Learn how QSP and PBPK modeling work together to support oncology drug development decisions, from dose justification to patient population identification.
About this webinar
Mechanistic modeling approaches are transforming how oncology compounds reach patients. This webinar explores how quantitative systems pharmacology (QSP) and physiologically based pharmacokinetic (PBPK) modeling, when used in combination, provide a powerful framework for informing critical decisions in drug development.
Using tipifarnib and alpelisib combination therapy for head and neck squamous cell carcinoma (HNSCC) as a case study, the session will walk through how these tools support dose justification, patient stratification by genotype, and assessment of drug–drug interactions and organ impairment.
学べる内容
- How QSP models can characterize tumor response across distinct patient genotypes to identify which populations are most likely to benefit from treatment and support dose justification
- How a logic-gated, mechanistic model is built, calibrated, and translated from preclinical data to clinical predictions
- How PBPK modeling supports drug–drug interaction (DDI) assessment, and organ impairment evaluation for oncology compounds
- How combining QSP and PBPK approaches within a single development program creates a stronger, more integrated evidence package for regulatory and clinical decisions
- Practical lessons from the tipifarnib program that apply across oncology drug development
お申込みはこちら
Piet van der Graaf
Senior Vice President, Head of QSPPiet van der Graaf, PharmD, PhDは、サターラのApplied BioSimulation担当シニアバイスプレジデントであり、 Leiden University システム薬理学教授、 Cincinnati Children’s Hospital Medical Center 小児科教授を務めています。Previously, he was the Director of the Leiden Academic Centre for Drug Research and held leadership positions at Pfizer in Discovery Biology, DMPK and Clinical Pharmacology. CPTの創刊編集長であり、Pharmacometrics & Systems Pharmacology before becoming Editor-in-Chief of Clinical Pharmacology & Therapeutics. Pietはロンドン大学キングス・カレッジにてノーベル賞受賞者サー・ジェームズ・ブラックのもとで臨床医学の博士課程を修了し、He was awarded the 2024 Gary Neil Prize for Innovation in Drug Development from the American Society of Clinical Pharmacology and Therapeutics (ASCPT) and the 2021 Leadership Award from the International Society of Pharmacometrics (ISoP). 英国薬理学会のフェローに選出されており、これまで定量的薬理学および医薬品開発の分野にて250本以上の論文を発表しています。
Vice President
Clinical Pharmacology, Kura Oncology, Inc.
Amitava is currently VP and Head of Clinical Pharmacology at Kura Oncology, where he supports global drug development programs. He has nearly 20 years of experience in the pharmaceutical industry supporting various therapeutic areas and has previously worked at Merck, Novartis and J&J. Amitava has supported several INDs and NDAs, including most recently the approval of Komzifti™. Amitava has a PhD in Pharmaceutical Sciences from University of Maryland, Baltimore. His main research interests include clinical pharmacology, modeling & simulation, pharmacokinetics, and biopharmaceutics. He has interacted with several regulatory agencies like FDA, EMA and PMDA on these topics. Amitava has published over 70 research and review articles and has more than 30 podium presentations in national & international conferences. Amitava has won several awards including the Novartis VIVA Leading Science award in 2019 for his modeling efforts, an award that celebrates exceptional contribution by scientists across the company’s R&D organization worldwide. He was elected an AAPS Fellow in 2022. Amitava actively volunteers in AAPS and ASCPT, and participates in IQ consortium. Amitava teaches a course on Clinical Pharmacology at the University of Maryland School of Pharmacy.
お申込みはこちら
