Organizer
China Chemical Enterprise Management Association Pharmaceutical Chemical Committee
Yaocheng Material Information Technology (Beijing) Co., Ltd.
Relevant Units
Antibody-drug conjugates (ADCs) have become a major focus in pharmaceutical research and development in recent years. As of the end of 2023, 15 ADC drugs have been approved for marketing worldwide, and over 900 ADC drugs are under development. Although ADC drugs have made breakthroughs in commercialization, they still face many challenges during development. To help relevant enterprises gain an in-depth understanding of the global clinical development path and typical registration issues of ADC drugs, we have specially invited experienced instructors to present a wonderful training session, combining successful and failed cases. The detailed notification is as follows:
Conference Arrangement
Conference Location: Tencent Meeting (specific address will be notified to registered participants)
Conference Date: November 16-17, 2024
Training Outline
Time 09:00-12:00 13:30-16:30
Chapter One: Overview of Approved ADC Drugs
1.1 Introduction to globally approved ADC drugs
1.2 Overview of the regulatory frameworks in China, the USA, and Europe related to ADC drug development and registration
1.3 Introduction to the targets and indications of approved ADC drugs
1.4 Overview of ADC drugs under development
Chapter Two: Introduction to the Clinical Development Path of ADC Drugs
2.1 Introduction to the classic clinical paths and related cases of ADC drugs approved in the USA
a) Detailed introduction to the global clinical development path (CDP) of the first ADC drug (Trastuzumab);
b) Detailed introduction to the global clinical development path (CDP) of the first ADC drug (Inotuzumab) used for first-line treatment;
c) Insights from the global clinical development of a revived ADC drug (Blenrep);
d) Introduction to how to effectively communicate with the FDA and advance the clinical development path of ADC drugs through practical cases;
e) Key points of FDA clinical review for ADC drugs and related case analysis.
2.2 Introduction to the clinical development path of ADC drugs approved in China
a) Expert consensus on the clinical application of antibody-drug conjugates for malignant tumors;
b) Introduction to ADC drugs approved by the CDE;
c) Key points of clinical review for ADC drugs and related case analysis;
d) Considerations for benefits and risk assessment of an ADC drug during the market application;
e) Insights for ADC R&D companies in China from the market withdrawal of Patisiran;
f) Sharing of failure cases in ADC drug development
Chapter Three: CMC Development Strategies for ADC Drugs
3.1 Preparation for CMC research work for ADC drugs at FIH;
3.2 Routine pharmaceutical changes of ADC drugs during clinical periods and their communication and application strategies;
3.3 Pitfalls and experience sharing in ADC drug registration inspections;
3.4 Analysis of several pharmaceutical issues in ADC drugs;
3.5 Solutions to several routine CMC issues affecting the R&D and registration of ADC drugs
Instructor Introduction
Teacher Zheng: Nearly twenty years of registration management experience in multinational pharmaceutical companies, responsible for global R&D and registration strategies for ADC drugs, and has conducted in-depth communication with regulatory authorities in China and the USA regarding ADC drug applications. Responsible for registration affairs in multiple therapeutic fields, and a specially appointed expert by the association.
Conference Description
1. Theoretical explanations, case analyses, special lectures, and interactive Q&A
2. All speakers are senior experts in the industry, and inquiries are welcome
3. Companies needing internal training and guidance, please contact the conference group
Training Fees
Conference Fee: 4000 RMB/account Conference fee includes: training, Q&A, electronic materials, video playback, etc.)
Remittance Account
Please note: ADC Training Conference Fee
Account Name: Yaocheng Material Information Technology (Beijing) Co., Ltd.
Bank: China Industrial and Commercial Bank Co., Ltd. Fangshan Branch, Liangxiang Branch
Account Number: 0200316909100078392
Registration Method
Scan the QR code below or click “Read Original“, register your information, and the conference staff will communicate with you about the training details.
This conference is limited to 100 participants, and welcome to send company name + name + phone to pre-register.
Add WeChat QR code, join the Antibody Circle WeChat group if eligible!Please specify: Name + Research Direction!
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