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Symposium | Virtual

Event Title
FDA NanoDay Symposium 2022
October 11, 2022

Date:
October 11, 2022
Time:
8:50 a.m. - 3:10 p.m. ET

 

Topics & Presentations

Speakers

FDA NanoDay Symposium 2022 Welcome, Keynote and Session 1

 

Welcome

Anil Patri, PhD
FDA Nanocore Director
Office of Scientific Coordination (OSC)
National Center for Toxicological Research (NCTR)

 

Keynote

Douglas Throckmorton, MD
Deputy Director for Regulatory Programs
Center for Drug Evaluation and Research (CDER) | FDA

CMC Guidance for Development of Products that contain Nanomaterials

Olen Stephens, PhD
Chemist
Office of New Drug Product (ONDP)
Office of Pharmaceutical Quality (OPQ) CDER

Nonclinical Perspective on Development of Drug Products Containing Nanomaterials

Wimolnut Manheng, PhD
Toxicologist
Division of Hematology Oncology Toxicology (DHOT)
Office of Oncology Drugs (OOD) | CDER

Session 1 Question & Answer Discussion Panel

Olen Stephens and Wimolnut Manheng

FDA NanoDay Symposium 2022 Session 2

 

Development and Characterization of Generic Drug Products Containing Nanomaterials

Darby Kozak, PhD
Deputy Division Director
Division of Therapeutic Performance 1 (DTPI)
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD) | CDER

Considerations for the Quality, Safety and Efficacy of Prophylactic Lipid Nanoparticle mRNA Vaccines

Keith Peden
Microbiologist
Division of Viral Products
Office of Vaccines Research and Review (OVRR)
Center for Biologics Evaluation & Research (CBER)

Session 2 Question & Answer Discussion Panel

Darby Kozak and Keith Peden

FDA NanoDay Symposium 2022 Session 3 & Closing Remarks

 

Safety Evaluation of Food Contact Substances Containing Nanomaterials

Raymond Brinas
Division of Food Contact Substances
Office of Food Safety and Applied Nutrition (OFSAN)
Center for Food Safety and Applied Nutrition (CFSAN)

Nanomaterial Standards Development at FDA

Anil Patri, PhD
FDA Nanocore Director
OSC | NCTR

Jiwen Zheng, PhD
Division of Health Technology 2 C
Office of Health Technology 2
Center for Devices and Radiological Health (CDRH)

Future of Continuous Manufacturing of Drug Products Containing Nanomaterials

Xiaoming Xu, PhD
Office of Testing and Research (OTR)
OPQ | CDER

Session 3 Q&A Panel Discussion

Raymond Brinas, Anil Patri, Jiwen Zheng, and Xiaoming Xu

Symposium Closing

Olen Stephens

 

Agenda

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ABOUT THIS EVENT

This symposium will address drug development of products that contain nanomaterials in their formulation and how the newly finalized guidance to industry for products that contain nanomaterials can be implemented in filings to the FDA. FDA speakers will present reviewer perspectives on drug development and laboratory efforts to facilitate further understanding of challenges to manufacture products that contain nanomaterials. Two additional speakers will address safety evaluations of food contact substances that contain nanomaterials and the development of standard materials and methods for nanomaterials.

  • FDA will discuss the primary Chemistry Manufacturing and Controls (CMC) and nonclinical hurdles for developing products that contain nanomaterials.
  • FDA will provide case studies on the development of the COVID mRNA lipid nanoparticle vaccine products.
  • FDA will present efforts to establish standards and standard methods for monitoring products that contain nanomaterials

INTENDED AUDIENCE

  • Regulatory science and regulatory affairs professionals working on drug products, including biologicals, that contain nanomaterials and submit IND/NDA/BLA/ANDA applications for FDA review.
  • Researchers working on applications of nanotechnology for pharmaceutical products, analytical methodology for control of pharmaceuticals that contain nanomaterials, and nonclinical studies to support human clinical trials.
  • Foreign regulators who review comparable pharmaceutical products that contain nanomaterials.

TOPICS COVERED

  • An overview and discussion of the recently finalized “Guidance to Industry: Drug Products, Including Biological Products, that Contain Nanomaterials”
  • A contextualized discussion of the development of the COVID mRNA lipid nanoparticle vaccine products
  • A nonclinical perspective of developmental challenges of products that contain nanomaterials
  • The development of regulatory standards and methods for controlling products that contain nanomaterials

FDA RESOURCES

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