Best Practices for Utilizing Modeling Approaches to Support Generic Product Development

FDA and the Center for Research on Complex Generics (CRCG) will host a free public workshop on October 27-28, 2022: Best Practices for Utilizing Modeling Approaches to Support Generic Product Development

Workshop Times:

Day 1 (Oct. 27): 8:30 a.m. – 5:00 p.m.

Day 2 (Oct. 28): 8:30 a.m. – 3:40 p.m.

Registration:

This workshop is FREE. Register now. 

About the Event:

Quantitative methods and modeling approaches have been increasingly utilized by the generic drug industry and regulatory agencies, including the FDA, to support generic product development and regulatory assessments. These quantitative methods and modeling involve mechanistic modeling such as physiologically based pharmacokinetic (PBPK) modeling and computational fluid dynamics (CFD) modeling, quantitative clinical pharmacology tool sets such as population pharmacokinetics (PPK) approaches, and advanced data analytics methodologies. Quantitative methods, modeling and simulation approaches are being utilized to support alternative bioequivalence (BE) approaches and to minimize the burden of (or even alleviate the need for) in vivo BE studies.

The purpose of this workshop is to discuss how to modernize approaches for efficiently demonstrating BE, to establish their role in modern paradigms of generic drug development, and to explore and develop best practices for the use of modeling and simulation approaches in regulatory submissions and approval. This workshop will engage experts from regulatory agencies, the generic drug industry, consultants, academia, and others in the field of modeling and simulation to discuss the opportunities and best practices for incorporating modeling and simulation approaches into generic drug development programs and regulatory submissions. The workshop will also identify commonalities in methodologies/workflows or in silico models supporting alternative BE approaches and clarify how a model master file may be leveraged to advance drug product development, facilitate regulatory assessment, and streamline drug product approval.

FDA and the CRCG—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:

  • Use of model integrated evidence to support demonstrations of BE in a regulatory context
  • Use of the same or similar model or modeling strategy across multiple submissions related to complex drug products
  • Mechanistic modeling approaches supporting BE assessments for oral drug products
  • Applications of quantitative comparative approaches to support the development of complex generic drug products
  • Case examples supporting the recently introduced concept of “model master files”

Audience:

The generic and new drug industry, research organizations, academia, international regulatory agencies, and other parties interested in, or whose work supports, the development of generic drug products.

Workshop Outline:

Symposium I: Modeling Best Practices for Generic Drug Development

Session 1: Experience Learned and Perspectives on Using Model Integrated Evidence (MIE) in the Regulatory Context

This session will share the experiences, lessons learned, and challenges faced by speakers from regulatory agencies based on regulatory submissions with MIE.

  • Presentations by experts from FDA and other regulatory agencies (3 presentations)
  • Audience Q&A with panelists from FDA, industry, and academia

Session 2: Use of the Same Model or Modeling Strategy Across Multiple Submissions:  Focus on Complex Drug Products

This session will discuss the development of a framework that would facilitate the use of the same or similar model (structure) or modeling strategy across multiple regulatory submissions involving complex drug products administered from non-oral routes.

  • Presentations by experts from FDA and industry (5 presentations)
  • Audience Q&A with panelists from FDA, industry, and academia

Session 3: Using Mechanistic Modeling Approaches to Support BE Assessments for Oral Products

This session will (1) discuss how mechanistic modeling can be used to support product development and regulatory submissions for oral dosage forms, (2) share the current state of mechanistic modeling for BE assessment through case studies pertaining to orally administered drug products, and (3) establish a consensus on best practices for using oral absorption PBPK modeling for risk-based assessments.

  • Presentations by experts from FDA and industry (4 presentations)
  • Audience Q&A with panelists from FDA, industry, and academia

Session 4: Development of Quantitative Comparative Approaches to Support Complex Generic Drug Development

This session will discuss the opportunities, challenges, and best practices of utilizing advanced quantitative methods in assessments of BE studies to support complex generic drug development.

  • Presentations by experts from FDA and industry (4 presentations)
  • Audience Q&A with panelists from FDA, industry, and academia

Symposium II: Model Sharing, Acceptance, and Communication with FDA

This symposium will explore and discuss practical and efficient ways to facilitate the concept of model master files as part of best practices in MIE implementation.

  • Presentations by experts from FDA and industry (4 presentations)
  • Audience Q&A with panelists from FDA, industry, and academia

For More Information:

If you have any questions about this workshop please contact complexgenerics@rx.umaryland.edu.