Official Announcement: Dr. Yaning Wang, a Chinese-American FDA scientist, Appointed CEO of Wuhan Langlai Technology

2021 On September 13 of this year, Dr. Wang Yaning, former Director of the Quantitative Pharmacology Review Section within the Clinical Pharmacology Review Division of the Center for Drug Evaluation (CDER) at the U.S. Food and Drug Administration (FDA), officially joined Wuhan Langlai Technology Development Co., Ltd. (hereinafter referred to as “Langlai Technology”) as Chief Executive Officer (CEO).

9 On the morning of the 13th, Langlai Technology held an inauguration ceremony, attended by all employees of the company and Langlai Technology’s wholly owned subsidiary. —— All employees of Shanghai Meiyue Biotechnology Development Co., Ltd. attended the ceremony, which was also graced by Mr. Wang Chaodong, Chairman of Langlai Technology, who extended a warm welcome to Dr. Wang Yaning on her joining the company.

Dr. Yaning Wang is a globally distinguished clinical drug research scientist and a leading figure among Chinese professionals in the biopharmaceutical field. After earning dual degrees—a Ph.D. in Pharmacy and a Master’s in Statistics—in 2003, Dr. Wang joined the U.S. Food and Drug Administration, where she spent nearly two decades conducting drug review and evaluation. She is recognized as an outstanding Chinese scientist within the FDA’s Office of Clinical Policy and Review, having spearheaded and actively participated in the development and implementation of FDA policies, regulations, and guidance documents. Her contributions have been instrumental in the approval and market launch of critical therapeutic products across several disease areas, thereby addressing unmet clinical needs of patients worldwide. Dr. Wang has been honored with the FDA Award of Merit and the FDA Outstanding Service Award.

Prior to joining Langlai Technology, Dr. Wang Yaning served at the Center for Drug Evaluation (CDER) of the U.S. Food and Drug Administration (FDA), where she held the position of Director of the Quantitative Pharmacology Review Division within the Clinical Pharmacology Review Branch. In this role, she was responsible for the review of quantitative pharmacology applications across all therapeutic areas, as well as for research projects and policy development in this field.

Dr. Wang Yaning delivered an inaugural address to all employees at the onboarding ceremony. Dr. Wang stated that the FDA was his first job, a position he held for 18 years, and that joining Langlai Technology marks his second career chapter. Although his original aspiration was to start his own business, after receiving Langlai Technology’s warm invitation, he conducted an in-depth assessment of the company and was profoundly impressed by its decades of accumulated R&D achievements, ultimately deciding to join—truly a remarkable karmic connection.

Dr. Wang expressed his enthusiasm about joining Langlai Technology and stated his aspiration to remain with the company until retirement. He believes that only with sufficient time can one build a career of lasting impact and cultivate genuine, meaningful relationships—relationships with influential individuals, friends, and colleagues. At the same time, Dr. Wang emphasized that quantitative pharmacology plays a pivotal role in regulatory review, with its most significant application being the guidance and optimization of clinical trial design, which in turn enables more precise and faster clinical research and ultimately brings benefits to patients worldwide. He hopes that Langlai Technology will one day become a household name—not because of the addition of any single individual, but because the innovative drugs it develops will improve the lives of patients around the globe. To earn recognition and respect, one must deliver results that truly merit such acknowledgment; he achieved this during his tenure at the FDA, but that is now part of the past. Moving forward, he will work closely with his colleagues at Langlai Technology, building on the solid foundation the company has established over the past nine years, to further elevate Langlai into a world-class pharmaceutical enterprise.

Colleagues in the U.S. pharmaceutical industry have highly praised Dr. Wang Yaning’s work.

“ “He is a great leader; his departure marks another significant milestone in the history of the FDA. To me, he is a hero, a friend, and a colleague—and a role model for all of us.” —Dr. Carl Peck, Founder and Chairman of NDA Partners LLC, Visiting Professor at the University of California, San Francisco, and Director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA).

“Dr. Wang Yaning is the Michael Jordan of clinical pharmacology.” —Dr. Bob Powell, Professor at the University of North Carolina and Director of the Quantitative Pharmacology Review Section within the Clinical Pharmacology Review Division of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA).

“It is a great honor for me to witness Dr. Wang Yaning’s outstanding achievements in quantitative pharmacology at the FDA, which have earned widespread recognition within the global pharmaceutical industry and among regulatory authorities.” —Dr. Lawrence Lesko, Professor at the University of Florida and Director of the Clinical Pharmacology Review Division at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA).

“Dr. Wang Yaning epitomizes science; he has never compromised on scientific rigor and has laid a solid foundation for the development of quantitative pharmacology and clinical pharmacology to their current standing, from which we all benefit.” —Dr. Jogo   Gobburu , CEO of Pumas-AI, Founder and Chair of Vivpro Corp, Professor at the University of Maryland, and Director of the Quantitative Pharmacology Review Section within the Clinical Pharmacology Review Division of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA).

“Dr. Wang Yaning’s departure is a significant loss for the FDA, and we will all miss him dearly.” —Dr. Robert Temple, Deputy Director for Clinical Science at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) and Senior Advisor to the New Drug Review Division.

With the addition of Dr. Wang Yaning, Langlai Technology has taken another solid step forward on the path to internationalization and capitalization, marking the dawn of a brand-new era for the company. We are confident that, under Dr. Wang Yaning’s leadership, The company will accelerate its development to become a leading innovator in specific disease areas. 。

Dr. Wang Yaning – Personal Profile

Yaning Wang graduated in 1996 from the Department of Pharmacy at the former Beijing Medical University and was directly admitted to the master’s program that same year. In 1999, after obtaining a master’s degree in instrumental analysis from the National Anti-Doping Center, she was accepted by the College of Pharmacy at the University of Florida in the United States to pursue a doctoral degree in pharmacy, and in 2003   After earning dual degrees in Pharmacy and Statistics, he joined the Clinical Pharmacology Review Division of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). Over his 18-year tenure, he advanced from reviewer to senior reviewer, team leader, deputy director for science, deputy director, and ultimately director of the Quantitative Pharmacology Review Office, collaborating with multiple FDA divisions to oversee review and approval across all therapeutic areas. As director of the Quantitative Pharmacology Review Office, he was responsible for quantitative pharmacology reviews, research initiatives, and policy development spanning all disease areas. During his time at the FDA, he also served as a regulatory expert instructor for three international training programs on new drug development—one each in the United States, Europe, and China.   Dr. Wang Yaning serves as a doctoral supervisor at several universities and as a member of their degree-conferral committees, having mentored more than 70 visiting scholars, postdoctoral researchers, and doctoral candidates. In addition, Dr. Wang has served on the Board of Directors of the International Society for Quantitative Pharmacology (ISoP) and was awarded ISoP’s Lifetime Fellowship. She is also a Standing Committee Member of the Chinese Society for Quantitative Pharmacology, a member of the Editorial Advisory Board of the Journal of Pharmacokinetics and Pharmacodynamics, a Visiting Professor at the College of Pharmacy at the University of Florida, a Visiting Professor at the Clinical Research Institute of Peking University, a Visiting Professor at the School of Pharmaceutical Sciences of Peking University, and a Visiting Lecturer at both the College of Engineering and the College of Pharmacy at the University of Michigan. Dr. Wang has published over 100 scholarly papers and, as an FDA expert, has delivered more than 280 presentations at various national and international conferences. Several former senior FDA officials have highly commended her outstanding contributions to new-drug development and regulatory affairs.  。

Attachment:

Audio of Dr. Wang Yaning’s Inaugural Address

Audio recordings of U.S. pharmaceutical industry colleagues’ evaluations of Dr. Wang Yaning:

1. Dr. Bob Powell’s evaluation of Dr. Wang Yaning

2. Dr. Carl Peck’s Evaluation of Dr. Wang Yaning

3. Dr. Jogo Gobburu’s Evaluation of Dr. Wang Yaning

4. Dr. Lawrence Lesko’s Evaluation of Dr. Wang Yaning