采访嘉宾：

Dr. Cynthia J. (C.J.) Musante is Vice President of Scientific Research and Head of Quantitative Systems Pharmacology (QSP) in Early Clinical Development at Pfizer in Cambridge, MA USA. She received her PhD in Applied Mathematics from North Carolina State University and has over twenty years of experience in QSP modeling. At Pfizer, her group is responsible for developing and applying systems models and disease platforms to enhance the robustness and quality of decision-making at the program- and therapeutic strategy-level. CJ is an advocate for model informed drug discovery and development approaches and currently serves on the Board of Directors and as President of the International Society of Pharmacometrics.

        Dr. So Miyoshi has been Head of Clinical Pharmacology at Pfizer R&D Japan since 2015. He has more than 20 years of experience in application of quantitative clinical pharmacology and pharmacometrics for clinical development and new drug application work not only for Japan but also for US, Europe, China and Korea as Global Clinical Pharmacology Lead and Pharmacometrician. He has chaired and organized sessions at many domestic and intranational conferences including the Population Approach Group in Japan, Japanese Society of Clinical Pharmacology and Therapeutics, and Drug Information Association. Dr. So Miyoshi has been a member of the Board of Directors of the International Society of Pharmacometrics (ISoP) as Asia representative since January, 2021.

采访人：

Dr. Jason Deng（邓洁心） received his Master’s degree in pharmaceutics from the Univ. of North Carolina at Chapel Hill and his Ph.D. degree from the Univ. of Florida College of Pharmacy. After his Ph.D., Jason worked as a Clinical Pharmacology Lead in Early Clinical Development at Pfizer in Cambridge, MA, USA from 2017 to 2020. There, Jason led clinical pharmacology strategy in first-in-human (FIH) study design, dose selection, dose-escalation PK review (NCA and compartmental modeling), safety monitoring, and regulatory interactions. Jason also performed pharmacometric analysis to predict clinical endpoints in rare disease using early biomarker readout to support Go/No-Go decision during interim analysis of registrational trial. In 2021, Jason joined the clinical pharmacology group at Pfizer China as a pharmacometrician to develop and execute model informed drug development (MIDD) plans across projects and disease areas in Development China.

Dr. Jason Deng: Dear Dr. Musante and Dr. Miyoshi, thank you for the acceptance of this interview for ISQP Organization Committee. As President and Asia representative on the ISoP (International Society of Pharmacometrics) Board, what are some of your initiatives and plans to promote quantitative systems pharmacology in China and broader Asia?

Dr. CJ Musante, ISoP President: Internationalization, by which we mean increasing our membership and initiatives beyond the US and Europe, is a pillar of ISoP’s Five-Year Strategic Plan. Part of this plan calls for increasing support for local meetings and training events in Asia and other underrepresented regions of the global pharmacometrics community and, of course, this would include QSP (quantitative systems pharmacology). Dr. So Miyoshi currently holds the Asia seat on ISoP’s Board of Directors and recently outlined his three-year plan specifically focused on advancing our efforts in Asia. So, would you like to comment on some of our plans and initiatives? 

Dr. So Miyoshi, Asia representative on the ISoP Board: Thank President CJ Musante for touching on the three-year plan. My aspiration is to increase attraction of ISoP in Asia so that research and implementation of pharmacometrics can be activated more in the region. This will lead to the revitalization of our community. ISoP have opened educationally and practically valuable webinars including QSP. A member in the Asian region can watch a video recording every time regardless of time difference, but it is not easy to have mutual communication to deepen understanding of science and interaction with global members. In the three-year plan, webinars and social gatherings with US and Europe lecturers and members in Asian time zone are planned.

Dr. Jason Deng: What can ISoP do in facilitating the exchange of ideas and collaboration amongst academic and industrial institutions of USA, China, and broader Asia? 

Dr. CJ Musante: Collaboration and partnership are at the core of our internationalization pillar. We welcome the opportunity to facilitate the exchange of ideas between academic, regulatory, and industry colleagues, not just between the US and Asia, but around the globe. This could be through financial and/or administrative support for local events; organization of joint sessions at international, regional, or local conferences and symposia; funding for speaker and student travel; offering webinars and other discussion forums in Asia time zones; just to name a few.

Dr. So Miyoshi: Reinforcing cross-collaboration between academia, regulatory agency, industry, physicians, pharmacists and other quantitative scientists is a key to accelerate drug development and minimize delays for patients to access new drugs in each region and country. For the purpose of cross-collaboration, launching a working group in ISoP is an idea to discuss and solve common issues that should be addressed by the entire region, i.e., all over Asia or the world. In order to identify the common issues, a joint symposium between ISoP and local societies, e.g., ISQP, JSCPT (Japan Society of Clinical Pharmacology and Therapeutics), KSCPT (Korean Society for Clinical Pharmacology and Therapeutics) etc., is considered to be a good starting point.

Dr. Jason Deng: In your opinion, what are some hurdles in training professionals dedicated to applying quantitative systems pharmacology principles and techniques in drug development? What are some opportunities ISoP can offer to students and young professionals in China and broader Asia?

Dr. CJ Musante: Even with its relative success within the drug development paradigm, there still are very few training programs in QSP; many QSP practitioners, including myself, completed their formal training in applied mathematics or engineering, for example, and learned the principles of pharmacokinetic and pharmacodynamic modeling on the job. About 5 years ago my co-authors and I published a perspective on some of the hurdles facing the field. While many of the challenges remain today, ISoP’s Special Interest Group (SIG) on QSP, participation in which is free to all members, has been leading the effort to overcome these hurdles and advance the science. In addition, ISoP’s Education Committee has undertaken a large initiative to offer pharmacometrics training and professional development materials to our members, including an ISoP mentorship program that was introduced earlier this year and, in 2022, many webinars and other discussion forums will be offered in Asia time zones. ISoP currently offers discounted membership fees for students and members in China and broader Asia; and, also in 2022, we plan to offer even deeper discounts for members based in low- and middle- income countries in Asia and around the world.  As you can see, there are many opportunities, and I may have missed some. So, please comment on areas I may have overlooked; for example, hosting local Asia events and forming local ISoP groups.

Dr. So Miyoshi: ISoP is an organization filled with diversity & inclusivity and also opens doors to Asia at every level. Several experienced and talented industry QSP scientists living in Asia have joined the QSP SIG. Such an active ISoP members based in Asia can contribute to bridging between Asia and US/Europe. ISoP plans to have a ISoP-Local Society Joint Symposium in the Asian region in 2022. To prepare a suitable agenda and topics for the symposium, I would like to listen to people’s voices through an interactive webinar. I hope that success at the local level will evolve upward into local ISoP groups in Asia. I believe that the local ISoP groups play a valuable role in fostering the next generation, unleashing the power and potential of talented people in Asia and throughout the world.

郑青山 教授

        博士，教授，博士生导师。上海中医药大学药物临床研究中心主任，第九届中国药理学会定量药理学专业委员会主任委员，中国医药教育协会医药统计专业委员会副主任委员；中国临床药理学与治疗学杂志副主编，7种核心学术刊物编委。2019年获国家科技进步一等奖。近5年所发表的研究成果被5个国际医学组织和国家写入疾病治疗学指南。主要研究方向：基于模型的的药物临床评价。

焦正 教授

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