The Gens & Associates Podcast

Host Steve Gens sits down with Olivier Pâris, founder of Ennov, to discuss the company’s next phase of growth and the evolving regulatory technology landscape. They explore Ennov’s leadership transition, the growing role of agentic AI, the importance of unified data, and how simpler, more connected platforms can help life sciences organizations prepare for the next era of regulatory work.

Host Steve Gens sits down with James Gianoutsos, founder and CEO of Rimsys, for a wide-ranging discussion on how AI is reshaping regulatory work in medtech. They explore emerging market-access models, the shift toward AI-supported impact assessments, evolving validation expectations, and how regulatory teams are adapting to a rapidly changing digital landscape.If you'd like to learn more about Rimsys, check out their website: https://www.rimsys.io/

Welcome back to the Gens & Associates Podcast, in today’s episode host Steve Gens sits down with James Kelleher, Chief Client Officer at Generis, and Max Kelleher, CEO of Generis, for a candid conversation on the future of information architecture in life sciences. Together they unpack how unified data models, governed AI frameworks, and automation are reshaping regulatory operations and accelerating innovation across the industry.Find out more about Generis at: https://www.caralifesciences.generiscorp.com/

Welcome back to the Gens & Associates Podcast! In today's special episode, Host Katherine Yang-Iott is joined by Steve Gens and Greg Brolund to share early insights from the 2026 Regulatory Operational Excellence & World Class RIM Study. They highlight some of the most compelling trends from this year’s data, including steady RIM performance gains, expanding regulatory remits, rising interest in AI and automation, and the debut of the new Future Readiness Indicator.

In today’s episode, Steve Gens sits down with Rainer Schwarz, CEO of KlearDoc and Executive Advisor, to talk about two decades of regulatory software innovation and the rise of AI in the space. In this episode they explore early NLP‑driven text extraction, today’s LLM‑powered review automation, and Rainer’s staged vision for AI adoption across regulatory.Listen now on your favorite podcast platform or on our website: https://gens-associates.com/gens-associates-podcast/Want to hear more from Rainer? Connect with him on LinkedIn: https://www.linkedin.com/in/rainerschwarz010371/

In this episode, host Steve Gens is joined by Omar Serang (EVP and GM of DNAnexus) to explore the evolution of trusted regulatory spaces. The conversation covers PrecisionFDA, Project PRISM, protocol digitalization, and the emerging shift toward faster, more collaborative global regulatory processes.Learn more about DNAnexus through their website: https://www.dnanexus.com/

In today’s episode, host Steve Gens is joined by Dominique Lagrave (Chief Regulatory Officer, Accumulus Technologies) to look at the future of regulatory collaboration — from one‑to‑many submissions to one‑click connectivity between sponsors and agencies. Join us for this insightful discussion on Regulatory Operations and the exciting future for Accumulus Technologies!To learn more about Accumulus, reach out at [email protected] — or visit their website here: https://accumulustechnologies.com

In this special episode, host Steve Gens sits down with Remco Munnik, founder of Arcana, to explore the story behind the company’s creation and its guiding mission. As Arcana takes its first steps, Remco shares the aspirations and early plans that will shape its journey ahead.

In todays episode, host Steve Gens sits down with Ari Caroline, Co-Founder and Chief Strategy Officer of Weave, to explore how generative AI and platform thinking are reshaping the regulatory landscape. Ari shares Weave’s origin story, the metaphor behind its name, and how the company is building a “superhighway” for regulatory content generation. If you'd like to get to know Weave more, please visit their website at: https://www.weave.bio/

In todays episode, host Steve Gens welcomes back Toban Zolman (Founder and CEO of Kivo) for a founder to founder discussion on Kivo's rapid growth, why sponsors and CROs are embracing the platform, and how tectonic shifts, like AI, are reshaping R&D. They explore the tipping point for AI adoption, emerging trends in Biotechs, and Kivo's unique relationship with the community. To learn more about Kivo’s unified platform for regulatory, quality, and clinical operations, visit kivo.io or follow them on LinkedIn.