About FDA
-
Publication and Presentation Citations
FDA Commissioner’s Fellows Publication and Presentation Citations Produced During Their Tenures as
FDA Commissioner's Fellows
- Class of 2010 Publication and Presentation Citations
- Class of 2009 Publication and Presentation Citations
- Class of 2008 Publication and Presentation Citations
Class of 2010 Publication and Presentation Citations
Alexander Bailey, Ph.D. (CBER/CDRH Regenerative Medicine Fellow)
Publications
A.M. Bailey, Balancing tissue and tumor formation in regenerative medicine. Sci Transl. Med. 4, 147fs28 (2012).
Robinson R, Bailey AM, & Ibrahim S, Understanding the regulatory pathway one video at a time. Sci Transl Med. 3, 94ec124 (2011).
Presentations
BIOSafe Special Biologics Working Group - 2011 BIOSafe Seminar (April 2011), "Preclinical Considerations for Cellular Therapy Products: Assessment of Cell Fate" (Oral Presentation)
BIOSafe Special Biologics Working Group - 2012 BIOSafe Seminar (June 2012), "CBER OCTGT Experience Evaluating Tumorigenicity Risk in IND Submissions" (Oral Presentation)
Matha Betz, Ph.D. (CDRH Fellow)
Publication
Peter E. Petrochenko, Qin Zhang, Peter L. Goering, Haorong Wang, Ted Sun, Bridget Wildt, Martha Betz, Roger J. Narayan. In-vitro cytotoxicity of rare earth oxide nanoparticles for imaging applications. Intl J Appl Ceramic Technol (E-pub ahead of print, April 2012) http://onlinelibrary.wiley.com/doi/10.1111/j.1744-7402.2012.02784.x/abstract.
Presentations
Carlye A. Austin, Georgia K Hinkley; Qin Zhang, Thomas H. Umbreit, Martha W. Betz, Kenneth M. Brown, Sabine Francke-Carroll, Saber M. Hussain, Stephen M. Roberts, Peter L. Goering. Distribution of intravenously-injected silver nanoparticles (AgNPs) in pregnant mice and developing embryos. The Toxicologist 126(1):300, 2012 - Society of Toxicology, 51st Annual Meeting, San Francisco CA, March 11-15, 2012.
Bridget E. Wildt* Martha W. Betz*, Peter L. Goering, Ron P. Brown(*Contributed equally) In vitro neurotoxicity of clinically relevant concentrations of cobalt and chromium in N1E-115 neuroblastoma cells. The Toxicologist 126(1):219, 2012 - Society of Toxicology, 51st Annual Meeting, San Francisco CA, March 11-15, 2012.
Patricia Bright, Ph.D. (OC Fellow)
Publication
Bright PL, Nelson RM. A capacity-based approach for addressing ancillary care needs: Implications for research in resource limited settings. J Med Ethics 2012 Nov;38(11):672-6. Epub 2012 May 5. http://jme.bmj.com/content/38/11/672.long
Annemarie Buchholz, Ph.D. (CFSAN Fellow)
Abstracts
Buchholz, A.L., E.E. Jackson, R.M. Reddy, and M.L. Tortorello. 2012. Indicator Methods to Validate Process Controls for Fresh Produce. Abst. Ann. Foods Program Science and Research Conference, Silver Spring, MD. August 1 - 2.
Buchholz, A.L., E.E. Jackson, R.M. Reddy, and M.L. Tortorello. 2012. Indicator Methods to Validate Process Controls for Fresh Produce. Abst. Ann. Mtg. Int. Assoc. Food Prot., Providence, RI. July 22 - 25.
Jackson, E.E., A.L. Buchholz, R.M. Reddy, and M.L. Tortorello. 2012. Growth of Escherichia coli O157:H7 in Common Preenrichment Broths. Abst. Ann. Mtg. Int. Assoc. Food Prot., Providence, RI. July 22 – 25
Presentations
Indicator Methods to Validate Process Controls for Fresh Produce, Ann. Foods Program Science and Research Conference, Silver Spring, MD, August 2, 2012.
Indicator Methods to Validate Process Controls for Fresh Produce, Ann. Mtg. Int. Assoc. Food Prot., Providence, RI, July 25, 2012.
Growth of Escherichia coli O157:H7 in Common Preenrichment Broths, Ann. Mtg. Int. Assoc. Food Prot., Providence, RI, July 23, 2012.
Xingrong Chen, Ph.D. (NCTR Fellow)
Publications
Xinrong Chen and Tao Chen. Roles of MicroRNA in DNA Damage and Repair, Chapter 18 of Book titled “DNA Repair”. Intech 2011. 341-354
Xinrong Chen, Yan Jian, and Tao Chen. Expression Level of mir-34a Rather Than P53 Gene Status Correlates with Mutability in Related Human Lymphoblast Cell Lines. Molecular Carcinogenesis 2012, Aug;51(8):674-7.
Presentations
2011 SOT
Expression level of MiR-34a correlates with mutagenicity of X-ray in human lymphoblastoid cells with different P53 status, SOT, 3-9-2011.
2012 SOT
Regulatory roles of miR-34a in mutagenesis in human lymphoblast cells, SOT, 3-12-2012.
2012 Arkansas Stem Cell and Regenerative Medicine Conference
Retinoids accelerate hematopoietic stem cell differentiation, Arkansas Stem Cell and Regenerative Medicine Conference, 4-17-2012.
Maria Cruz-Fisher, Ph.D. (CVM Fellow)
Oral Presentations
Campylobacter jejuni MICs to antimicrobials approved for use in poultry feeds, American Society for Quality, Washington D.C. and Maryland Metro, Sec. 509; Rockville, MD, June 12, 2012.
Campylobacter jejuni resistance to antimicrobials approved for use in poultry feeds, CVM/ONADE, Rockville, MD, March 20, 2012
Poster Presentations
Campylobacter jejuni resistance to antimicrobials approved for use in poultry feeds, FDA 2nd Annual Foods Program Science and Research Conference, August 2, 2012.
Campylobacter jejuni resistance to antimicrobials approved for use in poultry feeds, American Society for Microbiology General Meeting - San Francisco, CA, June 20, 2012.
Bazarragchaa Damdinsuren, M.D., Ph.D. (CDER Fellow)
Publication
Dement-Brown J, Newton CS, Ise T, Damdinsuren B, Nagata S, Tolnay M. Fc receptor-like 5 promotes B cell proliferation and drives the development of cells displaying switched isotypes. J Leukoc Biol 2012;91:59-67.
Presentations
Signaling properties of FCRL5 in interaction with BCR in human B cells, Gordon Research Conferences - Antibody Biology & Engineering; Galveston, TX, 3/25-30, 2012.
Signaling properties of FCRL5 in interaction with BCR in human B cells, 2011 NIH Immunology Retreat; Cambridge, MD, 9/12/2011.
Hongliu Ding, M.D., Ph.D., M.P.H. (CFSAN Fellow)
Publications
Ding H, Fu TJ, Smith MA. Microbial Contamination in Sprouts: How Effective Is Seed Disinfection Treatment? J Food Sci. 2013 Mar 6. doi: 10.1111/1750-3841.12064. [Epub ahead of print]. http://onlinelibrary.wiley.com/doi/10.1111/1750-3841.12064/pdf
Presentations
Ding H. Quantitative Microbial Risk Assessment Approach for Evaluation of Risk Management Options for Sprouts. 2011 Mid-Year Meeting, Institute for Food Safety and Health. Summit, IL, April 25-27, 2011.
Ding H, Fu TJ, Tortorello M. Microbial Contamination in Sprouts: How Effective Is Seed Disinfection Treatment? 1st Annual FDA Foods Program Science and Research Conference, Silver Spring, MD, June 21-22, 2011.
Ding H, Fu TJ, Tortorello M. Microbial Contamination in Sprouts: How Effective Is Seed Disinfection Treatment? 2011 Annual Meeting, Institute for Food Safety and Health. Oak Brook, IL, October 11-12, 2011.
Ding H. Quantitative Microbial Risk Assessment Approach to enhance Sprouts food safety:
Update. 2012 Mid-Year Meeting, Institute for Food Safety and Health. Burr Ridge, IL, April 10-11, 2012.
Update. 2012 Mid-Year Meeting, Institute for Food Safety and Health. Burr Ridge, IL, April 10-11, 2012.
Ding H, Fu TJ. Quantifying the benefit of Testing in Microbial Risk Reduction for Sprouts. 2nd Annual FDA Foods Program Science and Research Conference, Silver Spring, MD, August 1-2, 2012.
Ding H, Fu TJ, Chen Y, Dennis S, Tortorello M. Evaluation of Risk Management Options to Reduce Microbial Hazards in Sprouts through Quantitative Risk Assessment. FDA Commissioner’s Fellowship Graduation. September 25, 2012.
Kuppan Gokulan, Ph.D. (NCTR Fellow)
Publications
Gokulan K, Aggarwal A, Shipman L, Besra GS, and Sacchettini JC. Mycobacterium tuberculosis acyl carrier protein synthase adopts two different pH-dependent structural conformations. Acta Crystallographica Section D: Biological Crystallography,2011; 67:657-69.
Madina BR, Gokulan K, Vashisht AA, Liang YH, Downey KM, Wohlschlegel JA, Ji X, Sze SH, Sacchettini JC, Read LK, and Cruz-Ryes J. Guide RNA biogenesis involves a novel RNase III family in Trypanosome brucei. RNA, 2011; 10:1821-30.
Presentations
Novel Approaches for Drug Discovery: Three dimensional Structure and Fragment screening of Target. University of Arkansas Medical Center, Little Rock, Sep 22nd, 2011
The mechanistic and structural insights of polyketide synthase 11 from M. tuberculosis. University of Arkansas Little Rock, Feb 6th 2012
Involvement of transmissible plasmids of S. enterica Heidelberg isolates and its association with cell invasion and persistence: Homology modeling of inner and outer membrane complex of T4SS. Research and Regulatory aspects of food safety. April 11th, 2012.
Involvement of T4SS Encoding Plasmids in the Virulence of S. enterica serovar Heidelberg. American Association of Microbiology. June 16th 19th, 2012.
Evaluation of Virulence and Antimicrobial Resistance in Salmonella enterica serovar Enteritidis Isolates from Poultry-Associated and Human Sources. American Association of Microbiology. June 16th 19th, 2012
Activation of Host Cell Death Pathways by Non-Typhoidal Salmonella Serovar Containing Cytolethal Distending Toxin. American Association of Microbiology. June 16th 19th, 2012.
Involvement of Type IV Secretion System (T4SS) Encoding Plasmids in the Virulence of S. enterica serovar Heidelberg. 2ND Annual Foods Program Science and Research Conference Food and Feed Safety and Nutrition Research: The Foundation for Regulatory Policy. August 1-2, 2012.
Evaluation of Virulence and Antimicrobial Resistance in Salmonella enterica serovar Enteritidis Isolates from Poultry-Associated and Human Sources. 2ND Annual Foods Program Science and Research Conference Food and Feed Safety and Nutrition Research: The Foundation for Regulatory Policy. August 1-2, 2012.
Elizabeth Grasso, Ph.D. (CFSAN Fellow)
Publication
Keller, S., E. Grasso, L. Halik, G. Fleischman, S. Chirtel, and S. Grove. 2012. Effect of Growth on the Thermal Resistance and Survival of Salmonella ennessee and Oranienburg in Peanut Butter, Measured by a New Thin-Layer Thermal Death Time Device. Journal of Food Protection. 75(6):1125-1130.
Presentations
Cleaning and sanitation of Salmonella-contaminated peanut butter processing equipment, 2nd Annual FDA Foods Program Science and Research Conference. Silver Spring, MD, August 1-2, 2012.
Growth and survival of Salmonella in ground black pepper, 2nd Annual FDA Foods Program Science and Research Conference, Silver Spring, MD, August 1-2, 2012.
Prevalence, level, and survival of Salmonella in spices imported into the United States, 2nd Annual FDA Foods Program Science and Research Conference. Silver Spring, MD, August 1-2, 2012.
Cleaning and sanitation of Salmonella-contaminated peanut butter processing equipment, International Association for Food Protection, Annual Meeting. Providence, RI, July 22-25, 2012.
Growth and survival of Salmonella in ground black pepper, International Association for Food Protection, Annual Meeting. Providence, RI, July 22-25, 2012.
Assessment and mitigation of risk with the use of spices and other dry ingredients in the food industry, Institute of Food Technologists, Annual Meeting. Las Vegas, NV, June 25-28, 2012.
Impact of inoculum level on the transfer of Salmonella serovars from contaminated almond butter to food-contact materials, Institute of Food Technologists, Annual Meeting. Las Vegas, NV, June 25-28, 2012.
Sanitation of Salmonella contaminated nut butter processing equipment, Institute for Food Safety and Health - Midyear Meeting. Burr Ridge, IL, March 10-11, 2012.
Differences in thermal resistance of Salmonella Tennessee and Oranienburg in peanut butter related to growth as sessile or planktonic cells, International Association for Food Protection, Annual Meeting. Milwaukee, WI, July 31-August 3, 2011.
Differences in thermal resistance of Salmonella Tennessee and Oranienburg in peanut butter related to growth as sessile or planktonic cells, 1st Annual FDA Foods Program Science and Research Conference. Silver Spring, MD, June 21-22, 2011.
Differences in thermal resistance of Salmonella Tennessee and Oranienburg in peanut butter related to growth as sessile or planktonic cells, Institute of Food Technologists, Annual Meeting. New Orleans, LA, June 11-14, 2011.
Rosalee Hellberg, Ph.D. (ORA Fellow)
Publications
Hellberg RS, Haney CJ, Shen Y, Cheng C-M, Williams-Hill DM, Martin WB. Development of a Custom 16S rRNA Gene Library for the Detection and Molecular Subtyping of Salmonella enterica. Journal of Microbiological Methods 91: 448-458.
Pierce SE, Bell RL, Hellberg RS, Cheng C-M, Chen K-S, Williams-Hill DM, Martin WB, Allard MW. Detection and Identification of Salmonella enterica, Escherichia coli, and Shigella spp. via PCR-ESI-MS: Isolate Testing and Analysis of Food Samples. Applied and Environmental Microbiology. Applied and Environmental Microbiology 78(23): 8403-8411.
Rasmussen Hellberg RS, Naaum AM, Handy SM, Hanner RH, Deeds JR, Yancy HF, Morrissey MT. 2011. Interlaboratory evaluation of a real-time multiplex polymerase chain reaction method for identification of salmon and trout species in commercial products. Journal of Agricultural and Food Chemistry 59: 876-884.
Rasmussen Hellberg RS, Morrissey MT. 2011. Advances in DNA-based techniques for the detection of seafood species substitution on the commercial market. Journal of the Association of Laboratory Automation 16(4): 308-321.
RS Hellberg, MD Kawalek, KT Van, Y Shen, and DM Williams-Hill. 2012. DNA Extraction and PCR Preparation Methods for use in High-Throughput DNA Barcoding for Species Identification of Fish. Laboratory Information Bulletin No. 4526.
Hellberg RS, Hanner RH, Naaum AM, Handy SM, Deeds JR, Yancy HF, Morrissey MT. 2012. Real-time multiplex polymerase chain reaction assay for the identification of commercial salmon and trout species in food products. Laboratory Information Bulletin No. 4502.
Handy SM, Deeds JR, Ivanova NV, Hebert PDN, Hanner R, Ormos A, Weight LA, Moore MM, Hellberg RS, Yancy HF. 2011. Single laboratory validated method for DNA-barcoding for the species identification of fish for FDA regulatory compliance. Standard Operating Procedure.
Presentations
“Development of a multiplex PCR assay for the identification of commercial salmon and trout species (Oncorhynchus and Salmo) in North America," LabAutomation 2011, Jan. 29-Feb. 2, 2011.
“Emerging Techniques for the Detection and Characterization of Foodborne Pathogens,” Association of Public Health Laboratories 2011, June 5-8, 2011.
“DNA Sequencing for the Identification of Food Pathogens and Seafood Species,” FDA Foods Program Science and Research Conference 2011, June 21-23, 2011.
“Development of a 16S rRNA Library for the Identification of Foodborne Pathogens,” International Association for Food Protection 2011, July 31- Aug. 3, 2011.
“Development of a Polymerase Chain Reaction Electrospray Ionization Mass Spectrometer (PCR/ESI-MS) Assay for the Detection and Differentiation of Human Noroviruses,” Association of Public Health Laboratories 2012, May 20-23, 2012.
“Development of a Novel Polymerase Chain Reaction Electrospray Ionization Mass Spectrometer (PCR/ESI-MS) Assay for the Detection and Differentiation of Human Noroviruses,” Institute of Food Technologists 2012, June 25-28, 2012.
“Development of a Novel Polymerase Chain Reaction Electrospray Ionization Mass Spectrometer (PCR/ESI-MS) Assay for the Detection and Differentiation of Human Noroviruses,” International Association for Food Protection 2012, July 22-25, 2012.
“Development of a Novel Polymerase Chain Reaction Electrospray Ionization Mass Spectrometer (PCR/ESI-MS) Assay for the Detection and Differentiation of Human Noroviruses,” FDA Foods Program Science and Research Conference 2012. August 1-2, 2012.
Haijing Hu, Ph.D. (NCTR Fellow)
Publication
Mark E. Hart, Laura H. Tsang, Joanna Deck, Sonja T. Daily, Richard C. Jones, Huanli Liu, Haijing Hu, Morgan J. Hart and Mark S. Smeltzer, Hyaluronidase expression and biofilm involvement in Staphylococcus aureus UAMS-1 and its sarA, agr and sarA agr regulatory mutants: 2013. Microbiology 159:782-791.
Poster Presentation
Expression of hyaluronidase in Staphylococcus aureus UAMS-1 is regulated by SarA (poster), American Society for Microbiology, 112th general meeting, June 18, 2011.
Syed Imam, Ph.D. (NCTR Fellow)
Publications
Ali SF, Binienda ZK, Imam SZ.
Int J Environ Res Public Health. 2011 Dec;8(12):4702-13. Epub 2011 Dec 16. Review.
PMID: 22408597 [PubMed - indexed for MEDLINE] Free PMC Article
Imam SZ, Zhou Q, Yamamoto A, Valente AJ, Ali SF, Bains M, Roberts JL, Kahle PJ, Clark RA, Li S.
J Neurosci. 2011 Jan 5;31(1):157-63.
PMID: 21209200 [PubMed - indexed for MEDLINE] Free PMC Article
Dudek SM, Chiang ET, Camp SM, Guo Y, Zhao J, Brown ME, Singleton PA, Wang L, Desai A, Arce FT, Lal R, Van Eyk JE, Imam SZ, Garcia JG.
Mol Biol Cell. 2010 Nov 15;21(22):4042-56. Epub 2010 Sep 22.
PMID: 20861316 [PubMed - indexed for MEDLINE] Free PMC Article
Presentations
Hyperglycemia mitigates Parkinson’s disease: In vitro, animal model, and clinical epidemiologic evidence. Syed Z. Imam1,2,#,*, Mary Jo Pugh3,#,*, Eden Tareke1, Zbigniew Binienda1, Merle G. Paule1, William Slikker Jr.1, Balakuntalam Kasinath2, Syed F. Ali1, and Robert A. Clark2 1Division of Neurotoxicology, US FDA\National Center for Toxicological Research, Jefferson, AR; 2Department of Medicine & 3Department of Epidemiology and Biostatistics, University of Texas Health Science Center, San Antonio, TX. The MDS 16th International Congress of Parkinson's Disease and Movement Disorders, June 16-22, 2012
Inno-406, a second generation abl-inhibitor, as a parkinson’s disease therapy. Syed F. Ali1, William Trickler1, Zbigniew Binienda1, Merle G. Paule1, William Slikker Jr1, and Syed Z. Imam1,2, 1Division of Neurotoxicology, US FDA/National Center for Toxicological Research, Jefferson, AR, USA, 2Department of Medicine, UT Health Science Center, San Antonio, TX USA.
6th International Conference SUMO, Ubiqutin, UBL Proteins: Implications for Human Diseases, February 8-11, 2012
Parkin-dysfunction and α-synuclein aggregation might lead to cell-death in methamphetamine (METH)-treated rhesus monkeys and human METH users. Syed Z. Imam1,2,3, Zbigniew Binienda, William Slikker Jr., Merle G. Paule, Eliezer Masliah4, and Syed F. Ali, 1Division of Neurotoxicology, US FDA/NCTR, Jefferson, AR; 2Institute for the Integration of Medicine and Science, UT Health Science Center, San Antonio, TX; 3Department of Geriatrics, University of Arkansas for Medical Sciences, Little Rock, AR; 4Department of Neuroscience, University of California, San Diego, CA. Annual meeting of Society of Toxicology, March 11-15, 2012.
INNO-406, A SECOND GENERATION Abl-INHIBITOR, AS A PARKINSON’S DISEASE THERAPY. Syed Z. Imam1,2, William Trickler1, Zbigniew Binienda1, Syed F. Ali1, Merle G. Paule1, William Slikker Jr1, and James L. Roberts3, 1Division of Neurotoxicology, US FDA/National Center for Toxicological Research, Jefferson, AR, USA, 2Department of Medicine, UT Health Science Center, San Antonio, TX USA, 3Department of Biology, Trinity University, San Antonio, TX, USA. Annual meeting of Society of Neuroscience, November 12-16.
Alpha-synuclein-mediated activation of c-Abl and dopamine depletion in dopaminergic neuronal cells treated with iron-oxide nanoparticles or methamphetamine. Zbigniew Binienda1, Lamya Mohammed Saeed1,2, Bonnie Robinson1, Merle G. Paule1, Alexandru S. Biris2 , Syed F. Ali1, and Syed Z. Imam1 1Division of Neurotoxicology, US FDA/NCTR, Jefferson, AR 72079, USA, 2Nanotechnology Center, University of Arkansas at Little Rock, AR 72204, USA. Annual meeting of Society of Toxicology, March 11-15, 2012
Sudipan Karmakar, Ph.D. (CDER Fellow)
Publications
Lalmansing. A., Karmakar. S., Jin. Y. and Nagaich. A. (2012) Multiple Modes of Chromatin Remodeling by Forkhead Box Proteins. Biophysica Biochemica Acta, 1819(7):707-15.
Presentations
Direct Interaction of Estrogen and Glucocorticoid Receptor in Dexamethasone Mediated Interference of ERa Activity and ER-positive breast cancer cell proliferation, Keystone symposium on nuclear receptors, Whistler, BC, Canada, 17 April, 2012.
Seraphin Kuate, Ph.D. (CBER Fellow)
Presentation
Presentation Title: A Cell-Based Assay to Detect Rare Psi-Gag Recombinants in Lentiviral Vectors. 15th Annual American Society of Gene and Cell Therapy (ASGCT), Philadelphia, PA. May 16-19, 2012.
Ernest Kwegyir-Afful, Ph.D. (CFSAN Fellow)
Publications
Handy SM, Parks MB, Deeds JR, Liston A, Dejager LS, Luccioli S, Kwegyir-Afful E, Fardin-Kia AR, Begley TH, Rader JI, Diachenko (2011). Use of the chloroplast gene ycf1 for the genetic differentiation of pine nuts obtained from consumers experiencing dysgeusia. G. J Agric Food Chem. 2011 Sep 20
Kwegyir-Afful E, DeJager L, Begley T, Luccioli S. (2011). Pine Mouth Syndrome - An Emerging Food Hypersensitivity? Clin. Transl. Allergy 2011, 1 (Suppl. 1), P:25.
Kwegyir-Afful E. K., Foye O.T., Williams K., Luccioli S. (2012). A Bioassay for Assessing Dose-Response Relationships in a Food Allergic Mouse Model. The Journal of Allergy and Clinical Immunology, Volume 129, Issue 2, Supplement , Page AB175, February 2012
Presentations
Pine Mouth Syndrome - An Emerging Food Hypersensitivity?, European Academy of Allergy and Clinical Immunology Food Allergy and Anaphylaxis Meeting. Venice, Italy, Feb 16 – 20, 2011.
A Bioassay for Assessing Dose-Response Relationships in a Food Allergic Mouse Model, American Academy of Allergy Asthma and Immunology annual meeting. Orlando, Florida, March 2 – 6, 2012.
A Theoretical Approach to Establish Thresholds for Labeling Exemptions under FALCPA: Theory, Advantages and Complexities, 2nd Annual Foods Program Science and Research Conference. FDA, White Oak, Silver Spring, MD, Aug 1 - 2, 2012.
The Effect of Model Choice and Data Source on Threshold Dose Estimation, ILSI Europe Workshop - “Food Allergy: From Thresholds to Action Levels," September 13 - 14, 2012.
Tzu-Yun McDowell, Ph.D. (CDER Fellow)
Presentations
Assessing BP effects: the role of the population mean versus the outliers. Cardiac Safety Research Consortium Thinktank Meeting, July 18, 2012 (invited oral presentation).
Evaluation of the relationship between last available INR and efficacy /safety outcomes of warfarin. Office of Clinical Pharmacology XVII Annual Science Day, FDA, September 7, 2012 (poster presentation).
Zenghui Mi, M.D., Ph.D. (CDER Fellow)
Publication
Park, EJ, Wu K, Mi, Z (Co-first author), Dong, T, Lawrence, JP, Ko, CW, Huang, SM, Zhang, L, Crentsil, V, Zhang, J, and Xu, NN. A Comparison of Cockcroft-Gault and Modification of Diet in Renal Disease Equations for Dosage Adjustment. Ann Pharmacother 46:1174-1187, 2012, http://www.theannals.com/content/46/9/1174.abstract.fr.
Zohra Olumee Shabon,Ph.D. (CVM Fellow)
Publication
J. Boehmer, Z. Olumee-Shabon 2011 “Veterinary Biomarker Discovery: Proteomic Analyses of Acute Phase Proteins” In Tech. Rijeka, Croatia, pp189-210.
Presentations
Poster presentations:
Zohra Olumee-Shabon, Trevon Swain, Elizabeth A. Smith, and Jamie L. Boehmer "Biomarkers of Inflammation and Effects of Non-Steroidal Anti-Inflammatory Drugs Following Experimental Induction of Mastitis with Lipopolysaccharide in Goats", 1st Food Science & Research Conference, June 21, 2011.
Zohra Olumee-Shabon and Jamie L. Boehmer "Detection of Casein Phosphopeptides in Goat Milk", 60th ASMS Conference, Vancouver, CA, May 19-23, 2012.
Zohra Olumee-Shabon and Jamie L. Boehmer "The Detection of Casein Phosphopeptides in Goat Milk", 2nd Food Science & Research Conference, August 1, 21, 2011.
Oral Presentation:
Zohra Olumee-Shabon "Milk Protein Modulation Following Experimental Induction of Endotoxin Mastitis with Lipopolysaccharide in Goats", Biomed Biotech Special Interest Group, June 26, 2012.
Sarah Pierce, Ph.D. (ORA Fellow)
Publication
Pierce, S.E., Bell, R.L., Hellberg, R.S., Cheng, C.-M., Chen, K.-S., Williams-Hill, D.M., Martin, W.B., Allard, M.W., “Detection and Identification of Salmonella enterica, Escherichia coli, and Shigella spp. via PCR-ESI-MS: Isolate Testing and Analysis of Food Samples”, Applied and Environmental Microbiology, 78 (23), 2012, p. 8403-8411.
Presentations
“Emerging Techniques for the Detection and Characterization of Foodborne Pathogens,” 2011 APHL Annual Meeting and 5th State Environmental Laboratory Conference, June 5-8th, 2011. Omaha, NE.
“Rapid Detection and Identification of Foodborne Bacterial Pathogens with the Plex-ID System,”1st Annual FDA Foods Program Science and Research Conference, June 21-22nd, 2011. White Oak, MD.
“Rapid Multiplex Identification of Foodborne Bacterial Pathogens via PCR/MS on the Plex-ID System,” IAFP Annual Meeting 2011, July 31-August 3rd, 2011. Milwaukee, WI.
“PCR/ESI-MS for Rapid Foodborne Bacterial Pathogen Detection and Identification,” PittCon 2012, March 11-15th, 2012. Orlando, FL.
“Application of a PCR/ESI-MS Assay for the Identification of Foodborne Bacterial Pathogens,” 60th ASMS Conference on Mass Spectrometry and Allied Topics, May 20-25, 2012. Vancouver, BC, Canada.
“Application of PCR/MS Methodology to the Detection of Enteric Bacterial Pathogens in Food Samples,” IAFP Annual Meeting 2012, July 22-25th 2012. Providence, RI.
“Application of PCR/MS Methodology to the Detection of Enteric Bacterial Pathogens in Food Samples,” 2nd Annual FDA Foods Program Science and Research Conference, July 31st-August 2nd, 2012. White Oak, MD.
Rebecca Robinson, Ph.D. (CBER/CDRH Regenerative Medicine Fellow)
Publications
Robinson R. “3Rs of Animal Testing for Regenerative Medicine Products” Sci Transl Med 3(112) (2011) 112fs11.
Robinson R, Bailey AM, Ibrahim S. “Understanding the Regulatory Pathway One Video at a Time” Sci Transl Med 3(94) (2011) 94ec124.
Natalie Simpson, Ph.D. (NCTR Fellow)
Publications
Simpson N, Tryndyak V, Pogribna M, Beland F, Pogribny I. Modifying metabolically sensitive histone marks by inhibiting glutamine metabolism affects gene expression and alters cancer cell phenotype. 2012. Epigenetics. 7(12): pp. 1413-20. http://www.ncbi.nlm.nih.gov/pubmed/23117580.
Simpson N, Tryndyak V, Beland F, Pogribny I. An in vitro investigation of metabolically sensitive biomarkers in breast cancer progression. 2012. Breast Cancer Research and Treatment: 133(3) (pp. 959-68).
Kortubash I, Simpson N, Beland F, and Pogribny I. Alterations in histone H4 lysine 20 methylation: implications for cancer detection and prevention. 2012. Antioxidant and Redox Signaling: 17(2) (pp. 365-74).
Presentations
Simpson N, Beland F, Pogribny I. The identification of epigenetic, gene expression, and metabolic biomarkers in breast cancer progression and determination of epigenetic plasticity during metabolic disturbances as a target for breast cancer therapy. Class of 2010 Commissioner's Fellowship Program Final Oral and Poster Presentation. September 25, 2012.
Simpson N, Beland F, Pogribny I. Correction of metabolically sensitive histone epigenetic marks mediates the drug sensitivity of MDA-MB-231 human breast cancer cells. 103rd American Association for Cancer Research Annual Meeting. March 31-April 4, 2012. Poster Presentation.
Simpson N, Tryndyak V, Beland F, Pogribny I. An in vitro investigation of metabolically sensitive biomarkers in breast cancer progression. Commissioner’s Fellowship Program Mid-Program Oral Presentation. November 28, 2011.
Simpson N, Tryndyak V, Beland F, Pogribny I. An in vitro investigation of metabolically sensitive biomarkers in breast cancer progression. 102nd American Association for Cancer Research Annual Meeting. April 2-6, 2011. Poster Presentation.
Wei Song, Ph.D. (CVM Fellow)
Presentations
The Development of a Multiple-Residue Method for Detection of Hormones in Edible Fish Tissue by LC-MS/MS, 1st Annual FDA Foods Program Science and Research Conference, June 2011, Silver Spring, MD.
Simultaneous Determination of Sixteen Hormones in Finfish Muscle Tissue by LC-MS/MS, 125th AOAC Annual Conference,September 2011, New Orleans, LA.
Marla Swain, Ph.D. (CVM Fellow)
Publications
Swain MD, Orzechowski KL, Swaim HL, Jones YL, Robl MG, Tinaza CA, Myers MJ, Jhingory MV, Buckely LE, Lancaster VA, Yancy HF. P-gp substrate-induced neurotoxicity in an Abcb1a knock-in/Abcb1b knock-out mouse model with a mutated canine ABCB1 targeted insertion. Res Vet Sci. 2012 Nov 24.
Orzechowski KL, Swain MD, Robl MG, Tinaza CA, Swaim HL, Jones YL, Myers MJ, Yancy HF. Neurotoxic effects of ivermectin administration in genetically engineered mice with targeted insertion of the mutated canine ABCB1 gene. Am J Vet Res. 2012 Sep;73(9):1477-84.
Presentation
P-glycoprotein Substrate Induced Neurotoxicity in Knock-in/ Knock-out Mice with Inserted Mutated Canine ABCB1, 2nd FDA Food Program Science and Research Conference Offering Page, August 1, 2012, American Society for Quality- Biomed/Biotech Special Interest Group (SIG) Meeting, June 6, 2012.
Leposava Antonovic, Ph.D. (CVM Fellow)
Oral Presentations
Invited Speaker: US FDA: Development of in silico PBPK models to support population predictions for canine and human oral drug delivery systems. Vet Symposium - New Frontiers in Drug Development: Translational Research and Models for Veterinary and Human Health. 38th Annual Meeting & Exposition of the Controlled Release Society, July 2011.
Invited Speaker: In Vitro to In Vivo Correlations of Predicting the Effect of Drug Metabolism: P450 Interspecies Differences. American Association for Pharmaceutical Scientists (AAPS) Workshop. Veterinary Pharmaceuticals: Contemporary Challenges and Advances Impacting the development of Veterinary Pharmaceuticals, November 2010.
Invited Speaker: Drug Metabolism and Cytochromes P450: Pharmacogenetic Implications. Staff College, Center for Veterinary Medicine, October 2010.
Peer-Reviewed Published Ariticles
Antonovic, L., and Martinez, M. Role of cytochrome P450 enzyme system in veterinary pharmacokinetics: where are we now? Where are we going? Future Med Chem. 2011 3(7):855-79.
Sehgal, N, Agarwal, V, Valli, RK, Joshi, SD, Antonovic, L., Strobel, HW, Ravindranath, V. Cytochrome P4504f, a potential therapeutic target limiting neuroinflammation. Biochem Pharmacol. 2011 [Epub ahead of print] http://www.sciencedirect.com/science/article/pii/S0006295211002127.
Chaluvadi, MR., Kinloch, RD., Nyagode, BA., Richardson, TA., Raynor, MJ., Sherman, M., Antonovic, L., Strobel, HW., Dillehay DL., Morgan, ET. Regulation of Hepatic Cytochrome P450 Expression in Mice with Intestinal or Systemic Infections of Citrobacter rodentium. Drug Metab Dispos. 2009 37(2):366-74.
Peer-Reviewed Published Abstracts and Presentations
Marinez, M., Antonovic, L., Parker, H., Fuller, E., Ostrander, E. Canine Polymorphism in Drug Metabolism; FDA/NIH Collaboration Project. The Fifth International Conference on “Advances in Canine and Feline Genomics and Inherited Diseases”, Sept 22-25 2010, Baltimore, MD.
Contributions
Co-authored “Animal Drugs: Factors Influencing their Development and Use” in Encyclopedia of Pharmaceutical Technology, 2011.
Kannan Balan, Ph.D. (CFSAN Fellow)
Publications
Babu US, Sommers K, Plemons L and Balan KV. Effects of Fructooligosaccharide-Inulin on Salmonella-Killing and Inflammatory Gene Expression in Chicken Macrophages. Vet Immunol Immunopathol 149: 92-96, 2012
Abstracts
Calvo MS, Balan KV, Garthoff LH, Salem SJ and Babu US. High plasma 25-hydroxy Vitamin D2 in rats fed light-exposed mushrooms modulated innate immune response. 15th workshop on Vitamin D, Houston, TX, June 2012
Balan KV and Babu U. A time-course study of transcriptional responses in laying hen reproductive-tract tissues in response to Salmonella Enteritidis infection. Poultry Science Association, St. Louis, MO, July 2011
Babu US, Garthoff LH, Balan KV and Calvo MS. Vitamin D2 enriched mushrooms significantly reduced inflammatory cytokine and chemokine expression in the spleens of LPS challenged rats. Experimental Biology, Washington DC, April 2011
Babu US, Balan KV, Gaines D, Mehta A, Plemons L, Bigley E and Williams K. Role of caspases in Salmonella-Induced chicken macrophage apoptosis. Presentation at The American Society for Microbiology Conference, San Diego, CA, May 2010
Sudeepa Bhattacharyya, Ph.D. (NCTR Fellow)
Publications
Sun J., Schnackenberg L.K., Pence L., Bhattacharyys S, Doegre D., Bowyer J., and Beger, R.D. Metabolomic Analysis of Urine from Rats Chronically Dosed with Acrylamide Using NMR and LC/MS. Metabolomics 2010, 6:550-563.
Schnackenberg L.K., Sun J., Pence L., Bhattacharyya S., Sonko B.J., Beger R.D. Metabolomics for Personalized Nutrition Research and Clinical Applications: A 2010 Update. Current Pharmacogenomics and Personalized Medicine 2010. 8:202-217.
Sun J, Bhattacharyya S, Schnackenberg L, Pence L, Ando Y, Zhang J, Stewart S, Rosenzweig B, Rouse R, Portilla D, Beger R D. Discovery of Early Urinary Biomarkers of Gentamicin-Induced Kidney Injury and Recovery. Metabolomics 2012 DOI 10.1007/s11306-012-0423-7
Schnackenberg, L; Sun, J; Pence, L.; Bhattacharyya, S; Gamboa da Costa, G.; Beger, R D. Evaluation of Hydroxyproline as a Potential Marker of Melamine and Cyanuric Acid Nephrotoxicity in Male and Female Fischer F344 Rats Food and Chemical Toxicology 2012.
Posters
S. Bhattacharyya, J. Sun, L. Pence, L. Schnackenberg, D. Doerge, J. Bowyer, and R. D. Beger. Detection of Acrylamide Induced Toxixity in Urine Samples using LC-MS based Metabolomics and Pattern Recognition Techniques. MCBIOS 2010
J. Sun, L. K. Schnackenberg, L. Pence, S. Bhattacharyya, D. R. Doerge, J. F. Bowyer, and R. D. Beger. Metabolomic Analysis of Acrylamide-induced Metabolite Alterations in Urine. ASMS 2010.
L. K. Schnackenberg, J. Sun, R. D. Smiley, S. Bhattacharyya, and R. D. Beger. Development of NMR and LC-MS-Based assays for rapid screening of bacterial contamination in milk as a model system. NIH Metabolomics, 2010.
J. Sun, L. K. Schnackenberg, L. Pence, S. Bhattacharyya, J, Zhang, S. Stewart, B. Rosenzweig, R. Rouse, and R. D. Beger. Discovery of early metabolomic biomarkers for gentamicin-induced nephrotoxicity in rat urine. NIH Metabolomics, 2010.
Zhang Q, Gamboa da Costa, G, Beger R, Schnackenberg L, Sun J, Pence L, Bhattacharyya S, Jacob C, Brown R, Goering P. Urinary biomarker detection of melamine-cyanuric acid-induced kidney damage in rats. 50th SOT Washington DC March 8, 2011.
Bhattacharyya S. Sun J, Ando Y, Schnackenberg L, Gamboa da Costa G, Beger R. An integrated screening of NMR and LC-MS based metabolomic profiling data for potential biomarkers of Melamine-Cyanuric Acid induced rat liver injury. MCBIOS, College Station, TX on April 1, 2011.
Sun J., Ando Y., Yang X., Greenhaw J., Schnackenberg L., Pence L., Schmitt T., Bhattacharyya S., Salminen W., Mendrick D., and Beger R. D. Integrated LC/MS Metabolomic Investigation of Changes in the Rat Serum Metabolite Profile Induced by Acetaminophen. ASMS 2011, Denver CO.
Ando, Y. Sun, J., Schnackenberg, L., Yang, X., Greenhaw, Pence, L., Schmitt, T., Bhattacharyya, S., Salminen, W., Mendrick, D., Beger, R.,. Transcriptome and Metabolome Analysis Reveals Mechanism-linked Biomarker Candidates in Carbon Tetrachloride-Induced Hepatotoxicity. 51st SOT in San Francisco, CA on March 12, 2012
Bhattacharyya S, Pence L, Beger R , Yan K, Simpson P, Roberts D, James L. Targeted Metabolomics reveal changes in Serum Acylcarnitine profiles in Children and Adolescents with Acute Acetaminophen Toxicity. Metabolomics, Washington DC, June 20th, 2012.
Joslyn Brunelle, Ph.D. (CDER Fellow)
Publications
JK Brunelle and B. Zhang. (2010) Apoptosis assays for quantifying the bioactivity of anti-cancer drug products. Drug Resistance Updates 13(6): 172-179.
JA Ryan, JK Brunelle, A Letai. (2010) Heightened mitochondrial priming is the basis for apoptotic hypersensitivity of CD4+ CD8+ thymocytes. Proceedings of the National Academy of the Sciences 107(29): 12895-12900.
JK Brunelle, J Ryan, D Yecies, J Opferman, A Letai. (2009) Mcl-1 dependent leukemia cells are more sensitive to chemotherapy than Bcl-2 dependent counterparts. Journal of Cell Biology 187:429-442.
JK Brunelle and A Letai. (2009) Control of mitochondrial apoptosis by the BCL-2 family. Journal of Cell Science 122(4):437-441.
Kathryn Burke, Ph.D. (OC Fellow)
Publications
Burke, K.A., Freeman, S.N., Imoisili, M.A., and Coté, T.R. (2010). The impact of the Orphan Drug Act on the development and advancement of neurological products for rare diseases. Clinical Pharmacology and Therapeutics. 88(4):449-453.
Freeman SN, Burke KA, Imoisili MA, Cote TR. (2010). The Orphan Drug Act and the Development of Stem Cell-Based Products for Rare Diseases. Cell Stem Cell. 7(3):283-287.
Natalia Comella, Ph.D. (CDRH Fellow)
Presentation
Multiplex Risk Assessment Challenge. (2010). 2010 CBER and CDRH 9th Annual Best Practices Interactive Workshop for In Vitro Diagnostics. Silver Spring, MD. (co-presented)
Scott Freeman, Ph.D. (OC Fellow)
Publication
Freeman SN, Burke KA, Imoisili MA, Cote TR. (2010). The Orphan Drug Act and the Development of Stem Cell-Based Products for Rare Diseases. Cell Stem Cell. 7(3):283-287.
Dionna Green, M.D. (CDER Fellow)
Publication
Burckart GJ and Green DJ. The personalized medicine revolution: getting it right for children. Pediatric Transplantation 2011.
Abstracts
Pharmacogenomics and Pharmacometrics of Adverse Effects and Dosing of Anti-Proliferative Agents in Children Following Heart Transplantation, 2010.
Burckart GJ, Figg WD II, Brooks MM, Green D, Girnita DM, Troutman S, Chinnock R, Canter C, Addonizio L, Bernstein D, Kirklin JK, NaftelD, Price DK, Zeevi A, Webber SA. A Multi-Institutional Study of Outcomes After Pediatric Heart Transplantation: Effect of ABCC2 Polymorphisms. American Transplant Congress 2012, Boston, MA, June, 2012.
Poster
Pharmacogenomics of Outcome and Adverse Effects in Children Following Heart Transplantation, 2010
Presentations
Specific Populations: Pediatrics, FDA Commissioner’s Fellowship Program Introduction to Clinical Pharmacology, Silver Spring, MD, June, 2012
Pediatric Drug Development: What We Have Learned, Office of Clinical Phar, Silver Spring, MD, September, 2012
OCP Pediatric Innovations, Office of Clinical Pharmacology Senior Leadership Meeting, Silver Spring, MD, October, 2012
Cisplatin Ototoxicity: Case Study, University of Southern California School of Pharmacy, remotely delivered, Los Angeles, CA, November, 2012.
Contemporary Issues in Clinical Pharmacology Pharmacology: Pediatric Drug Development, American Society for Clinical Pharmacology & Therapeutics Annual Meeting, Indianapolis, IN, March 2013
"Pediatric Regulations", "The Written Request" at The Pharmaceutical Education & Research Institute (PERI) Pediatric Drug Development Course, 2011
"Replagal PK/PD Comparability" at Office of Clinical Pharmacology Biologics Oversight Board, 2011
“Case Study: Cisplatin Ototoxicity” at University of Southern California School of Pharmacy Pharmacogenomic Lecture Series, 2010
Joffre Angelo Green, Ph.D. (CDRH Fellow)
Publications
J. C. Hutter, J.A. Green, M.B. Eydelman (2012), “Proposed Silicone Hydrogel Contact Lens Grouping System for Lens Care Product Compatibility Testing.” Eye Contact Lens. 38 (6):358-362
J. A. Green, K. S. Phillips, M. Shoff, A. Lucas, V. Hitchins, J.C. Hutter, E.M. Rorer, M.B. Eydelman (2012), “Material Properties that Predict Preservative Uptake for Silicone Hydrogel Contact Lenses.” Eye Contact Lens. 38 (6):350-357
“Success Stories: Thinking About Applying for an NIDCR Postdoctoral Position?” NIDCR/NIH, Bethesda, MD, Interview describing research experiences at the National Institutes of Health, published at http://www.nidcr.nih.gov/CareersAndTraining/FellowshipsInternshipsSorted/TrainingatNIDCR/Green.htm, October, 2009
The above publications were part of an FDA Special Issue in Eye & Contact Lens that received an accolade from Contact Lens Spectrum - a leading clinical contact lens information source- as the "Contact Lens Event of the Year." http://www.clspectrum.com/articleviewer.aspx?articleID=107845
Presentations
J.A. Green (2012), “Silicone Hydrogel Lens Groupings and Testing Strategies.” Contact Lens Association of Ophthalmologists Invited Lecture, Las Vegas, Nevada
J.A. Green (2010), “Increasing the Safety Margin for Contact Lens Wearers by Enhancing the Disinfection Efficacy Testing of Lens Care Products.” FDA Commissioner’s Fellow Mid-Program Presentation Lecture, Silver Spring, MD
Shanil Haugen, Ph.D. (CDRH Fellow)
Publication
Haugen, Duraiswamy, Hitchins. Quantification by mass of residual debris in reusable medical devices. Horizons, 2012.
Mark Kreitz, Ph.D. (CDRH Fellow)
Posters
Lopez O, Pritchard W, Rad D, Bryant N, McDowell B, Kreitz M, Esparza J, Karanian JW. Geometric Characterization of Coronary Artery Bifurcations in Swine: Towards Improved Preclinical-Testing of Stents to Treat Coronary Bifurcation Lesions. Cardiovascular Research Technologies. 2011 (CRT2011). Washington, D.C.
Lopez O, Rad D, Bryant N, McDowell B, Kreitz M, Pritchard W, Karanian JW. Geometric Characterization of Coronary Artery Bifurcations in Swine: Towards Improved Preclinical-Testing of Stents to Treat Coronary Bifurcation Lesions. 2nd International Conference on Computational and Mathematical Biomedical Engineering 2011 (CMBE2011). Fairfax, VA.
Karanian J, Kreitz M, Lopez O, Chiesa OA, Pritchard WF. The Pharmacokinetics of Anti-proliferative Drugs From Catheter-Based Local Drug Delivery Systems. What are the Determinants of Safety and Efficacy? Transcatheter Cardiovascular Therapeutics 2010 (TCT2010). Washington, D.C.
Lopez O, Rad R, McDowell B, Dreher M, Nagaraja S, Kreitz M, Esparza J, Chiesa OA, Pritchard WF and Karanian JW. Quantitative Evaluation of Vascular Deformation and Implant Performance: Stent Design, Implant Configuration and Implant Site. FDA/NHLBI/NSF Workshop on Computer Methods for Cardiovascular Devices 2010 (WCMCD2010). Rockville, MD.
Karanian JW, Lopez O, Rad D, McDowell B, Kreitz M, Esparza J, Chiesa OA and Pritchard WF. Characterization of Vascular Implant Sites by Localized Quantitative Mapping of Vascular Geometry. FDA/NHLBI/NSF Workshop on Computer Methods for Cardiovascular Devices 2010 (WCMCD2010). Rockville, MD.
McDowell B, Kreitz M, Breton M, Lopez O, Rad D, Nagaraja S, Dreher M, Vossoughi J, Wood B, Chiesa OA, Karanian JW, Pritchard WF. Imaging and Analytical Tools in Biomedical Research: Stent Evaluation Case. Southern Biomedical Engineering Conference 2010 (SBEC2010). University of Maryland, College Park, MD.
Pritchard WF, Kreitz M, Lopez O, Rad D, McDowell B, Nagaraja S, Dreher M, Esparza J, Vossoughi J, Chiesa OA, Karanian JW. The Role of Imaging Tools in Biomedical Research: Preclinical Stent Implant Study. Southern Biomedical Engineering Conference 2010 (SBEC2010). University of Maryland, College Park, MD.
Haughey R, Kreitz M, Seward K, Desai P, Lopez O, Esparza J, Chiesa OA, Pritchard WF, Karanian JW. Comparison of Drug Distribution and Delivery Efficiency Following Transcatheter Perivascular Administration in Four Arteries. FDA Summer Symposium 2010. Silver Spring, MD. (not peer-reviewed)
Chiplis A, Adams C, Rad D, McDowell B, Lopez O, Kreitz M, Esparza J, Chiesa OA, Pritchard WF and Karanian JW. Prediction of Arterial Dimensions Using Noninvasive Measurements of Skeletal Structures. FDA Summer Symposium 2010. Silver Spring, MD. (not peer-reviewed)
Zviman A, Lopez O, Rad D, McDowell B, Kreitz M, Chiesa OA, Karanian JW, Pritchard WF. Computational Analysis of Vascular Kinematics and Deformation. FDA Summer Symposium 2010. Silver Spring, MD. (not peer-reviewed)
Saberi N, Lopez O, Kreitz M, Esparza J, Chiesa OA, William F. Pritchard WF and Karanian JW. Development of a Relational Database System to Standardize and Manage Data Collection in Preclinical Studies of Interventional Therapies. FDA Summer Symposium 2010. Silver Spring, MD. (not peer-reviewed)
Karanian JW, Kreitz M, Seward K, Desai P, Virmani R, Lopez O, Chiesa OA, Pritchard WF. Drug Retention in the Coronary and Femoral Arteries is Dependent on the Route of Administration in Swine: Intimal and Adventitial Endovascular and Systemic Pharmacokinetics and Toxicology with Nanoparticle Albumin Bound-Paclitaxel. Cardiovascular Research Technologies 2010 (CRT2010). Washington, D.C.
Karanian JW, Lopez O, Nagaraja S, Dreher M, Constante E, McDowell B, Rad D, Kreitz M, Chiesa OA and Pritchard WF. Predictors of Stent Fracture in a Swine Model: Role of Implant Site, Implant Material and Musculoskeletal Motion. Cardiovascular Research Technologies 2010 (CRT2010). Washington, D.C.
Sylva Krizan, Ph.D. (CBER/CDRH Regenerative Medicine Fellow)
Publication
S.J. Krizan, B. Schneider, J.T. Thomas, E. Frank. Cartilage Repair and Replacement in the Knee: A Regulatory Perspective. Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland. Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland. Advances in Orthopedics, May 2012.
Eric Landis, Ph.D. (CVM Fellow)
Publication
Turner JW, Paranjpye RN, Landis ED, Biryukov SV, González-Escalona N, et al. (2013) Population Structure of Clinical and Environmental Vibrio parahaemolyticus from the Pacific Northwest Coast of the United States. PLoS ONE 8(2): e55726. doi:10.1371/journal.pone.0055726.
Presentations
Eric D. Landis and Jennifer Matysczak (2011) Scientific Considerations in the Evaluation of Effectiveness Trials for Antiparasitic Drug Claims. Aquaculture America, New Orleans, LA.
Mark S. Strom, Rohinee N. Paranjpye, and Eric D. Landis (2010) Population Structure Analysis of Vibrio parahaemolyticus in the U.S. Pacific Northwest. Aquaculture 2010, San Diego, CA.
Eric D. Landis and Mark S. Strom (2009) Suppressive Subtractive Hybridization reveals differences between Vibrio parahaemolyticus isolates from the Puget Sound region and the pandemic strain. 101st Annual Meeting of the National Shellfisheries Association, Savannah, GA.
Hyung-yul Lee, Ph.D. (NCTR Fellow)
Publications
Lee, H.-y., Inselman, A.L., Kanungo, J. and Hansen, D.K. Alternative models in developmental toxicology. Sys. Biol. Reprod. Med. 58:10-22, 2012 [PMID: 22239077].
Inselman AL, Hansen DK, Lee HY, Nakamura N, Ning B, Monteiro JP, Varma V, Kaput J 2011 Assessment of research models for testing gene-environment interactions, Euro J of Pharm. Sep;668 Suppl. 1:S108-163
Poster Presentations
ABI-NCTR Joint Workshop on Stem Cells, Little Rock, AR, Apr., 2010
Annual meeting of South Central Chapter of the Society of Toxicology. Mississippi State, MS. October 14-15, 2010.
Mark Levi, Ph.D. (NCTR Fellow)
Publications
Mark S. Levi, Ralph E. Patton, Joseph P. Hanig, Karen M. Tranter, Nysia I. George, Laura P. James, Kelly J. Davis, John F. Bowyer, Serum myoglobin, but not lipopolysaccharides, is predictive of AMPH-induced striatal neurotoxicity, NeuroToxicology, Volume 37, July 2013, Pages 40-50, ISSN 0161-813X, 10.1016/j.neuro.2013.04.003.
(http://www.sciencedirect.com/science/article/pii/S0161813X13000557)
Bowyer, J.F.; Thomas, M.; Patterson, T.A.; George, N.I.; Runnells, J.A.; Levi, M.S. A Visual Description of the Dissection of the Cerebral Surface Vasculature and Associated Meninges and the Choroid Plexus from Rat Brain. J Vis. Exp. 2012, 69, e4285. doi:10.3791/4285 (2012).
Levi, M.S.; Divine, B.L.; Hanig, J.P.; Doerge, D.R.; Vanlandingham, M.M.; George, N.I.; Twaddle, N.C.; Bowyer, J.F. A Comparison of Methylphenidate, Amphetamine, Methamphetamine-Induced Hyperthermia and Neurotoxicity during the Waking Cycle. Neurotoxicol. Teratol. 2012, 34, 253-262. doi:10.1016/j.ntt.2012.01.007
(http://www.sciencedirect.com/science/article/pii/S0161813X13000557)
Bowyer, J.F.; Thomas, M.; Patterson, T.A.; George, N.I.; Runnells, J.A.; Levi, M.S. A Visual Description of the Dissection of the Cerebral Surface Vasculature and Associated Meninges and the Choroid Plexus from Rat Brain. J Vis. Exp. 2012, 69, e4285. doi:10.3791/4285 (2012).
Levi, M.S.; Divine, B.L.; Hanig, J.P.; Doerge, D.R.; Vanlandingham, M.M.; George, N.I.; Twaddle, N.C.; Bowyer, J.F. A Comparison of Methylphenidate, Amphetamine, Methamphetamine-Induced Hyperthermia and Neurotoxicity during the Waking Cycle. Neurotoxicol. Teratol. 2012, 34, 253-262. doi:10.1016/j.ntt.2012.01.007
Thilak Mudalige, Ph.D. (ORA Fellow)
Publication
Thilak Kumara Mudalige, S.W. Linder, “Development of Screening Methodologies for the Detection of Nanoscale Silver In Perishable Food Products Using Inductively Coupled Plasma Mass Spectrometry (ICP-MS), FDA Laboratory Information Bulletin, # 4514. http://inside.fda.gov:9003/downloads/PolicyProcedures/Laboratories/LaboratoryInformationBulletins/UCM299642.pdf
Erika Pfeiler, Ph.D. (CFSAN Fellow)
Publication
Abdel-Rahman A, Anyangwe N, Carlacci L, Casper S, Danam RP, Enongene E, Erives G, Fabricant D, Gudi R, Hilmas CJ, Hines F, Howard P, Levy D, Lin Y, Pfeiler E, Thurmond TS, Turujman S, Walker NJ. The safety and regulation of natural products used as foods and food ingredients. 2011. Toxicological Sciences. 2011.
Chad Reiter, Ph.D. (CBER Fellow)
Publications
Baek JH, Reiter CE, Manalo DJ, Buehler PW, Hider RC, Alayash AI. Induction of hypoxia inducible factor (HIF-1α) in rat kidneys by iron chelation with the hydroxypyridinone, CP94. Biochim Biophys Acta. 2011 Apr-Jun;1809(4-6):262-8
Reiter CEN and Alayash AI. Effects of carbon monoxide (CO) delivery by a CO donor or hemoglobin on vascular hypoxia inducible factor 1α and mitochondrial respiration. FEBS Open Bio 2012; 2: 113-118.
Poster
Chad E. Reiter, Jeffery L. Miller, and Abdu I. Alayash: Effects of Carbon Monoxide on Vascular Endothelial Cells Under Hypoxia and in the Presence of Cell-Free Hemoglobin and Sickle Red Blood Cells. Presented at the High Blood Pressure Research Symposium, September 2011, Orlando, FL.
Kareen Riviere, Ph.D. (CDER Fellow)
Publications
Riviere K, Kieler-Ferguson HM, Jerger K, Szoka FC. Anti-tumor activity of liposome fluoroorotic acid alone and in combination with liposome irinotecan. Journal of Controlled Release. Epub May 2011.
Duan J, Riviere K, Marroum P. In vivo bioequivalence and f2 similarity factor for dissolution profile comparisons of extended release formulations:How and when do they match? Pharmaceutical Resesearch. 2011; 28:1144-56.
Riviere K, Huang Z, Jerger K, Macaraeg N, Szoka FC. Antitumor effect of folate-targeted liposomal doxorubicin in KB tumor-bearing mice after intravenous administration. Journal of Drug Targeting. 2011; 19:14-24.
Presentations
American Association of Pharmaceutical Scientists, New Orleans, LA Nov 14-18, 2010. Title: Steps Toward Building a Biopharmaceutics Evaluation Tool.
Honggang Wang, M.D., Ph.D. (NCTR Fellow)
Publications
Honggang Wang, William B. Mattes, Patricia Richter, Donna L. Mendrick. (2012) An omics strategy for discovering pulmonary Biomarkers potentially relevant to the evaluation of tobacco products. Biomarkers of Medicine, Dec;6(6):849-60.
Beverly Lyn-Cook, Sulma Mohamme, Cornelius Davis, Honggang Wang and George Hammons. (2010) Gender Differences in Gemcitabine (Gemzar) Efficacy in Cancer Cells: Effect of Indole-3-Carbinol. Anticancer Research. Dec; 30(12):4907-1.
Brooke Whitney, Ph.D. (CVM Fellow)
Publication
Dwivedi, H. P., B. Whitney, L. A. Jaykus. 2012. Epidemiological Surveillance: Tracking Foodborne Pathogens and Their Diseases from Farm-to-Fork. In Omics Technologies and Microbial Modeling in Food-borne Pathogens Study. Editors: Yan, X., Juneja, V., Huang, L. DEStech Publications, Inc. Lancaster, PA.
Presentation
Whitney, B., S. Drake, N. Gonzalez-Escalona, A. DePaola, and L.A. Jaykus. 2011. Molecular typing of Vibrio vulnificus isolates from the Louisiana Gulf Coast. FDA Foods Conference, White Oak, MD.
Beverly Wolpert, Ph.D. (CFSAN Fellow)
Publications
Zheng YL, Amr S, Saleh D, Dash C, Ezzat S, Mikhail NN, Gouda I, Loay I, Hifnawy T, Abdel-Hamid M, Khaled H, Wolpert BJ, Abdel-Aziz MA, Loffredo C. Urinary bladder cancer risk factors in Egypt: a multi-center case-control study. Cancer Epidemiol Biomarkers Prev 2011 Dec 6 [Epub ahead of print; DOI: 10.1158/1055-9965.EPI-11-0589; accessed December 12, 2011 at http://cebp.aacrjournals.org/content/early/2011/12/06/1055-9965.EPI-11-0589.full.pdf.
Wolpert BJ, Amr S, Saleh D, Ezzat S, Gouda I, Loay I, Hifnawy T, Abdel-Hamid M, Mikhail NN, Zhan M, Zheng Y-L, Squibb K, Abdel-Aziz MA, Zaghloul M, Khaled H, Loffredo CA. Associations differ by sex for catechol-O-methyltransferase genotypes and bladder cancer risk in South Egypt. Urol Oncol. 2011 Mar 31. [Epub ahead of print; DOI: 10.1016/j.urolonc.2010.09.007; accessed December 12, 2011 at http://www.sciencedirect.com/science/article/pii/S1078143910002644.
Wolpert BJ, Amr S, Ezzat S, Saleh D, Gouda I, Loay I, Hifnawy T, Mikhail NN, Abdel-Hamid M, Zhan M, Zheng Y-L, Squibb K, Abdel-Aziz MA, Zaghloul M, Khaled H, Loffredo CA. Estrogen exposure and bladder cancer risk in Egyptian women. Maturitas 2010 Aug: online before print at http://www.maturitas.org/inpress (DOI: 10.1016/j.maturitas.2010.07.014).
Presentation
Wolpert B, Amr S, Zheng Y-L, Zhan M, Squibb K, Loffredo CA. Estrogen exposure and bladder cancer risk in Egyptian women. Anaheim, CA: 42nd Annual Society for Epidemiologic Research Meeting (June 23-26, 2009), Spotlight Session Presentation.
Poster
Wolpert B, Amr S, Zheng Y-L, Zhan M, Squibb K, Loffredo CA. Does estrogen exposure contribute to the sex difference in bladder cancer risk? Toronto, ON: Third Annual Meeting of the Organization for the Study of Sex Differences (June 4-6, 2009), Poster.
Wenge (Walter) Xie, Ph.D. (CVM Fellow)
Publication
Quality by Design I: Application of Failure Mode Effect Analysis (FMEA) and Plackett–Burman Design of Experiments in the Identification of “Main Factors” in the Formulation and Process Design Space for Roller-Compacted Ciprofloxacin Hydrochloride Immediate-Release Tablets. AAPS PharmSciTech (# 2012) DOI: 10.1208/s12249-012-9844-x. Raafat Fahmy, Ravikanth Kona, Ramesh Dandu, Walter Xie, Gregg Claycamp, and Stephen W. Hoag.
Dongyi (Tony) Du, M.D., Ph.D. (CDER Fellow)
Publications
Du, D., Zhou, E.H., et al. Atomoxetine Use during a Period of FDA Actions, Medical Care. 2012 Nov;50(11):987-92
Du, D., Goldsmith, J., Aikin, K., et al. The Effects of Direct-to-Consumer Prescription Drug Print Advertising on Patient Reporting of Adverse Events—Has FDAAA made a Difference? Health Affairs, 31(5) (2012):1022-1029
Martha Garcia, Ph.D. (CFSAN Fellow)
Publications
Garcia MC, Amankwa-Sakyi M, Flynn TJ (2011) Cellular glutathione in fatty liver In vitro models. Toxicol. in Vitro 25, 1501-1506.
Presentations
Garcia MC, Flynn TJ (2009) Evaluation of gender differences in response to hepatotoxicants using an in vitro fatty liver cell model. Clinical and Experimental Medical Journal Vol. 3, No.4, pp.556.
Wekell MM, Flynn TJ, Garcia M, Cinar H, Sahu S, Santillo M, Bandele O, Liu Y, Wiesenfeld P, Sprando RL (2010) In vitro alternatives to animal testing. 45th Annual Meeting of the UJNR Joint Panel on Toxic Microorganisms, Seattle, WA.
Posters
Garcia MC, O’Donnell MW, Flynn TJ (2009) The development of an in vitro fatty liver model to evaluate hepatotoxicity. CFSAN Science Day, Abstr. #TOX-3.
Garcia MC, Flynn TJ (2010) Study of sex differences on lipotoxicity using an in vitro fatty liver model. FDA Office of Women’s Health Science Day.
Noel Gerald, Ph.D. (CBER Fellow)
Publications
Gerald, N., et al. 2011. Protection from experimental cerebral malaria with a single dose of radiation-attenuated, blood-stage Plasmodium berghei parasites. PLoS One. 6(9):e24398
Oakley, M.S., Gerald, N., et al. 2011. Clinical and molecular aspects of malaria fever. Trends Parasitol. 27(10):442-9
Gerald, N., Mahajan, B., Kumar, S. 2011. Mitosis in the human malaria parasite Plasmodium falciparum. Eukaryotic Cell, 10: 474-482
Oakley, M.S., Majam, V., Mahajan, B., Gerald, N., Anantharaman, V., Ward, J.M., Faucette, L.J., McCutchan, T.F., Zheng, H., Terabe, M., Berzofsky, J.A., Aravind, L., Kumar, S. 2009 Pathogenic roles of CD14, galectin-3, and OX40 during experimental cerebral malaria in mice. PLoS One, 4(8):e6793.
Mahajan, B., Selvapandiyan, A., Gerald, N.J., Majam, V., Zheng, H., Tiwari, J., Fujioka, H., Moch, J.K., Kumar, N., Nakhasi, H.L., and Kumar, S. 2008. Centrins, cell cycle regulation proteins in Human malaria parasite Plasmodium falciparum. J. Biol.Chem., 283(46):31871-83.
Gerald, N.J., Coppens, I., and Dwyer, D.M. 2008. Molecular characterization and expression of a novel kinesin which localizes with the kinetoplast in the human pathogen, Leishmania donovani. Cell Motil.Cyt., 65:269-80.
Presentation
"Evaluation of a Radiation Attenuated, Blood-Stage vaccine Against Malaria in the Murine Plasmodium berghei model." Division seminar series. FDA CBER/OBRR/Division of Emerging Transfusion Transmitted Diseases, Bethesda, MD. 2/2010.
Maria-Teresa Gutierrez-Lugo, Ph.D. (CDER Fellow)
Publications
Gutierrez‐Lugo, M.T. and Bewley C. Susceptibility and mode of binding of the Mycobacterium tuberculosis cysteinyl transferase mycothiol ligase to tRNA synthetase inhibitors. Bioorganic & Medicinal Chemistry Letters. 2011; 21, 2480‐2483.
Gutierrez‐Lugo, M.T. Baker, H., Shiloach, J., Boshoff, H. and Bewley C. Dequalinium, a New Inhibitor of Mycobacterium tuberculosis Mycothiol Ligase Identified by High‐Throughput Screening. J Biomol Screen. 2009; 14 (6) 643‐652.
Gutierrez‐Lugo M.T. and Bewley, C. Natural Products, Small Molecules and Genetics in tuberculosis Drug Development. J Med Chem. 2008; 51 (9); 2606‐2612.
Abstracts and Presentations
Gutierrez‐Lugo, M. T. Comparability after Manufacturing Changes. 45th National Conference of Pharmaceutical Sciences, Ixtapa, Mexico, October 24, 2011.
Gutierrez‐Lugo, M.T., Antibiotic detoxification enzymes as tuberculosis drug targets. Division of Therapeutic Proteins. CDER/FDA. Bethesda, MD, March 2010.
Gutierrez‐Lugo, M.T., Baker, H. and Bewley, C. Binding epitope of a mycothiol‐S‐conjugate bound to Mycobacterium tuberculosis mycothiol‐S‐conjugate amidase and a model of its conformation at the active site. Gordon Research Conferences in Bioorganic Chemistry. Andover, NH, 2008 (Poster paper).
Paramjeet Kaur, Ph.D. (CDER Fellow)
Abstracts
P. Kaur, C. S. Chaurasia, S. H. Haider, R. Lionberger, L. X. Yu, D. P. Conner, and B. M. Davit. New US-FDA Bioequivalence Approaches for Generic Drug Products – J. Pharm. Pharm. Sci. 13(3), 2010
P. Kaur, B. M. Davit, D. P. Conner, and C. S. Chaurasia. A Reviewer’s Perspective on FDA Guidance on Bioequivalence Studies for Specific Drug Products – AAPS Journal, 11(S2), 2009
P. Kaur, B. M. Davit, and C. S. Chaurasia. Current Challenges Faced by Office of Generic Drugs in Recommending Optimal Bioequivalence Studies for Locally Acting Gastrointestinal Drugs – J. Clin. Pharmacol. 49 (9), 2009
Caitilin Hamill, Ph.D. (CBER/CDRH Regenerative Medicine Fellow)
Publication
“Considerations for Tissue Engineered and Regenerative Medicine Product Development Prior to Clinical Trials.” Lee MH, Arcidiacono JA, Bilek AM, Wille JJ, Hamill CA, Wonnacott KM, Wells MA, Oh SS. Tissue Eng Part B Rev. 2009 Sep 3.
Francesca Joseph, M.D. (CDRH Fellow)
Publication
Patel-Ramen SM, Chen EA, Joseph FD. Chapter 23 "Role of Government Agencies in Mechanical Circulatory Support-FDA". Kromos RL & Miller LW Eds. Mechanical Circulatory Support: A Companion to Braunwald's Heart Disease. Saunders, Philadelphia 2012.
Presentation
"Designing Small Clinical Trials" - NIH/PumpKIN contractors' meeting, Dec. 2011.
Lester "Jao" Lacorte, M.D., CCRP (CDRH Fellow)
Publications
Lacorte J, Chaudry A, Chan P, Wana J, (CTP and DHHS-Asian American Health Initiative). Tobacco Awareness and Your Health e-paper in Epoch Times Archives, pg. 9 of 32,March 26, 2012 and India This Week, April 27, 2012.
Oral Presentations
Lacorte J and Rudy S, “Intro to FDA’s Center for Tobacco Products (CTP) & Ensuring Human Subjects Protection in Clinical Tobacco Trials” Public Responsibility in Research and Medicine (PRIM&R) Conference, Dec 4, 2012.
Lacorte J, “An Introduction to FDA/CTP and its Role in Protecting Public Health”, George Mason University, Fairfax, Virginia, April 11, 2012.
Lacorte J, “CDRH ACE Program and An Intro to Medical Device Regulation” organized conference and presented, Stanford University, September 28, 2010.
Lacorte J, “How Does FDA Regulate Medical Devices?” Society of Clinical Research Associates (SoCRA) Chapter Meeting, Kaiser Permanente, Rockville, MD, June 9, 2010.
Lacorte J, “The US FDA Medical Device & Device-Drug Combination Product Inspection Experience in Emerging Markets” Drug Information Association (DIA) 22nd Annual Euro Meeting, Monaco, March 9, 2010.
Lacorte J, “Intro to FDA’s Clinical Research Review Process” Catholic University, Feb 24, 2010
Lacorte J, “An Intro to Medical Device Research: An Academic Centers for Excellence (ACE) Program” University of Medicine and Dentistry-Robert Wood Johnson Medical School, NJ, Dec 9, 2009
Lacorte J, “How Does FDA Regulate Medical Devices?” University of Pittsburgh IRB, Oct 23, 2009.
Web-based presentations
Lacorte J, on-line educational CDRH LEARN video: “Good Clinical Practice 101: An Introduction” Aug 2009. http://fda.yorkcast.com/webcast/Viewer/?peid=477af877491747379c36c4ab1c7421b9
Kiet Nguyen, Ph.D. (NCTR Fellow)
Publications
Tolleson, W.H., Jackson, L.S., Triplett, O.A., Aluri, B., Cappozzo, Banaszewski, J.K., Chang, C. and Nguyen, K.T. Chemical inactivation of protein toxins on food contact surfaces. Journal of Agricultural and Food Chemistry, 60: 6627-6640, 2012.
Tran, Q.T., Nawaz, M.S., Deck, J., Nguyen, K.T., and Cerniglia, C.E. (2011) “Plasmid-mediated quinolone resistance in Pseudomonas putida isolated from imported shrimp.” Applied Environmental Microbiology 77(5): 1885-7.
Tran, Q.T., Nawaz, M.S., Deck, J., Foley, S. Nguyen, K.T., Cerniglia, C.E. (2011) “Detection of Type III Secretion System Virulence and Mutations in gyrA and parC Genes Among Quinolone-Resistant Strains of Pseudomonas aeruginosa Isolated from Imported Shrimp.” Foodborne Pathog Dis 8(3): 451-3.
Posters
Nayak, R., Owens, K., Nguyen K., Tolleson, W., and Stefanova, R. Genetic Diversity of E. coli O157:H7 Antigenic Variants from Humans and Assessment of their Pathogenicity, Drug Resistance and Cytotoxicity. Presented at the 2009 Annual Meeting of the American Society of Microbiology, Philadelphia, PA. (Poster)
Nguyen, K.T., Melchior, W.B., Tolleson, W.H. Detecting the adenosine N-glycosidase enzyme activity of ribosome-inactivating protein toxins using a quantitative PCR assay method with a synthetic oligo-2’-deoxyribonucleotide substrate. Presented at the 2010 Annual Meeting of the Society of Toxicology, Salt Lake City, UT. (Poster)
Triplett, O.A., Nguyen, K.T., Jackson, L.S., and Tolleson, W.H. Inactivation of ricin cytotoxic activity by peracetic acid and sodium hypochlorite. Presented at the 2010 Annual Meeting of the Society of Toxicology, Salt Lake City, UT. (Poster)
Tolleson, W.H., Triplett, O.A., Nguyen, K.T., and Jackson, L.S. Influence of pH on the kinetics of chemical inactivation for abrin and ricin. Presented at the 2010 Annual Meeting of the Society of Toxicology, Salt Lake City, UT. (Poster)
Nguyen, K., Mugengana, A., Tolleson, W.H., and Melchior, W.B. Characterization of Shiga-like Protein Toxins I and II from Escherichia coli O157:H7. Presented at the 2011 Annual Meeting of the Society of Toxicology, Washington, DC. (Poster)
Mugengana, A., Nguyen, K., Tolleson, W.H., and Melchior, W.B. Characterization of Shiga-like Protein Toxins I and II from Escherichia coli O157:H7. Presented December 2011 at the Arkansas Chapter Meeting of the American Chemical Society, Hendrix University, Conway, AR. (Poster)
Tolleson, W.H., Triplett, O.A., and Nguyen, K.T. Differential scanning microcalorimetry to investigate the thermal stability of protein toxins. Presented April 11, 2012 at the NCTR/ARL Food Safety Conference, Jefferson, AR. (Poster)
Kirk Prutzman, Ph.D. (CBER Fellow)
Publication
Spadaccini, A., Ni, Y., Virnik, K., Prutzman, KC., Berkower, I. Expression of foreign genes by a live rubella virus vector. Vaccine 2010 Feb 3; 28(5): 1181-1187.
Bakary J. Sonko, Ph.D. (NCTR Fellow)
Publications
Schnackenberg L.K., Sun J., Pence L., Bhattacharyys S., Sonko B.J., Beger R.D. Metabolomics for Personalized Nutrition Research and Clinical Applications: A 2010 Update. Current Pharmacogenomics and Personalized Medicine 2010. 8:202-217.
Sonko BJ, Schmitt TC, Guo L, Shi Q, Boros LG, Leakey JEA, Beger RD. Assessmentof usnic acid toxicity in rat primary hepatocytes using 13C metabolic flux measuring techniques. Food and Chemical Toxicology 2011.49: 2968-2974.
Posters
B. Sonko, L Guo, T. Schmitt, J. Leakey, L. Boros, and R. Beger. In vitro usinic acid concentration/Time Dependency Toxicity evaluation. 49th SOT 2010.
Sonko B.J., Schmitt T., Boros L., Sakar S., Syed A., and Beger R. Effect of chronic MPTP administration on glycolysis and TCA cycle pathways in mouse model of parkinson’s disease. Abstract: 26th International Neurotoxicology Conference, Portland Oregon, June 6-10, 2010.
Cynthia Stine, Ph.D. (CVM Fellow)
Publications
Stine CB, R Reimschuessel, CM Gieseker, ER Evans, TD Mayer, NR Hasbrouck, E Tall, J Boehmer, G Gamboa da Costa, J Ward. 2011. A no observable adverse effect level (NOAEL) for pigs fed melamine and cyanuric acid. Regulatory Toxicology and Pharmacology. 60(3): 363-372.
Andersen W, S Turnipseed, C Karbiwnyk, E Evans, N Hasbrouk, T Mayer, C Gieseker, C Nochetto, C Stine, R Reimschuessel. 2011. Bioaccumulation of melamine in catfish muscle following continuous, low-dose, oral administration. Journal of Agricultural and Food Chemistry. 59(7): 3111-7.
Reimschuessel R, ER Evans, CB Stine, N Hasbrouck, TD Mayer, C Nochetto, CM Gieseker. 2010. Renal crystal formation after combined or sequential administration of melamine and cyanuric acid. Food and Chemical Toxicology. 48(10): 2898-2906.
Abstracts
Nochetto C, CB Stine, NG Rummel, DN Heller and R Reimschuessel. 2009. Simultaneous determination and confirmation of melamine and cyanuric acid in fish kidneys. 238th American Chemical Society National Meeting & Exposition, Washington, DC, August 16-20.
Reimschuessel R, ER Evans, CB Stine, TD Mayer, NR Hasbrouck and CM Gieseker. 2009. Fish: A nonmammalian model for determining a “No Observable Effect Level” (NOEL) for crystal formation in kidneys after exposure to melamine and cyanuric acid. 238th American Chemical Society National Meeting & Exposition, Washington, DC, August 16-20.
Presentations
Reimschuessel R, ER Evans, CB Stine*, TD Mayer, NR Hasbrouck and CM Gieseker. 2009. A ‘No observable effect level’ (NOEL) for renal crystal formation following exposure to melamine and cyanuric acid. 34th Annual Eastern Fish Health Workshop, Lake Placid, NY, April 27-30. *Presented
R Reimschuessel, CM Gieseker, ER Evans, CB Stine*, TD Mayer, NR Hasbrouck, C Nochetto, E Tall and J Ward. 2010. Fish and pig models of melamine toxicity. 147th American Veterinary Medical Association Annual Convention. Atlanta, GA, July 31-August 3. *Presented
Posters
CB Stine, J Ward, R Sprando, G Gamboa da Costa, S Rasmussen and R Reimschuessel. 2011. Melamine research at FDA: A model for the new FDA Foods Program. 1st Annual FDA Foods Program Science and Research Conference, White Oak, MD, June 21-22. Poster.
RL Sprando, R Reimschuessel, CB Stine, T Black, N Olejnik, M Scott, Z Keltner, O Bandele, S Yachetti, A Tkachenko, K Woodling, L Loukotkova, G Gamboa da Costa. 2011. Combined melamine and cyanuric acid exposure assessment: Gavage vs. feeding. 1st Annual FDA Foods Program Science and Research Conference, White Oak, MD, June 21-22. Poster.
RL Sprando, R Reimschuessel, CB Stine, N Olejnik, M Scott, S Yachetti, CM Gieseker, ER Evans, NR Hasbrouck, TC Crosby and T Black. 2011. Exposure to high doses of melamine alone induces the formation of renal crystals. 1st Annual FDA Foods Program Science and Research Conference, White Oak, MD, June 21-22. Poster.
CB Stine, J Ward, C Gieseker, ER Evans, T Mayer, N Hasbrouck, E Tall, C Nochetto and R Reimschuessel. 2010. No observable adverse effect levels (NOAELs) for fish and pigs fed melamine and cyanuric acid. Sixth International Symposium on Aquatic Animal Health, Tampa, FL, Sept 5-10. Poster.
Haihao Sun, M.D., Ph.D. (OC Fellow)
Publications
Haihao Sun (representing the Office of Pediatric Therapeutics and Pediatric and Maternal Health Staff): “Why some pediatric trials were not successful: lessons learned”. This article was published in AAP News, April, 2012.
Haihao Sun, et al: “Migraine Therapeutics in Adolescents: A Systematic Analysis Where It has Taken Us and What We Have Learned” JAMA Pediatrics 2013 Jan 28:1-7. doi: 10.1001/jamapediatrics.2013.872.
Published abstracts
Haihao Sun et al: published abstract in 2012 PAS Annual Meeting, “Migraine Therapeutics in Adolescents: A Systematic Analysis Where It has Taken Us and What We Have Learned”
Haihao Sun et al: published abstract in 2012 PAS Annual Meeting, “Impact of Supplementing Infant Formula with long-chain polyunsaturated fatty acids: A Systematic Literature Review”
Haihao Sun et al: published abstract in 2012 PAS Annual Meeting, “Review of Alternative Endpoints and Activity Indices Used in the Pediatric Ulcerative Colitis Trials”
Presentations
Haihao Sun et al: “why some pediatric trials were successful and some were not---Lessons learned” (a topic symposium in 2013 Pediatric Academic Societies Annual Meeting on May 7, 2013, in Washington, DC)
“The Experience that I have gained from the FPOD program and how I will apply it to the FDA’s mission” on December 11, 2012 at the FDA (Author: Haihao Sun, MD, PhD).
“Evidence-based strategy for engaging targeted African regulatory authorities to support the Food Safety Modernization Act” on December 7, 2012 at the FDA (Authors: Haihao Sun, MD, PhD, Beverly Corey, DVM; Grace Ramafi, PhD).
Delivered a speech to the South African Government in Pretoria, South Africa (Representing the US government): “Overview of the OPT and FDA’s pharmacovigilance structure” on November 1, 2012. (Author: Haihao Sun, MD, PhD).
Representing the FDA, delivered a speech the CDC colleagues stationed at Pretoria, South Africa: “Overview of the OPT and FDA’s pharmacovigilance structure” on November 9, 2012. (Author: Haihao Sun, MD, PhD).
Platform presentation “Migraine Therapeutics in Adolescents: A Systematic Analysis Where It has Taken Us and What We Have Learned” in the Pediatric Academic Societies 2012 Annual Meeting in Boston, MA on May 1st, 2012. This paper was accepted for the publication by the JAMA Pediatric in May, 2012. (Author and co-authors: Haihao Sun, MD, PhD; Eric Bastings, MD; Jean Temeck, MD; Brian Smith, MD; Angela Men, MD; Veneeta Tandon, PhD; Dianne Murphy, MD; William Rodriguez, MD, PhD).
Platform presentation “Impact of Supplementing Infant Formula with long-chain polyunsaturated fatty acids: A Systematic Literature Review” in the Pediatric Academic Societies 2012 Annual Meeting in Boston, MA on April 30th, 2012 (Author and co-authors: Haihao Sun, MD, PhD; William Rodriguez, MD, PhD; Brian Smith, MD, Wiley Chambers, MD, Dianne Murphy, MD).
Poster presentation “Review of Alternative Endpoints and Activity Indices Used in the Pediatric Ulcerative Colitis Trials” in the Pediatric Academic Societies 2012 Annual Meeting in Boston, MA on April 30th, 2012 (Author and co-authors: Haihao Sun, MD, PhD, Catherine S Lee, DrPH, Jessica J Lee, MD, Robert M Nelson, MD, PhD, Hari C Sachs, MD, William J Rodriguez, MD and Andrew E Mulberg, MD).
Jeremiah Wille, D.Sc. (CDRH Fellow)
Publication
“Considerations for Tissue Engineered and Regenerative Medicine Product Development Prior to Clinical Trials.” Lee MH, Arcidiacono JA, Bilek AM, Wille JJ, Hamill CA, Wonnacott KM, Wells MA, Oh SS. Tissue Eng Part B Rev. 2009 Sep 3.
Juandria Williams, Ph.D. (CDER Fellow)
Presentation
Williams,J.,Wu,H.,etal.“TheinsituAnalysisandCharacterizationofthe Coprecipitationofa ModelDrugandPolymer,”AIChE2009AnnualMeeting, Nashville,Tennessee,November 2009.
Maocheng (Tony) Yang, Ph.D. (CVM Fellow)
Publication
Peters SM, Yancy H, Deaver C, Jones YL, Kenyon E, Chiesa OA, Esparza J, Screven R, Lancaster V, Stubbs JT 3rd, Yang M, Wiesenfeld PL, Myers MJ (2012). In vivo characterization of inflammatory biomarkers in swine and the impact of flunixin meglumine administration. Vet Immunol Immunopathol. 148(3-4):236-42.
Donglei Yu, Ph.D. (CVM Fellow)
Publications
Badar Shaikh, Nathan Rummel, Donglei Yu, Charles Gieseker, Eric Evans, Nicholas Hasbrouck and Renate Reimschuessel. Marker residue determination of tritium labeled ivermectin in the muscle tissues of aquacultured largemouth bass, hybrid striped bass and yellow perch following oral treatment. Journal of Agriculture and Food Chemistry, 60 (18), 4465–4470 (2012).
Donglei Yu, Eric Evans, Nicholas Hasbrouck, Renate Reimschuessel and Badar Shaikh. Residue depletion of albendazole and its metabolites in aquacultured yellow perch (Perca flavescens). Journal of Veterinary Pharmacology and Therapeutics, 35 (6), 560-562 (2012).
Donglei Yu, Nathan Rummel and Badar Shaikh. Development of a method to detect albendazole and its metabolites in the muscle tissue of yellow perch using liquid chromatography with fluorescence detection. Journal of AOAC International, 94(2), 446-452 (2011).
Posters
Badar Shaihk, Nathan Rummel, Donglei Yu, Charles Geiseker, Eric Evans, Nicholas Hasbrouck and Renate Reimschuessel. “Marker Residue Determination of Tritium Labeled Ivermectin in the Muscle Tissues of Aquacultured Largemouth Bass, Hygrid Striped Bass and Yellow Perch Following Oral Treatment”, FDA 2nd Annual Foods Program Science and Research Conference, August 1 – 2, Silver Spring, MD.
Badar Shaihk, Nathan Rummel, Donglei Yu, Charles Geiseker, Eric Evans, Nicholas Hasbrouck and Renate Reimschuessel. “Marker Residue Determination of Tritium Labeled Ivermectin in the Muscle Tissues of Aquacultured Largemouth Bass, Hygrid Striped Bass and Yellow Perch Following Oral Treatment”, Aquaculture America 2012 Conference, February 29 – March 2, Las Vegas, NV.
Donglei Yu, Eric R Evans, Nicholas Hasbrouck, Badaruddin Shaikh. “Residue depletion of tritium-labeled ivermectin in yellow perch following oral administration” Florida Pesticide Residue Workshop, July 17 – 21, St. Pete Beach, FL
Donglei Yu, Eric R Evans, Nicholas Hasbrouck, Nathan Rummel, Renate Reimschuessel and Badar Shaikh. “Metabolism and Residue Depletion of Albendazole in Yellow Perch” 42th ACS Middle Atlantic Regional Meeting (MARM), March 21 – 24, 2011, College Park, MD.
Donglei Yu, Eric R Evans, Nicholas Hasbrouck, Nathan Rummel, Renate Reimschuessel and Badar Shaikh. “Marker Residue of Albendazole in Yellow Perch” FDA 1st Annual Foods Program Science and Research Conference, June 21 – 22, Silver Spring, MD.
Donglei Yu, Nathan Rummel and Badar Shaikh. “Determination of Albendazole and Its Metabolites in the Muscle Tissue of Yellow Perch Using Liquid Chromatography with Fluorescence Detection” 239th ACS national meeting, March 21 – 25, 2010, San Francisco, CA.
-
-
