This workshop will explore how Artificial Intelligence (AI) is transforming the biopharmaceutical industry across various stages, from drug development and clinical trials to Chemistry, Manufacturing, and Controls (CMC), regulatory submissions, and interactions with health authorities. We will examine both the opportunities and challenges of deploying AI in these contexts, sharing practical insights into current applications, common pitfalls, best practices, and emerging roles. Attendees will gain an understanding of what is possible with AI, how to best navigate its implementation, and what risks and considerations need to be managed to ensure successful outcomes.

Discussion Questions:

1. What are the most exciting applications of AI across different stages of biopharmaceuticals (e.g., development, clinical, CMC, regulatory)? And what tools and software are being used to develop applications?

A. What areas of AI do you think present the highest potential risks or need the most caution in biopharmaceutical applications?

2. What specific problems have organizations encountered when implementing AI solutions, and how have they addressed them?

A. How do you balance the benefits of AI tools with the risks of over-reliance on automation in critical decision-making processes?

3. What best practices have emerged for building AI systems in biopharma?

A. How can organizations ensure that their AI systems undergo rigorous testing, validation, and monitoring throughout their entire lifecycle to maintain high standards of quality and reliability (human-in-the-loop, new roles)?

4. What considerations are most important for integrating AI into the regulatory landscape, and how can companies work effectively with health authorities?

A. How might regulatory agencies adapt to the use of AI in the biopharmaceutical industry? What challenges could arise?

B. What metrics can be used to evaluate the safety, efficacy, and generalizability of AI models in the industry?

Lakshmi Khandke

Appearances