| Clinical Partnership with BS Research on Bio-compatible Surface Modification Technology
| Development of Regulatory Strategy 'FDA Expert Solution' with Ongoing Recruitment of Experts
SeungMi Lee, Executive Vice President of JNPMEDI, presenting at 'JNPMEDI Connect 2024' (Provided by JNPMEDI) / News1 ⓒ News1
(Seoul = News1) Reporter JinJoong Hwang = JNPMEDI has developed a comprehensive clinical trial consulting system to enhance its support for research in the bio-pharma and healthcare sectors. The company is consistently bringing in experts to establish specialized teams focused on regulatory strategies for advanced international markets.
On the 20th, JNPMEDI and BS Research has signed a bilateral MOU to advance clinical research and global market entry using bio-compatible surface modification technology. This agreement focuses on collaboration for domestic clinical trials, obtaining EU CE certification, and preparing for FDA registration.
Under this partnership, JNPMEDI will support the execution and operation of clinical trials in Korea. It will also offer guidance on CE and FDA certification procedures. Additionally, it will provide consulting on business development, licensing, investment attraction, and global network connections.
Meanwhile, BS Research will formulate R&D plans essential for product development and clinical trials, sharing data with JNPMEDI to produce key datasets required for obtaining CE and FDA certifications.
This collaboration is a strategic approach for bio-pharma companies, primarily driven by R&D experts, to address certain clinical research and international regulatory challenges.
JNPMEDI supports the entire process of clinical trial, including trial designing, data analysis, and regulatory procedures in compliance with domestic and international regulations, such as those of the Ministry of Food and Drug Safety, the FDA, and the European Medicines Agency (EMA). Leveraging such partnerships offers the advantage of reducing both time and costs involved in drug development and market entry.
JNPMEDI has been continuously strengthening its support services by recruiting specialized professionals this year. The company has brought on board Vice President SooHyun Lew, who serves as a specialist at the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). Other new hires include Executive Director SeungMi Lee, an expert in digital medical device clinical trials, Senior Director HyunSoo Lee, a clinical trial statistical analysis expert, and Director SooYoung Kwak, a specialist in FDA regulatory approvals, all of whom are participating in the 'FDA Expert Solution' program.
The FDA Expert Solution is a comprehensive consulting service for FDA clinical trial plan approvals and New Drug Application (NDA) submissions. It provides full support throughout the communication process with the FDA, including the preparation of clinical and non-clinical data, document preparation, clinical trial management, and regulatory strategy development.
Additionally, JNPMEDI collaborates with MediRama to offer full-cycle support for oncology drug development. This service combines MediRama’s clinical development consulting platform, ABCD (Advanced Business Model for Clinical Development), with JNPMEDI’s clinical trial data platform, Maven Clinical Cloud.
Through the ABCD platform, JNPMEDI provides consulting across the entire clinical development process, from initial planning to joint development and commercialization. The Maven Clinical Cloud enables efficient data management and decentralized clinical trial technologies.
SeungMi Lee, Executive Director of JNPMEDI, stated, "For Korea's bio-industry to gain a competitive edge globally, the support of specialized companies like JNPMEDI is essential. JNPMEDI will continue to drive innovation and expertise, serving as a key force in the advancement of Korea's bio-industry and its success in the global market."
✔️ Original Article Available at https://www.news1.kr/bio/pharmaceutical-bio/5638686
| Clinical Partnership with BS Research on Bio-compatible Surface Modification Technology
| Development of Regulatory Strategy 'FDA Expert Solution' with Ongoing Recruitment of Experts
SeungMi Lee, Executive Vice President of JNPMEDI, presenting at 'JNPMEDI Connect 2024' (Provided by JNPMEDI) / News1 ⓒ News1
(Seoul = News1) Reporter JinJoong Hwang = JNPMEDI has developed a comprehensive clinical trial consulting system to enhance its support for research in the bio-pharma and healthcare sectors. The company is consistently bringing in experts to establish specialized teams focused on regulatory strategies for advanced international markets.
On the 20th, JNPMEDI and BS Research has signed a bilateral MOU to advance clinical research and global market entry using bio-compatible surface modification technology. This agreement focuses on collaboration for domestic clinical trials, obtaining EU CE certification, and preparing for FDA registration.
Under this partnership, JNPMEDI will support the execution and operation of clinical trials in Korea. It will also offer guidance on CE and FDA certification procedures. Additionally, it will provide consulting on business development, licensing, investment attraction, and global network connections.
Meanwhile, BS Research will formulate R&D plans essential for product development and clinical trials, sharing data with JNPMEDI to produce key datasets required for obtaining CE and FDA certifications.
This collaboration is a strategic approach for bio-pharma companies, primarily driven by R&D experts, to address certain clinical research and international regulatory challenges.
JNPMEDI supports the entire process of clinical trial, including trial designing, data analysis, and regulatory procedures in compliance with domestic and international regulations, such as those of the Ministry of Food and Drug Safety, the FDA, and the European Medicines Agency (EMA). Leveraging such partnerships offers the advantage of reducing both time and costs involved in drug development and market entry.
JNPMEDI has been continuously strengthening its support services by recruiting specialized professionals this year. The company has brought on board Vice President SooHyun Lew, who serves as a specialist at the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). Other new hires include Executive Director SeungMi Lee, an expert in digital medical device clinical trials, Senior Director HyunSoo Lee, a clinical trial statistical analysis expert, and Director SooYoung Kwak, a specialist in FDA regulatory approvals, all of whom are participating in the 'FDA Expert Solution' program.
The FDA Expert Solution is a comprehensive consulting service for FDA clinical trial plan approvals and New Drug Application (NDA) submissions. It provides full support throughout the communication process with the FDA, including the preparation of clinical and non-clinical data, document preparation, clinical trial management, and regulatory strategy development.
Additionally, JNPMEDI collaborates with MediRama to offer full-cycle support for oncology drug development. This service combines MediRama’s clinical development consulting platform, ABCD (Advanced Business Model for Clinical Development), with JNPMEDI’s clinical trial data platform, Maven Clinical Cloud.
Through the ABCD platform, JNPMEDI provides consulting across the entire clinical development process, from initial planning to joint development and commercialization. The Maven Clinical Cloud enables efficient data management and decentralized clinical trial technologies.
SeungMi Lee, Executive Director of JNPMEDI, stated, "For Korea's bio-industry to gain a competitive edge globally, the support of specialized companies like JNPMEDI is essential. JNPMEDI will continue to drive innovation and expertise, serving as a key force in the advancement of Korea's bio-industry and its success in the global market."
✔️ Original Article Available at https://www.news1.kr/bio/pharmaceutical-bio/5638686