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Webinar Spotlight: “Bridging the Gap: Integrating Pharmacometrics with Quantitative Systems Pharmacology (QSP) for Smoother Clinical Phase Transitions”

网络研讨会

Master clinical phase transitions with insights from industry leaders! Join Piet van der Graaf, SVP and Head of QSP, Hugo Geerts, Head of Neuroscience Modeling QSP, Mirjam Trame, VP of Certara Drug Development Solutions, and Julie M. Bullock, PharmD, SVP of Drug Development Services at Certara. We are thrilled to welcome keynote speaker and panelist Larry Lesko, B.S., Ph.D., Clinical Professor Emeritus, and Founding Director, Center for Pharmacometrics and Systems Pharmacology at the University of Florida College of Pharmacy.

Key Takeaways:

  • Gain insights into modeling from limit to rich data during a development program.
  • Learn to simulate effective dose ranges for proof-of-concept studies in specific patient populations.
  • Navigate the challenges of transitioning from clinical data-rich outcomes to trial designs with limited clinical data but a solid understanding of pathology.
  • Explore case studies on utilizing quantitative understanding of diseases, such as Parkinson’s, to inform dosing strategies.
  • Address considerations for Phase 3 pivotal trials, including the relaxation of inclusion criteria and managing potential pharmacodynamic interactions.
  • Build a compelling argument for the integration of pharmacometrics and QSP in your drug development strategy.

Build a compelling argument for integrating pharmacometrics and QSP in your drug development strategy.

Don’t miss this opportunity to elevate your insights and strategies in drug development!

注意:Limited spots available. Reserve your place now to stay at the forefront of drug development strategies

Keynote Speaker and Panelist

Larry Lesko, B.S., Ph.D., Clinical Professor Emeritus, and Founding Director, Center for Pharmacometrics and Systems Pharmacology at the University of Florida College of Pharmacy

Dr. Lesko, Clinical Professor Emeritus at UF College of Pharmacy in Lake Nona, FL, is the Founding Director of the UF Center for Pharmacometrics and Systems Pharmacology. Formerly the Director of the Office of Clinical Pharmacology at FDA’s CDER, he chaired the clinical pharmacology coordinating subcommittee. Dr. Lesko established regulatory programs in pharmacometrics and drug safety, and was an author on over 210 peer-reviewed articles and book chapters. He received several awards, including the ASCPT’s Rawls-Palmer Progress in Medicine award, Gary Neil Prize for Innovation in Drug Development, and the Coriell Scientific Leadership Award for Personalized Medicine. Board Certified in Applied Pharmacology, Dr. Lesko served as ACCP President and is a Fellow in AAPS, the Japanese Society for the Study of Xenobiotics, and the College of Physicians of Philadelphia.

演讲嘉宾
Piet vanderGraaf
Piet van der Graaf, PharmD, PhD
Senior Vice President and Head of Quantitative Systems Pharmacology
Piet van der Graaf is Senior Vice President and Head of Quantitative Systems Pharmacology at Certara and Professor of Systems Pharmacology at Leiden University. From 2013-2016 he was the Director of Research of the Leiden Academic Centre for Drug Research. From 1999-2013 he held various leadership positions at Pfizer in Discovery Biology, Pharmacokinetics and Drug Metabolism and Clinical Pharmacology. He was the founding Editor-in-Chief of CPT: Pharmacometrics & Systems Pharmacology from 2012-2018 before becoming Editor-in-Chief of Clinical Pharmacology & Therapeutics. Piet received his doctorate training in clinical medicine with Nobel prize laureate Sir James Black at King's College London. He has been awarded the 2024 Gary Neil Prize for Innovation in Drug Development from the American Society of Clinical Pharmacology and Therapeutics (ASCPT) and was the recipient of the 2021 Leadership Award from the International Society of Pharmacometrics (ISoP). Piet is an elected Fellow of the British Pharmacological Society and has published >200 articles in the area of quantitative pharmacology and drug development.
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Hugo Geerts, PhD
Head of Neuroscience Modelling, QSP
Hugo 是 In Silico Biosciences 的共同创始人,在神经病学和精神病学领域基于机制的 QSP 建模方面有 18 年经验,此外还是比利时比尔斯 Janssen 研究基金会实验室的一名研究员,在药物发现和开发方面拥有 20 年经验。在 Certara,他带领着一个新成立的 Certara QSP 协会,该协会致力于神经退行性疾病研究。
Mirjam Trame
Mirjam Trame
Vice President, Pharmacometrics
Mirjam 是药物综合开发团队的定量药理学顾问,也是 Certara 定量科学解决方案的美国东北地区负责人。尽管她从事包括复杂生物制剂在内的各种不同模式的工作,但她在细胞和基因治疗方面提供专业支持。在 2022 年初加入 Certara 之前,Mirjam 工业界和学术界从事临床药理学、定量药理学和系统药理学工作超过 12 年,其中超过 3 年专注于细胞和基因疗法。
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Julie Bullock, PharmD
Senior Vice President, Global Head of Clinical Pharmacology & Translational Medicine

Julie has over 10 years of drug development experience within the FDA. Dr Bullock's past appointments include Clinical Pharmacology Team Leader and Senior Clinical Pharmacology Reviewer (FDA). Her regulatory experience was focused in the therapeutic areas of hematology/oncology and coagulation. She has unique insight in pediatric development, PK/PD approaches for biosimilar products, oncology dose finding strategy and streamlining development for breakthrough therapies and accelerated approval. Dr. Bullock has contributed to over 14 new molecular entity approvals during her 10-year FDA career.

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