Anil Patri Ph.D.

Director, Nanotechnology Core Facility — Office of Scientific Coordination

Anil Patri, Ph.D.
(870) 543-7121
NCTRResearch@fda.hhs.gov

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Background

Dr. Anil Patri began working in the nanotechnology field with the synthesis of dendritic nanomaterial and their application in targeted drug delivery and imaging for cancer before broadening his portfolio to various kinds of nanomaterial and applications. He joined FDA’s National Center for Toxicological Research (NCTR) in 2014 and serves as the Director of Nanocore and appointed chair of the Nanotechnology Task Force in the FDA Office of the Commissioner/Office of the Chief Scientist. He serves on the Nanoscale Science, Engineering, and Technology subcommittee and the Nanotechnology Environmental and Health Implications working group for inter-agency coordination on behalf of the FDA. Dr. Patri also serves as co-chair of the US-EU Communities of Research on Characterization. He is a member of the American Society for Testing and Materials (ASTM) International E56, ISO TC 229, and the Organisation for Economic Co-operation and Development’s Working Party on Manufactured Nanomaterials and facilitates standards development relevant to FDA.

Prior to joining FDA, Dr. Patri served as the Deputy Director of the National Cancer Institute’s Nanotechnology Characterization Laboratory. In a decade-long tenure, he oversaw translation and pre-clinical assessment of promising cancer nanomedicines with proof-of-principle efficacy for cancer with a multidisciplinary research team, resulting in many products in clinical trials. Dr. Patri was a guest researcher at the National Institute of Standards and Technology (NIST) and co-led the development of the first “Nanosized Gold Reference Material Standards" with NIST collaborators. He served at the University of Michigan, Center for Biologic Nanotechnology and he earned a Ph.D. degree in chemistry from the University of South Florida.

Research Interests

Dr. Patri’s group conducts regulatory-science research with a focus on nanomaterial characterization, structure activity, and stability studies that help to determine the nanomaterial’s impact on safety and efficacy. Dr. Patri and his laboratory members are pursuing collaborative consensus standards development that can help regulatory agencies and industry, supported by the National Toxicology Program.

The Nanocore was established as an FDA collaborative resource between NCTR, the Office of Regulatory Affairs (ORA), and the National Toxicology Program. Nanocore staff members from both NCTR and ORA along with FDA’s Center for Drug Evaluation and Research and Center for Devices and Radiological Health scientists provide hands-on training for reviewers from FDA product centers sponsored by the Nanotechnology Task Force. The labs are well-equipped with extensive state-of-the-art instrumentation for nanomaterial physico-chemical, in vitro, and in vivo assessment, including:

Scanning and Transmission Electron Microscopes equipped with Energy-Dispersive X-ray Spectroscopy detectors
Specialized Field-Emission Scanning Electron Microscope with 3-View capability
Low Voltage Electron Microscope
Atomic Force Microscopes
Optical, Confocal Raman, and Hyperspectral Imaging instruments
UV-Visible Spectrophotometry (UV-Vis), Fourier Transform Infrared (FTIR), Fluorescence, Raman spectroscopy
Nanoparticle Tracking Analysis
Dynamic, Static and X-ray Scattering instruments
High Performance Liquid Chromatography with UV-Vis, Fluorescence, Charged Aerosol Detector, and Evaporative Light Scattering Detector
Ultra-High Performance Liquid Chromatography with Mass Spectrometry
Asymmetric, Centrifugal Field Flow Fractionation instruments with multi-angle laser light scattering, dynamic light scattering and refractive index
Inductively Coupled Plasma Mass Spectrometry
Thermogravimetric Analyzer with Differential Scanning Calorimetry
Hyphenated Thermogravimetric Analyzer with FTIR-Gas Chromatography-Mass Spectrometry
Quartz Crystal Microbalance
96-well plate readers
Ultrasound imaging for animal studies

Current Major Collaborative Projects include:

Standards development for nanomaterial characterization and in vitro assessment
Liposomal drug products characterization, in vitro and in vivo assessment
Physico-chemical attributes of nanomaterial and their influence on radiation enhancement
Physiologically based pharmacokinetic analysis of liposomal drug formulations
Assessment of nanomaterial in feminine-hygiene products
Detection, identification, characterization, and quantitation of various attributes of nanomaterial in pristine state and in complex matrices
Investigation of nanomaterial in sunscreens
Biodistribution of gadolinium imaging agents
Genotoxicity of nanomaterial
Nanomaterial in dental composites and their effects on microbiota
Nanoparticle permeability through the gastrointestinal surface
Epigenetic effects of nanomaterial

Professional Societies/National and International Groups

Global Summits on Regulatory Science
Co-Chair
2016, 2019

Indo-US Science and Technology Forum
Emerging Material and Manufacturing Working Group Member
2016 – 2018

International Congress on Nanobiomedicine
Scientific Advisory Committee Member
2009 – 2018

Nanotechnology Environmental and Health Implications Interagency Working Group
FDA Representative and Member
2015 – Present

Nanotechnology Working Group, Global Coalition for Regulatory Science Research (GCRSR)
Co-Chair
2015 – Current

National Academy of Science, Engineering and Medicine Workshop on Emerging Technologies to Advance Research and Decisions on the Environmental Health Effects of Microplastics
Organizing Committee Member
2020

National Nanotechnology Initiative
Nanoscale Science, Engineering, and Technology Subcommittee FDA Representative and Member
2015 – Present

US-EU Communities of Research for Nanomaterial Characterization
Co-Chair
2015 – Present

Wiley’s WIREs Nanomedicine and Nanobiotechnology
Associate Editor
2013 – 2018

Select Publications

Optimization of Detection of Gadodiamide Brain Retention in Rats Using Quantitative T 2 Mapping and Intraperitoneal Administration.
Liachenko S.M., Sadovova N.V., Tripp A., Ghorai S., Patri A.K., Hanig J.P., Cohen J.E., and Krefting I.
J Magn Reson Imaging. 2022, doi: 10.1002/jmri.28149. Online ahead of print.

Regulatory Landscape of Nanotechnology and Nanoplastics From a Global Perspective.
Allan J., Belz S., Hoeveler A., Hugas M., Okuda H., Patri A., Rauscher H., Silva P., Slikker W., Sokull-Kluettgen B., Tong W.D., and Anklam E.
Regul Tox Pharmacol. 2021, 122, 104885.

Effect of Titanium Dioxide Nanoparticles on DNA Methylation in Multiple Human Cell Lines.
Pogribna M., Koonce N.A., Mathew A., Word B., Patri A.K., Lyn-Cook B., and Hammons G.
Nanotoxicology. 2020, 14, 4, 534-553.

Comparative Evaluation of US Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Physicochemical Characterization.
Su D.J., Rouse R., Patel V., Wu Y., Zheng J.W., Karmakar A., Patri A.K., Chitranshi P., Keire D., Ma J., and Jiang W.L.
Nanomaterials. 2018, 8, 1, 25.

Investigating the Susceptibility of Mice to a Bacterial Challenge After Intravenous Exposure to Durable Nanoparticles.
Khan S., Zhang Q., Marasa B.S., Sung K., Cerniglia C.E., Ingle T., Jones M.Y., Paredes A.M., Tobin G.A., Bancos S., Weaver J.L., Goering P.L., Howard P.C., Patri A.K., and Tyner K.M.
Nanomedicine. 2017, 12, 17, 2097-2111.

Repetitive Application of Sunscreen Containing Titanium Dioxide Nanoparticles on Human Skin.
Coelho S.G., Patri A.K., Wokovich A.M., McNeil S.E., Howard P.C., and Miller S.A.
JAMA Dermatol. 2016, 152(4):470-2.

Protein Corona Composition Does Not Accurately Predict Hematocompatibility of Colloidal Gold Nanoparticles.
Dobrovolskaia M.A., Neun B.W., Man S., Ye X., Hansen M., Patri A.K., Crist R.M., and McNeil S.E.
Nanomedicine. 2014, 10(7):1453-63. doi: 10.1016/j.nano.2014.01.009.

Commensal Bacteria Control Cancer Response to Therapy by Modulating the Tumor Microenvironment.
Iida N., Dzutsev A., Stewart C.A., Smith L., Bouladoux N., Weingarten R.A., Molina D.A., Salcedo R., Back T., Cramer S., Dai R.M., Kiu H., Cardone M., Naik S., Patri A.K., Wang E., Marincola F.M., Frank K.M., Belkaid Y., Trinchieri G., and Goldszmid R.S.
Science. 2013, 342(6161):967-70.

Common Pitfalls in Nanotechnology: Lessons Learned from NCI's Nanotechnology Characterization Laboratory.
Crist R.M., Grossman J.H., Patri A.K., Stern S.T., Dobrovolskaia M.A., Adiseshaiah P.P., Clogston J.D., and McNeil S.E.
Integr Biol (Camb). 2013, 5(1):66-73.

Challenges and Opportunities in the Advancement of Nanomedicines.
Wei A., Mehtala J.G., and Patri A.K.
J Control Release. 2012, 164(2):236-46.

Best Practices in Cancer Nanotechnology: Perspective from NCI Nanotechnology Alliance.
Zamboni W.C., Torchilin V., Patri A.K., Hrkach J., Stern S., Lee R., Nel A., Panaro N.J., and Grodzinski P.
Clin Cancer Res. 2012, 18(12):3229-41.

Nanoparticle Size and Surface Charge Determine Effects of PAMAM Dendrimers on Human Platelets In Vitro.
Dobrovolskaia M.A., Patri A.K., Simak J., Hall J.B., Semberova J., De Paoli Lacerda S.H., and McNeil S.E.
Mol Pharm. 2012, 9(3):382-93. doi: 10.1021/mp200463e.

Dendrimer-Induced Leukocyte Procoagulant Activity Depends on Particle Size and Surface Charge.
Dobrovolskaia M.A., Patri A.K., Potter T.M., Rodriguez J.C., Hall J.B., and McNeil S.E.
Nanomedicine (Lond). 2012, 7(2):245-56.

Dendronized Bi-2-Quinoline Ligands and Their Metal Complexes: Dendron Synthesis and Metalloassembly.
Patri A., Moorefield C.N., and Newkome G.R.
Heterocycles. 2012, 84, (2): 1023-1032.

Lipid Component Quantitation by Thin Layer Chromatography.
Clogston J.D. and Patri A.K.
Methods Mol Biol. 2011, 697:109-17.

Detecting and Measuring Free Gadolinium in Nanoparticles for MRI Imaging.
Clogston J.D. and Patri A.K.
Methods Mol Biol. 2011, 697:101-8.

SEM X-Ray Microanalysis of Nanoparticles Present in Tissue or Cultured Cell Thin Sections.
Zheng J., Nagashima K., Parmiter D., de la Cruz J., and Patri A.K.
Methods Mol Biol. 2011, 697:93-9.

Biological Tissue and Cell Culture Specimen Preparation for TEM Nanoparticle Characterization.
Nagashima K., Zheng J., Parmiter D., and Patri A.K.
Methods Mol Biol. 2011, 697:83-91.

Chromatographic Methods for the Quantification of Free and Chelated Gadolinium Species in MRI Contrast Agent Formulations.
Cleveland D., Long S.E., Sander L.C., Davis W.C., Murphy K.E., Case R.J., Rimmer C.A., Francini L., and Patri A.K.
Anal Bioanal Chem. 2010, 398(7-8):2987-95.

Energy Dispersive X-Ray Analysis of Titanium Dioxide Nanoparticle Distribution after Intravenous and Subcutaneous Injection in Mice.
Patri A., Umbreit T., Zheng J., Nagashima K., Goering P., Francke-Carroll S., Gordon E., Weaver J., Miller T., Sadrieh N., McNeil S., and Stratmeyer M.
J Appl Toxicol. 2009, 29(8):662-72.