A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs January 18, 2024

Virtual | Virtual

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• Date: January 18, 2024
• Time: 1:00 p.m. - 3:00 p.m. ET

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Topics & Presentations	Speakers
A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs
Introduction to MIE Industry Meeting Pilot Program.pdf	Liang Zhao, PhD Director Division of Quantitative Methods and Modeling (DQMM) Office of Research and Standards (ORS) Office of Generic Drugs (OGD) CDER
MIE Pilot Program: Process Overview.pdf	Maria Monroy-Osorio Regulatory Health Project Manager ORS | OGD | CDER
Potential Topics for Discussion Through the MIE Industry Meeting Pilot Program.pdf	Andrew Babiskin, PhD Lead Pharmacokineticist DQMM | ORS | OGD | CDER
Considerations and expectations when meeting with the FDA under the Industry Meeting Pilot MIE Program.pdf	Eleftheria Tsakalozou, PhD Senior Pharmacologist (Acting TL) DQMM | ORS | OGD | CDER
Speaker Panel Discussion	Moderator: Lanyan (Lucy) Fang, PhD Deputy Director DQMM | ORS | OGD | CDER | US FDA Panelists: Bhagwant Rege, PhD Division Director Division of Biopharmaceutics (DB) Office of New Drugs (NDP) Office of Pharmaceutical Quality (OPQ) CDER | US FDA Partha Roy, PhD Director Office of Bioequivalence (OB) OGD | CDER Robert Lionberger, PhD Director ORS | OGD | CDER Liang Zhao
Q&A Discussion Panel	Liang Zhao, Eleftheria Tsakalozou, Andrew Babiskin, Maria Monroy-Osorio And Fang Wu, PhD Senior Pharmacologist DQMM | ORS | OGD | CDER Meng Hu, PhD Lead Engineer DQMM | ORS | OGD | CDER
Closing Remarks	Robert Lionberger, PhD Director ORS | OGD | CDER

AGENDA

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ABOUT THIS WEBINAR

On October 1, 2023, FDA launched a new pilot offering meeting opportunities to prospective generic drug applicants and generic drug applicants who intend to use Model-Integrated Evidence (MIE) approaches for bioequivalence (BE) establishment in their abbreviated new drug applications (ANDAs). The use of MIE approaches for BE establishment is increasingly prevalent, particularly in the development of challenging products such as long acting injectables, orally inhaled drugs, and topically applied dermatological products. Industry regularly seeks FDA input on best practices for implementing MIE, including common model approaches, and addressing complex scientific and regulatory issues.

FDA will further discuss the MIE meeting pilot program, include considerations and expectations when meeting with FDA under the Industry Meeting Pilot MIE Program and discuss the types of potential topics that will be granted under the pilot program. Additionally, FDA will provide an overview of the submission and meeting process and a live Q&A with FDA experts to better assist generic drug applicants in their decision to submit a request for an MIE meeting under the pilot program.

INTENDED AUDIENCE

This webinar is for members of the generic drug industry, including current and prospective applicants who are interested in submitting an application for a generic drug, regulatory reviewers for generic drug assessments, consultants focused on bioequivalence, and clinical research coordinators.

TOPICS COVERED

• Goals and general principles of the MIE industry meeting pilot program
• Lessons learned from the pre-ANDA program and scope of topics to be granted under the MIE Pilot Program
• Overview of the MIE pilot program process

FDA RESOURCES

• Model-Integrated Evidence (MIE) Industry Meeting Pilot between FDA and Generic Drug Applicants
• MIE Pilot General Principles Document