Are you new to drug development research? Interested in learning more about obtaining FDA approval of an investigational drug product?
In this one-day drug development workshop, two groups will ‘role-play’ multidisciplinary drug development teams attempting to bring a new chemical entity from the idea stage all the way to review by the FDA. Each participant will be assigned a specific role on a typical oncology study team (i.e., project manager, discovery/pharmaceutical scientist, drug safety, regulatory, or market assessment specialist) and will serve as the expert in a particular component of the process.
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.
This will be a great professional development opportunity for those new to drug development research or looking to learn more. Please note this program is not CME accredited.
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.
Wednesday, March 20, 2019, 9:00AM-3:30PM
Graduate School of Biomedical Sciences, 145 Harrison Avenue, Boston MA
Admission to the workshop is by application only. To apply, please register here by March 6, 2019.
We are recruiting 16-18 early career investigators, clinical and/or research fellows, and other research staff. Admission to the workshop is by application only and priority will be given to researchers and clinical fellows from Tufts CTSI partner institutions. A background in oncology research is preferred though not required. All must commit to being an active participant in the full session. Once registration is full, you may be placed on a waitlist.
Attendance and active participation in the full workshop (9AM–3:30PM) is critical to this group-based workshop format. You will be expected to actively engage with your assigned role, participate in group discussion, and respectfully work as an active member of your oncology study team.
Tufts CTSI Professional Education & Expectation for Course Participants
Tufts CTSI’s Professional Education programs provide non-degree continuing education and training for clinical and translational research professionals from all Tufts CTSI partners and beyond.
Course enrollment priority is given to researchers from Tufts CTSI partner institutions. If your participation needs to be approved by your supervisor or a person responsible for your time release, you may provide their contact information when you register for the program.
This course is provided free of charge, and was supported by the National Center for Advancing Translational Sciences, National Institutes of health, Award Number UL1TR002544. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.