Address the synthetic challenges in the preparation of linker-payload constructs, explore the reactive groups necessary for attachment and release and assess the pros and cons of existing conjugation technologies available.
Naresh Jain, Chief Executive Officer, NJ Biopharmaceuticals
This workshop session will advance your understanding of the leading causes of toxicity in both preclinical and clinical development through leveraging lessons from failed and successful ADCs. Additionally, this session will establish the importance of finding the right target.
Rakesh Dixit, Chief Executive Officer, Bionavigen
Understand the characteristics of a solid tumor that make it harder to achieve efficacy than in hematological cancers, whilst comparing and contrasting payload type and efficacy in solid tumor including an overview of ADCs using topoisomerase I as the payload for solid tumor treatment. Looking at this from an early discovery and clinical perspective, this workshop will equip you with the toolkit to improve the development of your ADC when targeting solid tumors.
Amy Han, Director, Solid Tumor Targeted Therapies, Regeneron
Regina Reilly, Research Fellow, Oncology Discovery Research, AbbVie
This session will share the analysis of the ADC data in the IQ database, as well as that from nine approved ADCs, to support the strategy of pharmacokinetic characterization of all three analytes in early-phase development and progressively minimizing the number of analytes to be measured in the late-phase studies. Additionally, risk-based payload-mediated DDI will be discussed as the systemic
concentrations of unconjugated payload are usually too low to serve as a DDI perpetrator, however, the potential for unconjugated payloads as a victim still exists. A data-driven and risk-based decision tree was developed to guide the assessment of a circulating payload as a victim of DDI and will be shared in this workshop.
Chunze LI, Executive Director & Senior Principal Scientist, Head Oncology Clinical Pharmacology, Genentech
This workshop has been designed for both novices and seasoned veterans to provide you with the opportunity to understand how to approach the design of DoE studies and examine how DoEs are currently being executed by ADC developers. Furthermore there will be chance to explore how to develop a control strategy and examine how to build quality into the process over inspecting the final product. There will also be a regulatory focus by looking at
regulatory considerations for DoE studies and QbD based
submissions. Yuyi Shen, Ex-Director, Process Development & Manufacturing, Ex-Bolt Biotherapeutics
Yuyi Shen, Senior Director, Process Development, Manufacturing & Supply Chain, Abcuro
Ahmed Bassyouni, Independent Consultant, Bassyouni Consulting
A deep dive session aimed at those newer to the ADC field or to bring you up to speed with key challenges and processes that go in to ADC manufacturing. This is your opportunity to gain familiarity with the fundamental learnings that inform ADC CMC, review the key elements of ADCs and the CMC regulatory expectations, examine the CDMO landscape for ADCs and compare and contrast
approaches to outsource manufacturing or do it in house. There will also be an opportunity to understand the phase-dependent challenges that CMC for highly cytotoxic ADCs offer.
Brian Clark, Principal, GMP Operations Consulting LLC
Gain a short overview of cleavable vs. uncleavable vs. lysosomally processed vs. extracellular cleavage/ bystander effects and case study examples. Following this, there will be the opportunity to collaboratively design the best linker-payload for a given target expression profile, solid vs. liquid tumors and using known or novel payloads.
Ed Ha, Head, ADC Innovation, Iksuda
This session will provide an overview of immunogenicity assessment for ADCs, discuss challenges and solutions in developing anti-drug antibody assays for new ADC drugs, and explore the prospect of clinical immunogenicity assessment after COVID-19. You will also be equipped with an outline of regulatory guidance while reviewing case-studies for immunogenicity assessment of ADCs.
Anton Rosenbaum, Director, Integrated Bioanalysis, AstraZeneca
Weiping Shao, Senior Group Director, AstraZeneca
Mohsen Rajabi Abhari, Pharmacologist - Biologics Lead, FDA
Examine the physiological properties of the tumor microenvironment to improve the fundamental understanding of the basic biology. Furthermore, join your peers to discuss ADC engagement with the tumor microenvironment via Fc-FcgR interaction and explore payload-mediated activation of the immune system. Collaboratively this will provide the opportunity to develop future ADCs that optimize the tumor microenvironment for improved efficacy.
Fu Li, Director, Biology, Mersana Therapeutics
This workshop is designed to accommodate both attendees new to modelling and simulation as well as researchers more seasoned in ADC development. You will learn the basic tenets of antibody drug conjugate PK/PD and how to characterize these aspects using empirical and systems-based mathematical models. Simulations of recent clinically successful ADCs will be covered as examples. The
models include systemic PK (plasma clearance, payload deconjugation, target mediated drug distribution, etc.), tissue distribution (e.g. heterogeneous tumor concentrations), and cellular targeting (internalization, payload release, bystander effects, etc.). Real-time modelling examples will be conducted while reviewing the strengths and limitations of these approaches.
Greg Thurber, Associate Professor, University of Michigan
Learn the process behind ADC formulation and the unique challenges that developing an intravenous biologic drug possesses. Furthermore, this session will explore ultra-high concentration ADC formulation considerations and address the formulation challenges that novel ADC conjugation techniques possess.
Nathan Alves, Director, Translation Research, Indiana University
Lindsay Fay, Scientist, Formulation & Drug Product Development, Seagen
CMC development of the payload-linker portion is a critical aspect of ADC development and approval. A working group (WG) in the IQ Consortium has sought to benchmark current industry practices and propose scientific risk-based approaches to payload-linker development. Members of the WG will present results from benchmarking surveys covering starting material selection at clinical and commercial stages, impurity control strategies, experience
with regulatory agencies, and post-conjugation purification by ultrafiltration/diafiltration (UF/DF). A forward-looking proposal on principles for starting material selection will be presented, as will recommended best-practices for implementing post-conjugation UF/DF. Workshop participants will gain detailed insight into current payloadlinker practices, and have the opportunity to positively
influence future industry alignment and the establishment of best practices for the development of payload-linkers.
David Conlon, Consultant, Ex-Daiichi Sankyo
Michael Jones, Research Fellow, Pfizer
Paul Bulger, Director, Analytical Research & Development, Merck & Co.