A decision support application was developed for management and allocation of resources at the Safety Assessment division of a global Fortune 100 Pharmaceutical major. The application provides for quick analysis of the resources available, and their allocation to the development programs concerning the pre-clinical candidates in the pipeline. Since limited resources are available (e.g. animals needed for testing, lab personnel, biochemists etc.) there needs to be an optimal utilization of these resources such that the drug candidates with the highest potential for success are preferentially supported. A complicating factor is that the probability of success (POS) of each program is a dynamically changing factor that depends on a number of internal and external variables. The Planning Tool application developed by Optimal Solutions demonstrated that asset utilization can be predicted and optimized to maximize the number of pre-clinical candidates that can go through the development pipeline. The application also enables the company to study impacts of outsourcing.
Safety Assessment studies are on the critical path for the drug approval process undergone by pharmaceutical companies. At any given time there are a large number of drugs or New Drug Applications (NDAs) in the pipeline, needing to be resourced. Generally, better management of drug portfolios and resources leads to higher profitability and more successful drug launches. The ability of a company to support development/testing programs is dependent on its ability to minimize the high cost (in terms of resources, money and time) of taking a drug to market. Optimal Solutions was approached by the Safety Assessment group of a pharma major with the objective of developing an application for efficient allocation of resources to the various development/testing programs and pre-clinical candidates under study. The following business aspects were relevant to this project:
There existed no comprehensive and automated way to predict the load on various organizational resources, given a pipeline under development and a scenario of future pre-clinical candidates’ deployment. There existed no automated way of allocating Safety Assessment resources to different programs based on probability of success or financial impact. As a result, there was no way to assess the impact of allocation decisions on the future success of these programs.
Optimal Solutions was charged with the task of delivering a Planning Tool that:
The AIMMS platform that was used for developing the application boasts of class-leading GUI capabilities and an ability to interface with a variety industrial databases. The resulting application was test-driven using real data, and was successful in generating allocation plans under a variety of conditions. The user interface was designed to offer ease of use, and allow rapid tweaks to critical decision-making parameters that facilitate scenario analyses.
The application also offers a convenient method for inputting and importing/exporting data. Detailed User and Technical manuals were provided in addition to an online help functionality. The application also gives visibility to the end-users about data gaps and data inconsistencies and alerts them to data-maintenance activities.
As a result of installing the application, the planning capability of the Safety Assessment team was significantly improved over the existing, manual planning process. Resourcing of programs can now be made more effectively, aimed at maximizing the success of the drug pipeline within the company. Maintenance of the data was made simpler through the data interchange that could be accomplished from within the application. The Safety Assessment Planning Tool was delivered with built-in upgradability so that future modifications and linkages e.g. with a Portfolio Management/Optimization tool can be easily established.
The Safety Assessment team gave good reviews to the application delivered by Optimal Solutions. A second phase of this project, wherein additional capabilities will be added, is already in the works. Some specific features of particular value were:
A decision support application was developed for management and allocation of resources at the Safety Assessment division of a global Fortune 100 Pharmaceutical major. The application provides for quick analysis of the resources available, and their allocation to the development programs concerning the pre-clinical candidates in the pipeline. Since limited resources are available (e.g. animals needed for testing, lab personnel, biochemists etc.) there needs to be an optimal utilization of these resources such that the drug candidates with the highest potential for success are preferentially supported. A complicating factor is that the probability of success (POS) of each program is a dynamically changing factor that depends on a number of internal and external variables. The Planning Tool application developed by Optimal Solutions demonstrated that asset utilization can be predicted and optimized to maximize the number of pre-clinical candidates that can go through the development pipeline. The application also enables the company to study impacts of outsourcing.
Safety Assessment studies are on the critical path for the drug approval process undergone by pharmaceutical companies. At any given time there are a large number of drugs or New Drug Applications (NDAs) in the pipeline, needing to be resourced. Generally, better management of drug portfolios and resources leads to higher profitability and more successful drug launches. The ability of a company to support development/testing programs is dependent on its ability to minimize the high cost (in terms of resources, money and time) of taking a drug to market. Optimal Solutions was approached by the Safety Assessment group of a pharma major with the objective of developing an application for efficient allocation of resources to the various development/testing programs and pre-clinical candidates under study. The following business aspects were relevant to this project:
There existed no comprehensive and automated way to predict the load on various organizational resources, given a pipeline under development and a scenario of future pre-clinical candidates’ deployment. There existed no automated way of allocating Safety Assessment resources to different programs based on probability of success or financial impact. As a result, there was no way to assess the impact of allocation decisions on the future success of these programs.
Optimal Solutions was charged with the task of delivering a Planning Tool that:
The AIMMS platform that was used for developing the application boasts of class-leading GUI capabilities and an ability to interface with a variety industrial databases. The resulting application was test-driven using real data, and was successful in generating allocation plans under a variety of conditions. The user interface was designed to offer ease of use, and allow rapid tweaks to critical decision-making parameters that facilitate scenario analyses.
The application also offers a convenient method for inputting and importing/exporting data. Detailed User and Technical manuals were provided in addition to an online help functionality. The application also gives visibility to the end-users about data gaps and data inconsistencies and alerts them to data-maintenance activities.
As a result of installing the application, the planning capability of the Safety Assessment team was significantly improved over the existing, manual planning process. Resourcing of programs can now be made more effectively, aimed at maximizing the success of the drug pipeline within the company. Maintenance of the data was made simpler through the data interchange that could be accomplished from within the application. The Safety Assessment Planning Tool was delivered with built-in upgradability so that future modifications and linkages e.g. with a Portfolio Management/Optimization tool can be easily established.
The Safety Assessment team gave good reviews to the application delivered by Optimal Solutions. A second phase of this project, wherein additional capabilities will be added, is already in the works. Some specific features of particular value were:
