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First-In-Class Regulatory PBPK Modeling Guidelines from both Sides of the Pond

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Contributors

  • Ping Zhao, Ph.D.

    Ping obtained his BS in Pharmacy from Beijing Medical University in China in 1994, and his PhD in Pharmaceutics from University of Washington in Seattle, WA, USA in 2002. Since then, Ping worked as a DMPK scientist at Pfizer in La Jolla CA (2002-2005), a pharmacokineticist at Sonus Pharmaceuticals in Seattle (2005-2007), a clinical pharmacologist at Amgen in Seattle (2008), and the Scientific Lead of PBPK (physiologically-based pharmacokinetic modeling) Program and expert pharmacologist at the Office of Clinical Pharmacology, US FDA in Silver Spring, MD (2008-2017). At FDA, Ping led review of PBPK submissions in IND/NDA/BLAs, research in PBPK, and development of policy on PBPK, including authoring the agency’s first draft PBPK guidance (2016). In June 2017, Ping joined the Bill and Melinda Gates Foundation in Seattle, WA as a Senior Program Officer of Quantitative Sciences.

  • Anna Nordmark, Medical Products Agency (MPA)

    Dr. Nordmark joined the Medical Products Agency (MPA) in 2012 as Pharmacokinetic Assessor. Before that Anna worked within the Pharmaceutical Industry both in DMPK and Clinical pharmacology departments mostly supporting early clinical development. During that time Anna had an expert focus of drug interactions and PBPK.

    Anna is a member of EMAs Modelling and Simulation Working Group (MSWG) and the Rapporteur of the EMA Guideline “Qualification and reporting of PBPK modelling and analyses”. Dr. Nordmark received her M. Sc in Pharmacy from the University of Uppsala, and her PhD in Clinical Pharmacology in 2002 from the Karolinska Institutet. Her main areas of interest are drug‐drug interactions, drug metabolism and transport, as well as mechanistic models including PBPK.

September 14, 2017
Thu 12:30 PM EDT

Duration 1H 30M

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