Pre-Conference Seminar Day
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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. Covering essential elements in ADC discovery and early development, this workshop will enable you to:
- Gain an overview of the development process for ADCs
- Improve payload and linker design chemistry
- Understand the impact of conjugation site selection on your ADC
- Choose/choice of optimum “antibody” format
- Select the most appropriate ADC target which is easily accessible
- Learn about cellular assays
- Review the advantages and disadvantages of different preclinical animal models
Develop early stage assays and learn how to effectively interpret the data
Workshop Leader: John Lambert, Independent Consultant, Attager Consulting
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9.50 am Chair’s Opening Remarks
Rakesh Dixit, President & Founder, BioNavigen
10.00 am Lessons learned from Minimizing Target Based & Off-Target Toxicities of ADCs
- With eight approved ADCs and the great potential and advancements in ADC technologies, there is renewed enthusiasm and momentum in the world of oncolytic ADCs
- However, the success with oncolytic ADCs has come with high failures over the last two decades. The presentation will provide a comprehensive review of success factors and top 5 lessons learned from the development of ADCs in the past two decades
- A case study of learnings from Her-2 targeting ADCs will be presented
Rakesh Dixit, President & Founder, BioNavigen
10.20 am An Approach to Identifying Mechanisms of Non-Target ADC Uptake in Normal Cells
- Recognizing and binning routes of non-target uptake
- Testing involvement of potential routes of uptake/toxicity
- Drawing conclusions based on multiple lines of evidence
Prathap Kumar Mahalingaiah, Senior Scientist II, Investigative Toxicology and Pathology, AbbVie
10.40 am ADC Target Tissue Expression & Safety
- Discussing how the majority of ADC toxicities are antigen independent with case examples
- Reviewing how the type of payload and location of antigen expression play a role in antigen-dependent toxicities with case examples
- Demonstrating how Dose Response can also play a role with case examples
Nicola Stagg, Senior Scientist & Toxicologist, Genentech
11.00 am Live Discussion & Question Time
Nicola Stagg, Senior Scientist & Toxicologist, Genentech
Prathap Kumar Mahalingaiah, Senior Scientist II, Investigative Toxicology and Pathology, AbbVie
Rakesh Dixit, President & Founder, BioNavigen
11.30 am Lunch & Networking
1.00 pm Panel Discussion: Screening for Toxicity in the Early Studies to Optimize the Design
- Discussing how some linker warhead combinations may work with one antibody but not with another
- Is the combination that you use as a default or is it the most optimal approach
- Looking into conjugation chemistry that should be considered to be tested in early screening
Nicola Stagg, Senior Scientist & Toxicologist, Genentech
Prathap Kumar Mahalingaiah, Senior Scientist II, Investigative Toxicology and Pathology, AbbVie
Rakesh Dixit, President & Founder, BioNavigen
1.20 pm Trastuzumab Deruxtecan (T-DXd, DS-8201a): An Overview of Pharmacology, Clinical Pharmacology, and Clinical Activity
- Overview of the pharmacology of T-DXd
- Clinical pharmacology of T-DXd in cancer patients
- Summary of clinical studies in cancer patients
Ronald Fleming, Clinical Development Team Leader, Daiichi-Sankyo
1.40 pm Live Discussion & Question Time
Ronald Fleming, Clinical Development Team Leader, Daiichi-Sankyo
2.00 pm Chair’s Closing Remarks
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9.50 am Chair’s Opening Remarks
Louie Naumovski, Group Medical Director, AbbVie
10.00 am The Clinical Landscape of ADC Combinations
- Overview of combination partners for ADCs including rationale
- Summary of clinical trials with ADC combinations
- Data from ADC combination trials in the clinic
Jay Harper, Associate Director - Research Onocology, AstraZeneca
10.20 am Learnings from Combination ADCs with Checkpoint Inhibitors: a Rova-T Plus Anti-PD1 Phase 1b Study in Small Cell Lung Cancer
- Both Rova-T and checkpoint inhibitors are active in SCLC
- The combination did not appear to have unexpected safety findings
- The efficacy of the combination is under further investigation
Philip Vitorino, Associate Director of Cell Therapy, AbbVie
10.40 am The Dawn of a New Era: ADCs as Immunotherapeutics
- Three FDA Approved ADCs for solid tumors in 5 months – what can we learn?
- How antibody pharmacokinetics largely shape ADC efficacy and toxicity
- Using knowledge from antibody therapeutics and payload mechanisms of action to design rational combinations
Greg Thurber, Associate Professor, University of Michigan
11.00 am Live Discussion & Question Time
Jay Harper, Associate Director - Research Onocology, AstraZeneca
Philip Vitorino, Associate Director of Cell Therapy, AbbVie
Greg Thurber, Associate Professor, University of Michigan
11.30 am Lunch & Networking
1.00 pm Panel Discussion: What we Have Learnt from Combination Studies & Where do we go Next?
Greg Thurber, Professor, University of Michigan
Nick Choong, Executive Director, Seattle Genetics
Louie Namauvski, Senior Medical Director, AbbVie
Jay Harper, Associate Director - Research Onocology,AstraZeneca
1.20 pm Combining ADCs & Immunotherapy: Mechanistic Insights & Clinical Observations
- Discuss preclinical data demonstrating monomethyl auristatin E (MMAE) has the potential to drive immunogenic cell death
- Review preclinical and biomarker data on MMAE that support the induction of inflammatory cytokines and innate inflammatory responses which are consistent with
MMAE-induced ICD - Share insight from how our data provides the rationale for combining our ADCs with immuno-oncology therapies including PD-L1 checkpoint blockade
- Share data from combinations of ADCs with PD-1 inhibitors with implications for future development of these combinations
Nick Choong, Executive Director, Seattle Genetics
1.40 pm Role of Protein Engineering & Bioconjugation in Rational Design of Next Generation Nanoparticle Vaccines
- Well-defined biomaterial based nanoparticle as scaffold provides a modular platform to develop vaccines and related immune modulating agents.
- Covalent incorporation of antigen proteins and adjuvants using protein engineering and site specific bioconjugation offers well-defined immunoactive nanotherapies with enhanced activity durable response.
- In additional to reviewing of the state of the art, case studies focusing on influenza vaccine will be highlighted.
- Potential role in developing combination immunotherapy will be highlighted.
Pradeep Dhal, Senior R&D Director, Sanofi
2.00 pm Live Discussion & Question Time
Nick Choong, Executive Director, Seattle Genetics
Pradeep Dhal, Senior R&D Director, Sanofi
2.30 pm Chair’s Closing Remarks
Download the Full Event Guide for full session details.
9.50 am Chair’s Opening Remarks
Leo Kirkovsky, Clinical Assay Group, Pfizer
10.00 am Impact of Drug Load & DAR of an ADC on Binding & Potency
- Identifying sites of conjugation on a cysteine-based ADC
- Reviewing the impact of drug load and DAR on binding and in vitro and in vivo potency
- Understanding the structure-function relationship of drug load and DAR
Hillary Schuessler, Scientific Leader, GSK
10.20 am The Bell-shaped Bioanalytical Strategy for ADCs
- ADCs are complex therapeutic modalities forming multiple analytes in Vivo
- Outlining the different analytical platforms and a variety of assays that can be utilized for ADC PK characterization
- How do we choose what is appropriate to support decision making at the various stages of a project and how does one balance speed, quality and reagent availability to answer key questions during drug discovery or development?
Edit Tarcsa, Director, Research Fellow, DMPK-BA, AbbVie
10.40 am Automation of Analytics to Support Process Characterization
- Routine assays with repetitive steps are major components of analytical and bioanalytical support
- Evaluating how automating these tasks increases throughput, reduces performance variations and decreases repetitive strain
- Presenting strategies for automating bioassays and using high throughput analytics to support process characterization studies
Adrienne Wildt, Associate Director - Bioanalytical, Chemistry Manufacturing & Controls, ImmunoGen
11.00 am Live Discussion & Question Time
Adrienne Wildt, Associate Director - Bioanalytical, Chemistry Manufacturing & Controls, ImmunoGen
Edit Tarcsa, Director, Research Fellow, DMPK-BA, AbbVie
Hillary Schuessler, Scientific Leader, GSK
11.30 am Lunch & Networking
1.00 pm Clinical Pharmacology of Antibody-Drug Conjugates: A Regulatory Perspective
- Summary of clinical pharmacology studies/information submitted in support of BLA approvals of ADC products
- Case study of regulatory interest
- Closing remarks and recommendations
Salaheldin Hamed, Pharmacologist, FDA
1.20 pm Bioanalytic Strategy for ADCs: Perspectives from IQ ADC WG
- Overview of IQ/OCP meeting on October 2017
- ADC WG database
- Bioanalysis strategy for ADCs
Dong Wei, Associate Director - Bioanalytical, Biomarker, Drug Metabolism & Pharmacokinetics, Takeda
1.40 pm Integration of Bioanalytical Data into a Modeling Framework to Optimize Design & Development of ADCs
- PK/PD modeling and simulation can be used to determine feasibility of potential ADC targets, to help with lead ADC selection and optimization, and to provide a quantitative framework for preclinical to clinical translation of efficacy and safety of ADCs.
- The ultimate quality and confidence in these PK/PD models depends upon the data used to build or validate them, highlighting the need for high-quality bioanalytical measurements.
- To support PK/PD decision making -from early stage discovery through to the clinic, key bioanalytical measurements will be discussed, including PK and cellular measures
Alison Betts, Pfizer
2.00 pm Live Discussion & Question Time
Dong Wei, Associate Director - Bioanalytical, Biomarker, Drug Metabolism & Pharmacokinetics, Takeda
Salaheldin Hamed, Pharmacologist, FDA
Alison Betts, Pfizer
2.30 pm Chair’s Closing Remarks