Biotech and pharmaceuticals
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?
We look at all products within research and development, and evaluate their prospects for success and their synergies.
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
- make scientifically sound recommendations for each life cycle stage of a compound,
- forecast how the market segment for individual products is likely to develop,
- and which development investments are profitable over the long term
We have implemented projects such as the following
Assessment of the development plan for a biotechnological therapeutic agent
1. Challenge
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.
2. Approach
- Consideration and evaluation of the evidence
- Estimation of prospects for success
- Given this was a curative therapeutic agent, the number of eligible patients decreases with the duration of the product’s usage. Therefore, modelling of the development of patient numbers and translation into potential sales revenue using differential equation
- Modelling of the costs of the further development and marketing
- Analysis of personnel and technical risk factors
- Creation of a present-value model with scenarios (proprietary distribution, licence share, sale)
3. Outcome
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.
We have implemented projects such as the following
Review of the indication expansion for a cardiovascular medical drug
1. Challenge
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.
2. Approach
Analysis of the previous expert opinions and literature
3. Outcome
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.
Digitalisation and AI
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?
What we do:
System architecture
Data science & 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.
We have implemented projects such as the following
Development of a blueprint for the entire IT structure and evaluation of the AI procedures in use
1. Challenge
How can the IT architecture be optimised and AI be used in the company to better support the business processes?
2. Approach
- Selection and consideration of the most important, business-critical and business-specific processes as well as description of the problems to be solved, the data and procedures necessary for this purpose
- Formal presentation of the existing process support through IT systems, identification of pain points, possibilities for improvement and evaluation of current projects
- Design of a target architecture for improved support to processes, system integration and data architecture to allow for the productive use of data science and AI
- Determination of the costs for the creation and operation of the procedures; evaluation of benefits
3. Outcome
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.
What challenge
are you facing? Write to us.
Dr. Raija Kramer
info@cognotekt.com
+49 221-643065-10