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 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/

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 [email protected] — or visit their website here: https://accumulustechnologies.com

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, please visit their website at: https://www.weave.bio/

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.

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 by visiting their website at: https://getpeer.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/

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 [email protected] 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.

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 [email protected] or on her LinkedIn: https://www.linkedin.com/in/preeyabeczek/If you are interested in connecting with G&A team or have inquiries for our podcast, please reach out to our Digital Marketing Lead John Gens at [email protected] next time, cheers!

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 Marketing at Ennov and can be reached at [email protected].

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 leadership in the Regulatory space!

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 the future.

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 technology advances.In today’s episode, host Steve Gens is joined by Max Kelleher (CEO of Generis) to discuss innovations in the CARA Platform, how internal company culture reflects customer satisfaction, and Generis’ exciting future.

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.

In this Executive Series episode, host Steve Gens is joined by Raoul Lorenz (CEO of LORENZ) to discussThe critical Health Authority and Sponsor digital interchange, excellence in market performance over time, and future plans for LORENZ.

Welcome to The Gens & Associates Podcast: Executive Series. This exciting series will feature Steve Gens, G&A Managing Partner, conversing with key 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 technology advances.In this episode, Steve Gens is joined by Steve Nuckols (Chief Customer Officer at ArisGlobal) to discuss recent mergers, the benefits of advanced technology, and what is next for ArisGlobal going forward.

Welcome to The Gens & Associates Podcast: Executive Series. This exciting series will feature Steve Gens, G&A Managing Partner, conversing with key 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 technology advances.In todays episode, host Steve Gens is joined by Rajiv Rangan (Co-Founder and Co-CEO of Freyr) to discuss the unique combination of regulatory services and software, advanced technology, as well as regulatory intelligence and how it benefits their costumers.

Welcome to The Gens & Associates Podcast: Executive Series. This exciting series features Steve Gens, G&A Managing Partner, conversing with key 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 technology advances.In this episode, Steve Gens is joined by Priya Bhutani (Founder and CEO of Regdesk) to discuss how Regulatory Intelligence and AI has helped costumers and the exciting future for Regdesk!

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.In this episode, Katherine Yang-Iott asks Brooke Casselberry to share her thoughts on the progress of regulators working collectively with life science organizations to establish data standards across industry, including the ICH M4Q(r2) and other reliance programs.

Welcome to The Gens & Associates Podcast: Executive Series. This exciting series will feature Steve Gens, G&A Managing Partner, conversing with key 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 technology advances.In this episode, Steve Gens is joined by James Gianoutsos (Founder and CEO of Rimsys) to discuss Rimsys’ growth as a provider in the Medtech space and how it supports their costumers unique and complex regulatory requirements.

Welcome to The Gens & Associates Podcast: Executive Series. This new series will feature Steve Gens, G&A Managing Partner, conversing with key 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 technology advances.In Todays episode, host Steve Gens is joined by Martin Schmid (CEO of Extedo) to discuss the transition to new investors and the bright future for Extedo!

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.In this episode, Katherine Yang-Iott is joined by Pat Shafer and Bala Balasubramanian, 2 authors of the newly published DIA RIM eBook. They share how the collaboration between thought leaders in Regulatory and DIA RIM working groups resulted in a rich compilation of ever-expanding and evolving regulatory knowledge captured in the new resource.Pat Shafer, Managing Director, FTI Consulting, [email protected] 464-379-8307"Bala" Balasubramanian, Orion Innovation, [email protected], 732-890-2443Be sure to check out Pat and Bala's book, Achieving Excellence in Regulatory Information Management: https://www.amazon.com/Achieving-Excellence-Regulatory-Information-Management-ebook/dp/B0D3JFWX52/?_encoding=UTF8&pd_rd_w=kemSD&content-id=amzn1.sym.f8fbf489-893c-481c-b7fa-18e0b0ecaa0c%3Aamzn1.symc.a68f4ca3-28dc-4388-a2cf-24672c480d8f&pf_rd_p=f8fbf489-893c-481c-b7fa-18e0b0ecaa0c&pf_rd_r=S2CB14A317VYS4V9KB7G&pd_rd_wg=6JJxo&pd_rd_r=d0945e75-767f-4e68-8d7c-8a40faaa9479&ref_=pd_hp_d_atf_ci_mcx_mr_ca_hp_atf_d

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.In this episode, Katherine Yang-Iott and Steve Gens highlight key learnings about how organizational strategies strengthen culture, team dynamics, and workforce capabilities from the 2024 WCRIM Survey.

Welcome to The Gens & Associates Podcast: Executive Series. This exciting new series will feature Steve Gens, G&A Managing Partner, conversing with key 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 technology advances.In our premiere episode, Olivier Pâris (President & CEO of Ennov) joins Steve Gens to discuss recent acquisitions, company strategy, and key technology priorities.

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.In this episode, Katherine Yang-Iott asks Greg Brolund to share key findings and lessons learned from the Digital Strategy and Advanced Technology section of the 2024 WCRIM Survey.

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.In this episode, host Katherine Yang-Iott is joined by Preeya Beczek and Kelly Hnat to discuss the progress of life science organizations on their journeys of data governance and data quality.

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.WCRIM ratings are calculated based on 11 non-technology questions in the study - operational performance, benefit outcomes and foundational practices.

In this first episode of our WCRIM series, Host Katherine Yang-Iott and Managing Partner Steve Gens share preliminary insights on the 2024 WCRIM Benchmark Study and key topics subsequent episodes will cover.

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.In this episode, Host Katherine Yang-Iott, Managing Partner Steve Gens and Guest Deb Torchia explore the impact to organizational strategies and workforce evolution driven by the potential disruption of GenAI and AI.

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.In today’s episode, Host Katherine Yang-Iott and Managing Partner Steve Gens highlight recent conversations with our research team and clients about the importance of organizational thinking as regulatory work evolves.

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.In today’s episode, Host Katherine Yang-Iott speaks with Steve Gens and Niels Leander on how to approach the design of a digital strategy for your organization. 

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.In today’s episode, Host Katherine Yang-Iott and Managing Partner Steve Gens discuss what is in store for the upcoming year at G&A.

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.In this episode, host Katherine Yang-Iott along with guest Matt Neal and Steve Gens discuss how publishing has changed since the early e-submissions days and what is in store for the future.

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.In today’s episode Host Katherine Yang-Iott and Megha Sinha, Managing Partner and CEO of Kamet Consulting Group LLC, discuss G&A's Affiliate Study through a Med Tech lens. 

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.In today’s episode, Host Katherine Yang-Iott and Kelly Hnat discuss the 2023 Optimizing Affiliate Engagement Survey and how to use the survey results to improve your global RIM journey.

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.In todays episode, Host Katherine Yang-Iott, Greg Brolund, and Steve Gens discuss the key learnings from the 2023 Optimizing Affiliate engagement study and ways companies can improve collaboration between the affiliates and headquarters.  

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.In this episode, Host Katherine Yang-Iott and managing partner Steve Gens previews upcoming plans for the WCRIM Study – learn initial design thinking and how the industry standard benchmark may evolve in 2024.

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.In todays episode, Host Katherine Yang-Iott, Greg Brolund, and Kelly Hnat give an update on Regulatory organizations changing strategies for IDMP / SPOR and also eCTD 4.0 readiness.

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.In this episode, Host Katherine Yang-Iott asks managing partner of G&A, Steve Gens and John Cogan of JPC Advisory to share their thoughts on the significance and impact of recent regulatory software provider consolidations.