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Topics & Presentations	Speakers
2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials - Part 1
Welcome	Anil Patri, PhD FDA Nanocore Director Office of Scientific Coordination (OSC) National Center for Toxicological Research (NCTR)
Opening Remarks	Namandjé N. Bumpus, PhD FDA Chief Scientist Office of the Chief Scientist (OCS) Office of the Commissioner (OC) | FDA
Nanotechnology Meets Continuous Manufacturing: Learning from the Future.pdf	Xiaoming Xu, PhD Division Director Office of Testing and Research (OTR) Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) | FDA
CDER’s Perspective on the Continuous Manufacturing Journey: Past, Present, and Future.pdf	Thomas O’Connor, PhD Deputy Office Director OTR | OPQ | CDER
Continuous Manufacturing Platform for Lipid and Polymer-based Nanoparticle Therapeutics.pdf	Antonio Costa, PhD Assistant Research Professor University of Connecticut
2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials - Part 2
An Integrated Platform for Continuous RNA Nanoparticle Formulation and Drying.pdf	Kurt Ristroph, PhD Assistant Professor Agricultural and Biological Engineering Purdue University
Q&A Discussion Panel	Kurt Ristroph And Thomas O’Connor, PhD Deputy Office Director OTR | OPQ | CDER | FDA Antonio Costa, PhD Assistant Research Professor University of Connecticut Xiaoming Xu, PhD Division Director OTR | OPQ | CDER | FDA
2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials - Part 3
Quality Considerations and Controls for Drug Products Containing Nanomaterials – Where are We and How We Get Here.pdf	Hailing Zhang, PhD Branch Chief Office of Lifecycle Drug Products (OLDP) OPQ | CDER | FDA
Advanced Separations and Detection in Assessment of Quality for Drug Products Containing Nanomaterials.pdf	William Smith, PhD Research Scientist OTR | OPQ | CDER | FDA
Regulatory Science Programs and Outreach.pdf	Tina Morrison, PhD Director Office of Regulatory Science and Innovation (ORSI) OCS | OC | FDA
Q&A Discussion Panel	Hailing Zhang, William Smith, Tina Morrison, Anil Patri And Olen Stephens, PhD Chemist Office of New Drug Product (ONDP) OPQ |CDER | FDA
Symposium Closing	Olen Stephens

 

AGENDA

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ABOUT THIS EVENT

In this symposium, FDA will provide an overview of CDER experience with approving several solid oral drug products which benefited from the continuous manufacturing technologies. We will also provide case-studies of intramural and extramural research in the areas of nanomaterials and continuous manufacturing, to further encourage the innovation and adoption of continuous manufacturing. Lastly, we will discuss ways in which industry, academia and other regulatory agencies can collaborate and engage with FDA in advancing the field of nanotechnology and continuous manufacturing.

INTENDED AUDIENCE

• Regulatory science and regulatory affairs professionals working on IND/NDA/BLA/ANDA etc.
• Researchers working on nanomaterials, drug delivery system, gene delivery systems, liposomes, lipid nanoparticles, biologics or continuous manufacturing
• Consultants focused on early- and late- stage product development and manufacturing
• Foreign regulators

TOPICS COVERED

• CDER experience in approving solid oral drug products utilizing continuous manufacturing
• FDA extramural research on various types of continuous manufacturing technologies for liposomes and lipid nanoparticles
• FDA intramural research on characterization of drug products containing nanomaterials
• Regulatory considerations on nanomaterial drug products
• Ways to engage with FDA on regulatory science research

FDA RESOURCES

• Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry.
• Q13 Continuous Manufacturing of Drug Substances and Drug Products.
• FDA Emerging Technology Program.
• Adam F et al. An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US. International Journal of Pharmaceutics, (2022), 622, 121778.