A leading global manufacturer of medications and products and one of the largest drug manufacturers in Southern Africa, Aspen Pharmacare, has implemented a Launch Management System to manage the process whereby a new drug is introduced into the market.
Implemented by Microsoft partner Decision Inc., the system has improved data integrity, allowing for seamless workflow and tighter document control. Ultimately, the system will assist Aspen with its Six Sigma approach.
Aspen Pharmacare required a central repository for all data related to the commercialisation of Aspen’s intellectual property (IP) (or licensed IP and patents). This includes medical drugs, a complex repository with more than 1,000 fields of data, and a number of relationships between the data sets.
The system had to allow for the capture and approval of information at various stages in the launch process through complicated workflows, alongside the reporting and visibility of the progress. Users needed to examine information on a project plan, implement it and see amends and data synced with the enterprise project management (EPM) system.
One of the challenges facing Aspen Pharmacare was in establishing a consistent internal process which could seamlessly handle the development and introduction of new medical drugs to market. The organisation needed a system which could track the entire process, capture all of the information, manage approvals and allow for richer data analysis and control.
The solution created by Decision Inc. was tailored to the specific internal and regulatory requirements of the client and has transformed a lengthy, manual process into a seamless and centralised system.
“As the New Product Launch team, we use a project management methodology to commercialise our intellectual property,” said New Product Launch Manager at Aspen Pharmacare, Jeannine Terblanche.
“Throughout this process we communicate, collaborate and co-ordinate with role-players to ensure that launching Aspen’s IP is optimised and prioritised to ensure an on-time, within budget, successful launch. Our new Launch Management System developed with Decision Inc. greatly enables this process mainly through the early and up-to-date information which is available to all role-players on a 24/7 basis,” continued Terblanche.
The solution had to centralise all the information so that it was accessible from a single location and show the status of any particular drug at any stage of its movement through the approvals process. It had to streamline and standardise systems as different departments and individuals were handling things in different ways, and it needed to build in workflows and reminders to improve the overall efficiency and turnaround of various steps in the process.
“Aspen Pharmacare had made a previous attempt to construct a solution, but with limited success,” said General Manager: Content & Collaboration at Decision Inc., Craig Gillham.
“They then selected Decision Inc. to come in and transform the platform as we demonstrated a clear understanding of what they were trying to achieve and showed them how it could be done,” continued Gillham.
Decision Inc. developed a complex, custom solution, presented through the Microsoft SharePoint platform, which stored all information centrally, digitised documentation and remained seamlessly interconnected for instant, always-on access to data and product status. It allowed for workflow processes to be followed accurately and automated a number of elements to ensure that information is kept secure and up-to-date and acted upon timeously.
“The system starts with what the client entitles a Product Information Brief which is completed in as much detail as possible and then submitted to the New Product Launch Division,” explained Gillham.
“The brief explains what the active ingredient of the product is, in what strength it is to be offered (i.e. 20 milligrams) and the pack sizes in which the drug is to be marketed. It also includes data about the companies that will be responsible for packing, manufacturing and all other service providers along the chain,” continued Gillham.
Receiving MCC approval for the commercialisation of a product is an extensive and complex process. It is important that all role-players understand the impact that sub-approvals (e.g. name approval) has on the targeted commercialisation date of a product.
“The system has a large and complex database structure in the back and required significant time to scope, develop and ultimately populate with data. During the development lifecycle, we took an agile approach of build-and-show, testing the system as we incrementally developed functionality, so we could overcome the client’s very specific challenges and ensure they were happy every step of the way,” said Gillham.
“A lot of the requirements were not clearly understood or defined at the outset as well, we uncovered and detailed them as we moved through the build. This was particularly true for those few elements which were the exception to the rule – 90% of the time it was X, but for 10% of the time it was Y – and which required very specific functionality and workflow exceptions in order to function,” continued Gillham.
Terblanche added: “Our internal team assisted with testing thanks to the agile methodology adopted by Decision Inc. It allowed for our teams to test from the beginning and see where potential problems could lie and help in coming up with methodologies and processes which could mitigate these.”
Decision Inc. worked closely with the client throughout the development period to ensure they delivered a solution which adhered to the original brief and adapted to changes as and when required. As a result, Aspen Pharmacare now has a dynamic and versatile solution which integrates with their EPM and updates workflow, processes and status documents accordingly.
“We have seen tangible business results since the solution has come into play,” saidTerblanche. “Data integrity has improved and the history repository is now being created in an on-going fashion which can potentially eliminate project IP from residing with individuals. Workflows have also assisted with preventing documentation from getting lost and thereby negatively impacting on optimisation.”
The project took around six months to develop and implement, and Decision Inc. has subsequently engaged in an SLA post-project delivery agreement to undertake improvements and enhancements on a month-by-month basis. The system continues to evolve as it integrates with the organisation and is adaptive enough to accommodate requirements across a range of workflows and situations.
“The Aspen Pharmacare solution has been a great success and the client is very happy with the results. It wasn’t without its challenges as it is such a complex system, but we worked with the customer to overcome these and to create something rather remarkable. The result is scalable and adaptable enough to suit their business and compliance requirements while having a noticeable impact on efficiency,” concluded Gillham.
Due to the magnitude of the project, Aspen Pharmacare is rolling out the new platform over a period of time. Many of the drug-approval processes take three to five years so some components and functionality have not yet been fully utilised, but the central repository of information and automated efficiencies are already making significant impacts on process, accuracy and productivity.
“The learnings from developing this system has assisted with similar developments within the company. It has increased our awareness of the complexity of the data and the processes and the measurable data created will assist with our Six Sigma implementation as well,” concluded Terblanche.