a novel human developmental toxicity testing platform
Today, there are over 20,000 prescription drugs in the market and about 80,000 approved chemicals, with more being created every year. However, there is often little known about the effects of these new products on pregnant women. This is partly due to the limited predictive powers of developmental toxicity screenings using animal models, which can also be costly and time consuming. In addition, there is a significant and growing movement to reduce dependence on animal models.
To address these issues, an engineering team at the University of Michigan has developed a microfluidic technology called EmbryoTOX. This testing platform uses synthetic embryo-like structures derived from human stem cells to conduct developmental toxicity testing. Jianping Fu, Ph.D., Huaijing Tang, M.D., and Aidan Terhune have been developing the EmbryoTOX prototype since 2017, and the MIT Technology Review selected it as one of the “10 Breakthrough Technologies of 2018”.
“We’re revolutionizing the way we conduct developmental toxicity testing,” comments Fu. “Our team has developed a unique technology that is a win-win. It will not only fill the current need of a developmental toxicity test using synthetic human embryo-like structures, which is aiding the pharmaceutical industry in the drug development process and drug classification, but will also provide clear, concise, and useful guidance to healthcare providers, the couples preparing for pregnancy, and pregnant women.”
There is not a cost-effective and highly predictive assay platform to determine toxicity effects on embryonic development. Currently, the standards for developmental toxicity screenings rely on using animal models, a practice that has limitations and is under scrutiny given ethical concerns.
EmbryoTOX is a controllable and scalable microfluidic technology in which synthetic embryo-like structures derived from human stem cells (including both human embryonic stem cells and induced pluripotent stem cells) can be utilized for developmental toxicity testing. As such, this novel technology can use disease-specific and patient-specific stem cells for disease modeling. EmbryoTOX also allows screening using stem cells derived from different age and racial/ethnic groups, thus enabling the study of the different responses of different age and racial/ethnic groups to pharmacological compounds.
EmbryoTOX is an innovative developmental toxicity testing platform which offers, for the first time, the innovative concept of human-relevant, ‘organism-level’ toxicity testing without using intact natural human embryos. This innovative technology will reduce animal testing, increase assay throughput, reduce costs, and improve testing standards by providing a quantitative, reliable methodology. Most importantly, it will increase the predictive power of developmental toxicity assays.
- Intellectual Property – Two full, regular patents have been filed and obtained, with a third provisional patent application in progress.
- Commercialization Strategy – Form partnerships and collaborations with pharmaceutical companies developing new drugs. Form a startup company.
- Regulatory Pathway – Collaborate and establish informal connections within regulatory agencies to tailor the EmbryoTOX platform into an optimal tool for helping clients comply with federal regulations. Discuss the future of toxicology regulations concerning synthetic embryo-like structures with regulatory connections to ensure regulatory compliance in the future.
- Engage Investors – Target leading pharmaceutical companies and biotech firms in addition to contract research organizations, which perform over 25% of all non-clinical research services.
- Product Launch Strategy – Establish core laboratory to identify customer needs and refine EmbryoTOX platform. Possibly expand into other markets such as chemical industry. Present EmbryoTOX technology at leading toxicology conferences to gain groundswell.
- Finalize customer development
- Develop engineering requirements
- Generate initial prototype of semi-automated EmbryoTOX platform
- Validate predictive power of the EmbryoTOX platform
- Reach out to partners
- Produce formal prototype
- Present to partners
- Navigate regulatory landscape
- Form partnerships