Author: [AUTHOR] Published on 5/1/2023 12:00:00 AM

Lei Zhang, PhD, Deputy Director, Center for Drug Evaluation and Research, US Food and Drug Administration, Fulton, Maryland

What does receiving the Malle Jurima-Romet Mid-Career Leadership Award mean to you?
Receiving this award means a lot to me. This award is named after Dr. Malle Jurima-Romet, who was a great leader and volunteer to ASCPT. It is a great honor and recognition to be selected for this award. Knowing Dr. Jurima-Romet and having worked with her at ASCPT, receiving this award is even more special. I am proud to be among other recipients whom I respect highly. I am grateful to ASCPT for the opportunity to serve, lead, grow, and learn from many wonderful leaders. It has been my privilege to work with many excellent ASCPT staff and volunteers! I will continue my journey to lead regulatory sciences, mentor young professionals, and serve ASCPT to advance the clinical pharmacology field.

What professional accomplishment are you most proud of?
I am most proud of my contribution to regulatory sciences that enable science-driven, evidence-based regulatory decision-making. I was fortunate to work with many great professionals both within and outside the US Food and Drug Administration (FDA) to advance clinical pharmacology, particularly through my role in advancing transporters and their role in drug–drug interactions. I cloned the first Organic Cation Transporter when I was a graduate student in Dr. Kathleen Giacomini's lab. I also proposed the decision trees on P-glycoprotein to help determine the need for conducting in vivo drug interaction studies based on in vitro data. More decision trees were developed for additional transporters that are of clinical significance under the auspices of the International Transporter Consortium that I have been part of since its inception. I also significantly contributed to many clinical pharmacology guidances when I was in the Office of Clinical Pharmacology at the FDA. In my current job, I promote research to support generic drug development. I also lead the international harmonization efforts (serving as the Rapporteur of the ICG M13 expert working group) in developing the first ICH guideline on BE standards for immediate release oral drugs. I was recognized as an esteemed AAPS Fellow in 2013, which is a very prestigious award in the pharmaceutical research field. Serving on the ASCPT Board is another great honor and professional accomplishment that I am most proud of.

What is the most important leadership lesson you have learned the hard way?
I learned that people have different personalities and work styles. It is important to adjust your leadership style when working with different people. Communication is the key. “Words that work: It's not what you say, It's what people hear,” is one of the most powerful messages from Dr. Frank Luntz's book. When leading a group of people, listening to your team and landing messages properly are important to set the common ground and focus on the big picture. It's also important for leaders to lead by example and to have a clear vision and values that guide their decisions and actions. Being a good leader requires empathy, humility, and a continuous effort to improve and learn.

Who has inspired you in your career?
I am fortunate to have many great mentors throughout my career. I will mention three of them, all past ASCPT presidents. Dr. Kathleen Giacomini was my PhD mentor when I was at the University of California San Francisco. She taught me how to conduct research and make good oral and written communications. I continued to receive mentorship from Kathy through collaborations at the International Transporter Consortium and FDA regulatory science projects even today. Dr. Shiew-Mei Huang is my mentor at the FDA. She taught me to address regulatory questions with science and data. She also introduced me to ASCPT and encouraged me to lead by volunteering. Dr. John Wagner is another mentor I am thankful for. He appointed me as the Scientific Program Committee (SPC) Chair when he was ASCPT President and believed in me. He had many creative ideas, and I learned a lot from him.

What has been the greatest challenge in your career?
The biggest challenge is always that I do not have enough time to do what I would like to do, for example, balance work-life, find time to volunteer, spend time on research, and find time to write papers.

Do you have a favorite tip or trick for clinical practice or research that you want to share with fellow members?
Stay updated and continuously educate yourself on recent advancements in your field. This will not only help you improve your research or provide better care to your patients, but also keep you informed of the latest guidelines, best practices, and new developments. Stay curious, ask questions, and be willing to challenge your own beliefs and assumptions. In addition, many projects are interdisciplinary in nature, so collaboration and network are important too.

What is your favorite Society memory?
I most enjoyed serving as the Scientific Program Committee Chair for the ASCPT 2015 Annual Meeting in New Orleans. The Theme of the meeting was Advancing the Bioinnovation Engine. We introduced a new “TED”-style program in the “Bioinnovation Forum”, and the fun and educational “asparagus population PK study.” I had the opportunity to lead an international committee of 24 members who are world-renowned leaders in clinical pharmacology and therapeutics within their respective affiliations in the academic, government, industry, and consulting sectors, and learn a great deal from everyone. Serving on the SPC as a member and Chair is one of my favorite Society memories. Other great memories include being the first DRO Network Chair and serving on the ASCPT Board.

What's one thing people would be surprised to know about you?
During the pandemic, I got to spend a lot of time with my daughters' pet budgie bird. The bird liked to land on my shoulder or head when I was working. He also chirped a lot, so I needed to be careful that he was not chirping when I spoke on calls. He even stepped on my keyboard. I took many selfies with him. It was fun.

Another fun fact is that “I” have more than 12,000 publications based on a PubMed search – not because I actually have this many publications, but because I have a common first and last name.

Dr. Zhang has been a member of ASCPT since 2007.