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Symposium

General Pharmacometrics

C5B - FDA’s Model Master Files: Paving the Path for Innovative Technologies and Increased Regulatory Acceptance of Modeling and Simulation Approaches

Tuesday, October 21, 2025
1:45 PM - 3:15 PM MDT
Location: Red Rock 8/9

Disclosure(s):
Eleftheria Tsakalozou, PhD: No financial relationships to disclose
Cynthia J (CJ) Musante, PhD: No relevant disclosure to display
Rajanikanth Madabushi, PhD, MBA: No financial relationships to disclose
Timothy Nicholas, PhD: No relevant disclosure to display
Sivacharan Kollipara, M.Pharm: No financial relationships to disclose

Description of session (include background & scientific importance): Modeling and simulation approaches are increasingly informing decisions in the development of both innovator and generic drug products to reduce unnecessary human testing and support regulatory approval. When these approaches support regulatory submissions, they involve a rigorous development and documentation process by applicants and undergo a detailed scientific and regulatory assessment. To limit redundancy and to improve accessibility and reusability of these promising methodologies, the FDA has introduced the use of Model Master File (MMF), a Type V Drug Master File, in support of Abbreviated New Drug Applications (ANDAs).
An MMF “refers to a set of information and data on an in silico quantitative model or modeling platform supported by sufficient verification and validation”. Grounded on model-sharing and model-reusability, MMFs can support the model-integrated evidence (MIE) paradigm for generics by benefiting multiple regulatory applications of the same or similar in certain key aspects of products or by informing lifecycle management decisions for a product. For both innovator drugs and generics, MMFs that capture the dynamic nature of in silico models and methodologies may include, but not be limited to, a drug product-specific model, a verified and validated in silico framework for products with the same route of administration, and a recognized modeling methodology or framework for a particular context of use.
MMF submissions aim to advance the role of in silico methodologies in the development and regulatory approval of safe and effective therapeutic options through the standardization of these methods, improving their credibility towards decision-making and streamlining regulatory submissions.

Learning Objectives:

  • • Understand the role and operational aspects of MMFs as Type V DMFs in supporting regulatory submissions that include M&S approaches. • Understand the benefits for pharmaceutical industry and regulatory agencies on benchmarking in silico methodologies to increase acceptance and accessibility of M&S. • Identify pathways the MMFs can be leveraged in the product development paradigm and in regulatory submissions for generic drugs.

Presentations:

  • 1:45 PM - 2:05 PM MDT
    The Development and Framework of MMF as a Regulatory Initiative.

    Speaker: Eleftheria Tsakalozou, PhD – US FDA

  • 2:05 PM - 2:25 PM MDT
    Use of Fit-for-Purpose Program to Support the Reusability of Novel Tools for New Drug Development

    Speaker: Rajanikanth Madabushi, PhD, MBA – FDA

  • 2:25 PM - 2:45 PM MDT
    Model Development Lifecycle (MDLC) and Applications in Clinical Development. Implications for MMF

    Speaker: Timothy Nicholas, PhD – Pfizer

  • 2:45 PM - 3:05 PM MDT
    Model Master File Framework in Generic Product Development: Challenges, Opportunities and Case Examples

    Speaker: Sivacharan Kollipara, M.Pharm (he/him/his) – Dr. Reddy’s Laboratories Ltd

  • 3:05 PM - 3:15 PM MDT
    Panel - FDA’s Model Master Files: Paving the Path for Innovative Technologies and Increased Regulatory Acceptance of Modeling and Simulation Approaches

    Panelist: Eleftheria Tsakalozou, PhD – US FDA

    Panelist: Rajanikanth Madabushi, PhD, MBA – FDA

    Panelist: Timothy Nicholas, PhD – Pfizer

    Panelist: Sivacharan Kollipara, M.Pharm (he/him/his) – Dr. Reddy’s Laboratories Ltd