysis of why approvals were delayed or rejected based on actual data,” she explained. “The most frequently cited issues were related to manufacturing and quality processes.” According to Kim, approvals often failed due to insufficiently established manufacturing processes or a lack of evidence demonstrating consistent product quality.
Kim emphasized that this is not an issue Korean companies can afford to overlook. “Following past impurity-related incidents, inspections of biopharmaceutical manufacturing sites revealed multiple cases where actual manufacturing practices differed from approved specifications, as well as instances where documentation had been adjusted to appear compliant,” she said. “Manufacturing process issues are taken seriously across all regions, whether in Korea or the United States.”
Looking ahead, Kim identified data governance as another key factor that will shape competitiveness in the biopharmaceutical industry. “All data generated across laboratory research and manufacturing processes must be managed in an integrated manner,” she said. “As data will increasingly serve as the basis for demonstrating product value, this capability is essential.” She further emphasized that “data must be managed strategically from the outset, with data sets designed to anticipate future regulatory requirements and additional validation needs.”
However, she cautioned that simply accumulating data is not enough. “Standardized data sets must be established from the beginning and maintained at a quality level that meets the expectations of regulatory authorities such as the FDA and MFDS,” she said. “Data quality, standardization, and usability must all be ensured together.”
Regulatory preparedness in response to the growing use of artificial intelligence (AI) was also highlighted as a key challenge. “AI is no longer limited to drug discovery but is being applied across various areas, including product quality management, risk assessment, and digital medical devices,” she said. “Companies developing AI-based drugs or medical devices must maintain continuous communication with regulatory authorities while advancing both preparation and validation.”
Lastly, Kim stressed the importance of recognizing the value of failed research. “Looking back at failed studies often provides valuable insights,” she said. “The FDA’s decision to disclose reasons for regulatory rejection ultimately aims to enhance trust in the capital market and among investors, while fostering a healthier industry ecosystem in the long term.”
She concluded by noting that the coming years will be a critical period for both regulators and the industry. “In many organizations, management, regulatory, and data functions still operate in silos,” she said. “Data strategy must be designed from the outset alongside development strategy, and as regulations continue to evolve, a company’s overall roadmap must also be continuously refined in response.”
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| Clinical standards have advanced, but CMC capabilities remain a concern
| “Standardized data sets must meet regulatory expectations”
🧑💻 By DaeHyun Shin, KUKINEWS
The criteria for determining the success of drug development are shifting. Innovative drug candidates and strong clinical outcomes alone are no longer sufficient. Experts now emphasize that companies must demonstrate capabilities across manufacturing and quality processes, data management, and global regulatory strategy to successfully compete in the global market.
Yumi Kim, Advisor at JNPMEDI, said in a recent interview with KUKINEWS, “We are no longer in an era where strong clinical performance alone guarantees success,” adding, “True global competitiveness can only be achieved when business strategy, data management, and regulatory readiness are closely aligned.”
Kim is a regulatory science expert who has held key positions at the Ministry of Food and Drug Safety (MFDS), including Director of the Biopharmaceutical Policy Division, Pharmaceutical Management Division, and Medical Device Policy Division. After serving as Vice Minister of the MFDS until 2024, she currently serves as Advisor for Regulatory Affairs and External Relations at JNPMEDI and Of Counsel at Jipyong LLC.
Kim identified Chemistry, Manufacturing, and Controls (CMC) capabilities as a critical factor for building a successful biopharmaceutical company. “While safety and efficacy have long been emphasized—leading to a significant advancement in clinical standards—there are still concerns as to whether CMC capabilities, which follow the clinical phase, have been sufficiently advanced to match the level of global pharmaceutical companies,” she noted.
She added that this concern is also reflected in recent movements by the U.S. Food and Drug Administration (FDA). “Between 2020 and 2024, the FDA disclosed more than 200 cases, allowing analysis of why approvals were delayed or rejected based on actual data,” she explained. “The most frequently cited issues were related to manufacturing and quality processes.” According to Kim, approvals often failed due to insufficiently established manufacturing processes or a lack of evidence demonstrating consistent product quality.
Kim emphasized that this is not an issue Korean companies can afford to overlook. “Following past impurity-related incidents, inspections of biopharmaceutical manufacturing sites revealed multiple cases where actual manufacturing practices differed from approved specifications, as well as instances where documentation had been adjusted to appear compliant,” she said. “Manufacturing process issues are taken seriously across all regions, whether in Korea or the United States.”
Looking ahead, Kim identified data governance as another key factor that will shape competitiveness in the biopharmaceutical industry. “All data generated across laboratory research and manufacturing processes must be managed in an integrated manner,” she said. “As data will increasingly serve as the basis for demonstrating product value, this capability is essential.” She further emphasized that “data must be managed strategically from the outset, with data sets designed to anticipate future regulatory requirements and additional validation needs.”
However, she cautioned that simply accumulating data is not enough. “Standardized data sets must be established from the beginning and maintained at a quality level that meets the expectations of regulatory authorities such as the FDA and MFDS,” she said. “Data quality, standardization, and usability must all be ensured together.”
Regulatory preparedness in response to the growing use of artificial intelligence (AI) was also highlighted as a key challenge. “AI is no longer limited to drug discovery but is being applied across various areas, including product quality management, risk assessment, and digital medical devices,” she said. “Companies developing AI-based drugs or medical devices must maintain continuous communication with regulatory authorities while advancing both preparation and validation.”
Lastly, Kim stressed the importance of recognizing the value of failed research. “Looking back at failed studies often provides valuable insights,” she said. “The FDA’s decision to disclose reasons for regulatory rejection ultimately aims to enhance trust in the capital market and among investors, while fostering a healthier industry ecosystem in the long term.”
She concluded by noting that the coming years will be a critical period for both regulators and the industry. “In many organizations, management, regulatory, and data functions still operate in silos,” she said. “Data strategy must be designed from the outset alongside development strategy, and as regulations continue to evolve, a company’s overall roadmap must also be continuously refined in response.”
✔️ Read the Full Article: CLICK