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Strategic Application of PBPK Modeling for Predicting DDIs & the Effects of Smoking & Organ Impairment

Live webinar

Olanzapine is a highly effective antipsychotic, but its uses are limited by the risk of significant weight gain and metabolic effects. A combination of olanzapine and the opioid receptor antagonist samidorphan (OLZ/SAM) was recently approved in the United States for the treatment of adults with schizophrenia and bipolar I disorder. OLZ/SAM provides the antipsychotic efficacy of olanzapine while mitigating olanzapine-associated weight gain through opioid-receptor blockade. Physiologically-based pharmacokinetic (PBPK) modeling was used to assess the drug-drug interaction (DDI) potential of OLZ/SAM as well as to inform dosing in special populations, including smokers and those with organ impairment. Although the PBPK model and results will be described, the focus of the presentation will be on leveraging PBPK modeling during the development of OLZ/SAM and regulatory interactions.

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Speakers
Bio Pic KarenYeo
Karen Rowland Yeo, PhD
Senior Vice President, Client & Regulatory Strategy
Since 2002, Karen has led projects relating to the extrapolation of in vitro data to predict in vivo pharmacokinetics in humans. This has included development and implementation of the models into the Simcyp Simulator.  Her specific research interests include physiologically based pharmacokinetic modeling and prediction of drug-drug interactions.
Certara Lei Sun
Lei Sun
Vice President, Clinical Pharmacology and Translational Medicine Cogent Biosciences,
Dr. Sun serves as Vice President, Clinical Pharmacology and Translational Medicine at Cogent Biosciences with 20 years of experience in the biopharmaceutical industry. Before joining Cogent in December 2021, Dr. Sun served as Senior Director and Head of Clinical Pharmacology at Alkermes where she led Clinical Pharmacology support for multiple clinical programs in neuroscience and in immune-oncology. In today’s webinar, she will share her experience of utilizing model-based drug development approach such PBPK modeling to support the clinical development and FDA approval of LYBALVITM (OLZ/SAM) for the treatment of schizophrenia and bipolar I disorder. Earlier in her career, Dr. Sun held several roles of increasing responsibility in the area of Clinical Pharmacology, Translational Medicine and DMPK at Ziopharm Oncology, Alnylam and Wyeth/Pfizer. Dr. Sun received her Ph.D. in Chemistry & Chemical Biology and M.S. in Chemical & Biochemical Engineering from Rutgers University in New Brunswick, NJ and her B.S. in Material Sciences & Engineering from Tianjin University in China.
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