4th-6th March 2019
London

Day One
Tuesday 5th March 2019

Day Two
Wednesday 6th March 2019

08.00
Chair’s Opening Remarks

  • Alain Beck Senior Director, Biologics CMC and developability, Pierre Fabre Laboratories

08.10
Riding the ADC Rollercoaster: In-Depth Review of Current ADC Field, as well as Insights on Hotspots of Innovation

  • Alain Beck Senior Director, Biologics CMC and developability, Pierre Fabre Laboratories

Synopsis

• Reviewing the last 12 months of ADC research; lessons learned and 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 optimised linkers; the discovery of biorthogonal conjugation chemistries and cytotoxic issues
• Increasing homogeneity and stability through selection and engineering of antibodies for site-specific drug conjugation
• Exploring novel payload chemistries with differentiated mechanisms of action

08.40
Keynote: Making Sacituzumab Govitecan Foundational Therapy for High Unmet Need Indications

Synopsis

• Focusing on unmet need indications
• Sacituzumab Govitecan as a lead asset representing a highly differentiated ADC platform (unique MOA)
• Potential beyond mTNBC and development plans in ER+ mBC, Urothelial Cancer, NSCLC including combination therapies
• Commercial considerations

09.10
Session Reserved for Late Breaking Abstract

Synopsis

Listen to this talk to remain at the forefront of the ADC field. Continuing to bring you the very latest data this session will be revealing unpublished data, for the first time.

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

Discovering New Era Payloads with Differentiated Mechanisms of Action

11.00 Exploring Novel Lower Potency PBD Payloads

  • Next generation PBD payloads
  • Warhead optimisation
  •  Exploring the effect of N10 Capping group

Philip Howard, Chief Scientific Officer, Spirogen

11.30 ADCs with Novel Kinesin Spindle Protein Inhibitor Payloads & a Tailor-Made Linker Chemistry

  • Inhibitors of kinesin spindle protein (KSPi) have been developed as a novel payload class in antibody drug conjugates
  • To increase tumour selectivity of ADC metabolism, a tumour associated protease with a unique cleavage sequence is utilised for lysosomal ADC cleavage and release of active metabolites with an appropriate profile matching the KSPi mode of action

Hans-Georg Lerchen, Principal Scientist, Protein Engineering, Bayer

12.00 Targeting uPARAP in Sarcoma & Glioblastoma with ADCs Carrying a Site-Specific PBD Payload

  • The physiological function and structure of uPARAP
  • Expression pattern of uPARAP allows highly specific targeting using ADCs in several cancer forms
  • Production and humanisation of anti-uPARAP antibodies, and optimisation of anti-uPARAP based ADCs and their effect on cancer cells

Andreas Hald, Research Associate, Copenhagen University Hospital

Solving the Mystery: ADC Internalisation & Trafficking

11.00 Minimising Off Target Toxicity of ADCs

  • Mechanisms of off-target toxicity of ADCs
  • Approaches to minimise off-target toxicities
  • Innovative models to assist preclinical safety evaluation

Hong Wang, Associate Director & Senior Scientist, Development Toxicology, Genentech

11.30 Quantitative Evaluation & Critical Analysis of ADC Bystander Effect

  • This presentation will provide quantitative perspective on in vitro and in vivo bystander effect of ADCs
  • It will highlight how one can optimize dosing regimen to maximise the bystander effect of ADCs
  • The presentation will also demonstrate how an ADC with the bystander effect behaves differently when it comes to antibody coadministration strategy to overcome the binding-site barrier for ADCs

Dhaval Shah, Assistant Professor, Department, Pharmaceutical Sciences, State University of New York at Buffalo

12.00 Analytical Methods: Key Considerations to Efficiently Bring ADCs to the Market

  • Panel of analytical methods to be used for characterisation and QC release
  • Expectations of the regulatory authorities for intermediates (toxin and mAb), DS and DP
  • Strategy for method validation depending on the development phase
  • Notions of data integrity

Arnaud Delobel, Director, Research & Development, Quality Assistance

Reviewing Strategies & Technologies to Minimise ADC Manufacturing Costs

11.00 Optimisation of Analytical & Process Development for Bioconjugation

• Analytical optimisation
• Services and methods
• Analytical development
• ADCs characterisation
• Process development case study

Melanie Derde, Head, Analytical, Bioconjugation, Novasep

11.30 Strategies for Scaling-Up ADC Payload Production

• An overview of what to consider when scaling-up the synthesis of ADC payloads
• The importance of route design linker to safety and cost
• Case study 1: Tubulysin
• Case study 2: Tesirine

William Goundry, Associate Director, AstraZeneca

12.00 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

12.30
Lunch & Networking

12.30
Lunch Seminar: LC-MS Monitoring of Biopharmaceuticals & ADCs – Simple & Fast Routine Characterisation with Dedicated Hard- & Software

Synopsis

• How high resolution LsC-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

Sharing Innovations in Linker Chemistry

13.30 Tubulis® – A novel Platform for Next-Gen ADC Development

  •  ADCs are fascinating multi-component drugs consisting of a biological entity and a chemical small molecule entity
  • However, despite great potential to enable targeted chemotherapy, ADCs struggle to translate to the clinics
  • Tubulis® aims to provide a novel platform solution to catalyze successful ADC development

Jonas Helma, Project Leader, Biology, Ludwig

14.00 Novel Immune-Stimmulatory ADCs (iADCs) for Effective Targeting of Solid Tumours

  • Exploring site-specific conjugates with ultra-potent anthracycline toxins
  • Discovering immune-oncology function of NBE’s iADCs
  • Reviewing Preclinical validation of a ROR1 targeting iADC

Ulf Grawunder, Chief Executive Officer, NBE Therapeutics

14.30 Pro-PBDs: Novel Warheads for Targeted Therapies of Cancer

  • Conceptual design of next generation 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
  • Review the selection of the clinical candidate EC2629: the first-in-class pro-PBD-based conjugate

Iontcho Vlahov, Vice President, Endocyte

Sharing Preclinical Lessons Learned to Confidently Translate into the Clinic

13.30 Practical Aspects of Applying Preclinical Data to Clinical Biomarker Planning

  • Discussing types of preclinical work that can inform development planning
  • A focus on immunohistochemistry assay development/threshold setting
  • Practical applications of preclinical data to plan for clinical development

Rebecca Mosher, Executive Director, Translational Medicine, Mersana Therapeutics

14.00 Clinical & Non-clinical Translational of Dose-limiting Toxicities Associated with DNA Damaging Conjugates

  • Clinical landscape of DNA damaging conjugates
  • Review of preclinical translation for major dose-limiting toxicities associated with DNA damaging
  • Mylotarg case example – preclinical model for hepatic Veno-Occlusive Disease (VOD) and thrombocytopenia

Hadi Falahatpisheh, Research Fellow, AbbVie-Stemcentrx

14.30 Filling the Gaps with ADC Technology

  • An overview of the ADC technology available
  • How this can be used to enhance translation into the clinic
  • How the technology can be used to ‘fill the gaps’

William Kuziel, Director, Daiichi Sankyo

Discussing Key Learnings From Failed ADCs

13.30 What we Learnt from the Failed ADCs & Strategy to Make a Better One

  • What we learnt from the failed ADCs
  • What strategy to make a better one
  • Does antibody binding affinity influence ADC fate?
  • Does conjugation format affect the internalisation?

Andrew Huang, Chief Scientific Officer, MabPlex

Unravelling the Complexity of ADC Manufacturing: Global Supply Chains

14.00 Key CMC Considerations for Robust ADC Process Development & to Effectively Manage the CMC Supply Chain

  • Delving into the unique technical challenges ADCs create which require careful CMC considerations
  • Discussing insights on how to develop transferrable ADC processes
  • Sharing experiences on how to confidently manage the complexity in ADC supply chains

Eric Lacoste, Head, Bio-Organic, Chemistry Team, Sanofi

14.30 A Scalable Single Use Platform for Antibody Drug Conjugate Clinical & Commercial Manufacturers

• Scalable platforms for ADC process development and manufacturing using single use equipment
• Process development data demonstrating ADC purification using single use technologies
• Chemical compatibility of Sartorius’ single use ADC manufacturing platform

Ian Schwartz, Process Development Consultant, Sartorius Stedim

15.00
Afternoon Refreshments & Networking

Mitigating Toxicities to Maximise the Therapeutic Index of ADCs

16.00
Keynote: Lessons Learned from the Successful & Failed ADCs in Cancer Treatment: Moving Forward & Creating the Best Magic Bullets

  • Rakesh Dixit Vice President & Global Head, Biologics, MedImmune

Synopsis

• Maximising the therapeutic index of ADCs has proven challenging because of the complexity of the molecules. This Keynote will review lessons learned from both clinically successful and unsuccessful ADCs
• Addressing the challenges which are preventing the development of magic bullets
• Learning novel approaches and technologies to move ADC forward

16.30
Preclinical Pharmacokinetics & Pharmacodynamics of DCLL9718A: an Antibody Drug Conjugate for the Treatment of Acute Myeloid Leukaemia

Synopsis

• Explore the development of a novel ADC – DCLL9718A is an antibody-drug conjugate that targets C-type lectin-like molecule-1 (CLL-1)
• Reviewing data the characterisation of the in vitro and in vivo stability, the pharmacokinetics (PK) and pharmacodynamics (PD) of DCLL9718A and MCLL0517A in rodents and cynomolgus monkeys
• Discussing key PK analytes to measure to deepen understanding of ADC in vivo behaviour

17.00
Chair’s Closing Remarks

  • Alain Beck Senior Director, Biologics CMC and developability, Pierre Fabre Laboratories

17.10
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.