The Gens & Associates Podcast

Gens & Associates
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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.

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

    2D AGO

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

    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.

    29 min
  2. Service Provider Executive Series #18: Rainer Schwarz on Automating Regulatory Review with AI

    FEB 9

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

    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/

    28 min
  3. Service Provider Executive Series #17: Omar Serang of DNAnexus

    JAN 26

    Service Provider Executive Series #17: Omar Serang of DNAnexus

    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/

    31 min
  4. Service Provider Executive Series #16 - Accumulus' Dominique Lagrave on the Future of Global Regulatory Collaboration

    JAN 9

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

    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

    35 min
  5. Regulatory Executive Series Special: Remco Munnik (Owner and Founder of Arcana)

    11/28/2025

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

    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.

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

    11/07/2025

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

    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/

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

    10/16/2025

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

    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.

    27 min
  8. Service Provider Executive Series #13: Renato Rjavec (ArisGlobal)

    10/02/2025

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

    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

    24 min
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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.

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