Antibody-Drug Conjugate Insights | Manufacturing, Technology & News

Research & Development

The ADC Pendulum: Understanding ADC Withdrawals to build better therapies

Research & Development | White Paper The ADC Pendulum: Understanding ADC Withdrawals to build better therapies

Moving ADCs to the front-line: Perspectives from FDA Oncology Experts Image

Research & Development | White Paper Moving ADCs to the front-line: Perspectives from FDA Oncology Experts

HEOR Value demonstration for Antibody-Drug Conjugates: Lessons learned from the first 25 years. Image

Commercialization & Access | Industry Brief HEOR Value demonstration for Antibody-Drug Conjugates: Lessons learned from the first 25 years.

Twenty-Five Years of Antibody–Drug Conjugates: From Breakthroughs to Access by Design Image

Commercialization & Access | Industry Brief Twenty-Five Years of Antibody–Drug Conjugates: From Breakthroughs to Access by Design

Meet the experts

Meet the people behind the progress

Precision experts are fluent in the A to Z of ADCs, from development to delivery and access to impact.

Precision for Medicine Nicholas Richardson, DO, MPH

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Precision for Medicine Harpreet Singh, MD

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Precision AQ Greg Gregory, PhD

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Precision AQ Cherry Moldovan, PhD

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Precision AQ Ross Maclean, MD

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Precision AQ Hannah Deresiewicz

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Precision for Medicine Ivan Barrera, MD

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Beyond the breakthrough

Bridging the gap between promise and patients.

Some ADCs redefine standard of care. Others stall despite early promise. The difference often lies beyond the molecule, in the interpretation of evidence, strategic development and market access.

Promise Developing next-gen ADCs

Innovation might spark excitement. But successful ADCs rely on carefully planned development strategies tied to trial design, dose optimization, and regulatory engagement. The right decisions early on can drive longer-term success.

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Progress Turning data into decisions

As ADCs evolve, so do expectations. HEOR, real-world data and value communication strategies can help demonstrate the impact of innovation to decision-makers across the biopharma ecosystem.

Patients Bringing progress to people

The journey doesn’t end at approval. Market access planning, stakeholder engagement and commercialization strategies can all have a hand in ensuring ADCs reach the people who need them most.

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Where ADCs go from here

Get the latest perspectives on ADC development, from emerging scientific and clinical trends to evidence generation and market access.

Questions answered

ADC FAQs

Explore answers to some of the most common questions surrounding antibody-drug conjugates, from development and regulation to evidence generation and market access.

What are antibody-drug conjugates?

Antibody-drug conjugates (ADCs) are targeted cancer therapies that combine a monoclonal antibody, a cytotoxic payload and a chemical linker. Together, these components are designed to deliver treatment directly to tumour cells while limiting off-target effects.

Why are ADCs considered one of oncology’s most promising treatment approaches?

ADCs combine the precision of targeted therapy with the potency of traditional cancer treatments. By directing highly active payloads to specific tumor cells, they offer the potential to improve efficacy while managing toxicity. Recent clinical successes have accelerated investment, expanded development pipelines and increased interest in moving ADCs into earlier lines of therapy.

How do ADCs move from later-line treatment to front-line therapy?

Moving into earlier lines of therapy requires strong evidence demonstrating improved outcomes compared with existing standards of care. Developers must consider trial design, patient selection, dosing strategies and safety profiles while generating data that satisfies regulators, payers and clinicians.

What are the biggest challenges facing ADC developers?

Scientific innovation is only one part of the equation. ADC developers must navigate complex manufacturing requirements, optimize dosing strategies, manage safety considerations and generate evidence that supports both regulatory approval and market access.

Why is dose optimization so important in ADC development?

Dose optimization helps balance efficacy and safety. The objective is not simply to identify the highest tolerated dose, but the dose most likely to deliver meaningful clinical benefit while maintaining an acceptable safety profile.

How does the FDA evaluate new ADC therapies?

The FDA evaluates ADCs using many of the same principles applied to other oncology therapies, including safety, efficacy and overall benefit-risk assessment. The complexity of ADCs also requires consideration of linker stability, payload characteristics, manufacturing consistency and dose selection.

What role does HEOR play in ADC value demonstration?

Health economics and outcomes research helps translate clinical results into evidence that resonates with payers, providers and healthcare systems. Robust HEOR strategies can strengthen reimbursement discussions and support long-term adoption following approval.

Why is real-world evidence important for ADCs?

Real-world evidence can help demonstrate how ADCs perform across broader patient populations, support value communication and address questions that emerge after approval. It is becoming an increasingly important component of lifecycle strategy.

Inside the ADC Revolution

The ADC Pendulum: Understanding ADC Withdrawals to build better therapies

Meet the people behind the progress

Bridging the gap between promise and patients.

Where ADCs go from here

ADC FAQs