How AI Is Moving from Concept to Practical Use in Biopharma: A Q&A with Novavax's Kate Malachowski and Takeda's Malav Parikh

At PDA Week 2026, held in March, discussions increasingly centered on how digital tools are being applied in real manufacturing and quality environments. PDA Week 2026 Co-Chairs 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, reflect on a meeting focused on implementation, risk, and operational learning in an interview with BioPharm International®.

They note how discussions on the exhibit floor increasingly focused on implementation rather than concept. Conversations centered on how AI and digital quality tools are being used in good manufacturing practice (GMP) environments, how platforms perform in practice, and what it takes to scale them.

The discussions this year also consistently reflected an awareness that behind manufacturing data and operational decisions are real patients impacted by product quality and supply.

BioPharm: What were the most important themes and scientific highlights at PDA Week 2026?

Parikh (Takeda): This year felt notably balanced between science and practical execution. A standout for me was a session I moderated on smart supply chains, where predictive insights and digital modeling were being used to strengthen transportation robustness and support product integrity. What stood out was the movement from theoretical discussion toward application, with data and modeling increasingly used to manage real-world distribution risk.

Another highlight was the opening plenary, where a NASA speaker discussed knowledge management. The focus was on retaining institutional knowledge and strengthening decision-making frameworks alongside technical advances.

Dr. Malachowski (Novavax): For me, the defining thread was AI, but in a practical sense. The conversation has moved beyond “what is AI?” toward how it is being used in regulated environments, with several examples shared by attendees.

What do these trends say about where the industry is headed and PDA Week’s role in it?

Dr. Malachowski (Novavax): This year marked PDA’s 80th anniversary, which led to reflection on its history and role. But there was also clear focus on forward-looking topics. One consistent theme was the importance of the human dimension of quality systems. While technology is advancing quickly, people, judgment, and organizational culture remain central to how these systems are applied in practice.

Parikh (Takeda): The conversations around AI consistently included both opportunity and risk—how to use new tools while maintaining control in a regulated environment.

More broadly, there is a shift toward using data, digital systems, and operational insights to identify issues earlier, rather than relying only on reactive approaches such as deviations and CAPAs [corrective and preventive actions].

There is also increasing emphasis on connecting functions, like quality, manufacturing, digital, regulatory, and supply chain, so that decisions can be better informed and more aligned with patient outcomes.

What stood out on the conference floor, and how did it compare to previous years?

Parikh (Takeda): AI came up in nearly every conversation, but the tone was different from previous years. It was less about exploration and more about implementation. People were asking what others have already done, what has worked, and what measurable benefits have been achieved in GMP settings.

In the exhibit hall, the same pattern was evident. Vendors were not only presenting concepts but also real use cases in areas such as sterility assurance, packaging robustness, and fill/finish readiness.

Overall, conversations were more focused on what is working in practice, rather than whether the technology is possible.

Dr. Malachowski (Novavax): One of the most memorable moments for me was moderating a plenary on women’s health, health equity, and diversity in clinical trials. The response afterward was very personal. Attendees shared that they intended to bring the information back to family members or look into clinical trial eligibility for relatives.

The discussion clearly resonated beyond the professional setting and connected to personal experiences.

How is global uncertainty shaping the industry, and how may this impact PDA Week moving forward?

Parikh (Takeda): Global uncertainty has reinforced the importance of resilient supply chains and regulatory alignment. Many attendees have experienced recent disruptions, which has increased focus on preparedness, transparency, and cross-border collaboration.

In this context, PDA serves as a neutral, science-based forum where industry, regulators, and researchers can share experiences and learn from one another. That role becomes especially important when considering risks related to patient supply and product integrity.

How do you expect PDA Week to evolve as the industry changes?

Dr. Malachowski (Novavax): We will continue to see growth in applied AI, along with broader adoption of digitalization, automation, and advanced manufacturing approaches. These developments will continue to raise parallel needs in compliance, validation, and quality risk management.

A consistent theme is that future progress will depend not just on individual technologies, but on how well systems integrate across quality, manufacturing, and regulatory functions.

Parikh (Takeda): PDA Week brings together different parts of the industry—manufacturing, science, quality, digital, and regulatory—in a single forum. It reflects how interconnected these areas are in practice.

This year also highlighted engagement across experience levels, with early-career professionals, senior leaders, regulators, and vendors participating together. The emphasis remains on shared learning and alignment across the ecosystem.