PDA Week 2026 Showcased AI, Knowledge Management, and Proactive Quality Culture

At PDA Week 2026, held in Denver, Colo., on March 22-27, leaders from across the bio/pharmaceutical industry stressed how science, data, and human judgment are converging to reshape manufacturing and quality, according to Kate Malachowski, PhD, director of Manufacturing Science and Technology at Novavax, and Malav Parikh, director of Quality Risk Management, Global Quality Compliance and Systems, at Takeda in an interview with BioPharm International®. Dr. Malachowski and Parikh are the co-chairs of PDA Week 2026.

Dr. Malachowski, who has been a long-time member of the Parenteral Drug Association’s (PDA) planning committee, highlighted how the meeting reflected the organization’s 80-year legacy while pushing the industry forward. “One of the elements I saw {at PDA Week] was AI, but applied to our industry,” she says. “We've moved beyond just, what is AI? How does it work? And there were multiple instances of AI actually being utilized by the attendees that were at the conference.”

Sessions ranged from smart supply chains, for example, using predictive insights and digital defense to protect product integrity, to knowledge management lessons from NASA on retaining critical expertise and strengthening decision frameworks, Parikh notes.

How is AI reshaping quality and risk management in the industry?

As Dr. Malachowski emphasizes, a defining feature of this year’s event was the shift from “what is AI?” to real-world deployment in regulated environments, with attendees actively using AI tools and exploring compliant implementation.

Parikh highlights how digitalization and AI are transforming compliance from reactive to proactive. “From a compliance perspective, organizations are moving beyond that reactive compliance [of] focusing on CAPAs [corrective and preventive actions] and deviations and how do we tackle those … to more on how do we use science data, digital advancement, and any operational Insights to anticipate … issues earlier and make those better informed decisions?” he explains.

Through Parikh’s and Dr. Malachowski’s perspectives PDA Week is positioned as a catalyst for translating advanced science and AI into robust, patient-centric bio/pharmaceutical operations.

About the speakers

Kate Malachowski, PhD, Director, Manufacturing Science and Technology, Novavax, and PDA Week 2026 Co-Chair

In her role, Dr. Malachowski leads a team of scientists and engineers to support Novavax's global vaccine pipeline. Her team has oversight of tech transfers, non-conformance investigations, and manufacturing performance trending. She has also previously worked at Catalent supporting gene therapy projects and with the BioPhorum Extractables and Leachables work group. Dr. Malachowski previously served on the 2023 and 2024 PDA Annual Meeting Planning Committee and as the 2025 PDA Week co-chair. Before entering the biotech space, she worked in microscale medical and semiconductor devices at the Army Research Laboratory and Northrop Grumman. Dr. Malachowski holds a bachelor's degree in Chemical Engineering from Virginia Tech and a PhD in Chemical and Biomolecular Engineering from The Johns Hopkins University.

Malav Parikh, Director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, and PDA Week 2026 Co-Chair

In his current global role, Parikh is focused on implementing a harmonized and sustainable quality risk management (QRM) program embedded within the Quality Management System, including creating risk management procedures, tools, training, and workflows and consultation for risk-based strategies and assessments. Parikh has a graduate degree in mechanical engineering and has been involved in various areas within the pharmaceutical, biotech, and medical device domains, including new product introduction, supplier management, quality engineering, process validation and quality compliance/systems. Parikh is an active member of the Parenteral Drug Association (PDA) and has served on multiple committees. He is currently the co-lead for the PDA Quality Risk Management Interest Group.