The Gens & Associates Podcast

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.generiscorp.com/?utm_source=google&utm_medium=cpc&utm_campaign=22574197088&utm_term=generis&utm_content=753195402683&gad_source=1&gad_campaignid=22574197088&gbraid=0AAAAACG5I5RUKiAyiUq-E82GFztM5u0Cb&gclid=CjwKCAjwmdLSBhANEiwAkREMN26MH5VzrkxGkyD-w9v42j9LLQ8m7gErwCc1n5-9nocajBaQdLRnYhoCGPIQAvD_BwE

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