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U.S. Department of Health and Human Services

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The Office of Regulatory Affairs (ORA)

2013 Preceptors


Picture of Irshad M. Sulaiman

Irshad M. Sulaiman, M.Sc., M.Phil, Ph.D.
Microbiological Sciences Branch
Southeast Regional Laboratory (SRL)
Office of regulatory Affairs (ORA)
Atlanta, Georgia

Background:

Ph.D. – University of Delhi, India
M.Phil. – A. M. University, India
M.Sc. – A. M. University, India

FDA Experience – 4 and half years (2008-Present)

Professional Experience:

2011-Present: Adjunct Professor, Department of Biology, Georgia State University, Atlanta, Georgia
2008-Present: Research Microbiologist, Southeast Regional Laboratory, FDA, Atlanta, Georgia
2003-2008: Research Scientist, Division of Scientific Resources, CDC, Atlanta, Georgia
1997-2003: Visiting Scientist, Division of Parasitic Diseases, CDC, Atlanta, Georgia
1996-1997: Research Fellow, Medical College of Georgia, Augusta, Georgia
1993-1996: Young Scientist, National Institute of Immunology, New Delhi

Research Interests:

Dr. Sulaiman joined the Microbiological Sciences Branch, Southeast Regional Laboratory, U. S. Food and Drug Administration, Atlanta, Georgia as a Research Microbiologist on October 12th of 2008, with over 16 years of research experience and expertise in the field of molecular genetics and its application in method development to detect and differentiate various human-pathogenic emerging infectious agents. Before coming to FDA, Dr. Sulaiman worked at the Centers for Disease Control (CDC) for eleven and half years from 1997 to 2008. Dr. Sulaiman obtained his PhD degree in 1992 to study Conservation Biology, Population Genetics and Ecology of Endangered Species from University of Delhi.

Dr. Sulaiman’s research for over 20 years has focused on the molecular genetic characterization and rapid detection methods for human-pathogenic parasites (Cyclospora, Cryptosporidium, Giardia), bacteria (Cronobacter, Bacillus, Salmonella), viruses (orthopox, SARS, Hepatitis A), fungi (Microsporidia, Indicator fungal species from environmental swabs), and some pest species (the FDA “Dirty 22” species) responsible for the spreading of foodborne pathogens, from outbreak settings, routine surveillance and sporadic cases for their Detection, Prevalence, Epidemiology, Transmission Dynamics, Taxonomy, Phylogeny and Evolutionary Relationships of public health importance.

Dr. Sulaiman has published over 70 manuscripts in peer-reviewed journals with high impact factors, and written 4 book chapters in his area of expertise.

Proposed Regulatory Research Project for the FDA Commissioner's Fellow:

(i) Multi-locus genetic characterization of some apicomplexan parasites identified to cause the food-borne diseases and outbreaks for their rapid detection and differentiation

Cyclospora and Cryptosporidium are apicocomplexan parasites. Some of the species such as C. cayetanensis, C. hominis and C. parvum are human-pathogenic that infect the gastrointestinal track and cause acute gastrointestinal illness. In recent years, these parasites have led to several foodborne and waterborne outbreaks in the United States and Canada. Although in the last decade Cryptosporidium has been widely characterized, there is a need to characterize more C. cayetanensis isolates as little is known about its origin, apparent zoonotic reservoirs, and genetic relationships with other coccidian parasites (Sulaiman et al. 2013). Molecular characterization of human-pathogenic microorganisms has led to the development of several diagnostic assays which have helped in understanding the transmission dynamics and in conducting epidemiologic investigations. Thus, in the proposed study some conserved and regulatory genes of the above parasites will be characterized for their rapid detection from various food matrices and understanding their genetic diversity.

(ii) Development of mitochondrial cytochrome oxidase I (COI) gene based insect-barcoding to characterize the Group I, Group II, and Group III “Dirty 22” species known to spread foodborne pathogens.

To date, 22 common pest species (the “Dirty 22” species) have been regarded by this agency for the spreading of food-borne diseases. Recently, the “Dirty 22” species was further categorized into 4 different groups: Group I include 4 cockroach species, Group II includes 2 ant species, Group III includes 12 fly species, and Group IV includes 4 rodent species. A two-step SSU rRNA gene nested PCR based RFLP protocol was developed that can rapidly amplify and differentiate the 4 species of Group I which include Blattella germanica, Blatta orientalis, Periplaneta americana, and Supella longipalpa (Sulaiman et al. 2011). Later 3 nested PCR primer sets were designed based on the SSU rRNA, elongation factor 1-alpha (EF-1a) and wingless (WNT-1) genes for the multi-locus genetic characterization of both of the Group II “Dirty 22” species which include Monomorium pharaonis and Solenopsis molesta (Sulaiman et al. 2012). DNA barcoding has been widely successful in species identification in a wide range of zoonotic species that uses the 5’ region of the mitochondrial cytochrome oxidase I (COI) gene as the genetic marker. In the proposed study, COI gene based insect-barcoding will be performed to rapidly identify members of the Group I, Group II and Group III “Dirty 22” species. These novel PCR methods will be used when the specimens cannot be identified using the conventional microscopic methods.

(iii) Development of a molecular diagnostic method that can rapidly detect and differentiate the human-pathogenic Cronobacter species from infant food.

Currently in our food microbiology program, to determine the uniqueness of a Cronobacter isolate recovered from various sources, the said isolates are identified by performing the following analysis: (i) a real-time PCR protocol for rapid screening, and (ii) a cultural protocol for the final detection and isolation of Cronobacter species that include the utilization of Chromogenic agars to isolate the culture for confirmation. In the proposed study a rapid and robust molecular diagnostic method will be developed for the detection and differentiation of Cronobacter species in various food matrices consumed by the neonatal. This assay will be utilized when this human food-borne pathogen is recovered for faster confirmation using the state-to-the-art molecular techniques including the nucleotide sequence characterization. This novel assay will help in understanding the transmission dynamics of these human-pathogenic bacteria, and in their prevention and control. It will also be utilized for the confirmation of isolates recovered from an outbreak, sporadic cases, routine surveillance, and the environmental isolates of public health importance.

Applicant Requirements:

Applicants must have a Doctoral level degree (MD, DO, DVM, DDS, DPM, PharmD, or PhD in the field of biological sciences). Applicants must be U.S. citizens, non-citizen nationals of the U.S., or have been admitted to the U.S. for permanent residence at the time their applications are submitted. Applicants cannot be current FDA employees or FDA contractors

Selected Recent Publications:

Sulaiman IM, Torres P, Simpson S, Kerdahi K, and Ortega Y. 2013. Sequence characterization of heat shock protein gene of Cyclospora cayetanensis isolates from Nepal, Mexico, and Peru. J. Parasitol. 99: 000-000.

Sulaiman IM, Anderson M, Oi DH, Simpson S. and Kerdahi K. 2012. Multilocus genetic characterization of two ant vectors (Group II "Dirty 22" species) known to contaminate food and food products and spread foodborne pathogens. J. Food Protec. 75:1447-1452.

Sulaiman IM, Anderson M, Khristova K, Tang T, Sulaiman N, Phifer E, Simpson S, and Kerdahi K. 2011. Development of a PCR-RFLP protocol for rapid detection and differentiation of four cockroach vectors (Group I “Dirty 22” Species) responsible for food contamination and spreading of foodborne pathogens: A public health importance. J. Food Protec. 74: 1883-1890.

Sulaiman IM, Tang K, Osborne J, Sammons S, and Wohlhueter RM. 2007. GeneChip resequencing of smallpox virus genome can identify novel strains: A biodefense application. J. Clin. Microbiol. 45:358-363.

Sulaiman IM, Liu X, Frace M, Sulaiman N, Olsen-Rasmussen M, Neuhaus E, Rota P, and Wohlhueter RM. 2006. Evaluation of Affymetrix severe acute respiratory syndrome resequencing GeneChips in characterization of the genomes of two strains of coronavirus infecting humans. Appl. Environ. Microbiol. 72:207-211. 
 


Picture of Stephen D. Torosian

Stephen D. Torosian, Ph.D.
Winchester Engineering and Analytical Center (WEAC) Office of Regulatory Affairs (ORA)
Winchester, MA

Background:
B.S. Microbiology ‘77, PhD Microbiology ‘93, Prior to joining FDA in Jan. 2003, served as Faculty at the University of New Hampshire 

 

Research Interests:

Prior to joining FDA I conducted research in Cell Culture, Virology, Microbial Genetics and Select Agents. Research interests with FDA include rapid methods development with Select Agents in foods, virus in foods, high throughput molecular assays and methods as well as investigating nano potential for field capable real time food analysis.

Proposed Regulatory Research Project for the FDA Commissioner's Fellow:

The goal of the fellowship research project is to develop a portable biosensor platform for environmental and later, food analysis. Novel biosensor concepts are needed to reduce the time to process, weight of current prototype detection platforms and to reduce the quantities of chemicals required to run them. Small foot print biosensors with multiplexing capabilities that are robust and very sensitive will meet these requirements. Small hand-held lateral flow devices are light but have sensitivity levels ranging from 105 to 107cfu/g. Sensor platforms made from functionally derived electro-spun or melt-spun fibers can be prepared and conformally coated with conductive polymers by oxidative chemical vapor deposition (oCVD) to create electrochemical biosensor devices. The geometry of the melt-spun membrane is such that it creates an extremely high surface area for increased antibody attachment. Our goal is to utilize masking, lithographic or nano-stencil methods to construct grids of small independent “mini-sensors” that individually can detect 1-100 positive receptor/target interactions. Combining thousands or millions of these mini-sensors will allow our biosensor(s) the chance to interact with a single or very low number of pathogens in a very large sample and still report a positive result. The main objective is to develop small hand held electrochemical field capable detection devices utilizing nonwoven materials coated with conductive polymers. Studies are investigating the choice of the nonwoven membrane material and fiber diameter, the conductive polymer coating, and the process for depositing the conductive polymer onto the membrane. Ongoing studies will identify the best methods to functionalize the conductive membranes with pathogen specific antibodies, determine optimal distribution of Ab and to determine the most effective surface attachment chemistries. Lastly, an electrochemical cell will be designed and constructed in order to convert the antibody-antigen reaction into a measurable detection signal. The completion of an optimized electrochemical cell prototype will allow us to proceed to our final goal of having each “mini-sensor” directly interfaced with a computer for ongoing and instantaneous detection capability.

Applicant Requirements:

Experience working with nano-materials and particularly CVD, exposure or experience with systems engineering and or advanced degree in a relevant field with a high level of motivation and commitment will be considered.

Selected Recent Publications:

Torosian, S.D., Regan, P., Taylor, M. and A. Margolin. Persistence of Yersinia pestis in Seeded Bottled Water Samples. Can. J. of Micro., 2009, 55:(9) 1125-1129.

Torosian, S.D., Regan, P., Doran, T., Taylor, M. and A. Margolin. A Refrigeration Temperature of 4 °C Does Not Prevent Static Growth of Yersinia Pestis in Heart Infusion Broth. Can. J. of Micro. 2009, 55:(9) 1119-1124.

Torosian, S. D. and P. Regan. Constructing a Secure Containment System for Select Agent Analysis Using the PathatrixTM System. Laboratory Information Bulletin, Food and Drug Administration. 2007

Glucksman-Kuis, M. Alexandra, et al Polycystic Kidney Disease: The Complete structure of the PKD1 Gene and its protein. CELL 1995 Apr. 81(2): 289-298 .

High, A., Rodgers, F., and Torosian, S.D. Cloning, Nucleotide Sequence and Expression of a gene(omp M) encoding a 25 kDa Major Outer Membrane Protein of Legionella pneumophila in Escherichia coli.. J. Gen. Micro. 1993; 139:1715-1721.
 


Picture of Cong Wei

Cong Wei, Ph.D.
Supervisor, Radionuclides/Chemistry Section
Winchester Engineering and Analytical Center
Office of Regulatory Affairs, FDA                                          109 Holton Street
Winchester, MA 01890

Background:

Ph.D. in Chemistry, Yale University
M.S. in Chemistry, Boston University
M.S. in Electrical Engineering, University of
Electronic Science and Technology of China
B.S. in Physics, Sichuan University, China

Industry experience – 7 years
FDA Experience – 9 years
 

Research Interests:

Develop quick turnaround and high throughput technologies and methodologies for analyzing FDA regulated products.

Proposed Regulatory Research Project for the FDA Commissioner's Fellow:

The Japan’s nuclear power plant accident took place in 2011 reaffirmed an urgent need for quick screening technologies and methodologies so that quick turnaround sample triage, quick turnaround laboratory sample analysis, quick turnaround consequence management and regulatory decision making in a nuclear or radiological emergency can be realized. In a nuclear or radiological event, one of the needed fast screening analytical categories is sample triage decision making and detecting surface contaminations by radioisotopes. For performing meaningful analyses of surface contaminations by radioisotopes and designing a clear, efficient sample triage mechanism, it is essential to have a systematic understanding of how an isotope interacts with a surface, especially among food surfaces and surfaces of food packaging materials, e.g. if an isotope would stay on a surface or penetrate through a surface with a certain permeating rate. To date however, there has not been any systematic study for developing such understanding nor any methodology existing for systematically guiding sample triages and directing what types of quick turnaround analyses of radionuclides need to be followed. The objective of the proposed project is to establish knowledge base and develop a systematic understanding of the interactions between selected isotopes and surfaces of interest. Based on the understanding of the isotope/surface interactions, methodologies will be developed for guiding quick turnaround triage and analyses of radioisotopes. The project will involve both theoretical and experimental studies on paired isotope/surface systems of interest. The experimental studies can be conducted upon paired stable isotope/surface systems. The findings of the study can also potentially benefit applications such as safer packaging materials for foods, pharmaceuticals etc., medical devices, and environment cleaning.

Applicant Requirements:

Ph.D. in Chemistry or Physics with experiences in computer aided theoretical modeling, laboratory experiments, and analytical instruments.

Selected Recent Publications:

“Indirect endpoint detection by chemical reaction and chemiluminescence”, L., Li, J. A. Gilhooly, C. O. Morgan, William J. Surovic, C. Wei, United States Patent, Patent No.: US 6,440,263, Aug. 27, 2002.

“Optimization of CMP process by detecting of oxide/nitride interface using IR system”, L., Li, J. A. Gilhooly, C. O. Morgan, C. Wei, United States Patent, Patent No.: US 6,261,851, July 17, 2001.

“Endpoint detection by chemical reaction and photoionization”, L., Li, J. Gilhooly, C. O. Morgan, C. Wei, United States Patent, Patent No.: US 6,228,769, B1, May 8, 2001.

“A Comparison of the dynamics of CO oxidation by oxygen atoms and molecules on Pt and Pd surfaces”, C. Wei, G. L. Haller, J. Chem. Phys. 105, 810 (1996).

“The study of translational excitation of CO2 produced from CO oxidation on Pd using high resolution infrared chemiluminescence spectroscopy”, C. Wei, G. L. Haller, J. Chem. Phys. 103, 6806 (1995).