Date: Thursday | March 28, 2024
Time: 12 noon to 1pm PT
Location: Zoom
Registration: Free for OCRA-DG members; $20 for nonmembers
Artificial intelligence (AI) and machine learning (ML) technologies have the potential to advance drug development in multiple areas, including candidate identification and refinement, nonclinical and clinical research, manufacturing, and post market surveillance. The Food and Drug Administration (FDA) has recognized this potential, and is actively seeking feedback and engagement from stakeholders in this area as the agency works towards building a regulatory framework. In this program, we will review FDA’s current thinking on the use of artificial intelligence and machine learning in drug development, and explore ways in which drug companies are using these technologies to improve their business.
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Who Should Attend:
About the Speaker:
Bert Lao, JD, PhD
Counsel, Hogan Lovells
Bert Lao, JD, PhD, serves as Counsel at Hogan Lovells, bringing over a decade of experience in pharmaceutical law. His expertise lies in assisting drug companies in navigating regulatory requirements and legal challenges. Throughout his career, he has provided guidance to clients across various stages of product development, including clinical trials, FDA interactions, and approval processes.
In addition to his involvement in product development, Bert supports drug companies in maintaining regulatory compliance and addressing legal issues. His services encompass a range of activities such as assisting with securities filings, conducting internal investigations, drafting trade complaint letters, and reviewing promotional materials for pharmaceuticals, over-the-counter drugs, and cosmetics.
Bert Lao holds a JD from UC Berkeley School of Law and a PhD in Biomedical Engineering from UCLA.