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/

Executive Series: James Gianoutsos (Rimsys) - AI, Market Access, and the Future of Regulatory Work

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/

Discussing Future‑Proofing Information Architecture in the Age of AI with Generis

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.

Preliminary insights from The Regulatory Operational Excellence & World Class RIM Study

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/

Service Provider Executive Series #18: Rainer Schwarz on Automating Regulatory Review with AI

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/

Service Provider Executive Series #17: Omar Serang of DNAnexus 

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 connect@accumulustech.com — or visit their website here: https://accumulustechnologies.com

Service Provider Executive Series #16 - Accumulus’ Dominique Lagrave on the Future of Global Regulatory Collaboration

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.



Regulatory Executive Series Special: Remco Munnik (Owner and Founder of Arcana)

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/

Service Provider Executive Series Episode #15 - Weaving the Future of Regulatory Innovation with Ari Caroline

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 [https://kivo.io/] or follow them on LinkedIn.

Service Provider Executive Series #14: Building the Operational Fabric of Modern R&D - Toban Zolman, Founder & CEO of Kivo.

In today’s episode, Host Steve Gens sits down with ArisGlobal's Renato Rjavec (VP of Product Management, Regulatory). Together, they discuss ArisGlobal’s adoption of advanced technologies, the NavaX platform, and the next leaps for ArisGlobal in the near future.

You can learn more about ArisGlobal and their NavaX platform by visiting: https://www.arisglobal.com [https://www.arisglobal.com/]

Service Provider Executive Series #13: Renato Rjavec (ArisGlobal)

Gens & Associates  (@johngens_55) · Zencastr

Gens & Associates  (@johngens_55)

Welcome to The Gens & Associates Podcast, where key members of the consulting firm will discuss insights into their research, regulatory trends and hot topics, as well as converse with industry thought leaders.