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. Kivo’s modern architecture and collaboration tools streamline these processes, offering a ‘single pane of glass’ for managing regulatory documentation and compliance.

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

Toban also discussed the potential for AI to automate regulatory processes, such as document authoring and management. By leveraging AI to handle structured content, Kivo aims to improve efficiency and accuracy, reducing the burden on regulatory professionals while maintaining compliance.

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.

Join the Conversation

Toban and the Kivo team will attend the RAPS Regulatory Convergence in sunny Southern California. Those interested in diving deeper into these industry trends and innovations should connect with Toban and the team at Kivo on LinkedIn or their company website. It’s an excellent opportunity to connect with experts and learn more about the future of regulatory processes in life sciences.

You can listen to the full episode of the Life Sciences – In Focus Podcast on Spotify and Apple Podcasts or watch it on YouTube. Stay tuned for more fascinating conversations with global life sciences experts in our upcoming episodes.