Proceedings of the 2024 FDA-CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products.
Article in The AAPS journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
2 · The registry
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
5 · Who and what money
Authors and funding
45 authors.
Jennifer K Lee *Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0002-2282-2131
Ha-Na Lee *Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0001-5063-6689
Joseph A BalsamoOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0003-3646-9364
Andrew ClermanOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0009-0008-0230-3677
Kristina E HowardOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0001-8891-754X
SuJin HwangOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0009-0002-2898-7348
Yafei JinOffice of Pharmaceutical Quality Assessment I, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0002-2501-7787
Logan Kelly-BakerOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0003-4411-2058
Filip KolencSandoz Development Center Slovenia, Lek Pharmaceuticals d.d, Ljubljana, Slovenia.ORCID 0009-0004-6043-8191
Kirthiram Krishnaveni SivakumarOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0003-1857-817X
Jae H LeeOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0001-5588-6329
Yili LiOffice of Pharmaceutical Quality Assessment II, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0009-0009-6397-5781
Likan LiangOffice of Pharmaceutical Quality Assessment II, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0009-0007-2101-7142
Dahui LiuOffice of Pharmaceutical Quality Assessment I, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0009-0006-2970-8784
Yanyan LiuOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0002-7410-5476
Robert LionbergerOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0002-0598-1771
Markham C LukeOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0001-6887-3156
Mohanraj ManangeeswaranOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0002-4021-9352
Mirian MendozaOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0009-0002-3680-1232
Iilun MurphyImmediate Office, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0009-0006-8102-3694
Michael NorcrossOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0009-0008-2742-1610
James E PolliDepartment of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, MD, USA.ORCID 0000-0002-5274-4314
Montserrat PuigOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0001-8641-5706
Hobart RogersOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0001-5352-1270
Anna SchwendemanDepartment of Pharmaceutical Sciences and the Biointerfaces Institute, University of Michigan, Ann Arbor, MI, USA.ORCID 0000-0002-8023-8080
Sophie ShubowOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0009-0007-1087-4261
Seth G ThackerOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0001-9944-8937
Kui YangOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, St Louis, MO, USA.ORCID 0000-0001-6550-8583
Li ZhangOffice of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0002-2679-0712
Deyi ZhangOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0009-0000-0111-2280
Cameron J SmithOffice of Pharmaceutical Quality Assessment I, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0002-7091-150X
Eric S PangOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. eric.pang@fda.hhs.gov.ORCID 0009-0004-7618-5950
Daniela VerthelyiOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. Daniela.Verthelyi@fda.hhs.gov.ORCID 0000-0002-5450-3071
Funding
Intramural FDA HHS FD999999
6 · The paper itself
Abstract
On Oct 7 and 8, 2024, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) co-hosted a workshop titled "Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products". Stakeholders from the FDA, industry, academia, and contract research organizations convened to discuss strategies for advancing risk assessment methodologies and regulatory frameworks for complex generic products. By assembling experts from various sectors, the workshop explored various available strategies for immunogenicity risk assessment, providing valuable insights to support the development and assessment of generic peptide and oligonucleotide drug products. The discussions fostered a deeper understanding of how these methodologies can inform regulatory decision-making and enhance the development of safer and more effective therapeutics.
Indexed as
Drugs, GenericOligonucleotidesPeptidesDrug ApprovalHumansRisk AssessmentUnited StatesUnited States Food and Drug AdministrationDrugs, GenericOligonucleotidesPeptidesgenericsimmunogenicity risk assessmentimpuritiesoligonucleotide productspeptide products
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.
Proceedings of the 2024 FDA-CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products. · full record | OpenQuestion