Course Information

Course Information

• The course begins at the time stated below
• The course is broken up into sessions outlined below
• There will be breaks between sessions

15 July 2026

1-Day Live Online Training
Register at the top of the page.

Session 1

180 mins | 9:30 AM UK

Introduction to ADCs and Their CMC Challenges

• Overview of ADC structure: antibody, linker, and payload
• Comparison with monoclonal antibodies and small molecules
• Unique CMC challenges of ADCs

Manufacturing Considerations

• Antibody production and characterisation
• Linker and payload: synthesis, stability, and safety considerations
• Conjugation strategies and process development
• Formulation development and drug product challenges

Analytical and Quality Considerations

• Defining and controlling Critical Quality Attributes (CQAs)
• Analytical methods for ADCs (potency, DAR, heterogeneity)
• Impurities, stability, and comparability

Session 2

180 mins | 1:30 PM UK

Regulatory Landscape for ADCs

• FDA and EMA expectations for ADCs
• Relevant ICH guidelines (Q5, Q6, Q8–Q12, Q14/Q2(R2))
• Quality and safety considerations in regulatory submissions
• Common regulatory questions and challenges

CMC Development Strategies

• Linking CMC to clinical development stages
• Scale-up and tech transfer considerations
• Control strategies and risk management approaches
• Lifecycle management and post-approval changes

Case Studies and Best Practices

• Examples of ADC development and regulatory approval pathways
• Lessons learned from past submissions and regulatory feedback

Wrap-Up and Q&A

• Key take-home messages
• Open Q&A discussion

Andrew Willis is a regulatory and development consultant with 35 years of experience. His management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business and marketing strategies for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.

Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Experience covers multiple applications, scientific advice meetings, Clinical Trial applications (IND and IMPD compilation and submission), orphan drug applications. Significant Experience with novel drug delivery systems has been utilized in all of the above type of applications.

Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. More recently for IO Biotech, Andrew was SVP of Quality, Regulatory and CMC sitting on core C-suite providing CTO support activities – overseeing all pharmaceutical development of drug substance and drug products for peptide molecules and ensuring appropriate quality systems are in place.

He currently delivers extensive training courses in Quality By Design, Global Module 3 Requirements, global generic development and Optimizing the Life of Your Products. Specializing in Lifecycle management, creation of new line extensions and development strategies to maximize return on investment.