26-28 March, 2018
ProArte Maritim Hotel, Berlin, Germany

Day One
Tuesday 27th March, 2018

Day Two
Wednesday 28th March, 2018

08.00
Chair’s Opening Remarks

  • Alain Beck Senior Director, Physio-Chemistry Department, Pierre-Fabre

08.10
Explore Strategies & Challenges for the Next Generation of Antibody-Drug Conjugates

  • Alain Beck Senior Director, Physio-Chemistry Department, Pierre-Fabre

Synopsis

  • Review the current priorities for drug developers in ADC research
  • Discuss strategies to select the best target antigens, as well as suitable cytotoxic drugs; the design of optimized linkers; the discovery of biorthogonal conjugation chemistries and cytotoxic issues
  • Increase homogeneity and stability through selection and engineering of antibodies for site-specific drug conjugation
  • Explore novel mechanisms of action

08.40
Are We There Yet?: Maximizing the Clinical Potential of ADCs By Reducing Toxicities & Enhancing Tumour Antigen Targeting

  • Rakesh Dixit Vice President, Research & Development, MedImmune

Synopsis

  • Translational challenges to attaining maximal clinical potential with improved clinical therapeutic index
  • Significance of both on and off-target toxicities and efforts to mitigate
  • Five rights in ADC that help reduce both on and off-target toxicities
  • Translational approaches to rapid clinical development of ADCs

09.40
Speed Networking

Synopsis

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.

10.30
Morning Refreshments

Antibody Drug Conjugates: Design & Selection of Linker, Payload & Conjugation Chemistry

Stream Chair: Anette Sommer, Principal Scientist, Bayer 

11.00 Tunable Drug Conjugates: Holistically Redesigned Drug Conjugates

  • ADCs utilize a modular set of ligands, linkers and payloads with aligned characteristics to enable both rapid payload release in the tumour and rapid systemic clearance with the goal of significant improvements in Therapeutic Index
  • TDCs employ small molecule and proprietary antibody fragment ligands, proprietary pH-sensitive SiLinker and Payload Cassette technology, and Conditionally Activated Payloads (CAPs) whose features align with the design characteristics of TDCs
  • We are validating core aspects of the platform in a comprehensive Folate Receptor alpha targeted programme

Jutta Wanner, Vice President, Research, BlinkBio

11.30 Developing Novel Calicheamicin Antibody-Drug Conjugates

  • Design of the novel stable linkers for calicheamicin payload may lead to the calicheamicing ADCs with improved efficacy and safety profile
  • Review lessons learned in design and optimization of novel calicheamicin-based ADCs
  • Discuss the influence of the linker stability on ADC cytotoxicity in vitro, and efficacy and tolerability in vivo

Julia Gavrilyuk, Principal Scientist & Chemistry Lead, AbbVie-Stemcentrx

12.00 Novel Warheads for Targeted Therapies of Cancer - pro-PBDs: from Design to Clinical Candidates

  • Conceptual design of PBD-based prodrugs for targeted therapies of cancer
  • Explore Endocyte’s next generation latent warheads – the utility of oxime ethers in pro-PBD formats
  • Learn strategies for efficient synthesis of novel pro-PBDs and their conjugates
  • First in class pro-PBD conjugate selected for clinical development

Iontcho Vlahov, Vice President, Discovery Chemistry, Endocyte

12.30 Lunch & Networking

12.30 Sciex Lunch Seminar

LC-MS Monitoring of Biopharmaceuticals and ADCs – Simple and Fast Routine Characterisation with dedicated Hard- and Software

You’ll find out:

  • How high resolution LC-MS/MS technology can be accessed by all levels of users – from the MS specialist to non-expert users
  • How quality attributes of biotherapeutics can be monitored easily and with confidence using the power of high resolution LC-MS/MS
  • How dedicated software can support the development of ADCs and other biotherapeutics

Kerstin Pohl, Applications Specialist, Sciex

Register Here

Antibody Drug Conjugates: Design & Selection of Linker, Payload & Conjugation Chemistry

Stream Chair: Anette Sommer, Principal Scientist, Bayer

13.30 Towards Antibody-Drug Conjugates & Prodrug Strategies with Extracellular Stimuli-Responsive Drug Delivery in the Tumour Microenvironment for Cancer Therapy

  • Classical ADCs target an overexpressed and internalizing antigen on cancer cells
  • ADC have poor solid tumour penetration and their mechanism induces resistance
  • Cleavable ADC linkers can release permeable drugs in the tumour extracellular matrix
  • Learn how prodrug strategies allow controlled drug release in the tumour microenvironment

Nicolas Joubert, Associate Professor, CNRS  

14.00 Antibody-Pyrrolobenzodiazepine Conjugates

  • Development of Pyrrolobenzodiazepine (PBD) payloads for use in Antibody Conjugates
  • Update on the clinical progress of Antibody PBD Conjugates

Phil Howard, Chief Scientific Officer, Spirogen

14.30 Preclinical Validation of Site-Specifically Conjugated ADCs with Potent Anthracycline Payloads in Solid & Hematologic Tumor Models

  • Validation of a novel ultra potent anthracycline-toxin in ADCs
  • Preclinical validation of NBE’s lead ADCs in preclinical tumor models
  • Characterization of the immune-oncology function of NBE’s ADCs

Ulf Grawunder, Chief Executive Officer & Founder, NBE Therapeutics

15.00 Novel Mode of Action Payload Identified Through Phenotypic Screening

More details to follow
Jon Roffey, Senior Group Leader, Cancer Research UK

Confidently Translate from In Vitro to In Vivo Development

Stream Chair: Kurt Gish, Associate Director II, AbbVie

11.00 Discovery of the Determinants of Antibody-Drug Conjugate Efficacy & a Novel Resistance Mechanism to Herceptin-Based Therapeutics

  • Improve understanding that cathepsin B is dispensable for cellular processing of cathepsin B-cleavable antibody-drug conjugates (ADCs)
  • Review mass spectrometry studies of payload release which revealed that ADCs with the VC(S) linker, which is designed to be specifically cleaved by cathepsin B, have multiple paths to produce active catabolites
  • Discuss how the mechanistic studies show that this hit is specific to the properties of the HER2 target and represents an as of yet undiscovered mechanism of resistance for Herceptin-based antibodies

Nina Caculitan, Scientist, Genentech

11.30 Harnessing Bridging HER2 & Constitutively Internalizing Surface Protein

  • Enhance understanding of the importance of internalization rate and the route of intracellular trafficking
  • Explore a case study comparing the trafficking of ADC targets HER2 with prolactin receptor (PRLR)
  • Review results that emphasize intracellular trafficking of ADC targets is a key property for their activity, and further, that coupling an ADC target to a rapidly internalizing protein may be a useful approach to enhance internalization and cell killing activity of ADCs

Julian Andreev, Senior Staff Scientist, Regeneron Pharmaceuticals

12.00 Title to be Confirmed

  • More details to follow

Arnaud Delobel, Director, Research & Development, Quality Assistance

12.30 Lunch & Networking

12.30 Sciex Lunch Seminar

LC-MS Monitoring of Biopharmaceuticals and ADCs – Simple and Fast Routine Characterisation with dedicated Hard- and Software

You’ll find out:

  • How high resolution LC-MS/MS technology can be accessed by all levels of users – from the MS specialist to non-expert users
  • How quality attributes of biotherapeutics can be monitored easily and with confidence using the power of high resolution LC-MS/MS
  • How dedicated software can support the development of ADCs and other biotherapeutics

Kerstin Pohl, Applications Specialist, Sciex

Register Here

Discussing Development Strategy & Advances in Preclinical Modelling

Stream Chair: Kurt Gish, Associate Director II, AbbVie

13.30 Preclinical Development of ABBV-085, a Novel ADC that Targets LRRC15 in the Tumour Microenvironment

  • Review potent tumour growth inhibition, including regressions and cures, in multiple xenograft models of cancer following treatment with ABBV-085
  • In preclinical xenograft models, ABBV-085 enhanced the anti-tumour efficacy when combined with chemotherapy, radiation, or anti-PD1, compared to that seen with any single treatment
  • Improve understanding of the influence DAR had on ADC efficacy and safety
  • ABBV-085 is currently being investigated in a Phase 1 first-in-human safety study

Kurt Gish, Associate Director II, AbbVie

14.00 Approaches for PK/PD Modelling of Antibody Drug Conjugates

  • More details to follow

Session Reserved

14.30 Discovery & Development of Next Generation ADCs

  • Utilising informative preclinical models to enhance understanding of ADCs and the tumour micro-environment
  • Exploring the preclinical development of next generation ADC
  • Harnessing preclinical data to better inform clinical development strategy

Carli Uli Bialucha, Head, Oncology Biotherapeutics, Novartis

15.00 From the Lab to the Clinic: a PBD Dimer-Based ADC Case Study

  • Identifying a good ADC target
  • Screening and selecting a clinical candidate: balancing efficacy and tolerability
  • Bringing the ADC to the clinic

Francesca Zammarchi, Senior Cancer Biologist, ADC Therapeutics

Scaling Up of Process Development to Support Commercialization

Stream Chair: Ian Schwartz, Global Application Delivery Controllers Support & Process Development Consultant, Satorius Stedim

11.00 Bioconjugates: From Early Phase Development to Commercial Manufacturing

  • Approaches for scaling-up ADCs and other types of bioconjugates
  • Case studies and practical solutions will be presented

Laurent Ducry, Head, Bioconjugates Commercial Development, Lonza

11.30 Development of an Innovative Chemical Process for a Complex Antibody-Antibiotic Conjugate

  • Not your typical ADC: Increased volume requirements in “drug” synthesis
  • Overcoming challenges in the development of an effective semi-synthetic process
  • Differences in equipment and capability requirements from a traditional small molecule process

Stefan Koenig, Senior Scientist, Small Molecule Process Chemistry, Genentech

12.00 Challenges in Scaling Up Process Development from Clinical to Commercial

  • Experiences when moving to higher scales and what is required to maintain process characterisation and robustness
  • Differences from supporting FIH to pivotal trials
  • Ensuring consistency of yields and process integrity during tech transfer

Giorgio Salciarini, Technical Business Development Manager, BSP Pharmaceuticals

12.30 Lunch & Networking

12.30 Sciex Lunch Seminar

LC-MS Monitoring of Biopharmaceuticals and ADCs – Simple and Fast Routine Characterisation with dedicated Hard- and Software

You’ll find out:

  • How high resolution LC-MS/MS technology can be accessed by all levels of users – from the MS specialist to non-expert users
  • How quality attributes of biotherapeutics can be monitored easily and with confidence using the power of high resolution LC-MS/MS
  • How dedicated software can support the development of ADCs and other biotherapeutics

Kerstin Pohl, Applications Specialist, Sciex

Register Here

Building Robust ADC Technical Operations

13.30 Novasep’s Integrated Solutions for ADCs

  • Simplifying the supply chain through an integrated offer
  • Design considerations of a dedicated conjugation facility
  • Novasep’s strengths for ADCs: case studies

Francois D’Hooge, Head, Bioconjugation Unit (ADC), Novasep

14.00 Title to be Confirmed

  • More details to follow

Markus Eser, Head, Downstream Processing, Bayer

14.30 What are the Right Cleaning Limits & Safety Measures to Set During In-House Manufacturing?

  • Applying compound banding theory into practical guidance for internal staff
  • What are the implications for theoretical and acceptable validation limits
  • Flexibility in approach when managing different payload types

Silke Weber, Toxicologist, Occupational Health Specialist, Roche

15.00 Containment Risk Mitigation Strategies During Scale Up of ADC Process Development

  •  What are the appropriate safety measures and cleaning limits to set
  • Incorporating single use systems into the production workflow
  • Ensuring flexibility to support a variety of ADCs and payload

James (Maorong) Ruan, Senior Vice President, Quality, MabPlex

15.30
Afternoon Refreshments & Networking

The ADC Revolution: Exploring Next Generation ADCs & Development Approaches

16.30
Antibody Drug Conjugates: Lessons from 20 Years of Clinical Experience

Synopsis

  • Enhance understanding that ADCs are complex delivery systems for selective delivery of cytotoxic payloads
  • Review and categorize the difficulties in developing more clinically effective ADCs
  • Identify potential solutions to solve challenges faced in clinical development

17.00
Towards the Single Use of TFF Membranes in ADC Manufacturing

Synopsis

  • Expose the need of TFF steps in the ADC manufacturing
  • Describe the advantages of the single use capsule to avoid cleaning validation and ensure operator safety
  • Compare the performance and functionality of the single use vs the conventional TFF membranes

17.30
Chair’s Closing Remarks

  • Alain Beck Senior Director, Physio-Chemistry Department, Pierre-Fabre

17.45
Scientific Poster Session

Synopsis

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. During this session over 25 scientific posters will be presented from novel linker designs to validation of site specific conjugation technologies and more informative in vivo models.