Author: [AUTHOR] Published on 3/1/2023 12:00:00 AM

Liang Zhao, PhD, Associate Director, US Food and Drug Administration, Silver Spring, Maryland

What professional accomplishment are you most proud of?
I am proud that, as the founding director, we have built a productive modeling division in the realm of generics. Together with a group of talented scientists and support from our leadership, the Division of Quantitative Methods and Modeling (DQMM) has created and delivered tremendous value in drug development and regulatory approvals. First, we have developed an ecosystem across the Agency, the industry, and academia. It is very encouraging and fulfilling to see that executives from generic firms are cognizant and supportive of modeling and simulation in drug development as reflected in their public presentations. Second, we have significantly advanced modeling methods and tools and, as needed, created sub-scientific disciplines. We introduced and published the first machine learning paper from the pharmacometrics community. We are likely the first group who published research articles in Nature and Lancet sub-journals that have made some of the original modeling work out of clinical pharmacology visible in the broader scientific community, and we developed a few sub-scientific disciplines such as coupling computational fluid dynamics with physiologically-based pharmacokinetic (PBPK) models to characterize regional lung deposition for orally inhaled products. Third, we delivered key values for quantitative methods and modeling in regulatory practices, including hosting a significant number of model-focused pre-abbreviated new drug application (ANDA) meetings and using modeling and simulation outcomes to support product approvals in lieu of conducting clinical studies (e.g., the approval of generic diclofenac topical gel). Fourth, I am very happy that we have had a great run, in terms of developing high-performing modelers and quantitative clinical pharmacologists. In the past, we provided about 80 talents to different offices across the Agency (e.g., 12 clinical pharmacologists/pharmacometricians to the Office of Clinical Pharmacology) and industry. Finally, we have been active in sponsoring new regulatory concepts and initiatives, including using model-integrated evidence (MIE) for drug approval and Model Master File for model sharing.

What is your favorite memory in the field?
During the start of the COVID pandemic, we established a CASH group (Chinese Americans Supporting Hospital) and donated more than 200,000 masks and personal protection equipment (PPE) to 17 local hospitals in the greater DC area. The CASH group is mainly formed by FDA/NIH professionals including many clinical pharmacologists. I was awarded with the Humanitarian Award from the Victims' Rights Foundation with two US Senators and county chiefs in the ceremony.

How do you keep focused and motivated?
I do long-distance running (marathons), and I listen to daily audio Bible podcasts when I feel stressed.

What was your childhood dream job?
It chronologically ranged from martial artist, philosopher, and mathematician that could prove Goldbach's conjecture. Although I failed the attempt to prove the conjecture, I did develop a theorem that tells that all solutions for the first order ordinary differential equation systems can be approximated by an expansion of matrix convolutions with physical explanations for each of the components in the expanded forms, analogous to Taylor series expansion to closed form functions (https://www.aimspress.com/article/id/2742; J Pharmacokinet Pharmacodyn. 2011;38,83–104).

What's one thing people would be surprised to know about you?
I spent more than a month on set with Steven Spielberg when he was shooting Ready Player One as well as at movie premiers in London and Hollywood. This was because my son played the role of Sho in the movie. There, I learned CGI has an element of computational fluid dynamics and many amazing features of virtual reality. I have also interacted with many people outside of the scientific realm, a lot of them are actors and artists. Dr. Zhao has been a member of ASCPT since 2017.