FDA NanoDay Symposium 2022 October 11, 2022

Symposium | Virtual

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• Date: October 11, 2022
• Time: 8:50 AM - 3:10 PM ET

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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

• GUIDANCE DOCUMENT: Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry; APRIL 2022
• GUIDANCE DOCUMENT: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology - Guidance for Industry; JUNE 2014
• GUIDANCE DOCUMENT: Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; APRIL 2018
• GUIDANCE DOCUMENT: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products - Guidance for Industry; NOVEMBER 1995