10:45 – 12:15
PBPK Real World Applications Workshop: Special Populations
From real world cases studies, learn how Simcyp PBPK can be used to predict PK in special populations.
Facilitators:
Dr. Karen Rowland Yeo, SVP, Client and Regulatory Strategy, Certara
Dr. Hannah Jones, SVP, PBPK Consultancy Services, Certara
Dr. Iain Garder, VP, Head of Translational DMPK Services, Certara
Presenters:
- Analyzing Drug Transfer into Semen: Leveraging Simcyp Lactation Module for Safety Assessment Caroline Sychterz, Associate Director CP&P-QSP&PBPK, Bristol Myers Squibb
- Physiologically Based Pharmacokinetic Modeling and Simulation to Inform the Dose of Asciminib in Pediatric Patients with Chronic Myeloid Leukemia in Chronic Phase Heidi J. Einolf, Ph.D., Executive Director, PK SCIENCES / Translational Medicine, Novartis Pharmaceuticals Corporation
1:30 – 3:00
PBPK Real World Applications Workshop: Biopharmaceutics
From real world cases studies, learn how PBPK can be used to address biopharmaceutics questions.
Facilitator:
Dr. Nikunjkumar Patel, Sr. Director PBPK Consultancy, CertaraÂ
Presenters:
- Leveraging Simcyp VBE for Food Effect Biowaiver: BMS Experience Gaohua Lu, Ph.D., Senior Director, Head of PBPK Bristol Myers Squibb
Optimal Use of PBPK Modeling During Early Development of Oncology Candidates Balaji Agoram, Vice President, Head of Clinical Pharmacology and pharmacometrics, Arcus Biosciences
Physiologically Based Pharmacokinetic Modeling to Evaluate the Gastric Acid Modifier Effect on Rimegepant Exposure Richard Bertz, SVP, Clinical Pharmacology & Pharmacometrics, Biohaven
Panelists:
3:15 – 5:00
PBPK Real World Applications Workshop: DDI featuring Simcyp and The Drug Interaction Database (DIDB)
From real world cases studies, learn how Simcyp PBPK and The Drug Interaction Database (DIDB) can be used to predict DDI.
Facilitators:
Dr. Karen Rowland Yeo, SVP, Client and Regulatory Strategy, Certara
Dr. Hannah Jones, SVP, PBPK Consultancy Services, Certara
Dr. Iain Garder, VP, Head of Translational DMPK Services, Certara
Presenters:
- Assessing DDI Liability of Oncology Drugs Using PBPK Modeling Amitava Mitra, PhD, FAAPS, Executive Director, Clinical Pharmacology, Kura Oncology, Inc.
- High Impact Application of a Continuous LEARN, CONFIRM and INFORM – PBPK Modeling Strategy for Evaluation of DDIs in a Disease Population Jennypher Mudunuru, PH.D, DMPK Modeling. Research Technologies, GSK, USAÂ
- PBPK Applications in DDI Evaluation for Drugs Approved by the FDA in 2023Â Dr. Jingjing Yu, Associate Director, Drug Interactions Solutions, Certara