The IMPALA consortium is an engine of practical innovation, assembling expert teams to tackle high-priority challenges in the biopharmaceutical quality domain. These work product teams translate collaboration directly into impact, producing concrete, deployable assets like open-source software, novel methodology frameworks, and definitive guidance for immediate use.
May 2026 - Therapeutic Innovation & Regulatory Science Authors: Kiernan Trevett · Jennifer Emerson · Paula Walker · Timothé Ménard · Mariza Koukounari · Louise Anderson · Heike Barlow · Jamie Bridges · On behalf of the IMPALA (Inter coMPany quALity Analytics) Consortium.
March 2026 – Therapeutic Innovation & Regulatory Science Authors: Pekka Tiikkainen (Bayer), Björn Koneswarakantha (Roche) and Frederik Collin (Boehringer Ingelheim) On behalf of the IMPALA (Inter coMPany quALity Analytics) Consortium
In this episode, we share an important update on IMPALA’s mission, scope, and vision, and how the organization is expanding its focus to meet the demands of a rapidly changing biopharma landscape. While IMPALA was originally centered on advanced analytics, we are now broadening our impact to include a significant digital transformation agenda—advancing both data and digital capabilities across GCP and GVP. Hosted by Jeremy Jones, this episode features a dynamic discussion with Roshan Dsouza, Mike Pelosi, and Megan Selby, exploring the mindset shift underway within IMPALA and what it means for the projects and partnerships driving the future of quality across biotech and biopharma. If you're interested in how our industry is moving beyond traditional models toward digitally enabled, AI-powered, and risk-based quality, this conversation is for you.
In this episode, led by Kiernen Trivett (Roche) we feature around table discussion developed by one of our IMPALA Work Product Teams last year as part of staff development and knowledge sharing on modern R&D Quality practices. We explore how quality can enable key business outcomes by leveraging new technology and data to maximize quality oversight—while providing robust, risk-based assurance to regulatory agencies to support effective decision-making. The discussion highlights the work of the Critical to Quality Assessment Report Work Product Team (CAR WPT), which is driving a fundamental shift in the quality paradigm—moving away from retrospective, time-consuming traditional QA activities toward approaches that accelerate approvals and patient access to innovative therapies.
With the increasing use of Generative AI in the pharmaceutical industry, and the evolving regulations and guidance from various regulatory authorities, IMPALA aims to outline some key principles and guidelines helping the industry to adopt GenAI while assessing the risks and establishing the right controls to ensure safe use.
A change in the Quality paradigm to reduce the burden of retrospective, time-consuming traditional QA activities, and ultimately accelerate approval and patient access to innovative products.
This is a collaborative whitepaper which offers insights and guidance on transforming Quality Assurance (QA) in Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) through the application of advanced analytics.
Real-time Audit Package informed by Data (RAPID) is a data-driven approach that follows a pre-defined methodology to assess processes and identify systemic issues efficiently.
In order to comply with evolving regulation guidelines, pharmaceutical companies are challenged with the resource-intensive process of monitoring and implementing regulatory changes, along with the risk of overlooking critical updates due to human error. This Work Product Team aims to use AI technology to streamline how regulatory updates are handled.
Accurate and timely reporting of adverse events (AEs) in clinical trials is crucial to ensuring data integrity and patient safety. However, AE under-reporting remains a challenge, often highlighted in Good Clinical Practice (GCP) audits and inspections. Traditional detection methods, such as on-site investigator audits via manual source data verification (SDV), have limitations. To address this, we aim to develop an analytics approach that can facilitate rapid, comprehensive, and near-real-time detection of AE under-reporting and over-reporting at each clinical trial site.
To maintain high-quality data in clinical trials, it is crucial to be able to detect systematic anomalies in time series data at the site and subject level, which often stem from protocol misinterpretation or device miscalibration. Traditional approaches can be slow and resource intensive. We therefore aim to develop an analytics approach that can be run with minimal effort and with a high degree of reliability.
New workstream focused on leveraging Generative AI (GenAI) to support the drafting of audit findings . This initiative is part of a broader shift from exploratory discussions to structured implementation of GenAI in quality assurance.
To support Good Clinical Practice (GCP) and ensure clinical trial quality and integrity, sponsors need to conduct investigator site audits. However, due to resource constraints, it is not possible to audit every site in a clinical trial, and those that are selected for audits need to be selected based on a variety of risk factors. To improve audit site selection efficiency and accuracy, a shift towards data-driven is needed.
In this episode, Jeremy is joined by new members of the IMPALA Consortium: Meera Nagaria, Senior Data Scientist at J&J; Lucie Régné Martos, Clinical Quality Performance & Risk Management Head at Sanofi; Cedric Liu, Associate Director, AI/ML at Biogen; CJ Jassal, Head of Quality and Governance at Biogen; and Deepak Bandyopadhyay, Data Science Group Leader at J&J. Tune in and listen as they discuss the shift towards data-driven clinical audit site selection, the challenges in implementing these strategies, innovations in current practices, and how the IMPALA Consortium is advancing data-driven methodologies in clinical trial site selection.
In this episode, Sharon and Jeremy are joined by Ryan Dugan, Associate Director, Analytics & Insights, MRL QA at Merck. Join us as we explore the world of Artificial Intelligence (AI) and its fascinating subset, Generative AI. We also discuss the sudden surge of interest and advancements in Generative AI over the past year, attributing it to its promising applications in healthcare and touch upon the ethical considerations that come with using this technology. We then shift our focus to the impact of Generative AI on the Pharma QA space where Ryan shares some examples of its applications at Merck. Tune in to gain a deeper understanding of Generative AI and its implications in the Healthcare Industry!
In this episode, Sharon and Jeremy are joined by Pekka Tiikkainen, Lead of IMPALA’s Work Product Package on Anomaly Detection in Clinical Data, as well as Data Scientists Björn Koneswarakantha and Frederik Collin. Together, they discuss their individual journeys into the field of Data Science and provide insights into how this area has evolved over time. Furthermore, we will delve into the future of Data Science, exploring the possibilities and potential it holds.
April 2024 – Therapeutic Innovation & Regulatory Science. Authors: Björn Koneswarakantha, Ronojit Adyanthaya, Jennifer Emerson, Frederik Collin, Annett Keller, Michaela Mattheus, Ioannis Spyroglou, Sandra Donevska & Timothé Ménard On behalf of the IMPALA (Inter coMPany quALity Analytics) Consortium
In this episode Sharon and Jeremy are joined by Mike Pelosi, Co-Chair of IMPALA’s Strategic Steering Committee and Roshan D’Souza, Chair of IMPALA and Member of the Education Work Product Team. Listen as they take it back to the basics and answer fundamental questions such as: What exactly do we mean by Data? How are we using Data we are generating? Has data replaced Oil as the most valuable resource in the world?
In this episode Sharon and Jeremy are joined by Mike Pelosi, Co-Chair of IMPALA’s Strategic Steering Committee and Co-Lead of the Education Work Product Team, Joanna North, Co-Lead of the Education Work Product Team and Roshan D’Souza, Member of the Education Work Product Team. Listen as they delve into the industry-leading initiatives of the IMPALA Education Work Product Team and learn about what’s key to becoming a Data-Driven Quality Professional in the dynamic world of biopharma.
In this episode Sharon and Jeremy are joined by Timothe Menard, Co-Founder of IMPALA and Mike Pelosi, Co-Chair of IMPALA’s Strategic Steering Committee and Co-Lead of the Education Work Product Team. Listen as we discuss what IMPALA is and what they are trying to achieve. You’ll also get the chance to hear more about the current IMPALA work products, Tim and Mike’s vision for the future of IMPALA before they wrap up with how you can get involved!
Launched back on the 21st April 2021, Roche and the Research Quality Association partnered together in a new industry collaboration to bring its members the Certificate in Data Basics eLearning course, which is part of Roche’s Data Analytics University.
April 2024 – Therapeutic Innovation & Regulatory Science. Authors: Björn Koneswarakantha, Ronojit Adyanthaya, Jennifer Emerson, Frederik Collin, Annett Keller, Michaela Mattheus, Ioannis Spyroglou, Sandra Donevska & Timothé Ménard On behalf of the IMPALA (Inter coMPany quALity Analytics) Consortium
Quality functions from pharmaceutical sponsor companies aim to increase the use of analytics in their oversight of Good Clinical Practices and Pharmacovigilance activities. To leverage and accelerate progress, several companies decided to establish a collaborative model.