“Finally, a solution that supports design & decisions in drug development programs”
DESIGNALYSIS – The loop of Creativity and Analysis that leads to better options
Captario introduces a new approach to the design and decision making in drug development programs. It enables a loop of creative design and analytical thinking, where an idea of how to develop a drug is captured and then simulated to reflect the value and risk over the whole product life cycle. We have named this iterative approach DESIGNALYSIS and it helps teams find new and better ways to develop a drug.
Using Captario SUM, a team can leverage creativity and come up with innovative ideas of how to develop a drug. Almost any idea is worth testing, as there is really nothing to lose. An idea is sometimes designed, simulated and analyzed in a matter of minutes and not to forget, mistakes in silico have no real impact, other than learning.
Whether the team needs to choose an indication and create a Target Product Specification or wants to decide on the most suiting study design, Captario SUM provides creative tools that help the team design and put structure to ideas. This design also underpins quantitative models for simulation in an almost seamless way.
Patient-centric and differentiated target products
When deciding on a Target product, one must ensure that it makes a true difference to the patients, has a reasonable market potential and yet has a fair chance to reach launch. Captario SUM introduces a method to design for this process. The result is one or many documented Target Product Specifications, each with a model that forecasts the product’s time on market to be used in end-to-end simulations. The model accounts for uncertainty in all type of impacting factors such as adaption rate, market size, market share, price, cannibalization and order of entry.
The right questions asked at the right time
Just like science in general, drug development is much about asking the right questions at the right time. In early phase, creativity must be used to define hypotheses that are worthwhile and yet lead to either an increased confidence or potentially a project termination. Captario SUM introduces a method that puts structure to this strategic thinking and enables effective drug development. The result is a chain of hypotheses that bridges current knowledge with the aimed product properties and also underpins the assumptions for probability-of-success to be used in simulation.
Complete end-to-end options for simulation
In order to make an informed decision on a development approach, one needs to look beyond just one corporate function or just the next phase of development. Captario SUM introduces a method that captures a complete end-to-end option as a visual process flow and then uses this for simulation. A team can start with a high level process and then gradually increase the level of detail where needed. Project uncertainties are always captured, either as value ranges or probabilities, so that uncertainty is taken into account when evaluating options and assessing risk.
In less than a minute Captario SUM simulates a complete end-to-end option by running the project tens of thousands of times. The purpose is to capture nearly all possible outcomes in a set of raw data to be analyzed. The simulation keeps track of cost and revenue over time and adapts to uncertainty and any type of internal or external dependencies.
Captario SUM provides a broad range of graphs and performance indicators that enables the team to analyze and evaluate options objectively based on value and risk. This analysis brings new insights to the team and triggers new ideas that in turn can be designed, simulated and analyzed. The DESIGNALYSIS loop can continue.
Objective answers to key questions
In the simulation all the different uncertainties come into play and the project team can use the results to seek answers to questions, such as:
• What indication has the most attractive value and risk ratio?
• Is a front loaded development preferable?
• How likely is the project to keep within budget and timelines?
• What uncertainties constitute major risks?
• What activities tend to be on a critical path?
• How much is a saved month really worth in a certain phase?
The immediate feedback provides objective answers to key questions and provokes creativity to come up with new and better options.
The most important risks and the main value drivers
All quantitative assumptions express the team’s level of uncertainty. But which uncertainties cause the greatest risk to project time, cost and value? Captario SUM uses the raw data from simulation to answer these questions, which enables the team to reduce uncertainty where it counts the most. In addition, Captario SUM lists assumptions that constitute the most important drivers to project time, cost and value irrespective of uncertainty. This is of course a key to further design improvements.
All information, related to an option and its valuation is completely transparent. This includes all underpinning qualitative information as well as all assumptions and models. This enables stakeholders to understand the underlying thinking that led up to the quantitative analysis. In addition, raw data from the simulation can easily be exported to MS Excel for analysis in other environments.