What PDA Week 2026 Reveals About the Future of Applied AI in Bio/Pharmaceutical Quality

In the second half of an interview with BioPharm International®, PDA Week 2026 Co-Chairs Kate Malachowski, PhD, director of Manufacturing Science and Technology, Novavax, and Malav Parikh, director of Quality Risk Management, Global Quality Compliance and Systems, Takeda, continue their recap of this year’s event, which was held in Denver, Colo., on March 22-27. The two emphasize how industry leaders described a clear shift in how artificial intelligence (AI) and digital technologies are being discussed and deployed across bio/pharmaceutical manufacturing and quality functions.

Parikh notes that interest in AI continued to dominate conversations at the conference, but with a more practical lens than in prior years. Exhibit hall discussions focused on day-to-day manufacturing and quality challenges, including sterility assurance, packaging robustness, and finished product readiness, he describes. Meanwhile, vendors emphasized real good manufacturing practice use cases rather than conceptual pilots.

“We spoke about some of these already, but AI, again, absolutely everyone wants to talk about AI,” says Parikh, contrasting this year’s implementation focus with the more exploratory tone of previous PDA Week events.

How is applied AI transforming bio/pharma manufacturing and quality?

Dr. Malachowski, who moderated the second plenary session, highlights the intersection of technology, health equity, and human impact. The second plenary session addressed women’s health, health equity, and diversity in clinical trials, which she notes resonated deeply with attendees on a personal level as well as a professional one. She reports that many participants planned to share the plenary’s messages with family members and explore resources such as Clinicaltrials.gov for potential trial opportunities.

“I think we’re going to see a lot more applied AI,” Dr. Malachowski stresses, adding that digitalization, dark manufacturing, and automation will continue to expand alongside related concerns in compliance, regulation, and quality risk management.

Parikh describes PDA Week as a “homecoming” that integrates manufacturing, science, quality, AI, and digitalization while bringing together early-career professionals, senior leaders, regulators, and vendors. Both co-chairs emphasize that the event’s collaborative environment is intended to keep the industry aligned and prepared to address evolving technological and regulatory challenges.

You can watch the first half of their PDA Week recap interview here.

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.