- Menglun Wang, Food and Drug Administration
- Regulatory Perspective on Artificial Intelligence Integrated Drug Development
- 03/17/2023
- 3:00 PM - 4:00 PM
- C304 Wells Hall
- Mark A Iwen (iwenmark@msu.edu)
The application of Artificial Intelligence/Machine Learning (AI/ML) in drug development is expanding rapidly. AI/ML have the potential to improve the efficiency of drug development and advance precision medicine. However, there are unique challenges. The presentation will mainly focus on the topic of AI/ML applications in clinical trials, including the following parts:
1. The increasing numbers of submissions over years.
2. Hot therapeutic areas of AI/ML submissions.
3. Types of analysis and objectives in AI/ML in submissions.
4. Case examples.
5. Challenges and outlooks.
In the end of the presentation, opportunities of FDA-ORISE fellowship will be introduced to senior PhD students.
