Pre-Conference Workshops
Tuesday June 11

Workshop A and Workshop C will be running at the same time. Please select one of the two.

Workshop A

Advanced Design of ADCs: Principles & Applications with Next Generation Linkers & Site-Specific Technology

9:00am – 12:00pm

Let’s explore various ways to improve the therapeutic window of ADCs using a rational approach to improve clinical performance by building a better molecule. By incorporating improvements in solubility as well as attachment stability, great strides can be made. We will discuss various methods for obtaining a defined DAR, and the pros and cons of several key approaches. Also, attention will be given to dual and multi-warhead ADCs, and the various ways to achieve controlled multi-valency on native and engineered proteins. Lastly, with the emergence of Immuno-oncology, dual binding bi-specific antibodies will be discussed as a platform for ADC conjugations.

Chapters Summary
1) Welcome and Introductions
2) Background and Defining the Challenge
3) Solubilizing the Drug-Linker
4) Stabilizing the Linker
5) Site-Specific Strategies for Success
6) Multi-valency and Dual-Warheads
7) Bi-specific constructs as ADC platforms

Workshop Leader

Rick Powers - ADC Consulting

Rick Powers
ADC Consulting
Independent Consulant

With in-depth knowledge of the latest industry trends, Rick has extensive experience
in antibody drug conjugate (ADC) technology, including Bi-functional ADC constructs,
novel drug linker screening, analytical testing methods, and bioconjugation process
development and scale-up. His last 10 years at Abbvie/Abbott gave him great
experience with two ADC drugs in humans trials, including StemCentrx ADC process
development work. Prior to Abbvie, he conjugated with the Mylotarg pioneers at
Coulter Pharmaceuticals in 1999, then moved to Eos Biotechnology, were they had one
of the first ADC development contracts with Seattle Genetics. Eos Biotechnology was
acquired by Protein Design Labs, which eventually was acquired by Abbott/Abbvie.

Workshop C

Antibody Drug Conjugate Process Development & Manufacturing from Conjugation to Fill & Finish

9:00am – 12:00pm

A robust and scalable platform for ADC process development and manufacturing will be presented during the Workshop. Isolator Dispensing for the toxin and singleuse process technologies to accelerate development timelines and increase manufacturing predictability while decreasing scale up risks will be discussed. Case studies of single use ADC purification technologies will be presented. Additionally, the chemical compatibility of the materials described in ADC manufacturing platform to solvents typically used in ADC processing will be described. The workshop does also cover the Aseptic Fill & Finish part in Isolators, Cleaning and Cross Contamination requirements as well as Occupational safety for the operators.

 

Workshop Leaders

Richard Denk - SKAN

Richard Denk 
Head of Sales Containment
SKAN

SKAN Logo

Koji Ushioda 
Chief Executive Officer
SKAN

Ian Schwartz

Ian Schwartz
Technology Consultant, Bioconjugation
Sartorius Stedim

Workshop B

Covering All Aspects Analysis & Bioanalysis of Antibody Drug Conjugates

1:00pm – 4:00pm

• Technical challenges in ADC analytical characterization and bioanalysis
• Recent advancement in technologies and strategies and an update of regulatory perspectives
• Selection and correlation of various technologies and platforms in ADC bioanalysis
• The trend and future: discovery and development integrated bioanalytical strategy

• Stage specific and continuity of bioanalytical approaches, platforms and strategies at different phases of ADC development
• Recommended strategy in choosing ADC analytes, assay platforms and assay DAR characteristics
• Discussion on regulatory requirements
• Challenges and strategies of bioanalysis for new conjugate modalities

Workshop Leaders

Dian Su - Genentech

Dian Su
DMPK Scientist
Genentech

Jian Wang - Bristol Myers Squibb

Jian Wang
Senior Principle Scientist
BMS