Home Dr. Changqing Li, Co-founder & CMO of Eglin Pharma, Shares Insights on FDA's AI-Driven Review Trends and Strategic Responses

Dr. Changqing Li, Co-founder & CMO of Eglin Pharma, Shares Insights on FDA's AI-Driven Review Trends and Strategic Responses

Jul 16, 2025 09:35 CST Updated 09:35
Evergreen Therapeutics

Innovative Drug Developer

Image

We are honored to have invited to this conferenceEvergreen Therapeutics, Co-Founder & CMOLi ChangqingAttendNew Developments in FDA Regulatory OversightForum, bringing us the theme sharing 【Trends and Responses in FDA AI Review



Guest Profile

Dr. Li Changqing holds a Master's degree in Hospital Management from the University of Alabama at Birmingham and a Doctorate in Public Health. He is a licensed physician in the United States and has obtained certification as a specialist in clinical pathology. He once served as a senior medical reviewer at the U.S. FDA and was the first Chinese international student to enter the FDA’s clinical review process as a physician. Dr. Li has extensive global clinical trial experience ranging from Phase I to Phase IV studies in areas such as oncology, immunotherapy, anti-inflammatory treatments, gastrointestinal diseases, and gynecological conditions. He has led hundreds of clinical trials worldwide and over 30 new drug applications.




Image

图片
图片

◈ 09:00-09:25

Regulation Under the New FDA Policy

WangYaning

Evergreen Therapeutics, Founder & CEO



◈ 09:25-09:50

Trends and Responses in FDA AI Review

Li Changqing

Evergreen Therapeutics, Co-Founder & CMO



◈ 09:50-10:15

Considerations for Submitting Chinese Clinical Data to the US

Yuwen Gao

StemMed Senior Vice President and Global CBO


◈ 10:15-10:40

FDA Non-Clinical AI Review and Organoid Applications

Han Xiaomei

BroadLeap Bio, Founder & CEO


◈ 10:40-11:05

FDA New Non-Clinical Regulations and Response Strategies

Zhang Yongbin

JOINN Laboratories, Vice President and Chief Technology Officer



◈ 11:05-12:00

Panel: New Trends in FDA Regulatory Oversight

[ Host ]

    Du Xin  Evergreen Therapeutics, CEO

[ Guest ]

Li Changqing  Evergreen Therapeutics, Co-Founder & CMO

Yuwen Gao  Senior Vice President and Global CBO of Stem Pharmaceuticals

Han Xiaomei  BroadLeap Bio, Founder & CEO

Zhang Yongbin  Vice President and Chief Technology Officer of JOINN Laboratories


◈ 12:00-13:30

Lunch


◈ 13:30-13:55

New Trends in cGMP Compliance Regulation

Sun Zhigang

Senior Vice President of GreenLeaf Pharmaceuticals


◈ 13:55-14:20

New Developments in FDA Regulation of Botanical Drugs

Dou Jinhui

Former Senior FDA Review Expert


◈ 14:20-14:45

Communication on Interdisciplinary Key Controversial Issues in EOP2 Meetings

Yang Jing

Professor at the Center for Drug Metabolism Research, China Pharmaceutical University


◈ 14:45-15:10

Non-Clinical Safety Evaluation Studies of Advanced Therapy Products and the Application of New Safety Assessment Methods

Lu Jinhua

Stardust Bio, Co-Founder, CSO


◈ 15:10-15:35

Application of Real-World Data in New Drug Clinical Development

Shen Xiao

Libang Pharmaceuticals, Chief Scientific Officer


◈ 15:35-16:20

Panel: New Developments in FDA Regulation of Emerging Medical Products

[ Host ]

    Du Xin  Evergreen Therapeutics, CEO

[ Guest ]

Sun Zhigang  Luye Pharma Group, Senior Vice President

Dou Jinhui  Former Senior FDA Review Expert

Yang Jing  Professor at the Center for Drug Metabolism Research, China Pharmaceutical University

Lu Jinhua  Stardust Bio, Co-Founder, CSO

Sherry Xiao  Libang Pharmaceuticals, Chief Scientific Officer


*Guests and agenda are continuously updated, subject to the actual event on site....


Image


For business cooperation such as exhibition participation, sponsorship, and co-organization, please feel free to inquire:



Business Cooperation

CMC Pharma Expo 400-1662-808



Consultation for Participation

Ms. Li 18215607723 (Same for WeChat)




Image

- Welcome to the group for communication -