Pharmaceuticals, like many industries, constantly strives to maintain consistent quality and reduce product defects. It is also an industry that is closely regulated in the U.S. and in the other countries in which they do business.
Pfizer Incorporated, one of the world’s largest and most innovative pharmaceutical companies, partnered with Pega to enhance results in two key areas. The first involved designing a new clinical operations platform to streamline and speed up the processes of developing and bringing new drugs to market. The second focused on developing a new quality management system, or QMS, to ultimately improve product and patient outcomes.
Pega brought real-time oversight for clinical trials, established proactive risk management, improved patient safety, and reliable compliance leading to a substantial reduction in costs for Pfizer. Pega solutions have allowed Pfizer to seamlessly manage internal processes as well as those that touch partners outside of the organization including those in over 60 countries.
Representatives from Pfizer discussed these efforts as they presented “Adapting a Product-Centric Business to Patient-Centric World” at Pegaworld, an annual conference that gathers IT experts and business leaders who have partnered with Pega to solve their most challenging problems. This year’s event was held in Las Vegas. First to speak was Joe Guarnieri, Business Partner for Pfizer who explained how Pega helped his company revamp its pharmacovigilance (PV) process to attain better prescribing guidelines and produce even safer medicine.
Pharmacovigilance involves the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects and most commonly comes into play after a mediation has been approved. “It’s an ongoing thing to track safety signals and ensure that our product is still effective and efficient,” Guarnieri. Pega helped Pfizer streamline this.
“We have agreements with other partners on how we're going to run pharmacovigilance,” explained Guarnieri, “and usually it’s a big long word doc we put into a PDF file and sign off on with the partners.” The document basically outlines each stakeholders commitments and responsibilities. “Before Pega, we had multiple systems to track this and now with a robust BMS like Pega we have a workflow system that we can track, from soup to nuts, and make sure we are in compliance.”
The new system has been a success producing shortened timelines, easily accessible findings for audit purposes, and improved real-time metrics. “The result is we can make drugs that are safer and less expensive,” added Guarnieri.
Next to speak was Jeff Hanson, Senior Information Manager for Pfizer who took attendees deeper into the PVA process. With Pega, Pfizer was able to develop a PvX framework to capture data more efficiently, track it more accurately, and keep the process within budget and schedule constraints. “This PVA process is relevant to the entire life sciences industry,” he explained, “and the bigger issue at Pfizer and pharma as a whole is that they have these agreements. The requirement to have these PVAs is a regulatory requirement.”
For this project, Pega brought the technological expertise while Pfizer, of course, brought the business expertise which produced an iterative process. Development costs were shared. With improved communication and the ability to expose stakeholders that previously had not been involved in these processes, the new framework was a success.
Kim Tableman, Director of Core Process and Technology, -Worldwide R&D – Business for Pfizer then took the podium to talk about how Pega helped Pfizer build a new Quality Management System. This QMS was inspired, in part, by the so-called father of QMS, W. Edward Deming who introduced the concept in the 1940s when he was asked by the U.S. Census Bureau to help them redevelop their processes for counting the nation’s population.
Tableman explained how Deming was a proponent of delivering quality upfront in order to reduce defects later in the process. So successful was his work for the Census Bureau, he was sent to Japan after World War Two to help in the efforts to rebuild that ravaged nation. At a gathering of business leaders there, he explained this idea which of course resulted in Japanese businesses taking the lead in everything from cameras to cars. “That’s where I started with clinical QMS,” Tableman added.
QMS is defined as an integrated system through which organizations can systematically plan and achieve quality objectives linked to their broader strategic goals. The system that was previously in place at many pharma firms was unwieldy and created inconsistent results. By building a new framework, Pega and Pfizer were able to improve results. The key was getting stakeholders in the various processes to understand their roles in the overall QMS.
“If every person knows exactly what they are supposed to do,” said Tableman, “they’ll know when to hold the line if something is wrong.” This is an idea that Japanese automakers adopted decades ago, but was only implemented by American firms in the 1980s.
The hope is to increase automation in the testing process to further improve results and eliminate defects. “When you think of automation,” Tableman said, “you should think about building that consistency in the business process and we now have tech platforms to do that. We are partnering with Pega to implement this framework within Pfizer.”