Our Member Spotlight this month is C. Charles Tong, PhD.
Senior Director of Pharmaceutical Sciences Development Center in China at Worldwide Research and Development, Pfizer Inc. Charles has been a Member of ISPE since 2008. He is the 2013-2014 Chair of ISPE China, and has served on the ISPE China Board since 2011. He previously served as Chair of ISPE China’s Regulatory Committee, and was an industry representative to the Quality Working Group of SFDA ICH Study Group in China.
Charles has worked in the pharmaceutical industry for more than 15 years in various roles, including pharmaceutical development for investigational drugs, new drug applications and marketing authorization applications in the US, Europe, Japan and China. For the past two years, he has been working to establish and lead the Pfizer Pharmaceutical Sciences Development Center in China (Beijing, China) with the overall responsibilities to support China drug product portfolio development by leading regulatory CMC, clinical supplies, technology and sourcing in China.
Q. Tell us a little about your career to date. How did you get started in the Life Sciences industry, and how has your career progressed?
A. I received my undergraduate and graduate education in Chemistry in China and the US. Organic, polymeric and analytical chemistries were my favorite subjects, which helped me find my first job as an analytical chemist in a biopharmaceutical company developing polymer-based drug products in the US in 1997. Since I was curious about how a new drug was discovered, developed and manufactured commercially, I later joined Pfizer in 2001 to gain this type of understanding. I took various roles with increasing responsibilities, including leading analytical teams, co-development teams between the development and manufacturing organizations and regulatory CMC projects for new drug product development programs. In 2008, I came to Pfizer China to take a regulatory related assignment in Beijing, focusing on facilitating product portfolio CMC development and improving the regulatory environment in China. I then took on the current position.
Q. How did you get involved in ISPE, and what activities have you been involved in?
A. I became familiar with ISPE in 2007 through my Pfizer colleagues who volunteered to participate and lead the PQLI initiatives at ISPE. I was fascinated with the collaboration among the professionals through the network offered by ISPE to achieve common understanding for the implementation of Quality by Design (QbD). While in China, I joined ISPE China, organized QbD sessions and introduced PQLI at the ISPE China Annual Conference. I was also involved in establishing a Regulatory Committee for ISPE China to build a collaborative relationship with the regulatory agencies. Since being elected as Chair for ISPE China in January 2013, I have been working closely with the ISPE China Board of Directors and China Office to propose long-term goals and design the structure for ISPE China so that we can increase value to the membership.
Q. What is your proudest accomplishment from your work with ISPE?
A. Honestly, I do not think that I have done significantly enough to claim a proudest moment yet. However, I am confident that the work we are doing at ISPE China will bring positive changes and make ISPE a more valuable platform to more professionals and regulators by aligning with ISPE’s vision and mission, leveraging ISPE’s global resources and collaborating with China’s regulatory agencies to support the innovation and transformation of pharmaceutical industry in China.
Q. What advice would you have for those who would like to follow in your footsteps and become more involved in ISPE?
A. I would encourage them to learn more about ISPE by actively participating in ISPE activities in various committees and COPs, especially here in China. ISPE offers a valuable, neutral and effective platform that provides opportunities for like-minded professionals to network, take initiative and lead activities that can make positive impact to the industry and the regulators. One can be assured that it will be a satisfactory experience to make contribution to ISPE as a Volunteer because one can not only create value to the membership but also learn while doing so.