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          FDA NanoDay Symposium 2022 - 10/11/2022News & Events for Human Drugs Symposium
    Event Title
              FDA NanoDay Symposium 2022


                  October 11, 2022

  

    
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      Meeting InformationDate:
          
  


     
           

October 11, 2022   

 
 
        
                                      Time: 
                                      
8:50 AM
    - 3:10 PM
ET

 

  



Topics & Presentations
			SpeakersFDA NanoDay Symposium 2022 Welcome, Keynote and Session 1Welcome
			**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) | FDACMC Guidance for Development of Products that contain Nanomaterials
			**Olen Stephens, PhD***Chemist*
			Office of New Drug Product (ONDP)
			Office of Pharmaceutical Quality (OPQ) CDERNonclinical Perspective on Development of Drug Products Containing Nanomaterials
			**Wimolnut Manheng, PhD***Toxicologist*
			Division of Hematology Oncology Toxicology (DHOT)
			Office of Oncology Drugs (OOD) | CDERSession 1 Question & Answer Discussion Panel
			**Olen Stephens** and **Wimolnut Manheng**FDA NanoDay Symposium 2022 Session 2Development 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) | CDERConsiderations 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 RemarksSafety 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 | CDERSession 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 nanomaterialsINTENDED 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 nanomaterialsFDA 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

                                                                                  Content current as of:
      04/11/2023
         
                   
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