Accelerating Progress: How PDA Drives AI Innovation in Healthcare

About the Author

Andrew Chang, PhD is a multifaceted quality and CMC leader with 28 years of experience in medical product regulation. Chang is the chair for the BioAB at the PDA and a Board of Director for PDA and CASSS-Sharing Science Solutions. In Chang's current role as a Vice President of Quality and Regulatory Compliance, Regulatory Policy and Intelligence and Global Regulatory Affairs at Novo Nordisk, he provides strategic leadership on regulatory and quality related policy, external Affairs, strategic advice and solutions to quality and regulatory-related challenges.

Cristiana Campa currently works at GSK as External CMC Intelligence Lead, with more than 20 years’ experience in Chemistry, Manufacturing and Control (CMC) for biologics research and development. She is actively promoting dialogue across industry and with Regulatory Agencies on several topics, including innovative technologies, specifications setting, stability, accelerated development, and pandemic preparedness. For instance, she has been co-chair, committee member and speaker in several PDA events, co-author of the PDA Technical Report 89, and co- editor of a PDA cross-company book on Quality by Design (QbD). In 2023, she has joined the PDA Board of Directors (cycle 2023-2025), and, since 2024, she is the EFPIA lead in the ICH Expert Working Group for ICH Q6 (specifications) Guideline revision, co-chair of the PDA Vaccine Interest Group, and chair of the Vaccines Europe/ IFPMA CMC Adaptive Pathways team. Since 2025, she is a member of the Vaccines Expert Committee of the US Pharmacopoeia. After her PhD and Post-Doc in Chemistry, she has held several leadership roles including Head of Research Laboratory at Bracco Imaging, Head of Analytical Development at Novartis Vaccines, Head of QbD Integration, and Head of Science and Development Practices, and Global Advisor in Technical R&D at GSK Vaccines.

Peter Makowenskyj, MEng has 20 years of experience in the pharmaceutical and biopharmaceutical industries, focusing on process engineering and facility design. At G-CON Manufacturing since 2016, he has advised on cGMP facility design using prefabricated cleanrooms. He holds a B.S. and M.Eng. degree in Chemical Engineering from Cornell University and is active in the PDA, serving as BioAB vice-chair and co-leading key initiatives in advanced manufacturing and mobile facilities.

Toni Manzano is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platforms for the biotech and pharma industries. Manzano is also co-chair of both the Biomanufacturing IG and the CPV of the future initiative at PDA, an active collaborator in the AI initiative for AFDO and he teaches AI subjects at universities (UAB and OBS). Manzano has written numerous articles in the pharma field and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data in regulated environments in the cloud.

Ben Stevens PhD, is Director of CMC Policy and Advocacy at GSK, with nearly 15 years of experience in drug discovery, regulatory affairs, and policy. Before joining GSK, he was Director of Regulatory Affairs CMC at Alnylam, leading the global clinical CMC development and regulatory submissions for vutrisiran. Earlier, Ben served as a Principal Consultant at PAREXEL and Acting Branch Chief in the FDA’s Office of New Drug Products, where he collaborated with policy groups, CDRH, and USP. He began his career in medicinal chemistry R&D at Pfizer and Merck. Ben’s regulatory CMC expertise spans small molecules, oligonucleotides, biologics, and CGT. He holds a Ph.D. in Chemistry from the University of Pittsburgh and an M.P.H. from Johns Hopkins.

Gert Thurau, PhD, is the Head of Advocacy for Manufacturing Technology and Innovation in the CMC Reg PTR Policy team at Hoffmann-La Roche in Basel, Switzerland. His responsibilities include regulatory advocacy for the adoption of advanced technologies in GMP manufacturing—covering areas such as continuous processing, the use of process models, robotics and artificial intelligence, and novel QC methods. Recently, he has been very active in external policy discussions on topics related to “AI in Manufacturing,” including registration and GMP aspects.

Hugo Ta is Senior Manager of Quality Policy & Advocacy at Gilead Sciences. In this role, he works within Gilead’s global policy, advisory, and intelligence community to navigate the regulatory landscape—particularly in areas related to Quality and CGMP. Hugo also collaborates with internal and external stakeholders across several industry organizations to advance harmonization and innovation. He holds a bachelor's degree in mathematics from the University of California, Berkeley, and has 15 years of experience in the pharmaceutical industry spanning both GMP and GCP roles.

Lisa Wright brings over a decade of experience in the pharmaceutical and biopharmaceutical industries. She has held multiple positions with a primary focus on regulatory affairs and policy. In her current role at Novo Nordisk, Lisa engages with the FDA on regulatory CMC and device issues, advocating for advancements in areas such as advanced manufacturing, platform manufacturing technologies, and combination products. Before joining Novo Nordisk, she worked with several consulting firms, including Booz Allen Hamilton, where she supported clients at both CDER and CDRH within the FDA. Lisa began her career at the National Cancer Institute, conducting nonclinical research on keratinocyte tumorigenesis. She holds a Master of Science in Bioinformatics from Johns Hopkins University and a Bachelor of Science in Biology from the University of Maryland, College Park.