The Gens & Associates Podcast

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...

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 platfo...

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 Accumulu...

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, ple...

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 mo...

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

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 b...

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 thro...

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...

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.

Welcome back to the Gens & Associates Podcast AI Series. In todays episode, Host Katherine Yang-Iott and Preeya Beczek discuss the implications of the EU AI Act on Regulatory Organizations - what does the policy want to achieve, what challenges might it create and how regulatory should be preparing.  Preeya is a Regulatory process expert and can be reached at preeya@beczek.com or on her L...

Katherine Yang-Iott sits down with François Guely, VP of Strategic Marketing at Ennov, to explore how AI solutions are transforming regulatory processes—making them faster, smarter, and more efficient. As the landscape evolves over the next few years, what should organizations anticipate? Join us as we dive into the advancements shaping the future. François Guely is an engineer and VP of Strategic...

Kicking off this new series on AI/Automation, host Katherine Yang-Iott is joined by study leads Steve Gens and Greg Brolund. Together, they discuss industry / provider readiness for advanced technologies with a focus on AI. Hear about key study takeaways, changing sentiments in the AI era, and other considerations for your Regulatory organization. 

In today’s episode, host Steve Gens is joined by Celegence’s Sonia Veluchamy (CEO & Co-Founder) and Punya Abbhi (COO & Co-Founder). Together, they discuss their regulatory services and unique tech enabled toolkits, how Regulatory will evolve with AI / Automation, and Celegence’s exciting future!

In today’s episode, host Steve Gens is joined by Brian Williams (Managing Director at KPMG LLP). Together, they discuss improving operational efficiency and time to market, Innovation in Regulatory and Regulatory R&D function with A.I., and what to expect from the Regulatory practice at KPMG! If you enjoyed this episode, be sure to follow and subscribe to hear more from industry experts and le...

In Today's episode, host Steve Gens is joined by Frank D'Entrone (Head of Global Sales at FME Life Sciences). Together, they discuss Regulatory Modernization and Transformation best practices, AI enabled services, and what to expect from FME in the coming years!

In today’s episode, host Steve Gens is joined by Rachel Belani-Barker (Managing Partner, R&D Advisory at Syneos Health). Together they discuss supporting client’s transition through data strategy cross functionality, AI service tools, and whats up next for Syneos Health's regulatory/R&D practices.

In today's episode, host Steve Gens is joined by NNIT"s Rowan Nidd (Head of RA Advisory and MedTech for Europe). Together, they discuss how NNIT has helped its clients with their digital optimization journey, AI/Automation benefits for Regulatory, and what to expect from NNIT in the coming years!

Welcome to the Executive Series of the Gens & Associates Podcast. In today’s episode, host Steve Gens is joined by Toban Zolman (CEO of Kivo). Together, they discuss Kivo’s success with smaller stage companies, their process for quickly getting clients live on their platform, and Kivo’s exciting plans for the future!

In today’s episode, Steve Gens is joined by Navitas’ Marty Boom (Global Head of Regulatory & Safety) and Tris Nockles (Regulatory Nets Lead) to discuss Navitas’ “nets” and leading consulting services, opportunities and innovation with AI/Automation in Regulatory, and a look into the future at Navitas!

In the premiere episode of our Regulatory Executive Service Provider, host Steve Gens is joined by Padmanabham Navuluri or “Paddy” (Vice President and Head of Pharma Quality and Regulatory Affairs at Genpact) to discuss how Genpact has supported many regulatory organization transformations, the new era of innovation with A.I. and automation, and what to expect from Genpact regulatory services in t...

Welcome to The Gens & Associates Podcast: Regulatory Executive Series. This exciting series features Steve Gens, G&A Managing Partner, conversing with key regulatory senior executives that represent the software and services sectors. These informative one on one conversations will explore how they are guiding their organizations to effectively support key industry initiatives and technolog...

In today's episode, Host Steve Gens is joined by Marc Gabriel (VP, Vault Regulatory at Veeva) to discuss Veeva’s growth in the regulatory space, customer benefit realization, AI and advanced technology, and what’s next for their regulatory practice.