The BioInsights Podcast
The BioInsights Podcast: discussing the challenges of translating novel biologics from bench to clinic to market.
The BioInsights Podcast
Crossing the ADC inflection points: what separates clinical success from failure
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BioInsights
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Season 5
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Episode 1
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Lauren Coyle, Launch Commissioning Editor, Bioconjugate Insights, speaks with Antoine Yver, Board Chair, Ona Therapeutics, with more than three and a half decades of experience shaping global cancer drug development. In this conversation, they explore what determines whether an ADC successfully crosses the critical threshold and how teams should rethink dose finding, toxicity, and what it truly takes to set a program up for long-term success in the clinic.
1. You have led multiple oncology programs from discovery to approval. What do you see as the most critical translational inflection points, when looking specifically at ADCs, that determine whether a molecule successfully crosses the ‘bench-to-bedside’ t
2. ADCs often present atypical toxicity profiles and non-linear response kinetics. How should early development teams rethink dose-finding and safety management strategies to avoid applying conventional monoclonal antibody or small-molecule paradigms that
3. As payloads diversify and mechanisms evolve, what do you consider the most appropriate early clinical endpoints to convincingly demonstrate mechanistic value and accelerate early go/no-go decisions?
4. For modern ADCs, what level of biomarker maturity or target-expression characterization is truly required before entering first-in-human studies?
5. Preparing an IND for a first-in-class ADC places enormous pressure on analytical, CMC, and scalability planning. From your experience, what defines ‘IND-readiness,’ and what common CMC missteps most often jeopardize smooth progression into GMP manufact
6. Translating ADCs into the clinic increasingly requires seamless integration of discovery workflows with GMP-compatible conjugation and scale up. What operational principles or lessons learned from past programs do you believe are essential for avoiding
7. Lastly, what single innovation, whether technical, biological, or regulatory, would most profoundly improve the success rates of ADCs entering the clinic over the next decade?