Description

TARGET AUDIENCE

Oncologists and clinical pharmacologists, particularly those in industry

NEEDS STATEMENT

Traditional oncology dosing paradigms focused on maximally tolerated dosage are no longer appropriate in the context of immunotherapy and target-based therapeutics. Virtually all new oncology drugs have a maximal effective concentration, yet oncology drug development continues to utilize outdated clinical trial designs with little attention to key clinical pharmacology issues (i.e., pharmacokinetics and pharmacodynamics), particularly in the context of immunotherapy and oral drug delivery. This course aims to fill that gap through a combination of lectures and breakout sessions with thought leaders in oncology drug development and clinical pharmacology in an intimate setting.

COURSE OBJECTIVES

  • To educate oncologists and clinical pharmacologists, particularly those working in industry, regarding emerging concepts in anticancer drug development and clinical pharmacology
  • To provide an opportunity for course participants to consult confidentially with thought leaders in oncology drug development and clinical pharmacology
  • To facilitate networking among course participants and with thought leaders in the field

LEARNING OBJECTIVES

At the conclusion of the activity, participants will be able

  • To define appropriate strategies for identification of the optimal therapeutic dose (and/or schedule) of a drug alone, or in combination with other drugs
  • To identify appropriate tools, such as biomarkers, pharmacometrics, and simulation, to address common problems in oncology drug development
  • To interpret clinical pharmacokinetic and pharmacodynamic results in the context of preclinical drug metabolism and pharmacokinetic data

FORMAT

The 1.5-day program consists of lectures (including extensive time for questions and discussion), as well as small breakout sessions with thought leaders in oncology drug development and clinical pharmacology. Opportunities for confidential (i.e., limited to a single company) breakout sessions will be available. There will also be an opportunity for informal discussions during meals (including a social event).