in vitro at the Vanguard – Bioequivalence Testing and IVIVC

Recorded: September 27

This webinar will cover various aspects of in vitro bioequivalence (BE) testing, such as in vitro release testing (IVRT) and in vitro permeability testing (IVPT), establishment of in vitro/in vivo correlation (IVIVC), and regulatory perspective.

Agenda

• The importance of establishing an IVIVC or IVIVR for any route of administration ​
  • Ultimate goal for IVIVC/IVIVR: Establishment of safe space to gain regulatory flexibility (e.g. biowaivers)​
  • Approaches to build safe space: conventional vs. mechanistic (PBBM) ​
    • Regulatory considerations in the development and validation of IVIVCs/IVIVRs​
  • Regulatory applications of safe space​
    • The use of PBBM-Safe Space to guide the design of biopredictive in vitro release/dissolution methods​
• The special case of topically administered drugs: How do we assess BE in vitro? ​
  • Overview of IVRT and IVPT
  • Development, validation, and use of a product-specific method​

Moderated by:

Simon Taylor – Vice President DMPK, Drug Discovery Services Europe at Pharmaron

Speakers

Sandra Suarez-Sharp, Ph.D. – Vice President of Regulatory Affairs at Simulations Plus

Dr. Sandra Suarez-Sharp completed her undergraduate studies in Industrial Pharmaceutical Chemistry at the National Polytechnic Institute of Mexico City. Following her graduation, she gained practical experience working at Johnson and Johnson in Mexico. In 1997, she obtained her Ph.D. in Pharmaceutical Sciences from the University of Florida and later conducted postdoctoral research on Pulmonary Drug Delivery and Pharmacokinetics at the University of North Carolina. In 1999, Dr. Suarez-Sharp began her tenure at the U.S. Food and Drug Administration, in the Office of Clinical Pharmacology. For a decade, she served as a primary and secondary reviewer, providing support to multiple therapeutic divisions. She also worked as a reviewer in the Office of Generic Products, Division of Bioequivalence. Over time, she transitioned into the roles of Master Reviewer and Scientific Advisor within the Division of Biopharmaceutics, Office of Product Quality. Her expertise spanned several areas, including in vitro-in vivo correlation, biowaivers, real-time release testing dissolution models, and physiologically based biopharmaceutics modeling. During her tenure at the FDA, Dr. Suarez-Sharp actively contributed to the development of various industry guidance documents, with notable contributions to "The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls (PBBM)" published in October 2020. She also represented the FDA at national and international scientific events.

In March 2020, Dr. Suarez-Sharp joined Simulations Plus as Vice President of Regulatory Affairs. In this capacity, she leads a team of experienced professionals who have been extensively involved in drug development within regulatory, large pharmaceutical, biotech, and contract research organization settings. The team leverages cutting-edge modeling and simulation techniques to enhance strategic planning, expedite decision-making processes, and implement meticulous risk mitigation strategies. Dr. Suarez-Sharp has made substantial contributions to the field and has an extensive publication record in areas such as dissolution, in vitro-in vivo correlations, the establishment of drug product specifications with clinical relevance, and PBBM. Her work has advanced the fields of pharmaceutical sciences and regulatory practice.

Blair Miezeiewski – Associate Director of Scientific Operations at Pharmaron

Blair Miezeiewski, M.S. is the Associate Director of Scientific Operations at Pharmaron (Exton) Lab Services LLC. She earned her M.S. in Biology from West Chester University, with a focus on cell physiology. She then joined Absorption Systems (now Pharmaron) in 2006, fulfilling various roles including scientist and study director for BCS, transporter, and ex vivo permeability studies as well as in vitro bioequivalence studies. Her experience with cell physiology and knowledge of Pharmaron (Exton) Lab Service’s capabilities is beneficial in designing innovative studies to assess bioequivalence for complex drug products.