Navigating regulatory pathways and key compliance considerations in ADC development

Tuesday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET

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Navigating regulatory pathways and key compliance considerations in ADC development

ADCs are among the most dynamic areas in oncology research, offering targeted efficacy with expanding therapeutic potential. However, their complexity brings unique regulatory and compliance challenges across discovery, development, and manufacturing. While regulatory agencies have provided guidance through the approval of first-generation ADCs, does the next wave of technological innovation in this rapidly evolving field necessitate a rethink?

This expert panel-based webinar, brought to you by Bioconjugation Insights, will examine the critical regulatory pathways shaping ADC development both today and in the future. Insights will be shared on how to interpret existing frameworks, anticipate new requirements, and ensure compliance throughout the ADC lifecycle.

Attend this webinar to:

Gain insights into the current regulatory guidance for ADCs and what lessons can be applied to emerging product candidates in development
Explore how next-generation ADC formats are challenging existing regulatory frameworks
Understand the key compliance considerations during R&D, scale-up, and manufacturing of ADCs
Learn strategies to proactively address regulatory and quality expectations in a rapidly evolving field

Nathan C. Ihle, PhD.

Founder and Principal Consultant at Ihle CMC Solutions

Dr. Nathan Ihle is a leading expert in antibody-drug conjugate (ADC) research and development. His work centers on advancing targeted therapies, focusing on the design, optimization, and development of novel ADCs. With over 20 years of experience with ADCs, Dr. Ihle has played a key leadership role in the development of 6 approved and numerous clinical-stage ADCs from discovery through commercialization. He is widely recognized for his scientific rigor, cross-functional collaboration, and strategic insight in biologics R&D. Currently, he serves as Founder and Principal Consultant at Ihle CMC Solutions, supporting the next generation of bioconjugates and novel therapeutics.

Rakesh Dixit

Cofounder, President and CSO of Regio Biosciences; President and CEO of BIONAVIGEN

Rakesh Dixit is Cofounder, President, and CSO of Regio Biosciences, a spin-off of AstraZeneca, focused on developing therapies to reduce plaque burden and reverse cardiovascular disease. He is also President & CEO of BIONAVIGEN, a virtual drug development company. Previously, he was VP of Biologics Safety Assessment at AstraZeneca and held leadership roles at Merck, Johnson & Johnson, and MedImmune. Dixit played a pivotal role in developing 10 marketed biopharmaceuticals and contributed to over 100 INDs and 15 BLA/NDA approvals. A recognized expert in bioconjugates, he has led the development of multiple ADC therapies, successfully filing INDs for over 10 ADC drugs. He has published 80+ papers, delivered 130+ global presentations, and received PharmaVoice’s 100 Most Inspiring People award and the prestigious Long-Standing Contribution to ADCs award.

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