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  1. Commissioner's Fellowship Program

FDA Commissioner's Fellows Publication and Presentation Citations

Fellows

FDA is proud of the outstanding contributions its Commissioner's Fellows have made to the Agency and to the field of Regulatory Science. Since the program's inception, our graduates have produced 192 publications during their tenure as Fellows, based on their work in the program. They've also represented FDA with 254 regulatory science presentations, and authored or co-authored 917 reviews, ranging from original applications to supplements. We are pleased to provide their publication and presentation citations below.

Class of 2015 Publication and Presentation Citations

Sandy Ying-Hsin Hsieh (ORA Fellow)

Publications

Hsieh, Y-H, Simpson, S., Kerdahi, K., and Sulaiman, I.M.. A comparative evaluation study of growth conditions for culturing sixteen unique Campylobacter spp. Curr Microbiol. 2017 Sep 8. doi: 10.1007/s00284-017-1351-6.

Hsieh, Y-H, Wang, F., Moura, H., Miranda, N., Simpson, S., Barr, J., Kerdahi, K., and Sulaiman, I.M.. Application of MALDI-TOF MS systems in rapid identification of Campylobacter species of public health importance. J AOAC Int. 2017 Sep 12. doi: 10.5740/jaoacint.17-0266.

Presentations

Hsieh, Y-H., Simpson, S., Kerdahi, K., and Sulaiman, I.M. (2016). Evaluation of various media and comparison of growth conditions for ideal cultivation of Campylobcater spp. 65th ASTMH General Meeting, Atlanta, GA.

Hsieh, Y-H., and Sulaiman I.M. (2017). Evaluation of various media and comparison of growth conditions for ideal cultivation of Campylobcater spp. 31th SSAOAC Annual Meeting, Atlanta, GA.

Chia-Wen Hsu (CDER Fellow)

Presentations

Integrative systems approaches to repurposing drugs for treating Ebola virus disease, Gordon Research Conference on Drug Safety, June 27, 2016.

Integrative systems approaches to repurposing drugs for treating Ebola virus disease, FDA Scientific Computing Day, September 27, 2016.

Strategic drug repurposing via synergistic combinations for Ebola and Zika virus diseases using systems, pharmacology approaches, Office of Clinical Pharmacology Science Day, December 8, 2016.

Lakshmi Kannan (CDRH Fellow)

Publication

The Traumatic Brain Injury Endpoints Development (TED) Initiative: Progress on a Public-Private Regulatory Collaboration to Accelerate Diagnosis and Treatment of Traumatic Brain Injury. Manley GT et al. J Neurotrauma. 2017 Mar 31.

Presentations

  1. TED TBI consensus conference, Bethesda, MD. (2017) Panel
  2. Military Health System Research Symposium, Orlando, FL. (2016) Oral
  3. Stakeholder meeting with TED/TRACK TBI investigators, Fort Detrick, MD. (2016) Panel
  4. Neurotrauma Society Meeting, Lexington, KY. (2016) Panel
  5. TED’s Critical Path Institute meeting with CDER & CDRH, White Oak, MD. (2016) Panel
  6. FDA Biomarker Workshop Meet & Greet, White Oak, MD. (2016) Poster
  7. 6th Annual Traumatic Brain Injury Conference, DC. (2016) Attended
  8. TED initiative- Government Steering Committee Meeting, Fort Detrick, MD (2016) Panel
  9. FDA TBI public workshop, White Oak, MD. (2016) Oral
  10. PHEMCE Stakeholder meeting, Bethesda, MD. (2016) Attended
Flavia Morales (ORA Fellow)

Presentations

Morales-García, F., Development of Mass Spectrometry Based Methods for the Determination of Adulterants in Dietary Supplements, FDA Commissioner’s Fellow Program Graduation Ceremony, Silver Spring, Maryland, September 11, 2017.

Morales-García, F., D.M. Monroe, J. Hillegas, T.A. Majkol, J.M. Nandrea, F. Song, and A. El-Demerdash, Screening and Quantification of Unapproved Dietary Supplements using Liquid Chromatography with Quadrupole-Orbitrap Mass Spectrometry, 65th ASMS Conference on Mass Spectrometry and Allied Topics, Indianapolis, Indiana, June 5, 2017.

Ryan Ortega (CBER Fellow)

Presentations

Enhancing Regulatory Review of Computational and Mathematical Modeling and Simulation (CMMS) for Regenerative Medicine (RM) Products, Biomedical Engineering Society (BMES) Annual Meeting, 10/8/16.

Enhancing Regulatory Review of Modeling and Simulation for Regenerative Medicine Products, Tissue Engineering and Regenerative Medicine International Society (TERMIS) Annual Meeting, 12/13/16.

Enhancing Regulatory Review of Modeling and Simulation for Regenerative Medicine Products by Developing Best Practices and Test-Case Models, Food and Drug Administration Science Forum, 6/1/17.

Clarence Rolle (ORA Fellow)

Publications

“Computational Approaches on Photon-Attenuation and Coincidence-Summing Corrections for the Detection of Gamma-Emitting Radionuclides in Foods.” C.J. Rolle, III, Z. Lin and S. Healey, App. Radioat.Iso. 2017, (126disclaimer icon),p. 134-137.

Presentations

The 25th Council on Ionizing Radiation Measurements and Standards, in Gaithersburg, MA – ”A Comparison of Computational Approaches for the Detection of Gamma-Emitting Radionuclides in Foods.” (Talk) – April 2017

The 62nd Conference on Radiobioassay and Radiochemical Measurements, in Honolulu, HI – ”A Comparison of Computational Approaches for the Detection of Gamma-Emitting Radionuclides in Foods.” (Talk) – February 2017

Sixth Annual FDA Foods and Veterinary Medicine Science and Research Conference, Silver Spring, MD – ”Computational Approaches on Photon-Attenuation and Coincidence-Summing Corrections for the Detection of Gamma-Emitting Radionuclides in Foods.” (Poster) – October 2016

International Committee for Radionuclide Metrology - Low-Level Radioactivity Measurement

Techniques in Seattle, WA Computational Approaches on Photon-Attenuation and Coincidence-Summing Corrections for the Detection of Gamma-Emitting Radionuclides in Foods (Poster) – September 2016

The 24th Council on Ionizing Radiation Measurements and Standards, in Gaithersburg, MA – “Computational Approaches on Photon-Attenuation and Coincidence-Summing Corrections for the Detection of Gamma-Emitting Radionuclides in Foods.” (Talk) – April 2016

Amanda Windsor (CFSAN Fellow)

Presentations

Taxonomic issues in Callinectes sapidus and “Portunus haanii” and the role of the US FDA in seafood labelling. The Crustacean Society Summer Meeting: July 11, 2016.

Assessment of Molecular Methods to Confirm the Truthful Labeling and Safety of Blue Crab Products Sold in the United States. 6th OFVM Science and Research Conference, October 25, 2016.

Yan Zheng (ORA Fellow)

Publication

Zheng, Y. and Hu, Y. Development of a fast and efficient method for Hepatitis A virus concentration from green onion. J. Virol. Methods.

Presentation

Development of a rapid and efficient method for hepatitis A virus concentration from green, 2017 American Society for Virology Annual Conference, June 25, 2017.

Class of 2014 Publication and Presentation Citations

Sudhakar Agnihothram, Ph.D. (NCTR Fellow)

Publications

Agnihothram, S; Vermudez, S.; Mullis, L.: Townsend, T.; Manjanatha, MG;, and Azevedo MP. Silica Nanopartciles impair host response to virus infection and cause genotoxicity. 2016. Journal of Nanoscience and Nanotechnology 2016, 16, 7720-7730

Agnihothram, S. S.; Basco, M. D.; Mullis, L.; Foley, S. L.; Hart, M. E.; Sung, K.; Azevedo, M. P., Infection of Murine Macrophages by Salmonella enterica Serovar Heidelberg Blocks Murine Norovirus Infectivity and Virus-induced Apoptosis. PLoS One 2015, 10 (12), e0144911.

Presentations

A Novel In-vitro Model System for Screening Host Factors Involved in Norovirus Replication; Azevedo MP, Agnihothram S, Mullis L and Basco M. At 35th Annual Meeting of American Society of Virology, June 2016, Blacksburg, VA.

Silica Nanoparticles Impede Host Response To Virus Infection and Exert Genotoxic Effects In An In Vitro Model Of Calicivirus Replication. Mullis L, Agnihothram S, Vermudez S, Townsend TA, Manjanatha MG, and Azevedo MP. At 35th Annual Meeting of American Society of Virology, June 2016, Blacksburg, VA.

Silicon Dioxide Impedes Antiviral Response and Causes Genotoxic Insult in an In Vitro Model of Calicivirus Replication. Agnihothram S, Vermudez S, Mullis L, Townsend TA, Manjanatha MG, and Azevedo MP. At 55th Annual Meeting of Society of Toxicology, March 2016, New Orelans, Louisiana.

“S.enterica infection of macrophages reduces invitro replication of Murine Norovirus and prevents virus-induced apoptosis; Agnihothram S, Basco M, Mullis L, Foley S, Hart M, and Azevedo MP. At 32nd Clinical Virology Symposium, April 2015, Palm Springs, Florida.

“Evaluation of Virulence in Incompatibility Group FIB Positive Salmonella enterica Isolates”. Cox J, Sanad Y, Thakker R, Agnihothram S, Nayak R and Foley S. At National Center for Toxicological Research, July 2015, Jefferson, Arkansas.

Modulation of Norovirus replication and host response in Macrophages by Silica Nanoparticles”. Vermudez S, Mullis, L, Agnihothram S, Zhang Y, and Azevedo MP (2015). At National Center for Toxicological Research, July 2015, Jefferson, Arkansas.

“Differential Modulation of Norovirus Replication and Host Response in Macrophages by Structural Orthologues of Titanium Nanoparticles”. Azevedo M, Agnihothram S and Mullis L At 32nd Clinical Virology Symposium, April 2015, Palm Springs, Florida.

Yu-Ching Cheng, Ph.D. (CTP Fellow)

Presentation

“Patterns of Use and Characteristics of U.S. Adult Smokeless Tobacco Users: Preliminary Findings from Wave1 of the Population Assessment of Tobacco and Health (PATH) Study; 2016 Epidemiology Congress of Americas (abstract accepted and presented in June 2016).

Yu-Yi Hsu, Ph.D. (CDER Fellow)

Presentations

Authors: Yu-Yi Hsu, Jyoti Zalkikar and Ram C. Tiwari.
Title: Sensitivity Analysis for Prior Specification in Hierarchical Bayesian Approach to Subgroup Analysis.
Conference: DIA/FDA Statistics 2015 Forum (Poster).
Date: 04/20/2015

Authors: Jonathan G. Levine, Yu-Yi Hsu and Ram Tiwari
Title: Web-based application of likelihood ratio test (LRT) based method in openFDA.
Conference: FDA 2015 Scientific Computing Day (Poster, FDA internal)
Date: 09/08/2015

Authors: Yu-Yi Hsu, Jonathan G. Levine, Jyoti Zalkikar, and Ram C. Tiwari
Title: FDA FAERS data in openFDA ant its application to the signal detection methods.
Conference 2016 Joint Statistical Meeting (Poster)
Date: 08/01/2016

Catherine McCollum, Ph.D. (CFSAN Fellow)

Publications

Pinto, C., Kalasekar, S.M., McCollum, C.W., Riu, A., Jonsson, P., Lopez, J., Swindell E., Bouhlatouf, A., Balaguer, P., Bondesson, M. and Gustafsson, J-A. 2016. Lxr regulates lipid metabolic and visual perception pathways during zebrafish development. Mol Cell Endocrinol: 419: 29-43.

Hans, C., McCollum, C.W., Bondesson, M., Shah, S. and Merchant, F.A. 2015. Gradient weighted CO-HOG for analysis of caudal vein structural changes in toxin exposed zebrafish embryo. Conf Proc IEEE Eng Med Biol Soc: 524-527.

Peter Tobin, Ph.D. (CDRH Fellow)

Presentations

CLIA Waiver Processes and Submissions Update, FDA-Industry IVD Roundtable Meeting, November 20, 2015

CLIA Waiver Guidance, Clinical Laboratory Improvement Advisory Committee (CLIAC) Meeting, November 18, 2015

CLIA Processes and Categorizations, AMDM OIR 510(k) Submissions Workshop, April 21, 2015

CLIA Processes and Categorizations, AMDM OIR 510(k) Submissions Workshop, April 18, 2016

Todd Townsend, Ph.D. (NCTR Fellow)

Publications

  1. Townsend TA, Parrish MC, Engelward BP, Manjanatha MG. EpiComet: The Development of a High Throughput Modified Comet Assay for Assessment of Global and Region-Specific DNA Methylation Status. In Preparation, 2016.
  2. Clark CR*, Robinson JY*, Sanchez NS, Townsend TA, Arrieta JA, Merryman DW, Trykall D, Olivey H, Hong CC, Barnett JV. Common pathways regulate type III TGFβ receptor-dependent cell invasion in epicardial and endocardial cells. Cell Signal 28(2016): 688-98, 2016.
  3. Agnihothram SS, Vermudez SA, Mullis L, Townsend TA, Manjanatha MG, Azevedo MP. Silicon Dioxide Impedes Antiviral Response and Causes Genotoxic Insult during Calicivirus Replication. In Press, J Nanosci Nanotech 16(7):7720-7730, 2016.
  4. Li H-F, Shelton SD, Townsend TA, Mei N, Manjanatha MG. Evaluation of cII gene mutations in the brains of Big Blue mice exposed to acrylamide and glycidamide in drinking water. In Press/Accepted, J. Toxicol. Sci., 2016.
  5. Agnihothram SS, Mullis L, Townsend TA, Watanabe F, Mustafa T, Biris A, Manjanatha MG, Azevedo MP. Titanium Dioxide Nanoparticles Evoke Proinflammatory Response during Murine Norovirus Infection Despite Having Minimal Effects on Virus Replication. Submitted, 2016.
  6. Agnihothram SS, Townsend TA, Mullis L, Manjanatha MG, Azevedo MP. Exposure of Lung Epithelial Cells to Multiple Nanoparticles Enhances Genotoxic Potential of Murine Hepatitis Virus. In Preparation, 2016.
  7. Chen Q-Z*, Zhang Z-H*, Jiang F, Townsend TA, Mao C-J, You C-Y, Yang W-H, Sun Z-Y, Yu J-G, Yan H. Changes of TL1A and associated cytokines in the pathogenesis of diabetic retinopathy. In Revision, 2016.

Presentations

A. Townsend TA, Bishop ME, Shelton SD, Manjanatha MG. The Development of a Modified Comet Assay for Assessment of Global and Region-Specific DNA Methylation Status. Platform Speaker, Environmental Mutagenesis and Genomics Society (46th) Annual Meeting, New Orleans, LA, USA, September 28, 2015.

B-C. Townsend TA. Breaking Down Barriers: Novel Analytic Strategies for Complex Data. Invited Expert Speaker, B) Big Data Analytics in Pharma Summit 2015, delivered via webinar as a joint plenary session to the C) 14th Annual Laboratory Informatics Summit, Brussels, Belgium, October 1, 2015.

D. Townsend TA. CFP Mid-Program Presentation (FDA-Internal), White Oak Campus, February 28, 2016.

E. Townsend TA, Bishop ME, Shelton SD, Manjanatha MG. The Development of a Modified Comet Assay for Assessment of Global and Region-Specific DNA Methylation Status. Society of Toxicology (55th) Annual Meeting, New Orleans, LA, USA, March 14, 2016.

F. Townsend TA and Manjanatha MG. The Development of a Modified Comet Assay for High-Throughput Assessment of DNA Methylation Status. Arkansas Bioinformatics Consortium (2nd) Annual Meeting, Little Rock, AR, USA, April 17, 2016.

G. Townsend TA. Novel Analytic Strategies for n=1 Studies. Keynote Speaker and Event Chair (Day 1), Big Data & Analytics in Healthcare Summit, Philadelphia, PA, USA, May 10, 2016.

H. Townsend TA. Predictive Analytic Solutions for Volatility and Variability of Nonclinical Biomedical Data. Platform Speaker and Expert Panelist, 4th Global Big Data Conference, Santa Clara, CA, USA, August 30, 2016.

I. Townsend TA. Standardizing Endpoint Criteria and Power Analysis for Auxiliary Evidence. Plenary Session Speaker and Expert Panelist. 4th Annual Advanced Pharma Analytics (formerly Big DiP) Summit, Newark, NJ, USA, September 22, 2016.

J. Townsend TA. CFP Graduation Day Oral Presentation (FDA-Internal), White Oak Campus, September 21, 2016.

K. Townsend TA, Parrish MC, Bishop ME, Shelton SD, Engelward BP, Manjanatha MG. The Development and Validation of EpiComet-Chip, a Modified High-Throughput Comet Assay for the Assessment of DNA Methylation Status. Platform Speaker, Environmental Mutagenesis and Genomics Society (47th) Annual Meeting, Kansas City, MO, USA, September 26, 2016.

L. Agnihothram SS, Townsend TA, Mullis LB, Vermudez SA, Manjanatha MG, Azevedo MP. Silicon Dioxide Impedes Antiviral Response and Causes Genotoxic Insult in an In Vitro Model of Calicivirus Replication. Society of Toxicology (55th) Annual Meeting, New Orleans, LA, USA, March 16, 2016. Note: Presented by First Author Listed, not by CFP Fellow.

M. Mullis LB, Agnihothram SS, Vermudez SA, Townsend TA, Manjanatha MG, Azevedo MP. Silica Nanoparticles Impede Host Response to Virus Infection and Exert Genotoxic Effects in an In Vitro Model of Calicivirus Replication. (35th) Annual American Society for Virology Conference, Blacksburg, VA, USA, June 19, 2016. Note: Presented by First Author Listed, not by CFP Fellow. 

Class of 2013 Publication and Presentation Citations

Aaron Bandremer, M.S. (ORA Fellow)

Presentations

Design and Construction of Biochemiresistor on Various Platforms, 5th Annual FDA Foods and Veterinary Medicine Science and Research Conference, August 13-14, 2015.

Measurement Techniques for a Conductive Polymer Membrane Based Biosensor, FDA NanoSummit, May 29, 2015.

Measurement Techniques for Conductive polymer Membrane Based Biosensors, FDA Science forum, May 27-28, 2015.

Resistance and Potentiostatic Based Measurements of an Antibody Functionalized Conductive Polymer Coated Textile as a Biosensor, TechConnect- Washington DC, June 15-18, 2014.

Resistance and Potentiostatic Based Measurements of an Antibody Functionalized Conductive Polymer Coated Textile as a Biosensor, ORSI Symposium, April 27, 2014.

Brian Grabias, Ph.D.(CBER Fellow)

Publications

B. Grabias, H. Zheng, G. Mlambo, A. Tripathi, and S. Kumar. A sensitive enhanced chemiluminescent-ELISA for the detection of Plasmodium falciparum circumsporozoite antigen in midguts of Anopheles stephensi mosquitoes. J Microbiol Methods (2015) 108: 19-24.

S. Kumar, H. Zheng, B. Deng, B. Mahajan, B. Grabias, Y. Kozakai, M. Morin, E. Locke, A. Birkett, K. Miura, and C. Long. A slot blot immunoassay for quantitative detection of Plasmodium falciparum circumsporozoite protein in mosquito midgut oocyst. PLoS One (2014) 9: e115807.

Presentation

A oligonucleotide-based Sandwich Hybridization Assay for the Detection of Pathogens in Blood. Conference or National Society where the presentation was given: American Society of Tropical Medicine and Hygiene. 10/28/2015.

Aftin Ross, Ph.D.(MCMi/CDRH Fellow)

Presentations

Ross, A.M., Arszulowicz, J., 1/28/2015. NEPCE 2014 Functional Exercise Communications, FDA National Exercise Program Capstone Exercise (NEPCE) 2014 After Action Meeting, Silver Spring, MD.

Ross, A.M., 12/2/2014. Emergency Preparedness/Operations and Medical Countermeasures, Association for the Advancement of Medical Instrumentation, New Orleans, LA.

Ross, A.M., Thakur, N., Schwartz, S., Brookbank, J., Kumar, A. 11/20/2014. Emergency Preparedness: Functional Exercises and Beyond, Emergency Medical Countermeasures Experience, Silver Spring, MD.

Ross, A.M., Schwartz, S., Thakur, N., 3/5/2014. Emergency Preparedness/Operations and Medical Countermeasures and Respiratory Protective Devices, International Safety Equipment Association, Arlington, VA.

Ross, A.M., Bally, F., Durmaz, H., Waterkotte, B., Cheng, K., Nikolov, P., Deng, X., Giselbrecht, S., Lahann, J. 7/10/2014. Chemical Vapor Deposition as a Platform for Generating Multifunctional Surfaces for Biomedical Applications, International Society of Biomedical Polymers and Polymer Biomaterials, Herndon, VA

Pin Zhang,M.D., Ph.D.(CBER Fellow)

Presentations

A meta-analysis of the safety profile of inactivated trivalent influenza vaccines and quadrivalent influenza vaccines in children and adults. 18th Annual Conference on Vaccine Research. April 13-15, 2015.

A meta-analysis of the safety profile of inactivated trivalent influenza vaccines and quadrivalent influenza vaccines in children and adults. 1st ASM Conference on Polymicrobial Infections. November 13-16, 2014

Class of 2012 Publication and Presentation Citations

Basel Assaf, Ph.D. (CBER Fellow)

Publications

Basu J, Assaf BT, Bertram TA, Rao M. Preclinical Biosafety Evaluation of Cell-Based Therapies: Emerging Global Paradigms. Toxicol Pathol. 2014 Dec 4. PMID: 25476796

Baker JFM, Assaf BT. Preclinical Study Design for Evaluation of Stem Cell-Derived Cellular Therapy Products - a Pathologist’s Perspective. Toxicol Pathol. 2014 Oct 27. PMID: 25351922

Michael Bazaco, Ph.D. (CFSAN Fellow)

Presentation

Bazaco M.C., Parker C.C., Lando A. and Wolpert B.J. "Characteristics of unpasteurized (raw) milk consumers." Society for Epidemiological Research Annual Meeting, Seattle WA. June 24, 2014.

Srinivasulu Chigurupati, D.V.M., Ph.D. (NCTR Fellow)

Publications

Sarkar, S., Raymick, J., Mann, D., Bowyer, J. F., Hanig, J. P., Schmued, L. C., Paule, M. G., and Chigurupati, S. (2014) Neurovascular Changes in Acute, Sub-Acute and Chronic Mouse Models of Parkinson's Disease. Curr Neurovascular Res. 2014 Feb; 11(1):48-61.

Sumit Sarkar, Chigurupati, S, James Raymick, Dushyant Mann, John F. Bowyer, Tom Schmitt, Richard D. Beger, Joseph P. Hanig, Larry C Schmued, and Merle G. Paule (2014) Neuroprotective effect of the Chemical Chaperone, Trehalose in a Chronic MPTP induced Parkinson Disease Mouse Model. Neurooxicology. Aug, 2014.

Hanig J, Paule MG, Ramu J, Schmued L, Konak T, Chigurupati S, Slikker W Jr, Sarkar S, Liachenko S (2014 The Use of MRI to Assist the Section Selections for Classical Pathology Assessment. of Neurotoxicity Regulatory Toxicology and Pharmacology 2014 Sep 26. pii: S0273-2300(14)00215-3.

Poster Presentations

Notch signaling as a therapeutic target for Parkinson’s disease; 52nd Society of Toxicology and Expo Annual Conference San Antonio, TX March 13, 2013.

Neuroproective Effect of Tauroursodeoxycholic Acid (TUDCA) in Parkinson Disease Mouse; Model53rd Annual Meeting of the Society of Toxicology, March 25, 2014 at the Phoenix Convention Center in Phoenix, Arizona.

Invited Talks

Characterization of microRNAs in serum: a new class of biomarkers for diagnosis of Parkinson Disease in mouse model; Environmental Mutagenesis and Genomics Society 2014 Annual Meeting. September 13-17 at Hilton Lake Buena Vista, Orlando, FL.

The protective role of TRPC6-/- in a MPTP induced Parkinson disease mouse model; International Conference on Neuroprotective Agents 12th ICNA conference

Boar's Head Inn/Charlottesville, Virginia, September 28 - October 1, 2014.

Peng (Vincent) Duan, Ph.D. (CDER Fellow)

Presentations

Presented "Development of a transporter database and utilization of mechanistic models to predict drug-drug interactions (DDIs) on statins" at the 2012 CFP graduation ceremony. Silver Spring, MD. Sept 24, 2014.

Presented "Develop static models to predict statins drug-drug interactions (DDIs)" at 2013 Annual Meeting of American Association of Pharmaceutical Science (AAPS). San Antonio, TX. Nov 11-14, 2013.

Presented "Predicting statin associated drug-drug interactions (DDIs) with static models" at the FDA CDER/OCP Science Day. Silver Spring, MD. Sept 17, 2013.

Presented "Review of P-gp transporter related data in recently approved new drug applications (NDAs)" at 2013 AAPS Drug Transporter Workshop. North Bethesda, MD. Mar 5, 2013.

Carmen Gacchina Johnson, Ph.D. (CDRH and CBER Fellow)

Presentations

Gacchina Johnson C, TERMIS, Washington DC (December 2014).

Gacchina Johnson C, Abel D, Morales P. Considerations for Sponsor-Investigator IDEs. FDA/CDRH/DCD Clinical Rounds, Silver Spring, MD (September 2014).

Gacchina Johnson C, Cavanaugh KJ, Durfor CN, Oh SS. Cardiovascular Device-Biologic Combination Products. FDA Commissioners Fellowship Program Graduation Ceremony, Silver Spring, MD (September 2014).

Gacchina Johnson C. A Glimpse into the Life of a CDRH/ODE/DCD Reviewer, FDA/CBER Office of Cellular, Tissue, and Gene Therapy/ Division of Clinical Evaluation and Pharm/Tox DART Seminar, Silver Spring, MD (June 2014).

Gacchina Johnson C. Transcatheter arterial embolization for the treatment of liver cancer. FDA Device-Biologic Interest Group (DBIG), Rockville, MD (October 2013).

Yongli Guo, Ph.D. (NCTR Fellow)

Publications

Yongli Guo, Leming Shi, Huixiao Hong, Zhenqiang Su, James Fuscoe, Baitang Ning. Studies on Abacavir-Induced Hypersensitivity Reaction: A Successful Example of Translation of Pharmacogenetics to Personalized Medicine. Science China Life Sciences, 2013.

Lun Yang, Elvin T. Price, Ching-Wei Chang, Yan Li, Ying Huang, Li-Wu Guo, Yongli Guo, Jim Kaput, Leming Shi, Baitang Ning. Gene Expression Variability in Human Hepatic Drug Metabolizing Enzymes and Transporters. Plos One, 2013.

Krystl Haerian, M.D. (CTP Fellow)

Presentation

K Haerian, I Chen, W Aaronson. Automated Methods for Identifying Germane and Relevant Health Documents; FDA Scientific Computing Day 2013.

Anita Khatiwara, Ph.D. (CFSAN Fellow)

Presentation

Development and Validation of Environmental Testing Procedure for Listeria monocytogenes; Commissioner’s Fellowship Program Class of 2012 Graduation Ceremony.

Carol Lin, M.D. (CDRH Fellow)

Publication

Meier, K. L., Greenfield, D. S., Hilmantel, G., Kahook, M. Y., Lin, C., Rorer, E. M., . . . Liebmann, J. M. Special Commentary: Food and Drug Administration and American Glaucoma Society Co-sponsored Workshop. Ophthalmology. doi: 10.1016/j.ophtha.2014.05.024.

Bernard Marasa, Ph.D, (NCTR Fellow)

Publication

Marasa BS, Revollo J, Iram S, Sung K, Xu J, Khan S. Draft Genome Sequence of a Methicillin-Resistant Staphylococcus aureus ST1413 Strain for Studying Genetic Mechanisms of Antibiotic Resistance. Genome Announc. 2014 Mar 6; 2(2).

Presentations

Biomarker screening from post-transcriptional gene expression profiles of Bacillus anthracis infected human cells; FASEB 2014 SRC on Post-transcriptional Gene Regulation: Mechanisms of mRNA decay, Big Sky, MT. July 6-11, 2014.

Biomarker screening from post-transcriptional gene expression profiles of Bacillus anthracis infected human cells; MCMi Regulatory Science Symposium at White Oak, MD. June 2-3, 2014.

Synergy Between TiO2 and Vancomycin: Bacteriostatic and Genotoxic Effects of Titanium Dioxide Nanoparticles in Enterococcus spp.; Arkansas Nanotechnology for Health Conference (Petit Jean, AR, USA). April 2-4, 2014.

Genotypic Characterization of clinical isolates of Staphylococcus aureus from Pakistan; International Association for Food Protection (IAFPA), 2014. (Indiana, Indianapolis, USA). August 3-6, 2014.

Niharika Mishra, Ph.D. (CFSAN Fellow)

Presentations

Survival of Salmonella Related To Temperature and Water Activity During Extrusion Of A Simple Oat Flour Model Food; IFT annual meeting , 2014 and IFSH annual Meeting. 06/22/2014 and 09/17/2014.

Heat resistance of Salmonella at different water activities in flour matrices; IFT annual meeting , 2014 and IFSH annual Meeting. 06/23/2014 and 09/17/2014)

Yuzhuo Pan, Ph.D. (CDER Fellow)

Presentations

Application of the FDA PBPK knowledgebase in evaluating model predictability for drug-drug interactions; ASCPT annual meeting 2014. 3/21/2014.

Application of the FDA PBPK knowledgebase in evaluating model predictability for drug-drug interactions; CDER science day 2013. 9/20/2013.

Javier Revollo, Ph.D. (NCTR Fellow)

Publication

Marasa BS, Revollo J, Iram S, Sung K, Xu J, Khan S. Draft Genome Sequence of a Methicillin-Resistant Staphylococcus aureus ST1413 Strain for Studying Genetic Mechanisms of Antibiotic Resistance. Genome Announc. 2014 Mar 6;2(2). pii: e00162-14. doi: 10.1128/genomeA.00162-14. PubMed PMID: 24604656.

Presentations

454 Next Generation Sequencing Reveals A Catalogue of SNPs and Novel Genetic Anomalies in the Transcriptome of TK6 Cells; Society of Toxicology 2014.

March 24-27, 2014.

Identification of single nucleotide polymorphisms and novel genetic anomalies in the normalized transcriptomes of TK6, WTK1, and NH32 cells by next generation sequencing; Environmental Mutagenesis and Genomics Society 2014. September 13-17, 2014.

Justina Tam, Ph.D. (ORA Fellow)

Poster Presentations

A rapid, multiplexed, mobile phone-enabled point-of-care diagnostic device to detect field pathogens; Medical Countermeasures Initiative (MCMI) Symposium at FDA White Oak Campus, Silver Spring, MD. May 29-31, 2013.

A rapid, multiplexed, mobile phone-enabled point-of-care diagnostic device to detect Category A bioterror agents; Medical Countermeasures Initiative (MCMI) Symposium at FDA White Oak Campus, Silver Spring, MD. June 2-3, 2014.

Rapid detection of multiple pathogen markers, with real-time analysis; MIT Postdoc Association Poster Symposium: Scientists Share their Research, Cambridge, MA. May, 2014.

Directional conjugation of antibodies to gold nanoparticles for point-of-care device detecting dengue virus; Materials Research Society, Boston, MA. December 2, 2014.

Yueqin Zhao, Ph.D. (CDER Fellow)

Presentations

Bayesian Approach for Benefit-Risk Assessment. FDA/SCT Benefit-Risk Workshop. Dec 5-6, 2013. Rockville, MD.

Bayesian Approach for Benefit-Risk Assessment. Indian International Statistical Association 2014 Conference. July 11-13, 2014. Riverside, CA.

Bayesian Approach for Benefit-Risk Assessment. FDA/Industry Statistics Workshop. Sep 22-24, 2014. Washington, DC.

An Extension of Likelihood Ratio Test-Based Method for Signal Detection in a Drug Class with Application to FDA’s AERS Database. DIA 2014 Annual Meeting June 13-19, 2014. San Diego, MD.

Class of 2011 Publication and Presentation Citations

Absar Alum, Ph.D. (CFSAN Fellow)

Publications

Alum A., Y. C. Shieh, Y. Sun, D. S. Stewart, K. F. Reineke, M. Lou Tortorello. 2012. Method development for rapid concentration of noroviruses in water and tomato eluate. Annual Report of Institute of Food Safety and Health, pp 31-33

Alum A., C. Rock, and M. Abbaszadegan. 2013. A unified method to process biosolids samples for the recovery of bacterial, viral, and helminths pathogens. J Environ Sci Health A- Accepted

Elzein, M., A. Alum, and M. Abbaszadegan, 2013. Biochemical signature assay for use in a biosensor platform for rapid detection of bacteria in drinking water biofilms. J Environ Sci Health A - 48(8):925-932

Yavarmanish, M., M. Abbaszadegan, A. Alum, A. Mortazavi, M.B. Habibi-Najafi, M.R. Bassami, M.R. Nassiri.

2013. Impact of milk components on recovery of viral RNA of MS2 bacteriophage. Food and environmental virology - 5(2) 103-109.

Alum A, B. Sbai, H. Asaad, JR. Rubino, MK. Ijaz. 2012. Development and comparison of ECC-RT-PCR with in vivo method to determine the viability and infectivity of Giardia cysts. Int J Infect Dis 16;350-353

Precious B., H. Ryu, A. Brown, A. Alum, M. Abbaszadegan, and B.E. Rittmann, 2012. Distribution Systems as Reservoirs of Naegleria fowleri and Other Amoebae. JAWWA 104(1):49-50

Mahmood T., M. Saddique, A. Naeem, P. Westerhoff, S. Mustafa, A. Alum. 2011. Comparison of Different Methods for the PZC Determination of NiO" Industrial & Engineering Chemistry Research. 50: 10017-10023.

Abbaszadegan, M., A. Alum, H. Abbaszadegan and V. Stout. 2011. Cell Surface Display of Poliovirus Receptor on E. coli: A Novel Method for Concentrating Viral Particles in Water. Applied and Environmental Microbiology 77(15): 5141-5148.

Alum, A., C. Enriquez, and CP. Gerba. 2011. Impact of irrigation method, soil and virus type on produce contamination. Journal of Food and Environmental Virology 3(2):78-85

Presentations

Alum A. 2013. Development of a method to concentrate noroviruses in foods and evaluation of cell culture system for virus propagation. U.S. FDA Commissioner’s Fellowship Class of 2011 Graduation Program. Silver Spring, MD, September 4, 2013

Schwake OD, Alum A, Abbaszadegan M. Survival and nutritional requirements for Legionella in environmental waters. Water Quality and Technology Conference, Long Beach, California, USA, November 3-7, 2013.

Hesari N., Elzein M., Alum A., Abbaszadegan M. A biosensor for rapid detection of E coli in water. Water Quality and Technology Conference, Long Beach, California, USA, November 3-7, 2013.

Schwake OD, Alum A, Dunkin N, Kraft K, Abbaszadegan M. Presence of Legionella in water distribution systems. Water Quality and Technology Conference, Toronto, Ontario, Canada, November 4-8, 2012.

Kimberly M. Anderson, Ph.D. (ORA Fellow)

Posters Presentations

Kimberly M. Anderson, Shaohua Zhao, Eileen Liu, Sunee Himathongkham. "Using the DiversiLabTM Repetitive-Sequence-Based PCR System for Molecular Characterization of Shiga Toxin-Producing Escherichia coli." IAFP, July 28-31, 2013, Charlotte, North Carolina.

Kimberly M. Anderson, Shaohua Zhao, Eileen Liu, Sunee Himathongkham. "Using the DiversiLabTM Repetitive-Sequence-Based PCR System for Molecular Characterization of Shiga Toxin-Producing Escherichia coli." 113th ASM General Meeting, May 18-21, 2013, Denver, CO.

Nicole Herbold, Laurie M. Clotilde, Kimberly M. Anderson, Julie A. Kase, Sunee Himathongkham, Andrew Lin. "Clustering of Clinical and Environmental Escherichia coli O104 Using the DiversiLabTM System." 113th ASM General Meeting, May 18-21, 2013, Denver, CO.

Kimberly M. Anderson, Shaohua Zhao, Eileen Liu, Sunee Himathongkham. "Rapid Molecular Typing of Shiga Toxin-Producing Escherichia coli using the automated DiversiLabTM Repetitive Sequence-Based PCR System." 126th Annual AOAC Meeting, September 30-October 3, 2012, Las Vegas, NV.

Eileen Liu, Kimberly M. Anderson, Achal Deo, Okumu K’ Aluoch. "Comparison of Repetitive Sequence-Based PCR Characterization and PFGE for the Molecular Typing of Salmonella in Food Matrices." 16th Annual PulseNet Update Meeting, August 27-30, 2012, Atlanta, GA.

Olgica Ceric, Ph.D. (CVM Fellow)

Presentation

Presentation Title: Physical and Histological Characteristics of Chicken Jerky Treats.

Poster presentation.

Conference or National Society where the presentation was given: American Association of Veterinary Laboratory Diagnosticians. Greensboro, NC. Annual Meeting. October, 2012. Date(s) Presented: 10.20.2012.

Laurie Clotilde, Ph.D. (ORA Fellow)

Publications

Lin, A., J. A. Kase, M. M. Moore, I. Son, N. Tran, L. M. Clotilde, K. Jarvis, K. Jones, K. Kasturi, K. Nabe, M. Nucci, G. S. Wagley, F. Wang, B. Ge, and T. S. Hammack. 2013. Multi-laboratory validation of a Luminex microbead-based suspension array for the identification of the eleven most clinically relevant STEC O serogroups. J. Food Prot. 76:867-870.

Lau, H. K., L. M. Clotilde, A. P. Lin, G. L. Hartman, and C. R. Lauzon (both first authors contributed equally to this manuscript). 2013. Comparison of IMS platforms for detecting and recovering Escherichia coli O157 and Shigella flexneri in foods. J. Lab. Automation 18:178-183.

Clotilde, L. M., C. Bernard, IV, A. Salvador, A. Lin, C. Lauzon, M. Muldoon, Y. Xu, K. Lindpaintner, and J. M. Carter. 2013. A 7-plex microbead-based immunoassay for serotyping Shiga toxin-producing Escherichia coli. J. Microbiol. Methods 92:226-230.

Lin, A., L. Nguyen, L. M. Clotilde, J. A. Kase, I. Son, and C. R. Lauzon. 2012. Isolation of Shiga toxin-producing Escherichia coli from fresh produce using STEC heart infusion washed blood agar with Mitomycin-C. J. Food Prot. 75:2028-2030.

Presentations

Clotilde, L. M., N. M. Herbold, A. Lin, C. Bernard IV, A. Salvador, C. R. Lauzon, M. Muldoon, Y. Xu, J. M. Carter. 2013. Development of an automated multiplexed Immunomagnetic Separation System for Isolating Shiga toxin-producing Escherichia coli. International Association for Food Protection, Annual Meeting, Raleigh, NC.

Herbold, N., L. M. Clotilde, K. M. Anderson, J. Kase, S. Himathongkham, and A. Lin. 2013. Clustering of Clinical and Environmental Escherichia coli O104 Using the DiversiLabTM System. American Society for Microbiology, Annual Meeting, Denver, CO.

Lau, H. K., L. M. Clotilde, A. P. Lin, G. L. Hartman, and C. R. Lauzon (both first authors contributed equally to this manuscript). 2012. PathatrixTM Auto versus KingFisher Flex: Who is the winner? 126th Annual AOAC Meeting, Las Vegas, NV.

Lau, H. K., L. M. Clotilde, A. P. Lin, G. L. Hartman, and C. R. Lauzon (both first authors contributed equally to this manuscript). 2012. PathatrixTM Auto versus KingFisher Flex: Who is the winner? Second Annual Foods Program Science and Research Conference, White Oak, MD.

Salvador, A., L. M. Clotilde, C. Bernard IV, C. Crowe, D. Berger, A. Lin, G. Hartman, D. Lau, C. Lauzon, J. M. Carter. 2012. Development of a biphasic medium for detection of Shiga toxin- producing E. coli using Tetrahymena thermophila. American Society for Microbiology, Annual Meeting, San Francisco, CA.

Lin, A., L. M. Clotilde, C. Bernard, IV, L. Nguyen, J. A. Kase, I. Son, J. M. Carter, and C. R. Lauzon. 2012. Detection and isolation of non-O157 STECs in foods. American Society for Microbiology, Annual Meeting, San Francisco, CA.

Bernard, C., IV, L. M. Clotilde, A. Lin, G. L. Hartman, A. Salvador, C. Lauzon, M. Muldoon, K. Lindpaintner, D. K. Lau, and J. M. Carter. 2012. Microbead-based assays for simultaneous detection of various E. coli serogroups. American Society for Microbiology, Annual Meeting, San Francisco, CA.

Salvador, A., L. M. Clotilde, C. Bernard, IV, J. M. Carter, C. Lauzon, C. Crowe, A. Lin, G. Hartman, and D. Lau. 2011. Development of a faster method for detection of Shiga toxin-producing E. coli using Tetrahymena thermophila. Northern California - American Society for Microbiology, Fall Meeting, Santa Clara, CA.

Alifiya Ghadiali, Ph.D. (CFSAN Fellow)

Publication

Verotoxigenic Escherichia coli: Detection by Commercial Enzyme Immunoassays; Encyclopedia of Food Microbiology, Second Edition

Poster Presentations

Molecular Risk Assessment of non-O157 shiga toxin-producing Escherichia coli isolates using DNA microarrays (Abstract # 474). American Society for Microbiology. 113th General Meeting, Colorado. May 18-21, 2013

Molecular Risk Assessment of non-O157 shiga toxin-producing Escherichia coli isolates using DNA microarrays. Federal Partners Summit 2013, North Carolina. August 1-2, 2013.

Molecular Risk Assessment of non-O157 shiga toxin-producing Escherichia coli isolates using DNA microarrays (Abstract # 2M-39). Third Annual FDA Foods and Veterinary Medicine Science and Research Conference. Maryland. August 27-28, 2013.

Gumei Liu, Ph.D. (CDER Fellow)

Publications

Liu G, Gu B, He XP, Joshi RB, Wackerle HD, Rodriguiz RM, Wetsel WC, McNamara JO. (2013) Transient inhibition of TrkB kinase following status epilepticus prevents development of temporal lobe epilepsy. Neuron

Lebron ER, Liu G, Keiser MS, Behlke M and Davidson BL. (2013) Altered Purkinje cell miRNA expression and SCA1 pathogenesis. Neurobiology of Disease

Fiorentino R, Liu G, Pariser A, Mulberg A. (2012) Cross-sector sponsorship of research in eosinophilic esophagitis: A collaborative model for rational drug development in rare diseases. Journal of Allergy and Clinical Immunology

Helgager J, Liu G, McNamara J. (2012) The cellular and synaptic location of activated TrkB in mouse hippocampus during limbic epileptogenesis. Journal of Comparative Neurology

Presentations

Presentation Title: Endpoint Development For Rare Diseases: What We Learned From Eosinophilic Esophagitis
Conference or National Society where the presentation was given: 2nd Annual NORD/DIA National Rare Disease Conference
Date(s) Presented: Oct. 2012

Presentation Title: The role of natural history studies in rare diseases drug development
Conference or National Society where the presentation was given: 2nd Annual NORD/DIA National Rare Disease Conference
Date(s) Presented: Oct. 2012

Presentation Title: Rare Disease Drug Development: Regulatory Perspective
Conference or National Society where the presentation was given: 18th Annual Blood-Brain Barrier Consortium Meeting
Date(s) Presented: April, 2012

Clark Meyer, Ph.D. (CDRH Fellow)

Presentation

Presentation Title: Development of Atrial Septal Defect and Occluder Models.
Conference or National Society where the presentation was given: ASME Frontiers in Medical Devices 2013 Conference.
Date(s) Presented: September 12, 2013

Jeremiah Momper PharmD, Ph.D. (CDER Fellow)

Publications

Edginton AN, Shah B, Sevestre M, Momper JD. The integration of allometry and virtual populations to predict clearance and clearance variability in pediatric populations over the age of six years. Clin Pharmacokinet. 2013 Apr 16. [Epub ahead of print]

Presentations

Lee J, Momper JD, Kim MJ, Burckart GJ. Optimizing pediatric drug development: Neurogenic bladder drugs as a model. FDA Office of Clinical Pharmacology Science Day. Bethesda, MD. 07 Sep 2012.

Momper JD, Mulugeta, Y, Lee CS, Burckart G. Analysis of failed pediatric studies conducted under the FDA Amendments Act (FDAAA) of 2007. American Society for Clinical Pharmacology and Therapeutics Annual Meeting, National Harbor, MD. 15 Mar 2012.

Li Pang, M.D. (NCTR Fellow)

Presentation

Presentation Title: Expression of ABC Transporters in human pancreatic carcinoma cell lines and the correlation with gemcitabine sensitivity. Li Pang, Beverly Word, Honggang Wang, and Beverly Lyn-Cook
Conference where the presentation was given: AACR pancreatic Cancer: Progress and challenges, Lake Tahoe, NV
Date(s) Presented: June 18-21, 2012

Ji-Young Park, Ph.D. (ORA Fellow)

Presentations

"Development of methodologies for the characterization of the commercial liposomal dietary supplements: determination of physicochemical properties," (Authors: Ji-Young Park, Adam Keasling, Yvonne Jones, Angel Paredes, and Sean W. Linder) 2nd Annual FDA Foods Program Science and Research Conference, Silver Spring, MD. August 1-2, 2012.

"Comparative study for the physicochemical properties of commercial liposomes" (Authors: Ji-Young Park, Adam Keasling, Thilak K. Mudalige, Patrick N. Sisco, and Sean W. Linder) FDA Inaugural Nanotechnology Research Workshop, FDA White Oak Campus, MD. June 4, 2013.

"Comparative study for the physicochemical properties of commercial liposomes" (Authors: Ji-Young Park, Adam Keasling, Thilak K. Mudalige, Patrick N. Sisco, and Sean W. Linder) FDA Third Annual Foods Program Science and Research Conference, FDA White Oak Campus, MD. August 27, 2013.

Katya Petrova, Ph.D. (NCTR Fellow)

Publication

Metabolomics Evaluation of the Effects of Green Tea Extract on Acetaminophen-Induced Hepatotoxicity in Mice. Authors: Lu, Yihong, Sun, Jinchun, Petrova, Katya, Yang, Xi, Greenhaw, James, K.1, Salminen, William, Beger, Richard D., Schnackenberg, Laura. The manuscript was accepted for publication in Food and Chemical Toxicology on September 17th, 2013; Ms. Ref. No.: FCT-D-13-01416R1.

Presentations

"Metabolomics Evaluation of the Effects of Green Tea Extract on Acetaminophen-Induced Hepatotoxicity in Mice." Conference: Metabolomics Evaluation of the Effects of Green Tea Extract on Acetaminophen-Induced Hepatotoxicity in Mice. August 27, 2013.

"Metabolomics Evaluation of the Effects of Green Tea Extract on Acetaminophen-Induced Hepatotoxicity in Mice." Society of Toxicology (2013).

"Metabolomics Evaluation of the Effects of Green Tea Extract on Acetaminophen-Induced Hepatotoxicity in Mice." 3rd China Annual Meeting of Drug Toxicolagy and Research Forum on Drug Preclinical Safety Evaluation (2013).

Prakash Rath, Ph.D. (CBER Fellow)

Publications

Prakash Rath, Bachchu Lal, Olutobi Ajala, Yunqing Li, Shuli Xia, Jin Kim, John Laterra. "c-Met signaling modulates the Glioblastoma Tumor-initiating Cell Population". Translational Oncology, 2013 Apr;6(2):104-11. Epub 2013 Apr 1. PMID: 23556031. Cover article and illustration

Prakash Rath, James M. Wilson and Huidong Shi. Book Chapter "Presence of an Early Lineage Stem Cell Phenotype in Meningioma-Initiating Cells". Stem Cells and Cancer Stem Cells: Therapeutic Applications in Disease and Injury, Volume 10. Hayat, M.A (Ed.) 2013. Springer Science 2013. In Press, ISBN: 978-94-007-6261-9

Yanjue Wu, Shervin D. Wang, Jean-Philippe Richard, Prakash Rath, Shuli Xia, John Laterra. "Regulation of glioblastoma multiforme stem-like cells by inhibitor of DNA binding proteins and oligodendroglial lineage-associated transcription factors". Cancer Science, 2012 Jun;103(6) 1028-37. PMID: 22380883

Shervin D. Wang, Prakash Rath, Bachchu Lal, Jean-Philippe Richard, Yunqing Li, C. Rory Goodwin, John Laterra, Shuli Xia. "EphB2 receptor controls proliferation/migration dichotomy of glioblastoma by interacting with focal adhesion kinase". Oncogene, 2012 Feb 6. PMID: 22310282

Subrat Rout, Ph.D. (CDER Fellow)

Presentation

Presentation Title: Development of a liquid mid-density micro array assay for the detection of food-borne enteric viruses using Luminex® xMAPTM technology.
Conference or National Society where the presentation was given: 2nd Annual FDA Foods Program Science and Research Conference. Aug 01-02. FDA, White Oak. MD
Date(s) Presented: August 01-02, 2012

Shondelle Wilson-Frederick, Ph.D. (OC Fellow)

Presentation

Shondelle Wilson-Frederick, H. Sviglin, L. Rosario; J. Bull; S. Buckman-Garner. Demographic representation in aggregated diabetes clinical trials. Pharmaceutical Users Software Exchange Computational Science Symposium. Silver Spring, MD. March 18, 2014 (poster)

Jacquline Yancy, Ph.D. (CDRH Fellow)

Publications

Docket No. FDA-2013-N-0118 Federal Register 2013, 78, (35), 120567.

Docket No. FDA-2013-N-0001-0011 Federal Register 2013,78 (35), 120567.

Presentations

Presentation Title: "Promoting Medical Device Innovation and Safety"
Conference or National Society where the presentation was given: Virginia Tech Bio-based Materials Graduate Symposium, invited lecturer, Blacksburg, VA
Date(s) Presented: May 18, 2012

Presentation Title: "Extreme Weather Threats to the Safety, Quality, and Manufacturing Chains of Marketed Medical Devices"
Conference or National Society where the presentation was given: Devices Good Manufacturing Practices Advisory Committee Meeting, Gaithersburg, MD
Date(s) Presented: April 11, 2013.

Xiaoxia Yang, Ph.D. (NCTR Fellow)

Publications

Prediction and evaluation of route dependent dosimetry of BPA in rats at different life stages using a physiologically based pharmacokinetic model. Yang X, Doerge DR, Fisher JW. Toxicol Appl Pharmacol. 2013; 270(1):45-59. Cited by 1.

Absorption and disposition of bromate in F344 rats. Bull RJ, Kolisetty N, Zhang X, Muralidhara S, Quiñones O, Lim KY, Guo Z, Cotruvo JA, Fisher JW, Yang X, Delker D, Snyder SA, Cummings BS. Toxicology. 2012; 300(1-2):83-91. Cited by 1.

Pathways Patricia Ruiz, Xiaoxia Yang, Annie Lumen, and Jeff Fisher. (2013). Quantitative Structure-Actibity Relationship (QSAR) Models, Physiologcally Based Pharmacokientic (PBPK) Models, Biologically Based Dose Response (BBDR) and Toxicity. In Bruce A. Fowler (Ed.), Book title: Computational Toxicology: Methods and Applications for Risk Assessment. Publisher: Elsevier.

Presentation

Presentation Title: A Physiologically based pharmacokinetic model for Bisphenol A in rats at different developmental ages. Xiaoxia Yang, Daniel R. Doerge, and Jeffrey W. Fisher
Conference where the presentation was given: SOT's 52nd Annual Meeting, San Antonio, Texas
Date(s) Presented: March 10-14, 2013

Shifu Zhao, Ph.D. (OC Fellow)

Presentation

Comparison of CRT Data in Legacy vs. SDTM Formats - A Summary of Clinical Data of 51 Diabetes Studies Converted to SDTM Format in Support of Meta-Analyses. Drug Information Association (DIA) Regulatory Information Management (RIM) 2013. April 4, 2013.

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)

Martha 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.

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

Molecular aspects of dopaminergic neurodegeneration: gene-environment interaction in parkin dysfunction.

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

Related citations

Novel regulation of parkin function through c-Abl-mediated tyrosine phosphorylation: implications for Parkinson's disease.

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

Related citations

Abl tyrosine kinase phosphorylates nonmuscle Myosin light chain kinase to regulate endothelial barrier function.

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.

Karmakar. S., Jin. Y. and Nagaich. A. Interaction of Glucocorticoid Receptor (GR) with Estrogen Receptor-alpha (ERa) and Activator Protein 1 (AP1) in Dexamethasone-Mediated Interference of ERaActivity. The Journal of Biological Chemistry (published online June 28, 2013)

Interaction of Glucocorticoid Receptor (GR) with Estrogen Receptor (ER) α and Activator Protein 1 (AP1) in Dexamethasone-mediated Interference of ERα Activity.

Karmakar S, Jin Y, Nagaich AK. J Biol Chem. 2013 Aug 16;288(33):24020-34. doi: 10.1074/jbc.M113.473819. Epub 2013 Jun 28.

Presentations

Presentation Title: Direct Interaction of Estrogen and Glucocorticoid Receptor in Dexamethasone Mediated Interference of ERa Activity and ER-positive breast cancer cell proliferation
Conference or National Society where the presentation was given: Keystone symposium on nuclear receptors, Whistler, BC, Canada
Date(s) Presented: 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.

Zohra Olumee­Shabon,Ph.D. (CVM Fellow)

Publications

J. Boehmer, Z. Olumee-Shabon 2011 "Veterinary Biomarker Discovery: Proteomic Analyses of Acute Phase Proteins" In Tech. Rijeka, Croatia, pp189-210.

Z. Olumee-Shabon, J. L. Boehmer "Detection of Casein Phosphopeptides in Goat Milk" J. Proteome Res., 2013, 12, 6, 6064-6041.

Z. Olumee-Shabon,T. Swain, E. A. Smith, E. A. Tall, and J. L. Boehmer "Proteomic Analysis of Differentially Expressed Proteins in Caprine Milk during Experimentally Induced Endotoxin Mastitis" J. Dairy Sci., 2013, 96, 2903-2912.

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. 

Class of 2009 Publication and Presentation Citations

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 Articles

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, 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

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.

Bi-Feng Qian, M.D., Ph.D. (CFSAN Fellow)

Publication

Principato, MaryAnn; Qian, Bi-Feng. 2014. "Staphylococcal enterotoxins in the Etiopathogenesis of Mucosal Autoimmunity within the Gastrointestinal Tract." Toxins 6, no. 5: 1471-1489. doi:10.3390/toxins6051471

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.

Class of 2008 Publication and Presentation Citations

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).

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.

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

Lan Hu, Ph.D., M.D. (CFSAN Fellow)

Publication

Franco, A.A., M. H. Kothary, G. Gopinath, K. G. Jarvis, C. J. Grim, L. Hu, A. R. Datta, B. A.

McCardell, and B. D. Tall. 2011. Cpa, Outer Membrane Protease of Cronobacter sakazakii Activates Plasminogen and Mediates Resistance to Serum Bactericidal Activity. Infect. Immun. 79:1578-1587. Epub 2011 Jan 18.

Franco, A. A., L. Hu, C. J. Grim, G. Gopinath, V. Sathyamoorthy, K. G. Jarvis, C. Lee, J.

Sadowski, J. Kim, M. H. Kothary, B. A. McCardell, and B. D. Tall.2011. Characterization of Putative Virulence Genes Encoded on the related RepFIB Plasmids Harbored byCronobacter spp. Appl Environ Microbiol 77:3255-3267. published ahead of print on 18 March 2011, doi:10.1128/AEM.03023-10.

Jarvis, K. G., C. J. Grim, A. A. Franco, G. Gopinath, V. Sathyamoorthy, L. Hu, J.

Sadowski, C. Lee, and B. D. Tall. 2011. Molecular Characterization of Cronobacter Lipopolysaccharide O-Antigen Gene Clusters and Development of Serotype-Specific PCR Assays. Appl Environ Microbiol. 77:4017-4026. Epub 2011 Apr 29.

Gopinath, G., K. Hari, R. Jain, M. H. Kothary, K. G. Jarvis, A. A. Franco, C. J. Grim, L. Hu,

V. Sathyamoorthy, M. K. Mammel, A. R. Datta, I. R. Patel, S. A. Jackson, M. L. Kotewicz, J. E. LeClerc, M. Wekell, B. A. McCardell, M. D. Solomotis, and B. D. Tall. 2013. The Pathogen-annotated Tracking Resource Network (PATRN) System: A Web-Based Resource to aid Regulatory Science and Investigations of Foodborne Pathogens and Disease Food Microbiol. 34:303-318. doi: 10.1016/j.fm.2013.01.001. Epub 2013 Jan 23.

Jarvis, K. G., C. J. Grim, A. A. Franco, L. Hu, G. Gopinath, V. Sathyamoorthy, M. L.

Kotewicz, M. H. Kothary, C. Lee, J. Sadowski, Q. Q Yan, S. Fanning, and B. D. Tall. 2013. Identification and characterization of five new molecular serogroups of Cronobacter spp. Foodborne Path. and Dis.10:343-352. doi: 10.1089/fpd.2012.1344.

Carter, L., L. Lindsey, C. J. Grim, V. Sathyamoorthy, A. A. Franco, K. G. Jarvis, G.

Gopanath, C. Lee, J. A. Sadowski, L. Trach, M. Pava-Ripol, B.D. Tall, and L. Hu. 2013. Multiplex PCR Assay Targeting a Diguanylate Cyclase-Encoding Gene, cgcA, to Differentiate Species within the Genus Cronobacter. Appl Environ Microbiol. 79:734-737.

Grim, C. J., M. L. Kotewicz, K. A. Power, G. Gopinath, A. A. Franco, K. G. Jarvis, Q. Q.

Yan, S. A. Jackson, V. Sathyamoorthy, L. Hu, F. Pagotto, C. Iversen, A. Lehner, R Stephan, S. Fanning, and B. D. Tall. 2013. Genomic analysis of the pan genome of the emerging bacterial foodborne pathogen Cronobacter spp. suggests a species-level bidirectional divergence from a conserved genomic core. BMC Genomics 14:366 doi:10.1186/1471-2164-14-366.

Abstracts

Hu, L. V. Sathyamoorthy, J. Kim, and B.D. Tall. 2009. Characterization of Plasmids

possessed by Clinical Strains of Cronobacter species )formerly Enterobacter sakazakii( and the Development of a PCR Assay for the Presence of Two Common Plasmids. First International Conference on Cronobacter spp. (Formerly Enterobacter sakazakii). Dublin, Ireland, Jan 22-23, 2009.

Tall, B. D., M. H. Kothary, L. Hu, A. R. Datta, S. K. Curtis, L. Carter, V. Sathyamoorthy, M.

L. Kotewicz, E. W. Brown, K. R. O'Neill, G. Ziobro, L. Restaino, C. Iversen, S. Fanning, the JIFSAN, HACU and WIP Student Task Forces and B. A. McCardell. 2009. Phenotypic diversity among Cronobacter spp. (formerly Enterobacter sakazakii). First International Conference on Cronobacter spp. (Formerly Enterobacter sakazakii). Dublin, Ireland, Jan 22-23, 2009.

Hu, L, V. Sathyamoorthy, J. Kim, and B.D. Tall. 2009. Investigating Two Putative Virulence Plasmids in Cronobacter spp. (Formerly Enterobacter sakazakii) and the Development of a PCR Assay. ASM Abst. Gen. Meet. Abstract#: P-053.

I. R. Patel, I. R., S. A. Jackson, H. C. Harbottle, M. K. Mammel, J. Kim, L. Hu, S. K. Curtis, and

B.D. Tall. 2009. Characterization of the Genomic Diversity and Antimicrobial Resistome of Cronobacter species (formerly Enterobacter sakazakii) using a Novel High Density Genome Array. ASM Abst. Gen. Meet. Abstract#: R-037.

Tall, B. D., G. Gopinath, M. H. Kothary, R. Jain, K. L. Hari, A. R. Datta, K.G. Jarvis, A. A.

Franco, L. Hu, V. Sathyamoorthy, C. J. Grim, M. K. Mammel, I. R. Patel, S. A Jackson, M. L. Kotewicz, J. E. LeClerc, H. C. Harbottle, B. A. McCardell, and M. M. Wekell. 2010. Development and Application of a Pathogen Annotated Tracking Resource Network (PATRN) System to Aid Analysis of Foodborne Pathogens. ASM Abst. Gen. Meet. Abstract#: R-2447.

Jarvis, K. G., G. Gopinath, A. A. Franco, V. Sathyamoorthy, L. Hu, C. Lee, J. Sadowski, B.

D. Tall. 2010. Molecular Characterization of the Somatic O-Antigen Locus of Cronobacter spp. Using PCR. ASM Abst. Gen. Meet. Abstract#: B-1536.

Hu, L.,A. A. Franco, G. Gopinath, M. H. Kothary, V. Sathyamoorthy, C. J. Grim, K. G.

Jarvis, C. Lee, J. Sadowski, B. D. Tall. 2010. PCR Analysis of Curli, Cellulose and Regulatory Genes in Cronobacter spp. ASM Abst. Gen. Meet. Abstract#: B-1525.

Hu, L., A. A. Franco, G. Gopinath, V. Sathyamoorthy, K. G. Jarvis, J. Kim, C. Lee, J.

Sadowski, C. J. Grim, B. A. McCardell, and B. D. Tall. 2010. Identification and Characterization of the Putative Virulence Plasmids, pESA3 and pCTU1 Possessed by Cronobacter spp. ASM Abst. Gen. Meet. Abstract#: B-587.

Tall, B. D., G. Gopinath, M. H. Kothary, R. Jain, K. L. Hari, A. R. Datta, K.G. Jarvis, A. A.

Franco, L. Hu, V. Sathyamoorthy, C. J. Grim, M. K. Mammel, I. R. Patel, S. A Jackson, M. L. Kotewicz, J. E. LeClerc, H. C. Harbottle, B. A. McCardell, and M. M. Wekell. 2010. Development and Application of a Pathogen Annotated Tracking Resource Network (PATRN) System to Aid Analysis of Foodborne Pathogens. FERN National Meeting. Abstract #: 42, Page 36.

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.

 
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