Back to: FDA Generic Drug Science and Research Initiatives Public Workshop 2025
Presenters
Introduction
Bryan Newman, PhD
Lead Pharmacologist, 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)
Ahmed Zidan, PhD
Senior Research Pharmacologist
Division of Product Quality and Research V (DPQR V)
Office of Pharmaceutical Quality Research (OPQR)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Establishing Equivalence of TDS and OIDPs
Priyanka Ghosh, PhD
Lead Pharmacologist, 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)
FDA’s Perspectives on Current Quality and Bioequivalence Challenges for Complex Products
Andre O’Reilly Beringhs, PhD
Staff Fellow, 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)
Renishkumar Delvadia, PhD
Senior Staff Fellow, Division of Product Quality Assessment VIII (DPQA VIII),
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 and Opportunities for Complex Generic Products
Brandon Wood, BSc Sr.
Director, RA I & Combination Products Liaison
Teva Pharma USA, Inc.
Evolving Technologies Shaping New Research Needs for Future Pulmonary and Nasal Generics
Carla Vozone, PharmD, MBA
Vice President Specialty Drug Delivery, Catalent Pharma Solutions
A Taxonomy for Categorizing User Interface Design in Medical Device Development: Human Factors Application, Development Opportunities, and Potential Integration of AI and Machine Learning
Megan Conrad, PhD
Associate Professor of Mechanical Engineering
University of Detroit Mercy
Mary Beth Privitera, MDes, PhD
Professor, Biomedical Engineering
University of Cincinnati
Industry Insight: Clarity and Consistency for Complex Generics
Russell J. Rackley, PhD
Global Head, Clinical Pharmacology
Viatris
Abstract
The session “Future Horizons for Assessing the Bioequivalence of Complex Products: Challenges in the Next Five Years” at the FY 2025 Generic Drug Science and Research Initiatives Public Workshop explores critical issues in establishing equivalence for diverse complex generic products. Presenters from the FDA and industry discuss challenges for transdermal systems, including optimizing irritation and adhesion studies, and for orally inhaled drug products, particularly standardizing charcoal block PK studies and the number of inhalations for PK characterization. Discussions extend to the complexities of topical semisolids, where integrated modeling and Q3 assessment for compositional differences are explored, and to advanced injectables, ophthalmic, otic, peptide, and oligonucleotide products, highlighting needs for validated in vitro models, impurity characterization, and understanding excipient impact. Speakers also emphasize the ongoing propellant transition for metered dose inhalers, stressing the need for clear regulatory requirements and alternative bioequivalence pathways. The session addresses the critical role of human factors in medical device development, proposing a taxonomy and AI/ML integration for user interface design comparison to enhance patient safety. Industry insights highlight the need for greater clarity and consistency in guidance, particularly for analytical methodology, statistical analyses, and patient-based bioequivalence studies, while acknowledging GDUFA’s positive impact and calling for continued collaboration to accelerate patient access to these essential medicines.