It is critical to understand the perspectives and key criteria of global regulatory agencies in the consideration of biowaivers, but many companies have knowledge gaps that hinder their success. They are uncertain how modeling and simulation can help them anticipate and answer questions in their regulatory submissions.

Hear from industry experts working in regulatory agencies and pharmaceutical companies, sharing their experiences and insight about the use of PBPK/PBBM for achieving BCS class 3 biowaivers. They discuss scientific and regulatory obstacles, and gaps in knowledge that challenge PBPK/PBBM modeling in these instances.

Hear case studies that delineate potential paths forward on the use of PBPK/PBBM and risk assessment in support of BCS class 3 biowaivers.

PRESENTERS:

• Sivacharan Kollipara and Tausif Ahmend (Dr. Reddy’s) | “Utility of PBBM in biowaivers: Can we go beyond BCS classification criteria”
• Yuva Kanagasabapathy (Galenicum) | “Modeling approaches in biowaiver applications for fixed dose combinations of antihyperglycemic agents”
• Shereeni Veerasingham (Health Canada) | “PBBM-Informed Assessment of the Impact of Drug Degradation: A Case Study”
• Lanyan (Lucy) Fang (FDA) | Modeling and Simulation to Support Waiver of in vivo Bioequivalence Studies for BCS Class III products: Challenges and Opportunities
• Yunming Xu (FDA) | Regulatory Perspectives on Biopharmaceutics Challenges in Extending Biowaivers to BCS Class III Drugs

MODERATORS:

• Alfredo Garcia Arieta, Associate Vice President, Regulatory Strategies, Simulations Plus
• Sandra Suarez-Sharp, President, Regulatory Strategies, Simulations Plus