The Gens & Associates Podcast

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/