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11. Analysis of cancer drugs receiving FDA's Accelerated Approval between 1992 and 2021.

Author

Lim, Heeyeon, Kim, Minji, Kang, Geeyoon, Ko, Minji, and Kim, Eunyoung

Subjects
CLINICAL trials, DRUG approval, PROGRESSION-free survival, ANTINEOPLASTIC agents, DRUG development
Abstract

Objectives This cross-sectional study examines the Food and Drug Administration (FDA)'s Accelerated Approval (AA) pathway for cancer drugs from 1992 to 2021, which expedites the development and approval of new drugs, including biologics, for severe or life-threatening conditions such as cancers. Methods Based on the 'CDER Drug and Biologic AAs Based on a Surrogate Endpoint' report, the number of indications where anticancer agents received AA and the conversion rates to Full Approval (FA) were analysed. Outcome measures used in phase II and phase III trials for these drugs were obtained from US National Library of Medicine for comparison. Key findings Of the 278 AA-granted indications, 67% were for anticancer agents. Lymphoma, leukemia, and lung cancer had the highest number of AA indications among all cancer types. The conversion rates to FA varied among periods: Early (1995–2003), Middle (2004–2012), and Late (2013–2021). The conversion rates for drugs were 82%, 79%, and 31%, while biologics exhibited rates of 100%, 78%, and 27%, respectively. The overall response rate was often the primary outcome measure in phase II trials, whereas overall survival and progression-free survival were the common outcome measures in phase III trials. Secondary outcome measures included disease control rate and duration of response. Conclusions This study provides valuable insights for stakeholders seeking to understand the approval criteria and processes for cancer drugs via the AA pathway. However, limitations in data availability, phase-specific variations in drug doses and combinations, and the inability to manage uncertain data should be acknowledged. Research on the AA program to non-cancer drugs is also required. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Controllable Optical Features of Multiple‐Layered Axial Heterostructure Nanorods for Multicolor Polariton Nanolasers.

Author

Nam, Sangwon, Lee, SeungJe, Jeong, Seonghyun, Ko, Minji, Shim, Hyeong Seop, Hong, Eunha, Park, Seung Min, Do, Young Rag, and Song, Jae Kyu

Subjects
NANORODS, BAND gaps, INDIUM gallium nitride, OPTICAL devices, ENERGY bands
Abstract

The optical features of multiple‐layered axial heterostructures composed of III‐nitride semiconductors (GaN, InGaN, and AlGaN) are investigated to realize tunable nanolasers. The optical confinement effects develop exciton‐polariton in nanorods, leading to polariton lasing with distinctive dispersion. The lasing characteristics in the heterostructure are similar to those in the homostructure, although the carrier transfer between layers influences the optical gain. The energy‐dependent property of polariton changes the mode spacing of lasing peaks. The alloyed systems of InGaN can tune the color of lasing in the visible region, while the lasing of AlGaN is also achievable in the optimized configuration. The polarization of lasing indicates the predominant contribution of the fundamental transverse mode. Therefore, in the multiple‐layered heterostructure, controllable triple‐color lasing using the feature of polariton, modulation of band gap energy, and the amplification process of the waveguide is demonstrated for the first time, with the tunable color over a wide range of the visible region. Multicolor polariton nanolasers offer a promising path to diverse nanophotonic devices with controllable optical characteristics. [ABSTRACT FROM AUTHOR]

Published
2024
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21. Isolation of Bovine Milk Exosome Using Electrophoretic Oscillation Assisted Tangential Flow Filtration with Antifouling of Micro-ultrafiltration Membrane Filters

Author

Ko, Minji, primary, Kim, Hyeng Jin, additional, Park, Jaeeun, additional, Lee, Hansol, additional, Lee, Keyong Nam, additional, Kim, Kayoung, additional, Lee, Jaehyuk, additional, Yoon, Seok Jeong, additional, Kim, Tony, additional, Jeong, Sekyoo, additional, Heo, Kyun, additional, Lee, Young Kwang, additional, and Do, Young Rag, additional

Published
2023
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26. Postnatal hyperglycemia alters amino acid profile in retinas (model of Phase I ROP)

Author

Harman, Jarrod, Pivodic, Aldina, Nilsson, Anders, Ko, Minji, Yang, Jay, Neilsen, Katherine, Boeck, Myriam, Kinter, Michael, Hellstrom, Ann, and Fu, Zhongjie

Subjects
retina, targeted quantitative proteomics, selected reaction monitoring, retinopathy of prematurity
Abstract

Nutritional deprivation occurring in most preterm infants postnatally, can induce hyperglycemia, a significant and independent risk factor for suppressing physiological retinal vascularization (Phase I retinopathy of prematurity (ROP)), leading to compensatory but pathological neovascularization. Amino acid supplementation reduces retinal neovascularization in mice. Little is known about amino acid contribution to Phase I ROP. Significant changes in retinal amino acids (including most decreased L-leucine, L-isoleucine and L-valine) were found in mice modeling hyperglycemia-associated Phase I ROP, and parenteral (i.p.) L-isoleucine suppressed physiological retinal vascularization. In premature infants, severe ROP was associated with a higher mean intake of parenteral versus enteral amino acids in the first two weeks of life after adjustment for treatment group, gestational age at birth, birth weight and sex. The number of days with parenteral amino acids support independently predicted severe ROP. Further understanding and modulating amino acids may help improve nutritional intervention and prevent Phase I ROP The data uploaded here are from the selected reaction monitoring experiment using a triple quadrupole mass spectrometry system. Data are acquired as panels of validated protein assays based on detecting 2 to 3 peptides, formed by trypsin digestion, from each protein. These are raw data files from a Thermo Scientific instrument system. We analyze these files using the program Skyline., you can contact mike kinter if you have questions about these data

Published
2023
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32. Abstract 4246: ABL103, A novel T-cell engaging bispecific antibody, exhibits potent in vitro and vivo antitumor activity and low toxicity via B7-H4 dependent 4-1BB activation in tumor microenvironment

Author

Park, Kyungjin, primary, Lee, Yangsoon, additional, Lim, Saeyi, additional, Park, Kyeongsu, additional, Kim, Eunjung, additional, Lee, Hanbyul, additional, Yoo, Jiseon, additional, Pak, Youngdon, additional, Kim, Yeunju, additional, Ko, Minji, additional, and Won, Jonghwa, additional

Published
2022
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33. Omega-3/Omega-6 Long-Chain Fatty Acid Imbalance in Phase I Retinopathy of Prematurity

Author

Fu, Zhongjie, primary, Yan, Wenjun, additional, Chen, Chuck T., additional, Nilsson, Anders K., additional, Bull, Edward, additional, Allen, William, additional, Yang, Jay, additional, Ko, Minji, additional, SanGiovanni, John Paul, additional, Akula, James D., additional, Talukdar, Saswata, additional, Hellström, Ann, additional, and Smith, Lois E. H., additional

Published
2022
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35. A Highly Efficient and Versatile Genetic Engineering Toolkit For a Methanotroph-Based Biorefinery

Author

Jeong, Jiyeong, primary, Kim, Tae Hyun, additional, Jang, Nulee, additional, Ko, Minji, additional, Kim, Seong Keun, additional, Emelianov, Georgii, additional, Rha, Eugene, additional, Kwon, Kil Koang, additional, Kim, Haseong, additional, Lee, Eun Yeol, additional, Lee, Dae-Hee, additional, Lee, Hyewon, additional, and Lee, Seung-Goo, additional

Published
2022
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36. Metabolism in Retinopathy of Prematurity

Author

Tomita, Yohei, primary, Usui-Ouchi, Ayumi, additional, Nilsson, Anders K., additional, Yang, Jay, additional, Ko, Minji, additional, Hellström, Ann, additional, and Fu, Zhongjie, additional

Published
2021
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38. Passivation and Interlayer Effect of Zr(i-PrO)4 on Green CuGaS2/ZnS/Zr(i-PrO)4@Al2O3 and Red CuInS2/ZnS/Zr(i-PrO)4@Al2O3 QD Hybrid Powders.

Author

Ko, Minji, Yoon, Soyeon, Eo, Yun Jae, Lee, Keyong Nam, and Do, Young Rag

Subjects
PASSIVATION, QUANTUM dots, SURFACE passivation, POWDERS, OPTICAL properties, ZIRCONIUM, ALUMINUM oxide
Abstract

Broadband emissive I–III–VI quantum dots (QDs) are synthesized as efficient and stable I–III–VI QDs to be used as eco-friendly luminescent materials in various applications. Here, we introduce the additional passivation of zirconium isopropoxide (Zr(i-PrO)4) to improve the optical properties and environmental stability of green-emitting CuGaS2/ZnS (G-CGS/ZnS) and red-emitting CuInS2/ZnS (R-CIS/ZnS) QDs. The photoluminescence quantum yield (PLQY) of both resultant Zr(i-PrO)4-coated G-CGS/ZnS and R-CIS/ZnS QDs reaches similar values of ~ 95%. In addition, the photostability and thermal-stability of G-CGS/ZnS/Zr(i-PrO)4 and R-CIS/ZnS/Zr(i-PrO)4 QDs are improved by reducing the ligand loss via encapsulation of the ligand-coated QD surface with Zr(i-PrO)4. It is also proved that the Zr(i-PrO)4-passivated interlayer mitigates the further degradation of I-III-V QDs from ligand loss even under harsh conditions during additional hydrolysis reaction of aluminum tri-sec-butoxide (Al(sec-BuO)3), forming easy-to-handle G-CGS/ZnS and R-CIS/ZnS QD-embedded Al2O3 powders. Therefore, the introduction of a Zr(i-PrO)4 complex layer potentially provides a strong interlayer to mitigate degradation of I–III–VI QD-embedded Al2O3 hybrid powders as well as passivation layer for protecting I–III–VI QD. [ABSTRACT FROM AUTHOR]

Published
2022
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41. Fabrication of SiNx Nanopore Filters Using Combined Process of Nanoimprint and Dual‐Side Aligned Photolithography for Purified Cs3MnBr5 Green Phosphors.

Author

Kim, Hyeng Jin, Ko, Minji, Park, Sangwook, Lee, Keyong Nam, Yoo, Gang Yeol, Nam, Sangwon, Song, Jae Kyu, and Do, Young Rag

Subjects
*NANOPORES, *PHOTOLITHOGRAPHY, *PHOSPHORS, *NANOIMPRINT lithography, *MEMBRANE filters, *FLUIDIC devices
Abstract

A combined process of nanoimprint lithography and dual‐side aligned photolithography to address misalignment of subsequent layers for the fabrication of SiNx nanoporous membrane filters (SiNx nanofilter) is suggested. Here, in one process, 21 SiNx nanofilter chips are fabricated on a 6 inch Si wafer by aligning nanopore area of nanofilter and template area of nanofilter chip. An SiNx nanofilter chip‐integrated fluidic device is used to test the purification ability of the nanofilter in terms of its pore size and surface hydrophobicity or hydrophilicity. This is the first attempt at separating unnecessary chemical residues from a mixed reactant solution by nanoscale purification process using the tremendous number of nanoholes in the nanofilter. After purification by the nanofilter, high efficiency and narrow‐band Cs3MnBr5 phosphor is synthesized by evaporative crystallization. Here, the photoluminescent quantum yield (PLQY) of the purified Cs3MnBr5 phosphor is monitored to evaluate the purification ability of the SiNx nanofilter. The highest PLQY (53%) of Cs3MnBr5 green phosphors is obtained by purification of reactant solution using nanofilter with 50 nm nanopore diameter and hydrophilic surface. This combined process proves its potential for scalable manufacturing of complex designed SiNx nanofilter chips for chemical species sieving and other applications. [ABSTRACT FROM AUTHOR]

Published
2022
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45. Remote Manipulation of Slidable Nano‐Ligand Switch Regulates the Adhesion and Regenerative Polarization of Macrophages

Author

Choi, Hyojun, primary, Bae, Gunhyu, additional, Khatua, Chandra, additional, Min, Sunhong, additional, Jung, Hee Joon, additional, Li, Na, additional, Jun, Indong, additional, Liu, Hui‐Wen, additional, Cho, Youngkyu, additional, Na, Kyu‐Hwan, additional, Ko, Minji, additional, Shin, Hongchul, additional, Kim, Yoon Hyuck, additional, Chung, Seok, additional, Song, Jae‐Jun, additional, Dravid, Vinayak P., additional, and Kang, Heemin, additional

Published
2020
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47. In Situ Magnetic Control of Macroscale Nanoligand Density Regulates the Adhesion and Differentiation of Stem Cells

Author

Khatua, Chandra, primary, Min, Sunhong, additional, Jung, Hee Joon, additional, Shin, Jeong Eun, additional, Li, Na, additional, Jun, Indong, additional, Liu, Hui-Wen, additional, Bae, Gunhyu, additional, Choi, Hyojun, additional, Ko, Min Jun, additional, Jeon, Yoo Sang, additional, Kim, Yu Jin, additional, Lee, Joonbum, additional, Ko, Minji, additional, Shim, Gyubo, additional, Shin, Hongchul, additional, Lee, Sangbum, additional, Chung, Seok, additional, Kim, Young Keun, additional, Song, Jae-Jun, additional, Dravid, Vinayak P., additional, and Kang, Heemin, additional

Published
2020
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