Captario SUM in Pharma R&D

Captario SUM® introduces a new approach to decision-making in drug development programs and portfolios. It bridges a loop of creative design and analytical thinking, allowing drug development ideas to be captured and then run in the computer. The results reflect the value and risk over the entire product life cycle.

In Captario SUM® almost any idea is worth testing, as there is really nothing to lose; mistakes in silico have minimal impact, apart from learning.

Model, Simulate, Analyze

Captario SUM® sets a new standard for supporting strategic decision making in drug development projects and portfolios. Project teams can model, simulate and analyze development options and get the most benefit out of a drug. Similarly, portfolio teams can determine the investment strategy that best aligns with business goals and constraints at the enterprise level.

Qualitative Modelling – the What, Why and How of the project

The qualitative modelling in Captario SUM helps the team to define a robust drug development strategy.

The Product Vision focuses the team on the patients and their benefits, the current standard of care and the pipeline of competitor projects. The result is one or more sets of Target Product Properties that can be used as the end goal in the Hypothesis Tree.

Hypothesis Tree. This is a chain of hypotheses that bridges current knowledge with the target product properties, through the different development phases. The hypotheses define the key questions that must be answered in each phase by the activities modeled in the Program Design.

Program Design. Captario SUM® uses the familiar BPMN™ notation to model projects with events, activities, and outcomes (gateways), all connected by sequence flows. The BPMN diagram provides an instant overview of the entire project and highlights the important investment decisions.

In order to make an informed decision on a development approach, one needs to look beyond one corporate function or the next phase of development. Rather, one must consider the project life cycle in its entirety. A team can start with a high-level process and then gradually increase the level of detail where needed.

Quantitative Modelling – Describing the project with numbers

In Program Design, the core metrics of project activities – time, cost, revenue, and outcomes – can be expressed either as simple ranges or as complex expressions dependent on outcomes of previous activities or decisions. Project uncertainties are always captured, so that uncertainty is taken into account when evaluating options and assessing risk.

Captario SUM® not only highlights decisions in the project model, but it also models the underlying business logic. Teams can build efficacy thresholds and other decision criteria into the model, so that each simulation makes decisions in the same way that they would.

A product’s sales projection is captured in one or more process activities. The model accounts for uncertainty in all type of impacting factors such as adoption rate, market size, market share, price, cannibalization and order of entry. The market model is also integrated with the development model and adapts to the launch date and the outcome of the development activities.

The Captario SUM® project model is able to capture projects of any complexity, and the intuitive modelling interface means that solutions are limited not by software, but only by the ingenuity of the team.

9M ToxPivotaltrial setupPivotal trial 1Pivotal trial 2Long-term ToxBioequivalencestudyFormulationdevelopmentPOC StudyDeveloporal solutionBiomarkerevaluationMarketUSMarketEuropeEndAdvanced expressionsystem that successfullymodels the most complexmarketsDecisions, large and small, arerepresented by gateway diamonds.Captario SUM® focuses teamson business decisions.Events represent things thathappen in a project: start, end,and terminate (abort).Split clinical phases intoany number of activitiesand investment decisionsActivities are anything thathas a duration, cost, or revenue.They can cover anything from a singlemeeting to a whole clinical phase.TerminateSubmissionUSSubmissionEUStart

Simulate – Run the project in silico

In less than a minute Captario SUM simulates a complete end-to-end option by running the project tens of thousands of times. Each iteration in the simulation represents one possible future of the project. The simulation keeps track of cost and revenue over time and adapts to alternative paths, uncertainty and any type of internal or external dependency. Finally, managing risks in drug development becomes part of its decision making.

Analyze – From data to insights to decisions

Captario SUM® leverages the big data from simulations through high-utility visualizations that provide actionable insights. Decision-makers gain understanding into key drivers for project value. In addition, the optimum decision for any vital design element, such as number of study centers or threshold for Go/No-go decision, is easily determined to maximize project value.

With Captario SUM®, teams can easily compare options for projects and portfolios of projects. This enables teams to combine the best of each option into a potentially superior solution that can be simulated and analyzed.

Find the answers to essential strategic questions

In the simulation all aspects of the drug’s development and sales come into play and the project team can use the results to seek answers to questions, such as:

  • Indication
    • What indication has the most attractive value and risk ratio?
    • In what sequence should multiple indications be taken?
  • Clinical design
    • What endpoint is best suited to balance time/cost/uncertainty?
    • What sample size results in the highest project value?
    • What thresholds for project termination and alternative paths would best balance value and risk?
  • Operations
    • What number of study centers results in the highest project value?
    • How likely is the project to hit a critical milestone in time?
    • What is the likely critical path through development?

The immediate feedback provides objective answers to key questions allowing teams to come up with new and better options.

Flexible work

Working with Captario SUM®, users can dive straight into modelling – designing, simulating, and analyzing an idea in a matter of minutes – or work more thoroughly with the qualitative tools: product visions and hypothesis trees.

Build portfolios

The capabilities of Captario SUM® do not stop at individual projects. Portfolio users can build, simulate, analyze, and compare portfolios of projects managed by project users.

The portfolio functionality covers everything from intuitive drag-and-drop portfolio creation, to advanced portfolio simulation of combo projects. Captario SUM® delivers a set of visualizations tailored specifically for portfolio analysis and comparison.

Let us help you make better decisions

Captario offers trials and pilots of Captario SUM®. Our technical staff is ready to help set up a decision-making environment suited to your organization. Get in touch today and start your journey towards better decisions.