Conference Day 1
Wednesday June 12, 2019

8.50

Chair’s Opening Remarks

Mary Hu
Chief Executive
Officer Miracogen

9.00

Keynote: Antibody Drug Conjugate Development in Asia: Current Clinical Status & Future Directions
• Update on the key movements in the clinic
• Insight into the rapidly evolving pipeline
• Analysis of novel clinical ADCs

Letrishka Antony
Senior Analyst
Beacon

9.30

Keynote: Daiichi Sankyo DXd ADC Technology: DS-8201 & U3-1402:
Clinical Validation of an ADC Design Meant to Deliver a By-Stander Effect
• Design of novel drug-linker technology based on topo-I inhibitor Exatecan
• Highly efficacious ADC with high DAR, bystander effect, and excellent stability in systemic circulation
• Clinical outcomes of DS-8201a, U3-1402 and other ADCs

Takashi Nakada
Researcher
Daiichi Sankyo

10.00

Designing Novel ADCs Against Multiple Myeloma
• Levena has developed synthetic chemistry based site-specific conjugation methods,
K-Lock & C-Lock, together with its proprietary toxin Duostatin
• Novel ADCs against CD-38 and BCMA, based on Levena’s technology, have been developed for targeting multiple myeloma and demonstrated good efficacy and
safety profiles
• These ADCs have been CMC enabled and are currently under IND enabling studies

Hui Li
Chief Executive
Officer Levena

10.30

Speed Networking
This session is a great opportunity to introduce yourself to the attendees that you would like to have more in depth conversations with. This session is the ideal opportunity to get face-to-face time with many of the brightest minds working in the ADC field and establish meaningful business relationships.

11.30

Morning Refreshments

Discovery & Development Stream
Chair: Tse Wen Chang, CEO, Immunwork

CMC & Regulatory Stream
Chair: Firelli Alonso, Senior Director, External Supply, Pfizer

Effectively Translating into the Clinic

Reducing Manufacturing Costs Whilst Increasing Efficacy

12.30

12.30

Discussing an Overview of the ADC field and Lessons Learned from Translating into The Clinic
• Reviewing the preclinical ADC landscape
• Sharing lessons learned from translating into phase I
• Reflecting on the landscape and the next steps for ADCs
Feng Tian, Chief Executive Officer, Ambrx

Conjugation & Fill Finish: How to Secure the Supply Chain of ADCs
• Overview of the supply chain
• Driving a clinical product to the BLA
• Setting a robust commercial supply
Giorgio Salciarini, Technical Business Development Manager, BSP Pharmaceuticals

1.00

1.00

Breast Cancer Subtype-Specific Biomarker Identification By Phenotypic Selection
• For the discovery of diagnostic and therapeutic targets, we have developed a systematic approach for concurrent identification of Antibody and Antigen (Ab/Ag) pairs.
• In this presentation, the technical platform for the discovery of Ab/Ag pairs for molecular subpopulation of breast cancers will be presented.
• The potential value of the Ab/Ag pair for diagnostic, therapeutic biomarkers, and cancer therapy as antibody and antibody drug conjugate will be presented using the Ab/Ag identified using the platform as an example
Kristine Kim, Professor, Kangwon National University

ADC Manufacturing: ADC Outsourcing, Technology Transfer & CMO-Client Relationships
• How to choose the right CMO when outsourcing
• Guide you through the contractual agreement
• Understand the key elements to develop a partnership between the parties, covering all phases
Firelli Alonso, Senior Director, External Supply, Pfizer

1.30

Lunch & Networking

Sharing Novel & Innovative Technology Approaches

Sharing Lessons Learned from Experience with Regulatory Bodies

2.30

2.30

Amanitin-based Antibody-Drug Conjugates as New Therapeutic Modalities for Cancer Therapy
• Antigen-Targeted Amanitin-Conjugates (ATACs) represent a new class of ADCs using the payload Amanitin
• This payload introduces a novel mode of action into oncology therapy, the inhibition of RNA polymerase II
• The technology platform includes Amanitin supply, sitespecific conjugation, demonstrated safety profile and biomarker
• HDP-101 is the first ATAC directed against BCMA entering Phase I trials by the end of 2019
George Badescu, Vice President Scientific Affairs,
Heidelberg Pharma

Lessons Learned from Preparation of an IND Submission in US & China
• Outline the differences of regulatory expectation of Phase 1 submission of ADC in US and China
• Address the challenges of dual submission of Phase 1 IND package of an ADC molecule in US and China
• Share the lessons learned from the preparation of the CMC, pre-clinical and clinical development package of an ADC molecule
Ziping Wei, Chief Executive Officer, BlissBio

3.00

3.00

New Linker Technology & Next-generation of ADCs
• ADC overview
• NBT’s site-specific conjugation technology
• Case studies of ADC discovery with site-specific conjugation technology
Nianhe Han, Chief Executive Officer, NewBio Therapeutics

ARX788 Manufacturing & Comparability Strategy Meeting Regulatory Requirements
• Introduction to Ambrx technology
• Advantage of applying Ambrx technology to make ADCs
• ARX788 development and manufacturing strategy
• ARX788 comparability strategy and study results addressing process changes
Ying Buechler, Vice President of Development, Ambrx

3.30

Afternoon Refreshments & Networking

Optimization of ADCs: Maximizing the Therapeutic Window of Your ADC Candidate

4.10

Overcoming Challenges of Maximizing the Clinical Therapeutic Window of Antibody Drug Conjugates Case Study: RC48ADC
• Optimizing clinical trial design
• Overcoming operational challenges within Asia
• Delving into RC48ADC

Jianmin Fang
Chief Executive Officer
Remegen

4.40

Discovering ADC for Potential Treatment of Prostates Cancer
• Discover novel tubulysins that potently kill multiple MDR celllines
• Develop site-specific tubulysin ADC
• Demonstrate in vitro activity and in vivo efficacy in prostate models

Amy Han
Director of Chemistry Research & Development
Regeneron

5.10

Chair’s Closing Remarks

Mary Hu
Chief Executive Officer
Miracogen

5.20

Scientific Poster Session
After the formal presentations have finished, the learning and networking carries on. The Poster Session is an informal part of the conference agenda, allowing you to connect with your peers in a relaxed atmosphere and continue to forge new and existing relationships.