Description

FORMAT

This will be a small course limited to 30 participants, to allow maximal interactions with the five internationally recognized faculty. The course will include 10 lectures over 1 1/2 days, with ample opportunity for questions and discussions after each lecture. In addition, there will be five intimate breakout sessions over the lunch on Day 1 and over the breakfast on Day 2, each led by a faculty member, allowing attendees the opportunity to obtain individualized advice regarding subjects of their choice.

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all new oncology drugs have a maximal effective concentration, yet oncology drug development continues to utilize outdated clinical trial designs with little attention to key clinical pharmacology issues (i.e., pharmacokinetics and pharmacodynamics), particularly in the context of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

This is an advanced course aimed at medical oncologists and clinical pharmacologists working in the pharmaceutical industry. Although oncology drugs are markedly different than the drugs of the past, the industry continues to focus on defining the maximally tolerated dose. This course will discuss more sophisticated approaches to dose-finding that include evaluation of pharmacokinetics, pharmacodynamic biomarkers and pharmacometric modeling. Challenges in the development of combinations will also be discussed.

  • 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 with thought leaders in oncology drug development and clinical pharmacology
  • To facilitate networking among course participants and 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

UNIQUE COURSE FEATURES

This course provides a unique opportunity for learning from international experts in oncology drug development and clinical pharmacology.

  • Limited enrolment to ensure adequate opportunity for direct dialogue with course instructors
  • Breakout sessions to discuss specific clinical pharmacology issues identified by participants, including an optional opportunity for confidential discussions with a course instructor