12-15 November, 2018
Marriott Marquis & Marina, San Diego, CA

Pre-conference workshops

AM | Monday, 12 November 2018

Full Day
Workshop
Workshop A: Workshop C: Workshop E:
Primer Course: Introduction to the Design, Discovery & Development of ADCs Exploring Novel Mechanisms of Actions, Optimizing Payload & Linker Chemistry & Deepening Understanding of Payload Driven Toxicities Filing a Successful ADC IND – from Discovery to First in Human Study Preclinical Pharmacology & Mechanistic Modelling of Antibody Drug Conjugates in Support of Human Clinical Trials
9.00 – 16.00
(Full Day)
9.00 – 12.00am 9.00 – 12.00am 9.00 – 12.00am

This workshop will offer a one-day intense learning environment to establish core skills and understanding in the critical areas of ADC research and development.

 Designed for new entrants to the ADC field it will deliver critical knowledge in a number of the key problem areas that hinder antibody drug conjugate programs.

 

Workshop Leader: David Bramhill, Consultant, Bramhill Biological Consulting

Discussion will focus on how payload-linker combinations can affect ADC clinical activity and toxicities when attached to antibodies, and how the most appropriate payload-linker combination can be chosen for a particular antibody and/or cancer type.

Attend this workshop to explore the scientific biological rationale for maximizing the synergy of ADC payload- linker combinations.

Workshop Leader: To be confirmed

This workshop will cover early development needs from product candidate ID to successful initiation of the first-in-human study. Antibody-drug conjugates are complex products requiring additional consideration for successful IND preparation. The CMC requirements for the antibody, additional CMC challenges for analytics and safety considerations for first-in-human studies are covered in this broad overview for filing an initial IND.


Workshop Leader:
Karen Cha, Drug Development Consultant, Sapience Regulatory Consulting

This workshop will discuss the nonclinical methods and strategies to evaluate ADC pharmacology and mitigate the risk to success in the clinic.

You’ll learn the tools and insight to successfully submit an investigational new drug (IND) application by robustly demonstrating both reasonable safety for initial use in humans and exhibiting pharmacological activity.

This workshop will also share insight from non-clinical pharmacology studies that have demonstrated utility to identify combination therapies.

Workshop Leader:
Johnny Yin, Principal, Johnny Yin Biotechnology Consulting

PM | Monday, 12 November 2018

Full Day
Workshop
Workshop B: Workshop D: Workshop F:
Primer Course: Introduction to the Design, Discovery & Development of ADCs Design of Next Generation Linkers & Site-Specific Conjugation Techniques Revealing Cutting Edge Science for Selecting the Right Antibody Format for Payload Delivery Managing & Mitigating ADC Toxicities in Preclinical & Clinical Development
9.00 – 16.00
(Full Day)
13.00 – 16.00pm 13.00 – 16.00pm 13.00 – 16.00pm

….Continued 

Workshop Leader: David Bramhill, Consultant, Bramhill Biological Consulting

Let’s explore various ways to improve the therapeutic window of ADCs with more soluble and more stable linkers, multi-valency, and the use of site specific conjugation techniques.  We will look at ways to have a defined DAR, a stable linkage, and controlled multi-valency on native and engineered proteins.

 

Workshop Leaders: Rick Powers, Chief Consultant, ADC Consulting

Ed Ha, Principal Scientist, AngieX

Historically, focus has been on the conjugation of cytotoxic small molecules to monoclonal antibodies, which has achieved remarkable clinical success. Since then antibody fragments, domains and even small ‘scaffolds’ have been explored for targeted payload delivery. This workshop will optimise ADC R&D by assessing in detail different antibody formats, as well as critically evaluating their characteristics and effectiveness.

Workshop Leader: Nazzareno Dimasi, Associate Director, R&D, MedImmune

This translational session will focus on the mechanisms of clinical and nonclinical safety of novel ADC’s with an emphasis on understanding the mechanisms of the observed findings.   Emphasis will be placed on discussing ways in which the toxicities can be modified by rationale drug design or mitigating strategies in the clinical setting.

 

Workshop Leader:  Laurie Tatalick, Consultant, Laurie Tatalick Consulting