In this Life Sciences - In Focus Podcast episode, we catch up with Toban Zolman, the CEO of Kivo, a unified document management system transforming the regulatory landscape in life sciences. With over 20 years of experience developing and validating computerized systems for clinical trials, Toban has an extensive background that bridges regulatory rigor with modern technological innovation.

From Regulatory Pioneer to Digital Transformer

Toban's career began as an early employee at Image Solutions, Inc. (ISI), where he played a pivotal role in pioneering electronic submissions for regulatory processes. His work with ISI led him to collaborate with 47 of the top 50 pharmaceutical companies and consult with over 200 companies across 16 countries. Despite these achievements, Toban felt that the transition from paper to electronic systems, while significant, needed more revolutionary impact.

After ISI's acquisition, Toban ventured into various enterprise SaaS startups, gaining experience in diverse fields such as social cloud and DevOps. However, his passion for life sciences reignited a few years ago when he noticed significant shifts in the industry, driven by technological advancements and a changing market landscape. This realization led to the birth of Kivo, a platform designed to help emerging companies efficiently manage regulatory, clinical, and quality processes in a compliant manner. (Kivo GO is a unified Document Management System that lets your Regulatory, Clinical, & Quality teams get work done together in one efficient, compliant workspace.)

Addressing Market Needs and Technological Shifts

During our conversation, Toban highlighted the increasing role of smaller, venture-backed companies in clinical trials. He noted that companies now conduct 70% of clinical trials without a product on the market. This shift is fueled by a new funding model, with venture capital pouring into life sciences, enabling smaller companies to conduct trials and bring products to market independently.

Toban elaborated on how Kivo addresses these companies' unique needs.

Traditional regulatory processes can be cumbersome and inefficient due to decentralized teams and heavy reliance on contractors.

Innovation and Risk Management in Life Sciences

The discussion centered around the industry's inherent risk aversion, particularly within quality and regulatory teams. Toban acknowledged this cautious approach but emphasized the potential for innovation within safe boundaries. He pointed to the role of AI in drug discovery, where it can dramatically increase the pace of identifying promising compounds without compromising safety.

The Tsunami of Change

Toban predicted a seismic shift in the industry due to AI-driven drug discovery. With substantial investments in AI, the number of promising compounds entering clinical trials is set to explode. This surge will necessitate a paradigm shift in regulatory bodies, CROs, and drug development companies' operations.

About Life Sciences - In Focus Life Sciences - In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division. About Vistatec We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com Social Media: LinkedIn - https://www.linkedin.com/showcase/vistatec-life-sciences

On this insightful episode of the Life Sciences - In Focus podcast, Host María Mateos is joined by Brandon VanArman, a seasoned Software Systems Engineer and contractor at Medtronic, who shares his extensive knowledge and experience in software development for the life sciences and language industry. About Life Sciences - In Focus Life Sciences - In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division. About Vistatec We have been helping some of the world’s most iconic brands to optimize their global commercial potential since 1997. Vistatec is one of the world’s leading global content solutions providers. HQ in Dublin, Ireland, with offices in Mountain View, California, USA. To learn more about Vistatec, please visit https://www.vistatec.com Social Media: LinkedIn - https://www.linkedin.com/showcase/vistatec-life-sciences

In this Life Sciences In-Focus podcast episode, host Karen Tkaczyk sat down with Michelle Lott, the founder and principal of Lean RAQA, to discuss the intricate world of regulatory affairs within the life sciences sector. This conversation not only shed light on Michelle's unique journey into the field but also explored the challenges and nuances of navigating regulatory pathways in the United States and Europe.

About the Host

Karen Tkaczyk

Director of Sales for the Vistatec Life Sciences Division. Karen is an accomplished chemist and translator with extensive experience in the drug, medical device, and chemical industries. MChem in Chemistry with French from the University of Manchester, UK, and a PhD in Chemistry from the University of Cambridge, UK.

About Life Sciences - In Focus

Life Sciences - In Focus Podcast by Visatatec, a fascinating conversation with global life sciences experts. The show has multiple hosts and topics Follow Life Sciences - In Focus on Spotify for all the latest episodes, or subscribe to the show on YouTube and Apple and Google podcasts. Life Sciences - In Focus is available on many other podcast platforms. To learn more about the podcast, please visit https://vistatec.com/life-sciences-division.

About Vistatec Life Sciences

The Vistatec dedicated Life Sciences Division understands the importance of specialized workflows and expertise to deliver solutions for leading organizations worldwide.

Our clients benefit from accurate and high-quality solutions, with industry-leading expertise demonstrated across a portfolio that includes medical devices, health care software, clinical trials, biotechnology, mental health, pharmaceuticals, and pure and applied science.

Find out more: https://vistatec.com/life-sciences-division