Can Organoids and Human-Based Models Improve Drug Development Predictability?

As interest in non-animal testing methods continues to grow, researchers and drug developers are exploring whether organoids, organ-on-chip systems, and other human-based models can improve the predictability of preclinical research. At BIO International Convention 2026 in San Diego, California, Mohit Trikha, PhD, CEO of Kivu Bioscience, discusses these topics as part of the panel session, Beyond Animal Testing: How Organoids and Human-Based Models Are Transforming Drug Discovery.

Can New Preclinical Models Better Predict Clinical Success in Oncology?

In an interview with BioPharm International, Trikha reflected on the opportunities and challenges associated with emerging preclinical technologies. Drawing on a career that spans preclinical research, early clinical development, and translational science, he explained that working closely with patients and clinical trial teams has influenced his perspective on evaluating new models of human disease.

While encouraged by advances in human-based systems, Trikha said additional evidence is needed to demonstrate their ability to predict clinical outcomes. “I'm not sure I have seen compelling data that these preclinical models actually predict human disease,” he said. “The kind of data that I'd like to see is research scientists using approved cancer drugs, as well as drugs that did not make it to approval, and understand, could these preclinical models have predicted their failure in clinical trials?”

According to Trikha, retrospective analyses comparing successful and unsuccessful oncology therapies could provide valuable insight into the predictive value of these models. He also emphasized the importance of collaboration among discovery scientists, clinicians, and toxicologists to evaluate new approaches more effectively.

Beyond scientific validation, Trikha highlighted the need to accelerate development timelines for patients facing serious diseases. He stressed that early engagement with regulatory agencies, including the FDA, can help sponsors refine development strategies and address challenges before they become barriers. Ultimately, he said, successful drug development requires balancing innovation, regulatory input, commercial considerations, and the goal of addressing unmet patient needs.

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About the Author

Mohit Trikha, PhD, CEO, Kivu Bioscience

Dr. Mohit (Mo) Trikha is the CEO of Kivu Bioscience. He brings over 25 years of drug development expertise in oncology. He has been instrumental in advancing more than 40 programs from target identification to clinical trials in oncology. Previously, Mo was a venture partner at Apple Tree Partners, and also led oncology early development at AbbVie, where he oversaw the development of discovery-stage programs to clinical proof of concept, focusing on ADCs, bispecifics, and CAR-T therapies. He has contributed to the development of key drugs such as Kadcyla, Polivy, and vismodegib, and chaired collaborations with leading institutions like TeneoBio, Calibr, and The Scripps Research Institute. Earlier in his career, he held roles at Genentech, Centocor/Johnson & Johnson, and Triphase Accelerator. Mo earned his B.S. in Biochemistry from California State University, Los Angeles, and his PhD in Biochemistry and Molecular Biology from the University of Southern California.