Jerry Lin
JobTitle： Adjunct Assistant Professor
CurrentJob： Adjunct Assistant Professor
E-mail： D000020807@cgu.edu.tw
Phone： 0972930915
Education： Ph.D., in Biomedical & Health Sciences Program, Rutgers University, US
Expertise： 1. PIC/S：Guide to Good Manufacturing Practice for Medicinal Products 2. Regenerative Medicine Regulations 3. AI-Driven Quality Risk Management
Website： https://www.linkedin.com/in/chun-yi-lin-77578241/
Research Direction
1. PIC/S：Guide to Good Manufacturing Practice for Medicinal Products: PIC/S GMP regulations constitute essential professional knowledge for those involved in pharmaceutical manufacturing. As a member state of PIC/S, and in accordance with the Pharmaceutical Affairs Act, the manufacture of pharmaceuticals must comply with PIC/S GMP for Medicinal Products. This means that pharmaceuticals manufactured without adhering to the PIC/S GMP quality system may not be sold in PIC/S member states (e.g., the European Union, the United States, and Japan). With over a decade of experience as the Head of Quality Assurance at pharmaceutical companies specializing in small molecules, large molecules, and cell therapies, I hope to share this expertise in the classroom.2. Regenerative Medicine Regulations: Students with experience in biotechnology, combined with a solid understanding of regulations, will possess a strong competitive edge in the regenerative medicine industry, which is a key focus of national support. The "Dual Laws on Regenerative Medicine" (the Regenerative Medicine Act and the Regenerative Medicinal Products Act) were promulgated and took effect on New Year’s Day 2026, marking Taiwan’s formal incorporation of Advanced Therapy Medicinal Products (ATMPs) into its standard pharmaceutical regulatory framework. Due to their unique characteristics—such as high environmental sensitivity, release under conditions of high variability and short half-lives, and viral contamination removal technologies—these products enable pharmaceutical companies to establish extremely high technical barriers to entry. A solid legal basis is the cornerstone of the industry's future development, and now is the best time to enter the market.
3. AI-Driven Quality Risk Management: Smart pharmaceutical manufacturing is a major highlight in the pharmaceutical industry. In GMP quality management, regulations place a high priority on the oversight of quality risks, particularly for highly variable regenerative medical products. Traditional manual quality management approaches have inherent limitations, exposing the manufacturing process of regenerative medical products to extremely high risks. The focus of quality risk management lies in classification, and one of the strengths of large language models is precisely classification. Utilizing large language models to manage quality risks will represent a significant breakthrough in smart pharmaceutical manufacturing.
Publications
Journals1. Cellular Memory of HipA-Induced Growth Arrest: The Length of Cell Growth Arrest Becomes Shorter for Each Successive Induction. Lin C.Y., Hamini S., Tupa P.R., Masuda H. (2021). Microorganisms 9, 2594.
2. Characterization of YjjJ toxin of Escherichia coli. Maeda Y., Lin C.Y., Ishida Y., Inouye M., Yamaguchi Y., Phadtare S. (2017). FEMS Microbiol Lett 15, 364.
3. Transcriptional Repressor HipB Regulates the Multiple Promoters in Escherichia coli. Lin, C.Y., Awano, N., Masuda, H., Park, J.H., and Inouye, M. (2013). J Mol Microbiol Biotechnol 23, 440-447.
4. Crosstalk between Arg 1175 methylation and Tyr 1173 phosphorylation negatively modulates EGFR-mediated ERK activation. Hsu, J.M., Chen, C.T., Chou, C.K., Kuo, H.P., Li, L.Y., Lin, C.Y., Lee, H.J., Wang, Y.N., Liu, M., Liao, H.W., Shi, B., Lai, C.C., Bedford, M.T., Tsai, C.H., and Hung, M.C. (2011). Nat Cell Biol 13, 174-181.
5. CDK1-dependent phosphorylation of EZH2 suppresses methylation of H3K27 and promotes osteogenic differentiation of human mesenchymal stem cells. Wei, Y., Chen, Y.H., Li, L.Y., Lang, J., Yeh, S.P., Shi, B., Yang, C.C., Yang, J.Y., Lin, C.Y., Lai, C.C., and Hung, M.C. (2011). Nat Cell Biol 13, 87-94.
6. The suppression of MAD1 by AKT-mediated phosphorylation activates MAD1 target genes transcription. Chou, C.K., Lee, D.F., Sun, H.L., Li, L.Y., Lin, C.Y., Huang, W.C., Hsu, J.M., Kuo, H.P., Yamaguchi, H., Wang, Y.N., Liu, M., Wu, H.Y., Liao, P.C., Yen, C.J., and Hung, M.C. (2009). Mol Carcinog 48, 1048-1058.
7. Down-regulation of myeloid cell leukemia-1 through inhibiting Erk/Pin 1 pathway by sorafenib facilitates chemosensitization in breast cancer. Ding, Q., Huo, L., Yang, J.Y., Xia, W., Wei, Y., Liao, Y., Chang, C.J., Yang, Y., Lai, C.C., Lee, D.F., Yen, C.J., Chen, Y.J., Hsu, J.M., Kuo, H.P., Lin,C.Y., Tsai, F.J., Li, L.Y., Tsai, C.H., and Hung, M.C. (2008). Cancer Res 68, 6109-6117.
8. Dynamic localization and functional implications of Aurora-C kinase during male mouse meiosis. Tang, C.J., Lin, C.Y., and Tang, T.K. (2006). Dev Biol 290, 398-410.
Patent
Risk Vector Generation System: Republic of China Invention Patent (I919879), patent term expires on April 23, 2045.
Risk Vector Control System: Republic of China Invention Patent (I919880), patent term expires on April 23, 2045.
Awards
1. Passed a US FDA inspection regarding data integrity
2. Assisted the nation’s first cell therapy pilot plant in obtaining PIC/S GMP certification from the TFDA