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In what may be one of the most niche topics for a podcast, Operations Utopia is a podcast about the desperate need to streamline Life Sciences Operations to get treatments to patients faster and explores how life sciences organizations should operate—by examining why they usually don’t.
Disclaimer: The podcast content represents the opinion of the speakers, guests & host and does not reflect those of their organizations, system vendors, or service providers.
Disclaimer: The podcast content represents the opinion of the speakers, guests & host and does not reflect those of their organizations, system vendors, or service providers.
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John Jones is the founder and creator of the Nidura platform. He is Chief Executive Officer of Entitech Solutions and SVP, Head of Life Sciences Consulting at Tandym Group. Earlier roles include Practice Lead for IT Strategy & Implementation at Quintiles, Vice President of Application & Int…
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Guest Bio
Megha Sinha is the founder and CEO of Kolter AI, an autonomous regulatory planning platform for life sciences, and managing partner and CEO of Kamet Consulting Group, which she has run since 2023. She has spent 17 years inside major life sciences lifecycle-change programs — M&A integr…
Guest Bio
Leslie LaCosta is a fractional operations leader who embeds directly with client teams to fix broken processes and remove friction in customer experience, rather than handing over a deck and walking away. She spent 31 years in retail, working her way from a store-level associate to distri…
OU-009: Frank Nogueira — The Wait Is Optional
Guest Bio
Francisco (Frank) Nogueira is CEO of Accumulus Technologies, where he leads the continued evolution and global adoption of the Accumulus Platform, helping transform regulatory collaboration to accelerate patient access to medicines. Prior…
Jeff Sovis is founder and principal consultant of Mindful FDA Compliance LLC, which he started in 2015. He began his career in the lab at Genzyme Biosurgery manufacturing cell-therapy products for burn victims, then moved into life sciences quality and validation consulting — roughly 12 years of it…
Host: Matt Neal Guest: V. "Bala" Balasubramanian, PhD, MBA — DIA RIM Reference Model subteam lead
About the Guest
V. "Bala" Balasubramanian, PhD, MBA, is a strategic advisor in healthcare and life sciences and the subteam lead for the DIA RIM Reference Model. He has been associated with DIA for m…
About the Guest
Paul Slater helps professionals, leaders, and organizations navigate the human side of AI transformation. He is the author of The AI-Ready Human: Your 90-Day Program to Stay Relevant as Technology Transforms Work, host of the Humanity Working podcast, and founder of Paul Slater Adv…
Executive Summary
For most of life sciences history, validation has been a snapshot — freeze the configuration, prove it behaves as designed, trust the system until you change it. Nuno Valério has spent his career inside that paradigm, and he's now one of the clearest public voices on what has to …
Host: Matt Neal Guest: Scott Cleve, Vice President, Regulatory Operations, Information and Compliance, Daiichi Sankyo
Executive Summary
Few people have lived through more change cycles in regulatory operations than Scott Cleve. Across 20+ years at Accenture, AbbVie, Astellas, Boehringer Ingelheim…
About the Guest
Crystal Allard is Senior Director of Government Strategy at Veeva Systems, where she works with regulators and industry to shape the future of the submissions ecosystem and increase speed to market.
Crystal spent roughly 15 years at the FDA across innovation and technology roles —…
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