The globalization of Chinese innovative drugs is entering its 2.0 era.

The key to future competition is no longer the licensing-out of a single product, but the establishment of an FDA-ready industrialization system capable of consistently generating global products.

This "North America-China Innovative Drug Industry Collaboration Special Session" will, for the first time, systematically showcase a complete solution covering FDA IND submission, North American clinical implementation, and global commercialization translation. Built upon the regulatory and clinical execution framework established by JPCG and Polaris, combined with the innovative practices of leading platforms such as AIGM, Hope AI, Hill Research, Insilicom, and LINKMedicine.AI in AI-driven drug discovery, clinical trial design, statistical analysis, pharmacovigilance, and digital operations, this session aims to reshape the paradigm of drug R&D for the next decade.

Using nucleic acid drugs as a demonstration track, the session will provide an in-depth analysis of how to integrate China's innovation capabilities with North American clinical resources to build a global collaborative network covering R&D, regulatory affairs, clinical trials, data, compliance, and commercialization, accelerating the transition of Chinese innovative drugs from "licensed out" to "globally approved."

July 22–24, Shanghai National Exhibition and Convention Center. Join global industry leaders in exploring new pathways for Chinese innovative drugs to meet FDA standards and access global markets.

Special Session Agenda
Co-organizer: Beijing BioInno Technology

Curator
Yingchun Zhao：Founder, PolyEngine Technologies; Partner, Beijing BioInno Technology; Vice President, SAPA-DC

13:30-13:35　Opening Remarks: China Innovative Drug Globalization 2.0: Building a New FDA-Ready Industrialization Paradigm
Oliver Liang：Partner, Beijing BioInno Technology; Co-founder, Nuraydia Life Sciences

13:35-13:50    From China R&D to FDA IND: The First Gateway to Global Drug Development
Jinhui Dou：Consultant, JP Consulting Group

13:50-14:05　From IND Clearance to Patient Enrollment: Building North American Clinical Development Capabilities
Jane Fang：Founder & CEO, Polaris Strategic Partners 

14:05-14:20　From Real-World Data to FDA-Ready Drug Candidates: AIDD Across the Drug Development Lifecycle
Dr. Rico W. Tang：Chief Scientist, AIGM

14:20-14:35　AI-Native Clinical Development: Reconstructing the Future Clinical Decision-Making System
Will Ma：Founder & CEO, HopeAI

14:35-14:50    From Data to Decisions: How AI is Transforming Clinical Statistics and Regulatory Deliverables
Oliver Li：Co-founder & Head of Product, Hill Research

14:50-15:05　A New Paradigm for Pharmacovigilance in the FDA Era: Intelligent Safety Monitoring Powered by Knowledge Graphs and Large Language Models
Kaixian Yu：Founder & CEO, MedGraph Intelligence

15:05-15:20　From Patient Navigation to Global Trial Acceleration: How Digital Health is Transforming Clinical Development
Frank Chen：President & CEO, LINKMedicine.AI

15:20-15:35　Globalization of Nucleic Acid Therapeutics: From Technological Innovation to FDA-Ready Industrialization
Lisa Wu：General Manager, Cosynbio

15:35-16:20　Roundtable Discussion：China Innovative Drug Globalization 2.0: How to Build FDA-Ready North American Industrialization Capabilities?
Victor Liang：Partner, Beijing BioInno Technology; Co-founder, Nuraydia Life Sciences
Charles Li：Co-founder & CEO, Nuraydia Life Sciences; Partner, Beijing BioInno Technology
Jinhui Dou：Consultant, JP Consulting Group
Jane Fang：Founder & CEO, Polaris Strategic Partners
Dr. Rico W. Tang：Chief Scientist, AIGM
Will Ma：Founder & CEO, HopeAI
Oliver Li：Co-founder & Head of Product, Hill Research
aixian Yu：Founder & CEO, MedGraph Intelligence
Frank Chen：President & CEO, LINKMedicine.AI
Lisa Wu：General Manager, Cosynbio