Back to: FDA Generic Drug Science and Research Initiatives Public Workshop 2025
Presenters
Introduction
Cameron Smith, PhD
Supervisory Pharmaceutical Scientist
Division of Product Quality Assessment IV (DPQA IV)
Office of Product Quality Assessment I (OPQA I)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Yan Wang, PhD
Deputy Division Director
Division of Therapeutic Performance I (DTP I)
Office of Regulatory Science (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Immunogenicity Risk Assessment of Peptides: Progress and Remaining Challenges
Eric Pang, PhD
Senior Chemist, Division of Therapeutic Performance I (DTP I)
Office of Regulatory Science (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Generic Oligonucleotides – Challenges and Opportunities
Likan Liang, PhD
Supervisory Pharmaceutical Scientist
Division of Product Quality Assessment X (DPQA X)
Office of Product Quality Assessment II (OPQA II)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Challenges in Immunogenicity Risk Assessment for Complex Active Ingredients
MK Pananchukunnath, MCP
Chief Scientific Officer, Biocon Ltd.
Research Initiatives for Harmonization of Immunogenicity Risk Assessments for Generic Peptides
Andrew Graves, MS, SCYM
Director, Immunogenicity Assessment
Teva Pharmaceutical Industries Ltd.
Immunogenicity of Oligonucleotides
Sudhir Agrawal, DPhil
President, ARNAY Sciences
Affiliate Professor, University of Massachusetts
Immunological Challenges Associated with Nucleic Acid-Based Therapeutics
Raman Bahal, PhD
Associate Professor, University of Connecticut
Abstract
This session, “Assessment Challenges with Complex Active Ingredients: Peptides & Oligonucleotides,” examines the distinct immunogenicity risks and development hurdles for generic peptides and oligonucleotides. For peptides, speakers address the FDA’s review process for products with 40 or fewer amino acids, emphasizing the assessment of innate and adaptive immune responses to impurities. Challenges in in silico and in vitro assessments include predicting effects from modified amino acids, validating models, and the lack of standardized assays and working standards. For oligonucleotides, significant difficulties arise in demonstrating diastereomeric composition sameness due to the high number of possible diastereomers and limited analytical resolution, along with complex impurity analysis. Experts explain how the chemistry, sequence, and modifications of oligonucleotides influence immune activation through pattern recognition receptors. The session collectively highlights the critical need for harmonized protocols, standardized assays, and clear regulatory guidance to streamline generic drug development, reduce costs, and ensure consistent safety assessments. Collaborative research among regulatory bodies, industry, and academia is encouraged to advance analytical methods, validate in silico tools, and expand approval pathways for these complex generic drug products, ultimately enhancing patient access.