IEEE-ISTO today announces the formation of its newest member program, the IMPALA Consortium.

The Inter coMPany quALity Analytics (IMPALA) Consortium’s mission is 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 (e.g., pharma quality professionals, Health Authorities) to assure safe use, therefore building patient trust, accelerating approvals and ultimately benefiting patients globally.

“Data and technology are at the forefront of every industry today,” says Board Director Peter Alain, VP Head of Clinical Quality Assurance at Astellas. “We have a tremendous opportunity with the IMPALA Consortium to collaborate and incorporate advanced analytics capabilities to drive innovation and advancement of Quality Assurance across the pharmaceutical industry.”

The Consortium will contribute to a change in paradigm for QA, where co-developed advanced analytics and best practices can help detect and mitigate issues faster, reduce the burden of retrospective, time-consuming traditional QA activities, leading to improved patient outcomes and quality care at greater efficiency and greater speed.

“IMPALA firmly holds patients in the center of its collective efforts and helps accelerate new medicines to those who need it most,” states Michael Torok, VP, Quality Assurance Programs, Roche. “When you really think about the level of impact this work has in the lives of our friends and family members struggling with disease, it’s hard not to fall a little bit in love with IMPALA’s potential and building momentum!”

“One of the key advantages of the IMPALA consortium is the health authority engagement,” adds Board Director Peter Alain. “If the health authorities see that as an industry, we are doing things such as identifying risk and where to audit in the same way, we have an opportunity to have a valuable impact on the patients we serve.”

Initially established in July 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, the IMPALA Consortium provides the 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.

IEEE-ISTO President Adam Newman states “IEEE-ISTO welcomes the IMPALA Consortium as a new member program of IEEE-ISTO Federation of Programs. IEEE-ISTO looks forward to supporting the important work of the Consortium’s mission to transform the biopharmaceutical QA process.”

The IMPALA Consortium currently consists of biopharmaceutical Founding Member Organizations, with representatives from the organizations spanning the Board of Directors, Steering Committee, and six Work Product Teams working on focused projects to advance the Consortium’s objectives. Founding Members include Astellas, Bayer, Biogen, Boehringer Ingleheim, Bristol Myers Squibb, Johnson & Johnson, Merck KGaA, Merck & Co., Novartis, Pfizer, and Roche.