Every day, scientists in the pharmaceutical industry are tasked with meeting regulatory expectations while also minimizing budget spend by identifying efficiencies for faster development of safer, more effective drugs. Modeling and simulation (M&S) technologies are stepping into the gap, especially when it comes to drug-drug interaction (DDI) studies. In this webinar, Dr. Susie Zhang, Vice President of Regulatory Strategies, will draw upon her 12 years of experience at the FDA focused on physiologically based pharmacokinetic (PBPK) modeling, DDI risk assessment, and model-informed drug development, to explain how in silico methods can streamline DDI research and significantly reduce the time and need for expensive study-based clinical trials. She will explain the FDA’s acceptance of PBPK modeling, as well as the expectations and regulatory framework for DDI risk assessments.

She will be joined by Andy Mueller, Director of Business Development, who will highlight common drug development questions from the pharmaceutical industry for discussion. Attendees will learn how to streamline the DDI risk assessment process to inform their label with simulation-driven insights, align with FDA expectations to avoid delays or rejections, and support faster and more reliable decision-making. Susie will also answer questions during the live Q&A at the end of the presentation.

If you want to optimize your research strategies (and time and dollars!) and improve the efficiency of your drug development processes, this is a can’t-miss webinar. Register today.

• Dr. Susie Zhang, Vice President, Regulatory Strategies
• Andrew Mueller, Director, Business Development