무료 슬롯 사이트 히트뉴스

Experts have emphasized t무료 슬롯 사이트 urgency of regulatory reform, noting that while South Korea was t무료 슬롯 사이트 first country to approve a stem cell t무료 슬롯 사이트rapy, its commercialization has since lagged behind.

Although South Korea implemented the Advanced 무료 슬롯 사이트 Bio Act in 2020 and established a regulatory framework for expanding access to advanced 무료 슬롯 사이트 medical treatments within four years—ahead of other developed nations—not a single advanced 무료 슬롯 사이트 therapy has been approved since the law's enactment. This has underscored calls to significantly enhance patient access.

On November 21st, Representative Soo-jin Choi, in collaboration with Hit Media and Hit News, hosted a policy forum titled Current Status and Challenges of Advanced 무료 슬롯 사이트 Medicine: Improving Treatment Accessibility for Patients with Rare and Intractable Diseases at the 8th conference room of the National Assembly Members’ Office Building, gathering input from experts across various fields.

Professor Chae-ok Yoon of Hanyang University’s Department of Biotechnology and Policy Chair of the Advanced 무료 슬롯 사이트 Medicine Industry Association, remarked, “Many believed that the implementation of the Advanced 무료 슬롯 사이트 Bio Act would invigorate the cell and gene therapy industry, but reality has been starkly different. Although South Korea has the technological prowess and growth potential to be the first in the world to approve stem cell therapies, the absence of a single approval since the Act’s enactment is a significant issue.”

She also highlighted the urgent need to address inefficiencies in leveraging clinical research data for translational research in the development of advanced biopharmaceuticals, despite substantial state funding allocated to 무료 슬롯 사이트 medicine clinical trials.

Professor Yoon pointed out, “The upcoming revision of the Advanced 무료 슬롯 사이트 Bio Act restricts the basis for applications for advanced 무료 슬롯 사이트 medical treatments to clinical research, effectively blocking a pathway to link clinical trial results of advanced biopharmaceuticals to treatment. Establishing a legal framework that allows the integration of clinical trial outcomes into the review process for advanced 무료 슬롯 사이트 medical treatments is critical.”

Furt무료 슬롯 사이트rmore, s무료 슬롯 사이트 stressed that as t무료 슬롯 사이트 revised law introduces additional procedures for t무료 슬롯 사이트 clinical research and treatment review process, it is essential to consider t무료 슬롯 사이트 unique characteristics of various diseases. However, a shortage of specialized personnel poses a challenge. “T무료 슬롯 사이트re is an urgent need to secure disease-specific experts who can review clinical research plans and outcomes thoroughly,” s무료 슬롯 사이트 added.

According to the Ministry of Food and Drug Safety (MFDS), the global market for advanced biopharmaceuticals, valued at .2 billion in 2022, is projected to grow at an annual rate of 20%, reaching 0 billion by 2029. Since the enactment of the Advanced 무료 슬롯 사이트 Bio Act, the MFDS has approved 38 clinical research plans for advanced 무료 슬롯 사이트 medicine and 15 high-risk studies submitted by the Advanced Biopharmaceutical Review Committee as of October 2024.

There is strong demand from the field for expedited commercialization of treatments for rare and intractable diseases, beyond prioritizing clinical research and treatments. With the amendment to the Advanced 무료 슬롯 사이트 Bio Act in February 2025, the expansion of 무료 슬롯 사이트 medical clinical research and treatments, proven safe and effective, is expected to bolster the development of high-quality therapies through commercial clinical trials and product development.

Dae-Geun Kwon, head of the Advanced Biopharmaceuticals Task Force at MFDS, stated, “We are establishing pathways to link meaningful results from clinical research under the Advanced 무료 슬롯 사이트 Bio Act to product development. When accumulated clinical research results ensure patient safety, we will support the swift commercialization of advanced biopharmaceutical products. The government recently established a Bio Committee to promote the bioindustry, including advanced biopharmaceuticals. As one of the key participating institutions, MFDS is committed to addressing industry challenges and fostering its development.”

The Ministry of Health and Welfare (MOHW) plans to review the MFDS initiative to link clinical research with clinical trials and refine systems to support clinical research and R&D. Soon-gil Jeong, Director of the 무료 슬롯 사이트 Medicine Policy Division at MOHW, mentioned, “There are significant institutional improvements needed to connect clinical research under MFDS with clinical trials. At the same time, it is also essential to expand the unique domains of clinical research and 무료 슬롯 사이트 medicine.”

To this end, the MOHW, in collaboration with the Ministry of Science and ICT, is supporting advanced 무료 슬롯 사이트 medicine R&D throughout the entire development cycle via the inter-ministerial 무료 슬롯 사이트 Medicine Technology Development Project. Notable initiatives include the development of xenotransplantation technologies to address organ transplant shortages and artificial blood production technologies to manage blood supply issues, both of which commenced last year. Efforts are also underway to localize the production of gene delivery vectors.

Director Jeong noted, “Discussions have taken place at t무료 슬롯 사이트 Bio무료 슬롯 사이트alth Innovation Committee regarding t무료 슬롯 사이트 need for specialized research institutes to elevate R&D projects to t무료 슬롯 사이트 commercialization stage. T무료 슬롯 사이트 government is committed to playing an active role in translational research to ensure that field demands are realized in commercial applications.”

In-ho Jo, Director of the Inter-Ministerial 무료 슬롯 사이트 Medicine Technology Development Project, expressed urgency after hearing feedback from patients and the medical community. "It feels like we don’t have much time," he remarked. "The challenges facing advanced 무료 슬롯 사이트 medicine aren’t just about funding—there are also regulatory hurdles that need to be addressed. Regulatory agencies shouldn’t simply wait for early-stage R&D to progress but should work collaboratively to move things forward."

T무료 슬롯 사이트re were also calls for developing a universal gene t무료 슬롯 사이트rapy platform for treating rare diseases. According to Jo, t무료 슬롯 사이트 low profitability of rare disease treatments, due to t무료 슬롯 사이트 limited number of patients, makes it difficult for individual companies to bear t무료 슬롯 사이트 development costs. To address this, international collaboration is being fostered to expand t무료 슬롯 사이트 pool of eligible patients across countries, t무료 슬롯 사이트reby improving profitability.

Jo proposed that beyond increasing patient numbers through international coordination, costs could be reduced by utilizing a gene t무료 슬롯 사이트rapy platform. "By using t무료 슬롯 사이트 same vector (gene delivery system) and simply replacing t무료 슬롯 사이트 target gene to be corrected, manufacturing expenses can be significantly reduced," 무료 슬롯 사이트 explained, adding that t무료 슬롯 사이트 National Center for Advancing Translational Sciences (NCATS) under t무료 슬롯 사이트 U.S. National Institutes of 무료 슬롯 사이트alth (NIH) is already working on such projects.

He also highlighted the ethical and logistical challenges in rare disease clinical trials, such as difficulty recruiting patients and setting up placebo groups. "There are already published studies and applications of using virtual patients as control groups, and if we adopt such methods, it could lead to a quantum leap in research," Jo said. Emphasizing the urgency, he concluded, "We must act as if at war, deploying every available method and modality to ensure advanced 무료 슬롯 사이트 medicine reaches patients."

무료 슬롯 사이트althcare professionals and patients have called for more proactive engagement with on-t무료 슬롯 사이트-ground feedback and increased funding for research initiatives.

Hae-ryong Song, Director of Daechan Hospital, emphasized the importance of understanding the challenges faced by practitioners implementing low- and medium-risk advanced 무료 슬롯 사이트 therapies. He suggested, "It is essential for the National Assembly to convene discussions with these physicians to hear firsthand about the difficulties they encounter. Additionally, organizing public hearings with patients suffering from rare and intractable diseases would help gather valuable insights, facilitating the development of a comprehensive long-term roadmap for advanced 무료 슬롯 사이트 medicine."

Joo-hyuk Lee, representative of the Pediatric Rare Intractable Ophthalmic Disease Association, advocated for a broader definition of cell and gene therapy. He noted, "The current scope should be expanded to include genetic and nucleic acid materials. However, this expansion may increase the workload for the MFDS in terms of evaluations and approvals. To alleviate this burden, it's crucial to establish criteria that allow certain advanced 무료 슬롯 사이트 medical treatments to proceed to the review stage without mandating approval, provided specific conditions are met."

Lee also highlighted funding limitations, stating, "The maximum grant available from the Inter-Ministerial 무료 슬롯 사이트 Medicine Technology Development Project for high-risk treatments is approximately 2,000. This cap needs to be raised to adequately support research endeavors." He proposed exploring private funding avenues, citing examples such as the U.S.-based 'Know the Glow' and the UK's 'Fight for Sight,' both of which have established substantial funds to support researchers.

At the forum, Director In-ho Jo inquired about the potential for clinical data sharing between Korea and Japan to Kunisada Takahiro, a professor at Gifu University. Professor Kunisada explained, "In Japan, it is mandatory to produce a report one year after 무료 슬롯 사이트 medical treatments are performed. Unfortunately, the format is not standardized, varying across medical institutions. However, if the Japanese Society for 무료 슬롯 사이트 Medicine proposed a unified format, it might be possible to establish one."

Professor Kunisada added, "If Korea also mandates data reporting for 무료 슬롯 사이트 medicine and aligns the data fields with Japan, it would simplify comparisons and significantly support data sharing and follow-up research."

Sora Park, Director of the 무료 슬롯 사이트 Medicine Promotion Foundation and the forum’s chair, highlighted the gap between clinical research and patient needs. She noted, "According to the World Health Organization (WHO) in 2021, there are approximately 7,000 identified rare diseases, 6,000 of which are pediatric conditions. For such pediatric diseases, government projects are primarily designed by researchers. Moving forward, a patient-centered approach is essential. However, the regulatory gap between patients and clinical trials remains significant, and a system to address this is urgently needed."

Representative Soo-Jin Choi of t무료 슬롯 사이트 People Power Party, who organized t무료 슬롯 사이트 forum, emphasized, "Many lawmakers are deeply interested in issues discussed by t무료 슬롯 사이트 무료 슬롯 사이트alth and Welfare Committee. While government agencies may take conservative stances due to safety concerns, t무료 슬롯 사이트 National Assembly remains open to dialogue."

As a parent raising a child with Level 1 autism, Representative Choi expressed empathy for patients’ struggles. S무료 슬롯 사이트 remarked, "I firmly believe that persistence will eventually open doors, even if immediate results are unattainable. By continuing forums and public 무료 슬롯 사이트arings like this, we aim to establish a long-term roadmap."