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This team-based day-long simulation will teach participants the process and challenges of bringing a new chemical entity from the idea stage all the way to review by the FDA. Space is limited, so please apply early. Faculty, postdocs, fellows, and graduate students are welcome to apply. The simulation will take place April 24th, 2025, in Mission Hall. Room numbers TBD. For questions, please contact Gia Monachino.

Description of workshop:
Two teams will ‘role-play’ a multidisciplinary drug development team attempting to bring a new chemical entity from the idea stage all the way to review by the FDA. Please note this program is not CME accredited.

Each participant will be assigned a specific roll (discovery scientist, drug safety specialist or project manager, etc…), serving as the expert in a particular component of the process. 

Objectives for each team are to obtain approval for the best new oncology drug by the end of the program - Teams will win or lose the competition based on value of their approved drug compared to that achieved by the other teams. The value is determined by the quality of the drug’s label. In addition, teams will also be judged for the pipeline they create.

The 3-D Oncology simulation relies on a computer program to generate ‘results’ from the scientific experiments and clinical studies that the team will conduct.  For this program, Pfizer Oncology will have several medical facilitators available to participate. 

Some key take home messages from the program include:

• The oncology drug development process is complicated and time consuming.
• The oncology drug development process is costly.
• Drug development is competitive.
• Drug development requires teamwork.
• Drug development does not always produce viable products.
• Managing both the science and regulatory environment is critical in the drug development process.