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Artificial intelligence/machine learning (AI/ML) are increasingly being utilized in drug development. As pharmaceutical companies incorporate these new technologies, it is critical to understand their current strengths and limitations and how their use will be viewed by regulatory agencies. Dr. Qi Liu is the Associate Director for Innovation & Partnership at the Office of Clinical Pharmacology/Office of Translational Sciences at the Center for Drug Evaluation and Research (CDER). In this webinar, Dr. Liu will begin with an overview of AI/ML fundamentals, then summarize AI/ML-related regulatory submissions at CDER/FDA. She will share review and research examples, then discuss challenges and regulatory considerations for AI/ML in drug development and regulation. Don’t miss this opportunity to learn how to effectively leverage AI/ML in your development programs. Register to join us.
Presenter: Dr. Qi Liu, Associate Director for Innovation & Partnership at the Office of Clinical Pharmacology/Office of Translational Sciences at the Center for Drug Evaluation and Research (CDER). Moderator: Tom Sun, Vice President, Strategic Consulting Services, Clinical Pharmacology & Pharmacometrics Solutions
Thursday, August 22, 2024
8:00 am - 9:00 am PDT
Associate Director for Innovation & Partnership at the Office of Clinical Pharmacology/Office of Translational Sciences at the Center for Drug Evaluation and Research (CDER)
FDA
Qi Liu, Ph.D., M.Stat., FCP is the Associate Director for Innovation & Partnership in the Office of Clinical Pharmacology (OCP)/ Office of Translational Sciences, CDER, FDA.
She leads OCP’s innovative initiatives through strategic partnership.
She has helped developing OCP’s portfolio on artificial intelligence/ machine learning, real world evidence and digital health technologies, collaborating with internal and external experts.
She helped establishing the OCP Innovative Data Analytics Program and AI/ML review team, and currently serves as the lead.
She had the experience leading OCP’s Physiological Based Pharmacokinetic Modeling and Simulation Oversight Board and co-leading Biologics Oversight Board.
She is also on the executive board of CDER’s Quantitative Medicine Center of Excellence.
She was a co-lead initiating the Real-Time Oncology Review and Assessment Aid Pilot Programs.
During her career at the FDA, she also contributed to over 200 NDA/sNDA reviews, 20 BLA/sBLA reviews, and numerous IND reviews to support drug development.
She worked on working groups for FDA guidance documents and Manual of Policies & Procedures development.
She is an Associate Editor of Clinical Translational Science and on the editorial board of five scientific journals.
Before joining FDA, Dr.
Liu was a senior pharmacokineticist at Merck & Co.
Inc.
She obtained her Ph.D.
degree in Pharmaceutics and a concurrent Master's degree in Statistics from the University of Florida in 2004.
In addition, she has a Master's degree in Pharmaceutics and a Bachelors’ degree in Clinical Pharmacy from West China University of Medical Sciences.
Vice President, Strategic Consulting Services, Clinical Pharmacology & Pharmacometrics Solutions
Simulations Plus Tom Sun is Vice President, Strategic Consulting Services, at Simulations Plus. Dr. Sun has more than twenty years of pharmaceutical industry experience at Genentech (1998-2002), ALZA/Johnson & Johnson (2002-2004), Amgen (2004-2015), and Janssen (2015-2022). Prior to this current role, Dr. Sun was the Oncology Therapeutic Area Head, Clinical Pharmacology & Pharmacometrics Department and the Licensing & Acquisition Evaluation Head, Quantitative Sciences at Janssen R&D.
Dr. Sun received his B.S. in Pharmacy from Taipei Medical University (formerly known as Taipei Medical College) and his Ph.D. in Pharmaceutical Sciences from the University at Buffalo. He is specialized in translational Pharmacokinetic/Pharmacodynamic (PK/PD) research, Clinical Pharmacology, Modeling & Simulations, and product registration for small molecules, biologics, and CAR-T therapies. His recent research focus has been the application of model-based drug development in oncology. Dr. Sun has authored more than 40 peer reviewed articles and book chapter, and is an invited reviewer for eight scientific journals in the field of Clinical Pharmacology and PK/PD.
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