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Scientific Session Formats
Although other methods of clinical research workshops are available, the Accelerating Anticancer Agent Workshop provides a number of unique educational opportunities. It is the only workshop held in collaboration with the FDA to specifically discuss cancer drug development strategies. Rather than focusing on a single clinical trial, the students are asked to consider the entire development process, and be aware of decision points in drug development that will have consequences and ramifications to future studies. The students become aware of the need for high quality information to make decisions about prioritization, and how choices can impact opportunities to explore highly promising agents. At the workshop, learners understand the framework of a strategic plan for the development of anticancer agent in a Socratic teaching small group environment in which FDA and industry scientists responsible for the approval of the agents are the discussion leaders. Key decision points are discussed, and data that enabled decision making from both the FDA and industry scientists are presented and used to make teaching points. The workshop provides participants with an opportunity to completely review the pre-clinical/clinical development strategy that was required in order to obtain sufficient evidence from well-designed clinical trials to prove safety and effectiveness of anticancer agents that have been recently approved by the FDA. These small group sessions are complimented by plenary lectures and case studies. Informal breakout sessions are convened for in-depth discussion of specific topics. The number of learners accepted for the workshop is intentionally kept small in order to provide an interactive learning environment and exchange of ideas with faculty members. In addition, the workshop promotes the free exchange of ideas and allows conventional approaches to be challenged as well as provides networking opportunities with experts and regulators in the field.
The Accelerating Anticancer Agent Workshop provides the highest level of active engagement of academic and industry students with all stakeholders at the table, with FDA, industry and consumer leaders, providing lectures, small group sessions, and case studies. This scientific and regulatory exposure enables the students to appreciate the regulatory process, and the critical need for high quality data to inform FDA reviewers about the clinical efficacy and safety of anticancer agents. The unique features of this workshop allow for open discussion about the development of anti-cancer agents.
Teaching formats offered at the workshop are:
Plenary Sessions: An opportunity for learners to hear specific topics presented by experts and thought-leaders in their respective fields.
Question/Answer: All sessions provide an opportunity for learners to ask questions and seek clarification on the presented material.
FDA Core Curriculum: Essential topics in the cancer drug development process taught by FDA experts. Learners will have the opportunity of attending two of the modules out of three that will be offered.
Small Discussion Groups: Current topics of interest are presented in small discussion group format. These groups are highly interactive, spontaneous experiences that emphasize the free exchange of ideas. Learners will have the opportunity of attending one of the discussion groups out of the seven that will be offered.
Case Studies: These are actual case studies of anticancer agents recently approved by the FDA. Each study group follows a single agent through the various product development stages. The case studies are presented by industry representatives as well as FDA regulatory personnel. Topics covered will include Go/No-Go Decision Making, Regulatory Consideratiions, Critical Thinking, Lessons Learned, Marketing, Mulgi-organ Applications, and Global Access. These are highly interactive discussion groups that will challenge the decision-making skills of the learners. Learners will have the opportunity of attending two of the discussion groups out of the five that will be offered.
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