• Ep. 43: Running regulatory and clinical operations in an AI world

  • Sep 13 2023
  • Duración: 41 m
  • Podcast

Ep. 43: Running regulatory and clinical operations in an AI world Por arte de portada

Ep. 43: Running regulatory and clinical operations in an AI world

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  • Artificially intelligent tools are revolutionizing nearly every stage of the drug discovery process, offering substantial potential to reshape the speed and economics of the industry. As the drug discovery and preclinical stages speed up and potentially produce more drugs to test in the clinical trial phase, how do clinical researchers prepare and respond to these challenging opportunities?   In this episode, Toban Zolman, Chief Executive Officer at Kivo will share his thoughts on how AI-enabled successes in drug discovery will affect clinical operations and regulatory operations. We will discuss how advancements in technology and data analysis are reshaping the way we conduct clinical research.   --------------------------------------------------------   Episode Transcript: http://traffic.libsyn.com/thelatestdose/The_Latest_Dose-S01_E43.mp3   00;00;00;00 - 00;00;40;25 Hi, everyone, and welcome to the Latest Dose, the podcast that explores the depth of innovation and human compassion in clinical research. I'm your host, Katherine Vandebelt, global vice president of Clinical Innovation at Oracle Health Sciences. Traditionally drug discovery is a notoriously time consuming and expensive process. A host of artificial intelligence tools, AI, are said to be revolutionizing nearly every stage of the drug discovery process, offering substantial potential to reshape the speed and economics of the industry.   00;00;41;02 - 00;01;11;13 According to the Boston Consulting Group, as of March 2022, “ biotech companies are using an AI first approach had more than 150 small molecule drugs in discovery and more than 15 already in clinical trials”. Once the drug discovery and preclinical stages speed up and potentially produce more drugs to test in the clinical trial phase, how do we prepare and respond to this exciting new and challenging opportunity?   00;01;11;15 - 00;01;42;17 Today, our guest will share his thoughts on how AI enabled successes in drug discovery will affect clinical operations and regulatory operations. We will discuss how advancements in technology and data analysis are reshaping the way we conduct clinical research. Joining me today is Toban Zolman, Chief Executive Officer of Kivo. Toban has 20 years of experience in regulatory and clinical operations, drafting some of the first guidelines for electronic submission at Image Solutions.   00;01;42;19 - 00;02;09;06 Toban has consulted with 45 of the top 50 pharma companies in the world. After working in regulatory, Toban ran product teams for several tech companies. Toban has been at the forefront of multiple tech revolutions, such as cloud computing and the Internet of Things. Toban thinks the time has come for clinical trial management to level up. Toban, it is great to speak with you today.   00;02;09;06 - 00;02;45;17 Welcome to the Latest Dose. Yeah, thank you. Great to speak with you as well. In the intro I mentioned that you believe the time has come for clinical trial management to level up. What do you mean by that? Well, let me give you some context maybe on where that comment is coming from. So, I spent a chunk of my career helping tier one pharma transition to electronic submissions and kind of the promise of electronic submissions was improved process, improved visibility, faster review times by regulatory agencies.   00;02;45;19 - 00;03;22;16 And the way that we went about that as an industry, you know, 15 to 20 years ago, was really to take this new challenge, process challenge, of managing a ten X increase in the amount of documents going back and forth to a regulatory agency and controlling that incredibly tightly. And so literally, you know, I spent years and in windowless conference rooms with committees trying to figure out how to manage every aspect of increasingly complex process.   00;03;22;18 - 00;04;03;13 And honestly, it was soul crushing. So, I left the industry and spent over a decade working in other industries that were kind of on the edge of major transformations. E-commerce, social, cloud, IoT, and eventually circled back to life sciences. And I think the thing that struck me the most as I came back into life sciences and started to talk to clinical and regulatory leaders who were dealing with all of these advancements in how clinical trials operate, as this was kind of the same song, new verse.   00;04;03;16 - 00;04;32;03 The pace of clinical trials was accelerating. The complexity of tools was increasing. And the number of assets that they were having to manage that resulted from those advancements was also increasing.  And the approach to managing all of that was to just have leaders in life sciences, you know, these pharma companies just literally tighten their grip on the process even more.   00;04;32;05 - 00;05;14;08 And that's just not a model that works, and it's not a model that any other industry has embraced. And so, really, I think what we've really focused on, at Kivo, is helping companies...
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