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KMID : 1142220230180020193
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Regulatory Research on Food, Drug & Cosmetic
2023 Volume.18 No. 2 p.193 ~ p.201
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Non-clinical Trial Considerations for the Development of Advanced Regenerative Medical Products
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Kim Jee-Youn
Choi Woo-Sung
Sohn Seong-Goo
Ko Young-Hwa
Kim Soo-Jin
Kim Kyoung-Min
Jo In-Ho
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Abstract
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Advanced regenerative medicine is an important strategy to provide effective solutions to rare/intractable diseases, has shown rapid scientific and clinical achievements in recent decades. Research and development of pharmaceuticals and convergence medical products, including cell therapy, is being promoted by venture companies including many pharmaceutical companies. These new attempts are faced with the challenge of introducing methods that have not been previously tried in the verification of drug efficacy and safety for Research and development institutions. Therefore, active discussion and cooperation among R&D institutions, Contract Research Organization (CRO), and regulatory authories in the non-clinical field is required. Korean Fund for Regenerative Medicine (KFRM) is supporting domestic researchers to develop and commercialize excellent research technology in the field of advanced regenerative medicine. KFRM operates the Science Ambassador (S.A.) system, which directly visits the research site, listens to the researcher's difficulties, and provides support by setting the best research direction. From the results of the S.A. for research projects supported by the KFRM, we identified difficulties in conducting non-clinical trials for the development of advanced regenerative medical products and in order to overcome these difficulties, we intend to share useful information for the establishment and implementation of non-clinical trial strategies by discussing with R&D researchers in related fields.
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KEYWORD
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Advanced regenerative medicine, Korean Fund for Regenerative Medicine, non-clinical trials, rare/ intractable diseases, Science Ambassador
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