Antibody-drug conjugates (ADCs) are among the fastest-growing modalities in oncology, pairing the precision of a monoclonal antibody with the potency of a cytotoxic payload. That same architecture — a large biologic joined to a small-molecule drug through a designed linker — makes them one of the most demanding products to develop and register: an ADC must satisfy biologic and small-molecule expectations at once, and no single regulatory framework was written for it.
This workshop decodes the ADC development journey end to end, from CMC foundations through to market access. Across two focused days, it connects the disciplines that ADC programs too often treat in isolation:
- CMC and analytical control: characterization, drug-to-antibody ratio (DAR) and drug-load distribution, linker stability, comparability, and specifications across the lifecycle.
- Non-clinical strategy: toxicology, pharmacology and PK/PD approaches that separate the contributions of the antibody and the payload.
- Clinical development and expedited pathways: trial design for ADCs and the disciplined use of Fast Track, Breakthrough Therapy, Accelerated Approval and PRIME, including surrogate endpoints and post-marketing commitments.
- Global submissions and agency interactions: building coherent dossiers and engaging FDA, EMA and PMDA on novel conjugates.
- Emerging trends: next-generation ADCs (site-specific conjugation, novel payloads, bispecific ADCs) and the growing role of advanced analytics and real-world evidence.
Upon completion, participants will be able to anticipate agency questions, build defensible data packages, and move a program efficiently from molecule to market. They will work from recently approved ADCs case studies and interactive problem-solving.
Learning Objectives
Upon the completion of the program, participants will be able to:
- Build and defend the CMC and analytical control strategy that ADCs uniquely require — DAR and drug-load distribution, linker stability, comparability, and lifecycle specifications.
- Design integrated non-clinical and clinical development plans for ADCs that separate the antibody and payload contributions and leverage expedited pathways without creating unmanageable post-marketing commitments.
- Assemble global regulatory submissions and lead health-authority interactions (FDA, EMA, PMDA) that carry an ADC coherently from first-in-human through approval and market access.
Who Should Attend?
Experienced regulatory affairs professionals, CMC and analytical development scientists, and quality, clinical and program leaders working on antibody-drug conjugates or other complex biologics. The program is designed for those already engaged in developing, manufacturing or registering ADCs — including teams preparing global submissions (IND/IMPD, BLA/MAA) and consultants or regulatory-intelligence specialists who need a current, integrated, lifecycle view of how ADCs are developed and reviewed. A working knowledge of biologics development is assumed.
Audience Learning Level
Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.
Agenda
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
