White Paper

A New Era Of ADC Development Demands A New Kind Of Partner

By Erin Finot, MS, MBA, VP, Immuno-Oncology & Cell and Gene Therapy, IQVIA Biotech, Jeffrey Hodge, MS, VP, Early Phase Oncology and Precision Medicine, Hematology, Oncology Center of Excellence, IQVIA, and Gerhard Du Toit, VP and Global Head, Oncology, IQVIA Biotech

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Antibody-drug conjugates (ADCs) have transitioned from experimental innovations to cornerstone precision therapies, yet the path from discovery to clinical success is increasingly defined by scientific and operational complexity. Modern development requires navigating far more than just potent molecular design; it demands mastery over intricate variables like biomarker-driven patient selection, meticulous dose optimization, and the logistical rigors of global supply chains. As the field matures, the focus has shifted toward managing these multifaceted hurdles to ensure stability, safety, and efficacy across diverse and often global patient populations.

The next generation of designs is pushing therapeutic boundaries by incorporating bioactive degraders and immune-stimulating backbones, reaching beyond oncology into autoimmune and inflammatory conditions. To keep pace, developers are increasingly using artificial intelligence to refine candidate selection and improve the efficiency of patient enrollment. This technological shift coincides with an evolving regulatory landscape where initiatives like the FDA’s Project FrontRunner encourage seeking approvals for earlier lines of treatment. Successfully translating these complex platforms into viable therapies requires a strategic approach that balances cutting-edge science with the practicalities of global clinical execution.

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