Proceedings of the 2024 FDA-CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products

Jennifer K. Lee, Ha-Na Lee, Sudhir Agrawal, Joseph A. Balsamo, Andrew Clerman, Sofie Denies, Anne De Groot, Jeremy Fry, Nicolas Gaudenzio, Andrew J. Graves, Kristina E. Howard, SuJin Hwang, Vibha Jawa, Yafei Jin, Logan Kelly-Baker, Emilee Knowlton, Filip Kolenc, Kirthiram Krishnaveni Sivakumar, Jae H. Lee, Yili Li, Likan Liang, Dahui Liu, Yanyan Liu, Robert Lionberger, Markham C. Luke, Mohanraj Manangeeswaran, Mirian Mendoza, Iilun Murphy, Michael Norcross, James E. Polli, Montserrat Puig, Narasimha Rao SP, Hobart Rogers, Anna Schwendeman, Robert Siegel, Sophie Shubow, Noel Smith, Seth G. Thacker, Sophie Tourdot, Kui Yang, Li Zhang, Deyi Zhang, Cameron J. Smith, Eric S. Pang, Daniela Verthelyi

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DOI: 10.1208/s12248-025-01164-0
Published: 2026-02-12
Container: The AAPS Journal
Publisher: Springer Science and Business Media LLC
Open access: unknown

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Cite this work

BibTeX

@article{allodium:10.1208/s12248-025-01164-0,
  title = {Proceedings of the 2024 FDA-CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products},
  author = {Jennifer K. Lee and Ha-Na Lee and Sudhir Agrawal and Joseph A. Balsamo and Andrew Clerman and Sofie Denies and Anne De Groot and Jeremy Fry and Nicolas Gaudenzio and Andrew J. Graves and Kristina E. Howard and SuJin Hwang and Vibha Jawa and Yafei Jin and Logan Kelly-Baker and Emilee Knowlton and Filip Kolenc and Kirthiram Krishnaveni Sivakumar and Jae H. Lee and Yili Li and Likan Liang and Dahui Liu and Yanyan Liu and Robert Lionberger and Markham C. Luke and Mohanraj Manangeeswaran and Mirian Mendoza and Iilun Murphy and Michael Norcross and James E. Polli and Montserrat Puig and Narasimha Rao SP and Hobart Rogers and Anna Schwendeman and Robert Siegel and Sophie Shubow and Noel Smith and Seth G. Thacker and Sophie Tourdot and Kui Yang and Li Zhang and Deyi Zhang and Cameron J. Smith and Eric S. Pang and Daniela Verthelyi},
  year = {2026},
  journal = {The AAPS Journal},
  doi = {10.1208/s12248-025-01164-0},
  url = {https://doi.org/10.1208/s12248-025-01164-0}
}

RIS

TY  - JOUR
TI  - Proceedings of the 2024 FDA-CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products
AU  - Jennifer K. Lee
AU  - Ha-Na Lee
AU  - Sudhir Agrawal
AU  - Joseph A. Balsamo
AU  - Andrew Clerman
AU  - Sofie Denies
AU  - Anne De Groot
AU  - Jeremy Fry
AU  - Nicolas Gaudenzio
AU  - Andrew J. Graves
AU  - Kristina E. Howard
AU  - SuJin Hwang
AU  - Vibha Jawa
AU  - Yafei Jin
AU  - Logan Kelly-Baker
AU  - Emilee Knowlton
AU  - Filip Kolenc
AU  - Kirthiram Krishnaveni Sivakumar
AU  - Jae H. Lee
AU  - Yili Li
AU  - Likan Liang
AU  - Dahui Liu
AU  - Yanyan Liu
AU  - Robert Lionberger
AU  - Markham C. Luke
AU  - Mohanraj Manangeeswaran
AU  - Mirian Mendoza
AU  - Iilun Murphy
AU  - Michael Norcross
AU  - James E. Polli
AU  - Montserrat Puig
AU  - Narasimha Rao SP
AU  - Hobart Rogers
AU  - Anna Schwendeman
AU  - Robert Siegel
AU  - Sophie Shubow
AU  - Noel Smith
AU  - Seth G. Thacker
AU  - Sophie Tourdot
AU  - Kui Yang
AU  - Li Zhang
AU  - Deyi Zhang
AU  - Cameron J. Smith
AU  - Eric S. Pang
AU  - Daniela Verthelyi
PY  - 2026
JO  - The AAPS Journal
DO  - 10.1208/s12248-025-01164-0
UR  - https://doi.org/10.1208/s12248-025-01164-0
ER  -

APA

Lee, J. K., Lee, H., Agrawal, S., Balsamo, J. A., Clerman, A., Denies, S., Groot, A. D., Fry, J., Gaudenzio, N., Graves, A. J., Howard, K. E., Hwang, S., Jawa, V., Jin, Y., Kelly-Baker, L., Knowlton, E., Kolenc, F., Sivakumar, K. K., Lee, J. H., Li, Y., Liang, L., Liu, D., Liu, Y., Lionberger, R., Luke, M. C., Manangeeswaran, M., Mendoza, M., Murphy, I., Norcross, M., Polli, J. E., Puig, M., SP, N. R., Rogers, H., Schwendeman, A., Siegel, R., Shubow, S., Smith, N., Thacker, S. G., Tourdot, S., Yang, K., Zhang, L., Zhang, D., Smith, C. J., Pang, E. S., & Verthelyi, D. (2026). Proceedings of the 2024 FDA-CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products. The AAPS Journal. https://doi.org/10.1208/s12248-025-01164-0

Source records

crossref · retrieved 2026-09-27T09:30:14.190Z