Would you like to know whether an indication extension for your medicinal product is worthwhile?
Are you wondering whether you should continue to invest in the proprietary development, or whether a timely exit and/or a partnership is the better way forward?
Do you require a scientific-economic assessment on whether you can take the step to the next phase of clinical studies?
For this purpose, we take into account the cell-biological mechanisms and the evidence from clinical development at each stage. We also evaluate the market potential of the individual product or the entire portfolio of your company. In this way, we can
The biotech company had results from therapeutic agent tissue obtained by in-vitro tissue culture and the subsequent implantation in patients (phase 1). The requirement was to model the potential of the therapeutic agent in order to make a decision concerning the proprietary development or sale of the patent following phase 2a.
Based on the data analysis, it was possible to obtain a convincing present-value model. Moreover, we recommended the optimum moment for the sale of the product. The implementation increased the value of the company.
A final expert opinion was requested to determine whether a phase 2b/3 study was worthwhile for an indication expansion. Contradictory expert opinions were already available.
Analysis of the previous expert opinions and literature
The key reference study contained an error in the formulation of the statistical model. The supposed effect in a cardiological clinical picture was only a pseudo-effect. The basis for a new indication was therefore lacking. The customer decided against the phase 3 study and therefore against a costly bad investment.
Would you like to know whether your IT infrastructure is equipped for future requirements?
Do you require an independent analysis to know which of your business processes could be automated with the use of AI?
We analyse the problem which needs solving with the use of data-driven approaches and/or artificial intelligence. On this basis, we evaluate the existing models and adapt them where necessary. If no existing model is available or if it is unsuitable, we develop new solutions.
How can the IT architecture be optimised and AI be used in the company to better support the business processes?
Establishing of a customised and future-proof IT architecture that significantly improves the economic benefit and uses AI in the correct way. By training the responsible employees, they can also select AI projects more appropriately and on the basis of the simplicity of the procedures in the future.
are you facing? Write to us.
Dr. Raija Kramer