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)

In this episode, host Steve Gens sits down with Anita Modi, Co-Founder and CEO of Peer AI, for an insightful and forward-looking conversation on the future of AI enhanced authoring. They explore Peer’s founding story, early momentum, benefits of Agentic AI, and what the authoring environment could look like by 2030 — plus what’s ahead for Peer in the coming years!

You can find more about Peer AI by visiting their website at: https://getpeer.ai [https://getpeer.ai/]

Service Provider Executive Series #12 - Anita Modi (Peer AI)

In today’s episode, host Steve Gens is joined by Kevin Morgan (Chief Growth Officer of Glemser). Together, they discuss Glemser’s current focus, differentiating in the clinical space, and what to expect from Glemser in the coming years.

Enrollment is official open for the Regulatory Operational Excellence & World Class RIM(SM) Study! But it’s not too late, rolling enrollment will continue through September. Don’t miss your chance to participate in the survey built for all of Regulatory Life Science industry.

Make your mark and see how you compare to your peers: https://gens-associates.com/world-class-rim-research/

Service Provider Executive Series #11: Kevin Morgan - Glemser

In today’s episode, host Steve Gens is joined by Docuvera’s Steve Owens (Chief Executive Officer) and Murali Menon (Chief Revenue Office). Together, they discuss how Docuvera is meeting the content generation transformation needs in the Regulatory/Clinical space, Structured Content Authoring vs. GenAI, and what to expect from Docuvera in the near future.

For inquires into the Gens & Associates Podcast, reach out to our producer at jgens@gens-associates.com

Time is running out to enroll in the “Industry Standard” Regulatory Life Science benchmark with Gens & Associates’ Regulatory Operation Excellence and World Class RIMSM Study. Visit https://gens-associates.com/world-class-rim-research/ and enroll to make your mark on industry and find how you rank amongst your peers.

Service Provider Executive Series Episode #10: A discussion with Docuvera's Steve Owens and Murali Menon

In today’s episode, host Steve Gens is joined by Gabor Fari, Co-founder and Principal of InteliNotion, to discuss how structured content authoring has evolved, the value of combining it with GenAI, and what to expect from InteliNotion in the short/long term.

Service Provider Executive Series Episode #9 - Gabor Fari (InteliNotion)

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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