FDA and the Center for Research on Complex Generics (CRCG) hosted a free public workshop on November 3, 2022: Formulation Characterization and Cutaneous Pharmacokinetics to Facilitate Generic Topical Product Development
About the Event:
The limited number of certain generic topical products may have resulted from the difficulty in demonstrating bioequivalence (BE) efficiently. To address this public health issue, FDA invested in research and developed new in vitro (laboratory), in silico (computational modeling) and in vivo (clinical) approaches, which could be used to establish the BE of topical products in a far more efficient manner. Efficient characterization-based approaches to demonstrate BE are now established for prospective generic drug products, but their utility is limited to instances when the formulation composition of prospective generic products is well matched to that of the reference standard. In other instances, comparative clinical endpoint BE studies continue to be utilized.
The purpose of this workshop is to discuss efficient, science-based BE approaches in development that may be useful for certain prospective generic products that are compositionally different compared to the reference standard. These approaches may utilize sophisticated techniques that have been developed to characterize the physical, structural, sensorial and thermodynamic properties of topical drug products applied on the skin, as well as in vivo cutaneous pharmacokinetics (PK) studies. The workshop will provide an update on the progress of research activities funded by the Generic Drug User Fee Amendments, explore challenging issues that would benefit from broader discussion, identify areas that should be targeted with further research, and discuss opportunities for coordination and collaboration between FDA, the generic industry, academic institutions, contract research organizations, consultants and others involved in generic drug development.
FDA and the Center for Research on Complex Generics—which is a collaboration between the University of Maryland School of Pharmacy and the University of Michigan College of Pharmacy—are dedicated to advancing programs that stimulate scientific dialogue, disseminate current insights about complex generics, and generate new knowledge in support of FDA’s mission to promote and protect the public health by increasing access to safe and effective generic medicines.
Topics:
- Understanding the influence of inactive ingredients and other aspects of topical formulations on their performance
- Establishing the theoretical framework and scientific principles for well-controlled in vivo cutaneous PK studies that are sensitive and discriminating
- Elucidating practical challenges associated with method development and validation of in vivo cutaneous PK methodologies
Audience:
The generic drug industry, academic institutions, contract research organizations, consultants, and others involved in, or whose work supports, the development of generic drug products.
Workshop Recordings:
- 2022 Topical Product Formulation Workshop Welcome & Opening Remarks
- 2022 Topical Product Formulation Workshop Session 1 Presentations & Panel Discussion
- 2022 Topical Product Formulation Workshop Session 2 Presentations & Panel Discussion
- 2022 Topical Product Formulation Workshop Session 3 Presentations, Panel Discussion, Summary, Close
Workshop Slides:
Welcome and Opening Remarks
James Polli, PhD, Co-Director, CRCG
Anna Schwendeman, PhD, Co-Director, CRCG
Clinical Relevance of Understanding the Impact of Formulation on Product Performance
Markham Luke, MD, PhD, FAAD, Director, DTP-I, ORS, OGD, FDA
Overview of GDUFA Research Efforts to Develop Efficient Approaches by which to Demonstrate BE for Drug Products Applied to the Skin
Sam Raney, PhD, Associate Director for Science, ORS, OGD, FDA
SESSION 1: Understanding the Influence of Formulation Differences on Product Performance
Introduction to Session 1
Priyanka Ghosh, PhD, Senior Pharmacologist, DTP-I, ORS, OGD, FDA
Effect of Formulation Differences on Critical Quality Attributes and Performance of the Complex Topical Products
Sameer Sachdeva, PhD, Associate Director/Sr. Research Scientist, Amneal Pharmaceuticals
Development Strategies for Generic Topical Products with Formulation Differences to Reference Product
Vaibhav Dubey, MPharm, PhD, Deputy GM, Specialty Formulations, Alembic Pharmaceuticals Ltd.
Establishing Bioequivalence Using Characterization Based Approaches For Topical Products–Challenges & Solutions
Romit Jani, MS-Pharm, Director, Formulation R&D, Solaris Pharma Corporation
Influence of Progressive Change in the Degree of Saturation of API on the Performance of Topical Products
S. Narasimha Murthy, PhD, CSO, Topical Product Testing, LLC
Development of Methods for Evaluation of Formulation Differences and their Impact on Therapeutic Equivalence: Broadening the Therapeutic Scope
Yousuf Mohammed, PhD, Sr. Research Fellow/Leader, Univ. of Queensland, Diamantina Institute
Q&A Session with Panel
- Moderator: Priyanka Ghosh, PhD, Senior Pharmacologist, DTP-I, ORS, OGD, FDA
- Panelists:
Vaibhav Dubey, PhD, Deputy GM, Specialty Formulations, Alembic Pharmaceuticals Ltd.
Romit Jani, MS, Director, Formulation R&D, Solaris Pharma Corporation
Likan Liang, PhD, Branch 5 Chief, DLBP-II, OLDP, OPQ, FDA
Markham Luke, MD, PhD, FAAD, Director, DTP-I, ORS, OGD, FDA
Yousuf Mohammed, PhD, Sr. Research Fellow/Leader, University of Queensland, Diamantina Institute
Narasimha Murthy, PhD, CSO, Topical Product Testing, LLC
Sam Raney, PhD, Associate Director for Science, ORS, OGD, FDA
Sameer Sachdeva, PhD, Associate Director/Sr. Research Scientist, Amneal Pharmaceuticals
SESSION 2: Development of Cutaneous PK Based Approaches
Introduction to Session 2
Sam Raney, PhD, Associate Director for Science, ORS, OGD, FDA
A Microdialysis Approach to Assess Cutaneous Pharmacokinetics of Topical Dermatological Drug Products
Benjamin Kuzma, PhD, Research Scientist, Global DMPK, Vertex Pharmaceuticals Inc.
Continuous Skin Sampling Methods for the Assessment of Cutaneous PK-Based Bioequivalence
Frank Sinner, PhD, VP Regulatory & Strategic Affairs, IBHS, Joanneum Research, GmbH
Cutaneous PK-based Techniques: Translating Scientific Advances to Regulatory Methods
Tannaz Ramezanli, PharmD, PhD, Senior Pharmacologist, DTP-I, ORS, OGD, FDA
Q&A Session with Panel
- Moderator: Sam Raney, PhD, Associate Director for Science, ORS, OGD, FDA
- Panelists:
Charlie DiLiberti, MS, President, Montclair Bioequivalence Services, LLC
Candis Edwards, MS, Senior Vice President, Regulatory Affairs, Amneal Pharmaceuticals
Benjamin Kuzma , PhD, Research Scientist, Global DMPK, Vertex Pharmaceuticals Inc.
Hiren Patel, PhD, Staff Fellow, DB-II, OB, OGD, FDA
Tannaz Ramezanli, PharmD, PhD, Senior Pharmacologist, DTP-I, ORS, OGD, FDA
Chinmay Shukla, PhD, Clinical Pharmacology Team Leader, DIIP, OCP, OTS, FDA
Frank Sinner, PhD, VP Regulatory & Strategic Affairs, IBHS, Joanneum Research, GmbH
Nageshwar Thudi, PhD, VP Global Generics and Biosimilar Clinical Dev/Ops, Teva Pharmaceuticals
SESSION 3: Method Development and Validation of Cutaneous PK Based Approaches
Introduction to Session 3
Tannaz Ramezanli, PharmD, PhD, Senior Pharmacologist, DTP-I, ORS, OGD, FDA
Q&A Session with Panel
Topics:
- Method development and validation strategies
- Data analysis
- Anticipated non-technical challenges
- Moderator: Tannaz Ramezanli, PharmD, PhD, Senior Pharmacologist, DTP-I, ORS, OGD, FDA
Panelists:
Manfred Bodenlenz, PhD, Senior Scientist, Joanneum Research, GmbH
Robert Lionberger, PhD, Director, ORS, OGD, FDA
Hiren Patel, PhD, Staff Fellow, DB-II, OB, OGD, FDA
Sam Raney, PhD, Associate Director for Science, ORS, OGD, FDA
Elena Rantou, PhD, Lead Mathematical Statistician, Office of Biostatistics, OTS, FDA
Nilufer Tampal, PhD, Associate Director, OB, OGD, FDA
Eleftheria Tsakalozou, PhD, Senior Pharmacologist, DQMM, ORS, OGD, FDA
Miyoung Yoon, PhD, Team Lead, DQMM, ORS, OGD, FDA
Jinhui Zhang, PhD, Chemist, DPQR, OTR, OPQ, FDA
For More Information:
If you have any questions about this workshop please contact info@complexgenerics.org.
