Pharma Leaders in China Embrace Simcyp Science

Pharma Leaders in China Embrace Simcyp Science

Will the 21st century go down in history as the “Chinese Century”? If the status of its pharmaceutical industry is a barometer for China’s global position, then the answer may be “yes.” The size of the Chinese pharmaceutical market is second only to the US. In 2014, it was worth $105 billion. By 2020, the Chinese market is expected to balloon to $200 billion and dominate Asia.

Big Pharma (e.g. GSK, AstraZeneca, Roche, Pfizer, Sanofi and Novartis) is capitalizing on this projected growth by setting up more and more Chinese research centers. Scientists at these centers are keen to learn how to apply modeling and simulation to their drug development programs.

One approach to modeling and simulation—physiologically-based pharmacokinetic (PBPK) modeling—has been used to optimize dosing and clinical trial designs. As PBPK models are getting more and more complex, scientists will require extensive training on both the theoretical and practical aspects of using tools such as the Simcyp Simulator, the gold standard. In this blog post, I will discuss my recent experience as a tutor for an educational workshop in Shanghai, China and reflect on their changing landscape for modeling and simulation.

The rise of modeling and simulation in China

Like their industry counterparts, many academic units in China—PUMC (Peking Union Medical College), CPU (Chinese Pharmaceutical University), Beijing University, Fudan University, etc.—have strived to adopt PBPK modeling and simulation. These domestic changes in academia and industry have coincided with the US FDA’s acceptance of modeling and simulation to inform drug labels. This paradigm change has spurred the CFDA (China Food and Drug Administration) to learn and apply these new tools.

Bringing Simcyp science to China

In 2012, we held our first week-long PBPK Workshop for Chinese scientists in Shanghai. We chose this location due to it being a drug development hot spot. The Pudong district of Shanghai is China’s national and international epicenter for pharma R&D. Pudong is also home to multiple national research institutes including SIMM (Shanghai Institute of Materia Medica) and CSIPI (China State Institute of Pharmaceutical Industry).

The inaugural five-day workshop was a great way to introduce Chinese scientists to the Simcyp Simulator. Despite the fact that many of the attendees were modeling novices, they worked very hard and gained a basic understanding of PBPK modeling from drug discovery to clinical trials. It was successful enough that we decided to hold a second PBPK workshop in Shanghai in 2013. Many of the original attendees came back and retook the course. In 2014, we changed up the workshop’s format by coordinating with PUMC and holding the course in Beijing. This format was so successful that we decided to collaborate with the Huashan Hospital—affiliated with Fudan University in Shanghai—for last fall’s workshop.

How do you say “PBPK” in Mandarin?

Having helped teach workshops in both the US, the UK, and China, I’ve noticed some unique challenges about teaching in different cultural settings. The language barrier was one of the biggest challenges. The English language proficiency of the attendees at the Chinese workshops varied considerably. To make sure all of the attendees fully understood the course content, Certara staff translated the material into Chinese. The workshop lectures were then delivered in English. During the “hands on” component of the workshop where attendees tackled modeling exercises, their questions were answered in Chinese or English.

A closer look at the 2015 workshop

After three years of training on the Simcyp Simulator, the concept of leveraging PBPK has become widely accepted by Chinese scientists in academia and industry. The extent of this technological adoption can be seen in the many recent articles using PBPK modeling and simulation that have been published by Chinese universities.

The atmosphere of the 2015 Shanghai workshop was slightly different from previous Chinese workshops. Because the conceptual framework had been laid over the past couple of years, the attendees in 2015 were able to engage with us at a more advanced level. More attendees came with a concrete project in mind, asked specific questions, showed their project plans, and sought extra help after the workshop.

Our work in China is part of Certara’s larger effort to train scientists around the globe in using the Simcyp Simulator. Consequently, the PBPK community can look forward for some exciting projects being published in the next couple of years from universities in China, Korea, India and the Netherlands in the fields of drug metabolism, transporters, absorption and special populations.

What our Chinese colleagues had to say about the workshops

To maximize the effectiveness of our workshops, we always seek feedback from attendees at the conclusion of the course. Here is a snapshot of some of the insights that we attained. Professor Jing Zhang from Huashan Hospital (affiliated with Fudan University, first row, third from the right) is a leading Chinese scientist who performs clinical research on antibiotics. She also serves on the leadership committee of the Chinese Pharmacological Society. Prof. Zhang praised this course and encouraged us to expand this course to more Chinese researchers. After the course ended, she invited us to join their project discussions and sought our advice on how to apply PBPK modeling to their projects.

We were also excited to have two scientists from Chinese regulatory agencies attend the workshop. They were particularly interested in learning more about virtual bioavailability studies. At the conclusion of the workshop, they indicated that the workshop had helped them learn PBPK, gave them an introduction to using the Simcyp Simulator, and that they hoped to be able to use it daily in the future. Professor Ming Zhao (Principal Reviewer at CFDA, first row, first from the right) joined our first Chinese workshop in 2012. After this workshop, he thanked us and told us that by attending for multiple years, he had been able to further expand his knowledge of PBPK.

Overall, our attendees felt that the workshop was a worthwhile experience. The fact that the workshop was booked to capacity indicates the high demand for learning PBPK in China. Due to the increased number of registrations, we even had to staff the workshop with an extra tutor! Supporting our clients through scientific education is a priority for us. We see the growth in demand for workshops as a positive trend.

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Conclusion

At the 2015 Simcyp workshop in Shanghai, attendees graduated from learning the basic concepts of PBPK to using the Simcyp Simulator for specific projects. After a string of successful workshops, we have refined our ability to provide high quality training to Chinese scientists. By learning to leverage PBPK models, our colleagues in China will be better positioned to support their booming pharmaceutical market. I’m already excited for the 2016 Simcyp Simulator workshop that will take place at the Chinese Pharmaceutical University in Nanjing (date to be confirmed)!

Learn more about how Certara’s biosimulation solutions can help you!

We are presenting a monthly scientific webinar series on hot topics in drug development. Register to attend the live events or watch later on-demand!

Register for webinars!

To learn more about how PBPK modeling is used to support drug development, please watch a webinar my colleague, Dr. Karen Rowland Yeo, gave on this topic.

Bo Liu

About the Author

Bo Liu received his PhD from the School of Pharmacy and Pharmaceutical Sciences in Trinity College, Dublin in 2012. He is currently a Research Scientist at Certara. His research interests include application of modeling and simulation in drug delivery research and clinical pharmacokinetics.