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Clinical Drug Development & Investigations
Symposia

Symposium 14: Recent Trends in Food Effect Assessment in Supporting Dosing Recommendations for Oral Oncology Drugs

Tuesday, September 12, 2023
3:30 PM - 5:00 PM PT
Location:Grand Ballroom E-H
CE: 1.5

    Co-Chair & Faculty(s)

  • Xiaoming Cui, PhD (she/her/hers)

    Director, PK Sciences, Translational Medicine
    Novartis Inst for Biomedical Research

  • Yvonne Lau, PhD

    Executive Director, Oncology, Quantitative Clinical Pharmacology
    Daiichi Sankyo Inc

    • Faculty(s)

  • Brian Booth, PhD

    Director, Office of Clinical Pharmacology, CDER
    US Food & Drug Administration

  • Lawrence Lesko, PhD

    Clinical Professor & Director, Ctr for Pharmacometrics & Systems Pharmacology
    Univ of Florida Coll of Pharmacy

The target audience for this Symposium is clinical pharmacologists in industrial settings, academia scientists in the clinical pharmacology field and treating physicians in clinical trial settings or general practice settings.

Goals & Objectives:

Following the completion of this activity, the learner will be able to:
  • Explain the interplay of various factors that influence the food labeling decision and the importance of adherence to the label, for oral oncology drugs to achieve the best risk/benefit ratio;
  • Adopt different strategies to obtain optimal dosing recommendations with regard to food at different stages of oncology drug development;
  • Discuss the recent trends of exploratory food evaluation in early clinical trials to better inform food condition decision in pivotal trials and meet the need of accelerated oncology drug development.

Presentations:

  • Dose & Prandial Condition Optimization from Phase 1 to Post-marketing

    Co-Chair & Faculty: Yvonne Lau, PhD – Daiichi Sankyo Inc

  • Can “Given With Food” Be a Default Food Condition?

    Co-Chair & Faculty: Xiaoming Cui, PhD (she/her/hers) – Novartis Inst for Biomedical Research

  • Food: Leveraging the Clinical Pharmacology of Your Oncology Drug

    Faculty: Brian Booth, PhD – US Food & Drug Administration

  • Why Are FDA-approved Drug Labels Pertaining to Food-Drug Interactions Essential to the Advancement of Therapeutic Optimization of Oral Cancer Drugs?

    Faculty: Lawrence Lesko, PhD – Univ of Florida Coll of Pharmacy

  • Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation