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According to the news and confirmation of Pharmaceutical Times, Dr. Wang Yaning, an industry veteran expert who had worked in the U.S. Food and Drug Administration (FDA) for 18 years and was promoted to the director of the quantitative pharmacology review department of the FDA's clinical pharmacology review office, has left Langlai Technology and founded Shanghai Ruiningkang Biopharmaceutical.
Dr. Wang Yaning graduated from Peking University with a bachelor's degree in pharmacy in 1996, received a master's degree in biochemistry from the National Doping Testing Center in 1999, and received a doctorate in pharmacy and a master's degree in statistics from the University of Florida in 2003.
Dr. Wang joined the U.S. Food and Drug Administration (FDA) in 2003 and worked there for 18 years, from reviewer, senior reviewer, team leader, undersecretary of science, acting director, to the head of the quantitative pharmacology review department of the Clinical Pharmacology Review Office until leaving the FDA in September 2021. During this time, Dr. Wang was responsible for quantitative pharmacology reviews, research programs, and policy development in all disease areas, and played a key role in the decision-making of new drug approvals for multiple major diseases.
During his time at the FDA, Dr. Wang participated in the development of a number of guidelines and regulations, and received several honors, including the FDA's highest award (Award of Merit) and the Outstanding Service Award. Dr. Wang is the lead developer of the CQT method recommended in the ICH E14 guideline.
In September 2021, Dr. Wang returned to China and joined Langlai Technology Development Co., Ltd. as the Chief Executive Officer (CEO) until May 2024. During this period, he led the team to promote nearly 10 new drug R&D projects to different clinical stages, and completed a series A financing of 500 million yuan during the capital winter, successfully promoted a number of projects to the international market and reached high-value transactions.
In June 2024, Dr. Wang founded Shanghai Ruiningkang Biopharmaceutical Co., Ltd. to provide professional consulting services for new drug research and development, overseas expansion and listing.
Dr. Wang has published more than 120 papers and more than 400 reports at domestic and international conferences as an expert in new drug development and regulation.
· He has served as a regulatory expert lecturer for three international new drug development trainings, a doctoral supervisor and a member of degree conferment committees at several universities, and has supervised more than 70 visiting scholars, postdoctoral scholars and doctoral candidates.
· He served as a director of the International Society for Quantitative Pharmacology (ISoP) and received the ISoP Lifetime Achievement Award.
· He is a member of the Standing Committee of the Chinese Committee of Quantitative Pharmacology and a member of the Editorial Advisory Committee of the Journal of Pharmacokinetics and Pharmacodynamics.
· He is a visiting professor at the University of Florida, Peking University, and Shanghai University of Traditional Chinese Medicine.
· In 2023, he was honored as a distinguished leader in health in Washington, D.C., USA.
· In the same year, he was appointed as a member of the first committee of the Regulatory Science and International Standards Professional Committee of the Chinese Pharmaceutical Association by the Chinese Pharmaceutical Association, and provided expert think tank support for the review and approval of new drugs and the formulation of policy guidelines for the China Food and Drug Administration.
· Served as an expert for the evaluation of national disruptive projects by the Ministry of Science and Technology of China, reviewing projects with technological disruptive and product transformation potential.
· Advised a number of Wall Street investment institutions and banks on new drug development and marketing.
Dr. Yaning Wang's career has demonstrated his deep expertise and leadership in the field of medicine, as well as his outstanding achievements in new drug research and development, regulatory policy development, and international collaboration.
Colleagues in the American medical community spoke highly of Dr. Wang's work.
01
"He is a great leader, and his departure represents another important milestone in the history of the FDA, and he is a hero, friend, and colleague to me, and a role model for all of us."
——Dr. Carl Peck
Founder and Chairman of NDA Partners LLC, Adjunct Professor at the University of California, San Francisco, and former Director of the Center for Drug Evaluation (CDER) of the U.S. Food and Drug Administration (FDA).
02
"Dr. Yaning Wang is Michael Jordan in the field of clinical pharmacology."
——Dr. Bob Powell
Professor at the University of North Carolina, former director of the Quantitative Pharmacology Review Division of the Center for Drug Evaluation (CDER) of the U.S. Food and Drug Administration (FDA), former executive of Glaxo, Pfizer, and Roche.
03
"I am very honored to witness Dr. Yaning Wang's outstanding achievements in quantitative pharmacology at the FDA, and his achievements have been widely recognized by the global pharmaceutical community and regulatory authorities."
——Dr. Lawrence Lesko
Professor at the University of Florida and former Director of the Clinical Pharmacology Review Division of the Center for Drug Evaluation (CDER) of the U.S. Food and Drug Administration (FDA).
04
"Dr. Yaning Wang was the only professional who could realize my vision, and he was the only one who was crazy enough to get a double degree in pharmacy and a master's degree in statistics in four years. Dr. Yaning Wang has revolutionized the role of clinical pharmacology in FDA's regulatory decision-making and the perception of FDA reviewers.
His excellence and excellence have attracted more talented people to join the FDA. As long as it is Dr. Wang's evaluation report, I can sign it with my eyes closed. Dr. Yaning Wang represents science, and he is unequivocal in his science and has laid the most solid foundation for quantitative pharmacology and clinical pharmacology to develop to where it is today, from which all of us benefit. I would like to express my deep gratitude for their contributions to the industry and their service to public health. ”
——Dr. Jogo Gobburu
CEO of Pumas-AI, Founder and Chairman of Vivpro Corp, Professor at the University of Maryland, and former Director of the Quantitative Pharmacology Review Division of the Center for Drug Evaluation (CDER) of the U.S. Food and Drug Administration (FDA).
05
"Dr. Yaning Wang is very good at translating complex questions and analyses into explanations that clinicians can understand, which is very valuable, and his departure is a significant loss to the FDA, and we will all miss him very much."
——Dr. Robert Temple
Associate Director of Clinical Sciences and Senior Advisor to the Division of New Drug Evaluation (CDE) of the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation (CDER).
The team of Pharmaceutical Times warmly congratulates Dr. Wang Yaning on his entrepreneurship!
I wish the new business a prosperous and successful success!
I would like to express my heartfelt thanks to Dr. Wang for his trust and support in the pharmaceutical era!
Dr. Wang once praised the live broadcast of the FDA's ODAC meeting with the FDA to discuss Innovent/Eli Lilly's PD-1 inhibitor sintilimab as "the Spring Festival Gala of China's pharmaceutical industry", which was watched by ~42,000 professionals and friends that night, and 300,000 people watched the replay the next day. The grand occasion is unprecedented, and it is of milestone commemorative significance.
Pharmaceutical Times has also been paying attention to and reporting on Dr. Wang. The reports and articles have received the attention and love of the majority of friends!
Resources:
Official announcement! Dr. Yaning Wang, a top Chinese scientist from the FDA, was appointed CEO of Wuhan Langlai Technology (same as Freehand)
A series of articles on the age of medicine
Other publicly available information