In the first few months since its launch, the Inter coMPany quALity Analytics (IMPALA) Consortium welcomes its newest BioPharma members: Amgen, AstraZeneca, Eli Lilly and Company, GSK, Galapagos, and Sanofi. IMPALA officially launched in October 2022 as a member program of IEEE-ISTO with a mission to transform the Biopharmaceutical Clinical Quality Assurance (QA) process in the Good Clinical Practice and Good Pharmacovigilance Practice areas, by using advanced analytics and promoting the adoption of this new approach and associated methodologies by key industry stakeholders to assure safe use, therefore building patient trust, accelerating approvals and ultimately benefiting patients globally.
The IMPALA Consortium was initially established in 2019 as an informal group of biopharmaceutical organizations with the common goal to share knowledge and better understand opportunities in applying advanced analytics for QA. Via it’s official launch, the Consortium is able to provide a strategic focus for working across the Biopharmaceutical ecosystem to develop and gain industry-wide consensus for the adoption of improved QA using advanced analytics and best practices to be used across the industry. IMPALA Consortium has generated interest through its features in various industry presentations and conferences, including RQA sessions, DIA, and the APEC Roundtable.
“I have recently been challenged to ensure that our teams are utilizing a data driven approach to quality assurance and risk management; leveraging data to work smarter and more efficiently. We are exploring how to leverage data and analytics to predict and have real time insight into quality issues so that we can be more efficient and effective in all aspects of our work within quality” comments Maria Brynildsen, Senior Director, Clinical Quality Performance, Sanofi. “After hearing a presentation on the IMPALA Consortium, I was very excited to be part of it as I knew immediately that we would be able to contribute to their goals while also benefiting from the experience and work that has been accomplished to date. I look forward to collaborating on the groundbreaking needs to advance data driven quality management within our company and the industry as a whole.”
Work Product Teams include Audit Site Selection, Anomaly Detection in Clinical Data, Anomaly Detection in Audit Trails, Quality Briefs, and Education. These Work Product Teams consist of experts from various member companies who collaborate under the Consortium’s anti-trust guidelines to solve issues faced in the industry. Completed Work Products include an Open-Source Package for Clinical Safety reporting and an RQA Workshop on Data Analytics.
The IMPALA Consortium welcomes biopharmaceutical companies to apply as BioPharma Sponsor members. New members have the opportunity to partake in the shift of the quality assurance paradigm in the biopharmaceutical industry, alongside other leading biopharmaceutical organizations such as Founding Members: Astellas, Bayer, Biogen, Boehringer Ingleheim, Bristol Myers Squibb, Johnson & Johnson, Merck KGaA, Merck & Co., Novartis, Pfizer, and Roche. For more information, visit the IMPALA membership page, or email membership@impala-consortium.org.
