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Tuesday, June 26 • 2:00pm - 3:15pm
#265: ICH M9 BCS-Based Biowaivers

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-600-L04-P; CME 1.25; IACET 1.25; RN 1.25

The ICH M9 Expert Working Group has developed a preliminary draft of a harmonized guideline for BCS-Based Biowaivers that focuses on standardizing Biopharmaceutics Classification System criteria for demonstrating solubility, permeability/absorption, other pharmacological attributes and in vitro comparative dissolution. This session will provide a summary of the objectives for establishing a harmonized guideline that will be applicable globally and highlight current contentious issues to be resolved including: • Solubility: Highest Strength vs. Highest Therapeutic Dose • Permeability: Applicability of in vitro data (Caco-2) • Dissolution Comparability: Establishing Harmonized Conditions & Methodology Criteria • Formulation Similarity: Product Composition Applicability & Influence of Excipients This session will highlight regional challenges and differences and opportunities for harmonized reconciliation.

Learning Objectives

Describe the current challenges related to biowaivers and the progress and potential of the future ICH M9 guideline.


Roger Nosal, PhD


ICH M9 BCS Based Biowaivers: Progress and Challenges
Roger Nosal, PhD

Revisiting Classification Criteria for Demonstrating Solubility, Permeability, and Comparative Dissolution
Paul Seo, PhD

Regional Challenges for Comparative Dissolution and Post-Approval Changes: Excipients
Talia Flanagan, PhD


Talia Flanagan

Associate Principal Scientist, Biopharmaceutics, AstraZeneca
Talia is Associate Principal Scientist in Biopharmaceutics in AstraZenecas Product Development group. She has extensive experience of developing biopharmaceutics and clinically relevant dissolution strategies in development and post-approval settings. Talia is EFPIA Deputy Topic Lead... Read More →
avatar for Roger Nosal

Roger Nosal

Vice President, Head of Global CMC, Pfizer Inc, United States
Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several ICH, PhRMA, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees... Read More →
avatar for Paul Seo

Paul Seo

Director, Division of Biopharmaceutics, ONDP, OPQ, CDER, FDA
Paul has worked for the FDA 15 years, and has gained experience in the Office of Generic Drugs, Office of Pharmaceutical Science, and Office of New Drug Quality Assessment. He currently oversees review processes in the Division of Biopharmaceutics, Office of New Drug Products, as... Read More →

Tuesday June 26, 2018 2:00pm - 3:15pm EDT
Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Session