Antibody Drug Conjugates (ADCs) and bi- and multi-specific antibodies are transforming the oncology landscape by delivering highly targeted therapies designed to improve patient outcomes and reduce the burden of side effects. However, advancing these therapies presents unique opportunities and operational challenges.
Learn how to avoid the $50M operational mistakes sponsors make when advancing antibody-drug conjugates into earlier treatment lines. Whether you are approaching your first ADC trial or expanding an existing program into new mechanisms or indications, this session equips you with the framework to move forward with confidence.
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The ADC pipeline has exploded, and most sponsors are operationally unprepared.
As antibody-drug conjugates and multispecific antibodies advance into earlier treatment lines with next-generation linker technologies and tumor-agnostic targeting, trial design complexity has intensified. Sites capable of managing mechanism-specific toxicities remain limited. Regulatory expectations for biomarker integration continue to evolve. Infrastructure requirements now determine feasibility before scientific rationale does.
Biotech sponsors face a critical question: how do we execute pivotal ADC trials without losing two years and tens of millions learning operational realities the expensive way?
This webinar delivers the clinical and operational perspective you need right now. PSI’s specialized oncology team partners with Dr. Christian Squillante, Medical Oncologist and Director of Solid Tumor Research at MD Anderson Cancer Center at Cooper, to examine what executable ADC trials actually require in practice.
What you can expect to learn
Drawing on real-world expereince running complex oncology studies globally, we will cover:
Why trial design is shifting as ADCs move earlier-line, and how that impacts eligibility criteria, comparator selection, endpoint hierarchy, and the patient populations sites can realistically enroll
What executable ADC trials look like in practice through a case study covering patient pathways, feasibility realities, and the operational decisions that determine trial velocity
Your ADC readiness checklist, including country and site selection criteria for ADC-capable centers, safety committee design for mechanism-specific toxicities, biomarker infrastructure requirements, and supply chain considerations for complex drug handling
The people in the room
Dr. Christian Squillante, MD
Medical Oncologist and Director of Solid Tumor Research
MD Anderson Cancer Center at Cooper University Health Care
Vince Calderon
Therapeutic Area Director
PSI CRO
Nick Quinn
Therapeutic Area Lead
PSI CRO
Advance your ADC program with a team that has done it before
PSI’s registrational data underpins 10% of all novel oncology drugs FDA-approved since 2000, spanning ADCs, radiopharmaceuticals, cell therapies, and more. If you are planning or refining a pivotal ADC program, our oncology team is ready to discuss your specific timeline, site strategy, and protocol requirements.
