The industry commitment to drug development for brain pathologies is experiencing a fast rate decreasing, a critical situation in a worldwide scenario where the number of patients affected by brain pathologies like Alzheimer’s (AD) or Parkinson’s (PD) disease are expected to greatly increase in the next decades.
One critical point is that the development of new drugs is a three-phase process, that currently requires 10-15 years and investment of 1-3 billion euros against a failure rate of about 99.6% for AD new drugs. The reasons of this discouraging scenario are multifaceted, but an important percentage of failure depends on the weak quality of biological target validation assays, mainly due to the presence of the blood-brain barrier and the complexity of brain physiology that make challenging the brain disease modelling.
Hence, it is particularly crucial to implement an innovative, reliable in vitro cell model able to predict the potential of a new drug to cross the blood-brain barrier (BBB) and effectively target the brain.
DIANA (Organ-on-a-chip Drug screenIng device to tArget braiN disease) project aims to perform the technical and commercial feasibility of an integrated, stand-alone BBB-brain model in-vitro, Chip4DBrain, based on a patented organ-on-a-chip technology, providing the basis for a new generation of innovative devices.
DIANA has been run by a consortium between the Politecnico di Milano and an industrial partner, Neuro-Zone srl (Contract Research Organization – CRO – specialized in R&D for drug development in brain diseases for pharma) combining a solid technological expertise and an in-depth knowledge of the market.
A summary of the main results follows.
The Chip4DBrain organ-on-a-chip device has been obtained; the cell related protocols and the fluid-dynamic parameters have been fine-tuned in order to guarantee the best biological performance of both the BBB and Brain units of the Chip4DBrain (Task 1; Goal: Technical feasibility).
The drug testing of the complete, cell loaded Chip4DBrain has been performed by using two commercially available bioactive molecules (Task 2; Goal: Field Testing Operations feasibility).
We performed the development of a market opportunity recognition, need and competitive intelligence analysis and the development of an exploitation roadmap to investigate the value proposition, the possible exploitation options, and design the route towards the market. The patent related to DIANA organ-on-a-chip device has been extend with an international patent application and nationalized in selected countries (Task 3; Goal: Commercial feasibility and IP issues).
An open access peer reviewed publication, two press releases, reported also to social media, a dedicated page on the Politecnico di Milano website and on the ERC-CoG “MINERVA” website have been finalised, together with the participation to three brokerage events, and several one-to-one-meetings with top-level scientists, industrial stakeholders and potential end users (Task 4; Goal: Project Management and dissemination).
