NIA Small Business Showcase: Biopico Systems Inc.
Preclinical drug discovery research for Alzheimer’s disease (AD) is hampered by the lack of preclinical models. Although several drugs have shown some promise in animal models, many human clinical trials of therapies for AD have failed. Further, the blood-brain barrier integrity that prevents toxins from entering the brain and the molecular communications between the central nervous system and the enteric nervous system are critical for AD therapeutic strategy in the in vitro models. Models with 3D perfused recirculation organ systems can help with quantitative and mechanistic data in costly and risky drug testing. However, a high-throughput portable passive system that can connect multiple organs and provide quantitative pharmacokinetics data remains to be realized.
Biopico will commercialize multi-organ plate products (OrganRXTM) that will mimic true human physiology, so that responses to medicines, chemicals, and diseases can be predicted accurately. The OrganRXTM products consist of a recirculation system, a disposable plate, and a transepithelial electrical resistance (TEER) monitoring system.
The primary applications for Biopico’s organ technology are preclinical drug discovery programs. The global organ-on-a-chip market is expected to generate revenue of $1.6 billion by 2030 at a compound annual growth rate of 39.70%. Given its differentiated technology, Biopico expects to take a 25% share of the market in three major domains: drug development ($39.5 million), toxicology ($15.3 million), and physiological models ($5.6 million). An economic analysis for common toxicities that result in drug attrition revealed that a research and development (R&D) productivity of $24 billion is gained by supplementing existing preclinical in vitro models with organs-on-a-chip.
The OrganRXTM system provides a more predictive model for interactions between a tissue-specific parenchymal layer and an endothelial layer, or between tissues of two or more organs. The OrganRXTM system provides unidirectional flow of media across multiple organs and integrated monitoring in a scalable high-throughput format with high portability and open access of samples for post-processing. Improved process stability, increased performance, and reduced turnaround time and labor and facility costs are the value proposition for the OrganRXTM system.
- 2021: Development of a multi-organ system for collaborators
- 2022: Validation of multi-organs and ß-customers (in progress)
- 2023: Validation across the International Consortium for Innovation & Quality in Pharmaceutical Development (IQ Consortium) microphysiological systems (MPS) guidelines
- 2024: Autologous multi-organs validation and pharma
- 2025: Clinical trials
- 2021: Multi-organ proof-of-concept development
- 2022: OrganRXTM system release
- 2023: Pharma partnership
- 2024: Organ-ready marketing
- 2025: Clinical trials with partners
Biopico Systems Inc. has raised $4 million; that includes private funding, federal grants, and contracts. The company currently has $2 million and Q3 2023 seed investment for completing lead identification and optimization in 12 months. Biopico plans to raise $10 million to carry out clinical trials.
Biopico has multiple issued patents and pending patents for cells and organs processing and monitoring. The company has developed significant know-how in terms of the design and development of the OrganRXTM system. With the basic design and recirculation technology to culture and monitor organs and multi-organs, Biopico can penetrate the market. The company will seek assistance from its partners to further the patent landscape for multiple targeted applications.
Product Development and Regulatory Strategy
Biopico will validate the OrganRXTM system for different applications with collaborators and ß-customers. Before the OrganRXTM system is used for patient trials, it will be tested for effectiveness through verification and validation activities. Further, with regulatory guidelines provided by the IQ Consortium for MPS, Biopico will deploy the OrganRXTM system for multiple applications with customized kits to advance into the research and pharmaceutical markets.
Biopico will market multi-organ systems to research and pharma customers for pharmacology, mechanistic studies, and safety and pharmacokinetics. The company will develop a revenue model through a strategic partnership for the sale of the OrganRXTM system, instrumentation, and consumables kits (disposables and reagents). The OrganRXTM system will be sold as a package to research and pharma customers. Biopico will also collaborate with relevant partners for co-developing pharmaceutical agents.
- John Collins, Ph.D., CEO
- Henry Wong, Ph.D., R&D
- Masashi Kitazawa, Ph.D., Advisor for AD
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