mission statement 3ob/gyn & utis respiratory infectious diseases blood-borne pathogens...

Mission Statement ............................................................................ 3

Executive Personnel ........................................................................ 5

Intellectual Property ......................................................................... 6

Divisions............................................................................................ 7

Molecular & Cellular Biology ...................................................... 7

Antimicrobial Resistance ...........................................................11

Pharmacogenomics .................................................................. 14

Clinical Assay Development Division ...................................... 17

Antigen Discovery ..................................................................... 22

VENENUM Biodesign ..................................................................... 25

HUMIGEN, LLC: the Institute for Genetic Immunology ............... 26

HUMIGEN Publications .................................................................. 32

Table of Contents

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Mission StatementAt Medical Diagnostic Laboratories, L.L.C. (MDL), we believe that life science research is

constantly evolving to improve human health and longevity. Our curiosity and resources

are directed toward meeting these challenges. Our research is focused on the creation and

fostering of research excellence centers that define the relationship and interactions between

host cells, disease causing agents and Pharmacogenomics.

The Research and Development at MDL is intellectual property driven, and serves to create an

accelerated bridge between basic research, product development and clinical implementation.

Through its multiple discipline integrated division-based scientific strategy, our Research and

Development Department encourages and supports the creation of innovative projects in

the fields of Microbiology, Women’s Health and Gynecology, Pediatric Infectious Diseases,

Cancer, Genetic Immunology, and Pharmacogenomics.

This state-of-the-art research program promotes and fosters research collaborations and

strategic partnerships with local, national and international Universities, Research Institutes

and Biopharma companies.

Eli Mordechai, Ph.D.

CEO and President

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MDL’s Research & Development Department Structure

MDL’s Research and Development Department is divided into two broad-based major divisions, aptly named ‘Research’ and ‘Development’.

The Research Division is comprised of the following subdivisions: Molecular & Cellular Biology, Antimicrobial Resistance, and Pharmacogenomics. Within each, we have established multiple Centers of Excellence with common priorities consistently applied to their individual research projects—the publication of scientific information in peer-reviewed research journals, the presentation of this work at national and international scientific symposia, the pursuit of novel intellectual property, and the acquisition of outside governmental and commercial research support to aid in continued expansion.

The Development Division is comprised of the following subdivisions: Obstetrics / Gynecology / Urinary Tract Infections, Blood-Borne Pathogens, Respiratory Infectious Diseases, Cancer Diagnostics, and Genetic Carrier Screening for Human Genetic Disorders and Antigen Discovery. The priorities of this group are the conception, development and rigorous validation of state-of-the-art clinical diagnostic assays for use in our CLIA-certified laboratory and also for licensing to other manufacturing companies to be incorporated in FDA-approved serological diagnostic assays. Innovation in the collection of biological specimens and transport to the laboratory for downstream testing is also actively sought through ongoing collaborations with physicians and hospitals.

Pathogenesis

Immunity

Women's Health

Cancer

Molecular & Cellular Biology

Antibacterial Resistance

Antifungal Resistance

Antimicrobial Resistance

Host Response to Virus

Virus Replication and Assembly

Virology

Pharmacogenomics Divison

Basic Research

OB/GYN & UTIs

Respiratory Infectious Diseases

Blood-Borne Pathogens

Cytogenetics

Molecular Diagnostics

Antigen Discovery

Clinical Assay DevelopmentBasic Research


Pathogenesis

Immunity

Women’s Health

Cancer





Pathogenesis

Immunity

Women's Health

Cancer





Host Response to Virus

Virus Replication and Assembly

Virology


Basic Research

OB/GYN & UTIs


Blood-Borne Pathogens

Cytogenetics


Antigen Discovery

Clinical Assay DevelopmentClinical Assay Development


OB/GYN & UTIs

Cancer

Blood-borne Pathogens

Antigen Discovery


Genetic Carrier Screening

Fertility

Human Genetic Disorders

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Our Research and Development Department at Medical Diagnostic Laboratories (MDL) is comprised of experts in the fields of Molecular Biology, Molecular Virology, Microbiology, Immunology, and Molecular Oncology. Our main theme of research is in the field of infectious diseases with an emphasis on the use of PCR methodologies.

Martin E. Adelson, Ph.D. – Vice President and Director of Research & Development

• Ph.D. Graduate of the Fels Institute for Cancer Research and Molecular Biology at Temple University in Philadelphia, PA.

• Recipient of The Daniel Swern Memorial Fellowship.

• Postdoctoral work on HIV-1 based gene therapy at the University of Medicine and Dentistry of New Jersey.

• Recipient of a competitive Postdoctoral Fellowship from the National Lung and Blood Institute of the National Institute of Health entitled “Pseudotyped Lentiviral Vector Gene Therapy of Hemophilia”.

• Currently investigating co-infection aspects of Lyme Disease, participating in clinical pathogen prevalency studies with physicians and researchers in the New Jersey, Pennsylvania, and California areas, and developing new clinical diagnostic assays.

• Member of the American Society of Microbiology, and the International Organization for Mycoplasmology, and the Association for Molecular Pathology.

• Guest reviewer for Infection and Immunity (2003), Clinical and Diagnostic Laboratory Immunology (2003), Applied and Environmental Microbiology (2003-2004), Clinical and Diagnostic Laboratory Immunology (2003-2004), Clinical and Diagnostic Microbiology (2003, 2005), Journal of Clinical Microbiology (2003-2007), Journal of Applied and Experimental Microbiology (2003-2004), and the Journal of Dermatological Science (2005), and Clinical Vaccine Immunology (2007).

• Appointed to the Editorial Board of the Journal of Clinical Microbiology (2005 -2011) and Diagnostic Microbiology and Infectious Disease (2008 - present).

• Member of the Thomas Jefferson University Biotechnology Advisory Committee.

Executive Personnel

Chief Executive Officer & Founder - Eli Mordechai, Ph.D.

Ph.D. Graduate of Temple University Department of Biochemistry in Philadelphia, • Pennsylvania.

The Florence Gloria Freedman Cancer Research Award Recipient.•

Postdoctoral work at The Barrow Neurological Institute specializing in Molecular • Neurobiology.

Published many research papers in the fields of Infectious Diseases and Chronic • Illnesses.

Director and Associate Member of the American Association of Bioanalysts. •

Member of the American Association for the Advancement of Science and the • American Society of Microbiology.

Licensed and certified Laboratory Director for the New York State Department of • Health.

Serves on the Board of Trustees of Rider University.•

Appointed to the Science Advisory Boards of the Hepatitis B Foundation, Burlington • County College and Rider University.

2007 Ernst and Young Entrepreneur of the Year Award Recipient.•

Recipient of the Distinguished Achievement Entrepreneur Award of Hamilton Township.•

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Richard C. Tilton, Ph.D. - Medical Co-Director

• 30 years experience in Clinical Microbiology and Immunology.

• 200 peer reviewed papers and 15 books.

• Professor of Laboratory Medicine at the University of Connecticut School of Medicine, retired.

• Medical Staff: John Dempsey Hospital, University of Connecticut Health Center, retired; Hamilton, Bermuda, Department of Pathology (1994-2000).

• Founder and Medical Director, BBI Clinical Laboratories, a national reference laboratory for Infectious Diseases.

• Founder and Principal - The Tilton Technical Group, a consulting consortium for clinical and environmental microbiology, laboratory compliance and regulation, and laboratory information systems.

• Board Certified, Public Health and Medical Microbiology: American Board of Medical Microbiology.

• Editor-In-Chief, Journal of Clinical Microbiology, 1990-2000.

Intellectual PropertyAdelson, M.E., Feola, M., Trama, J., and Mordechai, E.M. Methods and compositions related thereto for detecting and 1. identifying

distinct species of nucleic acids from causative agents. 10/7/05 11/246,9762.

Trama, J., Adelson, M.E., Mordechai, E.M. Oligonucleotides useful in methods for detecting and characterizing 3. Aspergillus fumigatus. 12/9/05 11/299,362

Adelson, M.E., Trama, J., Mordechai, E.M. Methods and compositions for detecting and identifying species of Candida. 4. 12/29/05 11/321,984

Adelson, M.E., Mordechai, E.M. Method and kit for the collection and maintenance of the detectability of a plurality of 5. microbiological species in a single gynecological sample. 1/31/06 11/343,858

Adelson, M.E., Mordechai, E.M. Method of receiving and handling a plurality of clinical samples for reporting a sum of diagnostic 6. results for each sample. 1/31/06 11/343,826

Adelson, M.E., Mordechai, E.M. Integrated method for collection and maintenance of detectability of a plurality of microbiological 7. agents in a single clinical sample and for handling a plurality of samples for reporting a sum of diagnostic results for each sample. 1/31/06 11/343,822

McCool, T.L., Chien Chang Loa, Mordechai, E.M., Adelson, M.E. Antibodies specific to antigens of 8. Bartonella henselae and use of these antigens in immunoassays. 5/3/06 11/418,409

Trama, J., Adelson, M.E., Mordechai, E.M. Methods and compositions for detecting serotypes of 9. Chlamydia trachomatis capable of causing Lymphogranuloma venereum. 5/18/06 11/436,506

Trama, J., Adelson, M.E., Mordechai, E.M. Compositions and methods for detecting 10. Atopobium vaginae. 8/10/06 11/502,694

Feola, M., Gofman, L., Adelson, M.E., Mordechai, E.M. Compositions and methods for detecting human metapneumovirus. 11. 3/2/07 11/713,408

Feola, M., Adelson, M.E., Mordechai, E.M., Novak, L. Compositions and methods for detecting 12. Borrelia afzelii. 5/29/08 12/156,029

Feola, M., Adelson, M.E., Mordechia,E.M., Entwistle, J. Compositions and methods for detecting 13. Cryptococcus neoformans. 6/18/08 12/214,317

Gygax, S., Vermitsky, J., Chadwich, S.G., Self, M.J., Adelson, M.E., Mordechai, E.M. Antifungal resistance of 14. Candida glabrata vaginal isolates and the development of a qRT-PCR-based azole susceptability assay. 3/12/09 12/381,492

Hoey, J. G., Venit, H., Adelson, M.E., Mordechai, E.M., Valoris-Cruz, F. 15. Babesia microti Genomic Clones Containing Novel Antigens Useful in the Diagnosis of Babesiosis . 4/14/09 12/386,097

Gygax, S.E., Prasad, A., Adelson, M.E, Mordechai, E.M. Detection of Penicillin Tolerance in Group B Streptococcus: Single 16. Nucleotide Polymorphisms in Penicillin Binding Protein 4. Filing Date: 5/18/09 Application No. 12/454, 408

Blaho, J. A Method of Determining Susceptibility of a Tumor Cell to a Chemotherapeutic Agent: Novel Use of Herpes Simplex 17. Virus. Filing Date: 6/30/09 Application No. 12/459,332

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Molecular and Cellular Biology DivisionThe Molecular and Cellular Biology Division has basic and clinical research interests within the fields of cancer and infectious disease. The Molecular and Cellular Biology Division embraces a multi-discipline approach, applying molecular, cellular, microbiological, biochemical, and genetic techniques to investigate problems in pathogenesis and host response. The group is dedicated to the identification and development of novel biomarkers and therapeutic targets for clinical use.

MCBD Research Teams

Cancer: The Cancer Team is interested in identifying cellular targets for use as biomarkers for cancer diagnosis and as candidates for therapeutic strategies. Current research focuses on using non-invasive sampling methods, primarily urine, to detect biomarkers associated with bladder cancers.

Biomarker Identification and Diagnostic Test Development: • Our goal is to discover and utilize markers for use in the diagnosis, prognosis, and treatment of cancer.

Tumor metastasis: • Our goal is to characterize novel protein function in tumor cell migration and invasion to identify potential targets for therapeutic intervention.

Pathogenesis: The Pathogenesis Team is characterizing the molecular and cellular interactions of bacteria with the host immune response. Current research focuses on two main areas: urinary tract infections and probiotic treatment of inflammatory bowel disease

Uropathogenic • Escherichia coli: Each year over seven million women in the United States experience urinary tract infections (UTIs). Uropathogenic Escherichia coli is the cause of over 70% of these infections. Diagnosis of a UTI relies upon the number of bacteria in urine, with greater than 100,000 E. coli per milliliter of urine defined as an acute UTI. However, lower counts are difficult to interpret; as low as 100 E. coli per milliliter of urine can still indicate an infection, but their presence can also be due to contamination by commensal E. coli. In addition, it is very difficult to obtain uncontaminated urine specimens from non-potty trained children. Our goal is to develop novel molecular diagnostic assays that can distinguish uropathogenic from commensal E. coli to facilitate diagnosis and treatment of UTIs.

Women’s Health: The Women’s Health Team is characterizing the role of fastidious vaginal microorganisms in several obstetric and gynecologic conditions. Current research focuses on two main areas: bacterial vaginosis and pre-term delivery.

Bacterial Vaginosis (BV): • Our goal is to develop novel diagnostics to better diagnose and treat patients with BV.Pre-Term Delivery:• Our goal is to investigate the association of fastidious vaginal microorganisms and inflammation with outcome.

Research Divisions

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Jason Trama, Ph.D. - Division HeadPh.D. in Biomedical Sciences from University of California, San Diego.•Post-doctoral research in The National Cancer Institute/National Institutes of Health.•Published articles in • Journal of Immunology, Journal of Clinical Microbiology, Journal of Clinical Virology, Molecular and Cellular Probes, and Infectious Diseases of Obstetric and Gynecology.

Erika K. Libby, B.S.B.S. in Biotechnology from Thomas Jefferson University, Philadelphia, Pennsylvania•B.A. in Biochemistry from Arcadia University, Glenside, Pennsylvania.•Published articles in • Microbes and Infection.Identifying cellular targets for cancer therapeutics.•

David W. Hilbert, Ph.D.Ph.D. in Microbiology and Immunology from Temple University.•Postdoctoral research in the Departments of Cell Biology and Microbiology at Columbia •University.Recipient of National Science Foundation Postdoctoral Research Fellowship in Microbial •Biology.Published articles in • Current Opinion in Microbiology, European Journal of Clinical Microbiology and Infectious Diseases, Journal of Bacteriology, Microbes and Infection, Microbiology and Molecular Biology Reviews, Molecular Microbiology, Protist and Surgery.Identifying biomarkers for detection of uropathogenic • Escherichia coli.Developing screens to identify compounds that inhibit C.• difficile sporulation.

Shannon M. Eble, M.S.M.S. in Biotechnology from Thomas Jefferson University, Philadelphia, Pennsylvania.•Developing screens to identify compounds that inhibit C.• difficile sporulation.

Terry Paulish, M.S.M.S. in Microbiology from The University of Montana.•Identifying biomarkers for detection of uropathogenic • Escherichia coli.Developing novel probiotics for the treatment of Inflammatory Bowel Disease.•

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Lamar Smith, B.A.B.A. in Biology from Holy Family University in Philadelphia, Pennsylvania.•Developing novel diagnostic tests for women’s health conditions.•

Michael Scher, Ph.D.Ph.D. in Biochemistry from the University of Medicine and Dentistry of New Jersey / Howard •Hughes Medical Institute. Recipient of The Commission on Science and Technology of New Jersey postdoctoral •fellowship.Developing noninvasive diagnostic tests for bladder cancer.•

Antara Datta, Ph.D.Ph.D. in Biochemistry from The Ohio State University.•Postdoctoral research in Department of Oncology at The Cancer Institute of New Jersey.•Published articles in • Journal of Virology, Retrovirology, Molecular and Cellular Biology.Developing noninvasive diagnostic tests for bladder cancer.•

Jack H. Mydlo, MD – Scientific ConsultantProfessor and Chair, Department of Urology, Temple University School of Medicine.•Serves on the GU sub-committee for Radiation Therapy Oncology Group (RTOG).•Extensive presentations and publications in journals and texts pertaining to urology and •surgery.Reviewer for the • Journal of Urology, Urology and BJU International.

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Libby EK, Pascal KE, Mordechai E, Adelson ME, Trama JP1. . 2008. Atopobium vaginae triggers an innate immune response in an in vitro model of bacterial vaginosis. Microb Infect, 10(4):439-446.Hilbert DW, Pascal KE, Libby EK, Mordechai E, Adelson ME, Trama JP2. . 2008. Uropathogenic Escherichia coli dominantly suppresses the innate immune response of bladder epithelial cells by a lipopolysaccharide- and Toll-like receptor 4-independent pathway. Microb Infect, 10(2):114-21.Trama JP, Pascal KE, Zimmerman JA, Self MJ, Mordechai E, Adelson ME3. . 2008. Rapid detection of Atopobium vaginae and association with organisms implicated in bacterial vaginosis. Mol Cell Probes, 22(2):96-102.Trama JP, Pascal KE, Zimmerman JA, Self MJ, Mordechai E, Adelson ME4. . 2007. Identification and genotyping of Molluscum Contagiosum virus from genital swab samples by Real-Time PCR and Pyrosequencing. J Clin Virol, 40(4):325-329.Trama JP, Adelson ME, Raphaelli I, Mordechai E5. . 2005. Detection of Candida species in vaginal samples in a clinical laboratory setting. Infect Dis Obstet Gynecol, 13(2):63-7.Trama JP, Mordechai E, Adelson ME6. . 2005. Detection and identification of Candida species associated with candida vaginitis by Real-Time PCR and Pyrosequencing. Mol Cell Probes, 19(2):145-52.Trama JP, Mordechai E, Adelson ME7. . 2005. Detection of Aspergillus fumigatus and a mutation that confers reduced susceptibility to itraconazole and posaconazole by Real-Time PCR and Pyrosequencing. J Clin Microbiol. 43(2):906-8.

Hilbert DW, Paulish TE, Mordechai E, Adelson ME, Trama JP1. . 2008. O serogroups, phylogeny, and virulence factors of cervicovaginal and rectal Escherichia coli isolates. Eur J Clin Microbiol Infect Dis. 27(12):1265-8.Libby EK, Pascal KE, Mordechai E, Adelson ME, Trama JP.2. 2008. Atopobium vaginae triggers an innate immune response in an in vitro model of bacterial vaginosis. Microbes Infect. 10(4):439-46. Hedges SR, Smith WL, Kaunitz AM, Adelson ME, Dorak MT, Mordechai E, Trama JP.3. Variations in distribution of fastidious vaginal microorganisms in a general gynecologic population. 35th Annual Scientific Meeting of the Infectious Diseases Society for Obstetrics and Gynecology, Seattle, WA, August 14-16, 2008.Hilbert DW, Paulish TE, Libby EK, Pascal KE, Mordechai E, Adelson ME, Gygax SE, Trama JP.4. O serotypes, virulence factors, plasmid replicons and antibiotic resistance of rectal and cervicovaginal Escherichia coli isolates. 108th American Society for Microbiology General Meeting, Boston, MA. June 1-5, 2008.Stemmer SM, Adelson ME, Mordechai E, Trama JP5. . Detection of human papillomavirus in U. S. women using Real-Time PCR: Prevalence and genotype distribution. American College of Obstetricians and Gynecologists, New Orleans, LA. May 3-7, 2008.Stemmer SM, Adelson ME, Mordechai E, Trama JP.6. Detection rates of Trichomonas vaginalis, in different age groups, using Real-Time PCR. American College of Obstetricians and Gynecologists 56th Annual Clinical Meeting, New Orleans, LA. May 3-7, 2008.Trama JP, Hilbert DW, Pascal KE, Libby EK, Mordechai E, Adelson ME.7. Uropathogenic E. coli subverts innate immune function of bladder epithelial cells. Experimental Biology 2008, San Diego, CA. April 5-9, 2008.Hilbert DW, Pascal KE, Mordechai E, Adelson ME, Trama JP8. . Uropathogenic E.coli subverts innate immune function of bladder epithelial cells. 107th American Society for Microbiology General Meeting, Toronto, Canada, May 21-25, 2007.Trama JP, Libby EK, Mordechai E, Adelson ME9. . Cervicovaginal epithelial cell cytokine production in response to microorganisms associated with bacterial vaginosis. The 94th Annual Meeting of the American Association of Immunologists, Miami Beach, Florida, May 18-22, 2007.Trama JP, Zimmerman JA, Mordechai E, Adelson ME10. . Detection of the Chlamydia trachomatis L serovars that cause Lymphogranuloma venereum by Real-Time PCR. Association for Molecular Pathology 2006 Annual Meeting, Orlando, FL, November 16-19, 2006.Adelson ME11. . Atopobium vaginae, a potential indicator for bacterial vaginosis? Infectious Diseases Society for Obstetrics and Gynecology 33rd Annual Scientific Meeting, Monterey, CA, August 2-5, 2006.Trama JP, Pascal KE, Mordechai E, Adelson ME12. . Real-Time PCR detection of Atopobium vaginae and association with organisms implicated in the development of bacterial vaginosis. 106th American Society of Microbiology General Meeting, Orlando, FL, May 21-25, 2006.Trama JP, Libby EK, Gygax SE, Mordechai E, Adelson ME13. . Differential induction of pro-inflammatory cytokines by vaginal and cervical epithelial cells in response to Group B Streptococci. Immunology 2006, Boston, MA, May 12-16, 2006.Trama JP, Libby EK, Gygax SE, Mordechai E, Adelson ME14. . Host, pathogen, and drug host, pathogen, and drug Interactions in an in vitro model of vaginal candidiasis. 8th Annual American Society of Microbiology Conference on Candida and Candidiasis, Denver, CO, March 13-17, 2006.Trama JP, Mordechai E, Adelson ME15. . Detection of Molluscum Contagiosum virus by Real-Time PCR and Pyrosequencing. American Society of Microbiology 105th General Meeting, Atlanta, GA, June 5–9, 2005.Trama JP, McReynolds JR, Mordechai E, Stemmer SM, Adelson ME16. . Sequencing the genome of Atopobium vaginae, a possible indicator of bacterial vaginosis. American College of Obstetricians and Gynecologists 53rd Annual Clinical Meeting, San Francisco, CA, May 7–11, 2005.Trama JP, Mordechai E, Adelson ME17. . Novel Real-Time PCR and Pyrosequencing technique for the detection of Aspergillus fumigatus and a mutation that confers triazole resistance. American Society for Microbiology 104th General Meeting, New Orleans, LA. May 23-27, 2004.Mordechai E, Trama JP, Raphaelli I, Adelson ME.18. Prevalency of Candida species associated with candida vaginosis in the United States. American Society for Microbiology 104th General Meeting, New Orleans, LA, May 23-27, 2004.Trama JP, Stemmer SM, Mordechai E, Adelson ME19. . Analyzing Candida albicans gene mutations that contribute to azole resistance by Pyrosequencing. American College of Obstetricians and Gynecologists 52nd Annual Clinical Meeting, Philadelphia, PA, May 1-5, 2004.Trama JP, Stemmer SM, Mordechai E, Adelson ME20. . Novel technique for identification of vulvovaginal candidiasis by Real-Time PCR and Pyrosequencing. American College of Obstetricians and Gynecologists 52nd Annual Clinical Meeting, Philadelphia, PA, May 1-5, 2004.

Abstracts & Presentations

Publications

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Antimicrobial resistance is a major problem today in which early detection and susceptibility of a pathogen could dictate the proper course of treatment and outcome of infection. Our group focuses on understanding the molecular mechanisms involved in antimicrobial resistance in addition to developing novel molecular point-of-care and in-house diagnostic tests to identify susceptibility in bacterial, fungal, and parasitic pathogens. Currently our research interests involve three main projects. First, we are investigating the mechanisms involved in penicillin tolerance in a gram-positive bacterium, Group B Streptococcus. This opportunistic pathogen is a leading cause of life-threatening infections in neonates and recently has presented itself as an emerging pathogen in the elderly. The second project involves investigating the mechanisms of azole resistance amongst Candida species, in particular Candida glabrata. Candida infections, in particular C. albicans and C. glabrata, are the leading cause of fungal infections that can affect both healthy (yeast infections in women) and immune compromised (patients with HIV/AID or undergoing chemotherapeutic or immune suppressive therapy) individuals. The third project involves the development of point-of-care diagnostic tests for GBS and Methicillin Resistant Staphylococcus aureus (MRSA), a major healthcare problem due to the level of morbidity and mortality from community and hospital acquired infections. Investigating these mechanisms in bacteria and fungi can lead to improved diagnostics and targets for new antimicrobial compounds.

Antimicrobial Resistance Division

Scott E. Gygax, Ph.D. – Division HeadPh.D. Graduate of the Biomedical Sciences Program at the University of Connecticut • Health Center. Studied the DNA Damage Response of the filamentous fungus Aspergillus nidulans.

Post-doctoral work at Yale University School of Medicine, Department of Pediatrics. • Studied the contribution of mitochondrial respiration to filamentation/morphogenesis in the fungal pathogen, Candida albicans.

Extensive experience with molecular, genetic, and cellular techniques.•

Currently investigating the genetic factors that contribute to antimicrobial resistance and • developing new clinical point-of-care and in-house diagnostic assays. The organisms currently under investigation include Group B Streptococcus, Methicillin Resistant Staphylococcus aureus (MRSA), and Candida spp.

Clinical Assistant Professor at Thomas Jefferson University, College of Health Professions, •Department of Bioscience Technologies and Adjunct Assistant Professor at University of Medicine and Dentistry of New Jersey.

Member of the American Society for Microbiology, Eastern Pennsylvania Branch of ASM, • and the Association for Molecular Pathology.

John-Paul Vermitsky, Ph.D.• Ph.D. graduate of the Molecular and Cell Biology Program at Drexel University College of

Medicine. Studied the mechanisms of azole resistance in Candida glabrata.

• Extensive experience with molecular, genetic, and cellular techniques.

• Currently investigating the mechanisms of resistance in Candida isolates along with understanding the regulation of PDR1, a transcriptional regulator of ABC transporters in C. glabrata involved in drug efflux. Finally to determine virulence factors of C. glabrata via genomic and proteomic approaches.

• Adjunct Professor at Camden County College, Department of Arts and Sciences, and Adjunct Assistant Professor at University of Medicine and Dentistry of New Jersey.

• Member of the American Society for Microbiology and Eastern Pennsylvania Branch of ASM.

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Jessica A. Schuyler, M.S.• M.S. Graduate of Thomas Jefferson University, College of Health Professions, Department of

Bioscience Technologies.

• Currently investigating bacteriophage transduction in Group B Streptococcus and Staphylococcus aureus.

Currently developing novel point-of-care diagnostic tests for Group B • Streptococcus and Methicillin Resistant Staphylococcus aureus (MRSA) and investigating the novel regulation of the virulence factor hemolysin/cytolysin of Group B Streptococcus.

Matthew J. Self, M.S.M.S. graduate of Rutgers University, Department of Biology.•

Currently investigating the mechanisms of azole resistance in • Candida glabrata via the regulation of PDR1, a transcriptional regulator of ABC transporters involved in drug efflux.

Adjunct Laboratory Instructor at Burlington County College, Department of Science, Math, and •Technology.

Aditya Prasad, B.S.• B.S. Graduate of Thomas Jefferson University, College of Health Professions, Department of

Bioscience Technologies.

• Currently investigating the mechanisms of penicillin tolerance in Group B Streptococcus.

• Member of the American Society for Microbiology.

Sean G. Chadwick, B.S.• B.S. graduate of Richard Stockton College of New Jersey, Department of Biology.

• Currently developing antibiotic susceptibility assays for clinical isolates of Staphylococcus aureus and developing novel point-of-care diagnostic tests for bacterial and fungal pathogens.

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Prasad, A., Mordechai, E., Adelson, M.E., and Gygax, S.E.1. 2009. PBP4 Polymorphisms Generate Penicillin Tolerance in Group B Streptococcus. Nature Medicine. Manuscript in preparation.

Vermitsky, J.-P., Self, M.J., Chadwick, S.G., Katiyar, S.K., Mordechai, E., Adelson, M.E., Edlind, T.D., and Gygax, S.E.2. 2009. cAMP-PKA kinase Tpk3 negatively regulates Candida glabrata Pdr1. Antimicrob. Agents Chemother. Manuscript in preparation.

Vermitsky, J-P., Chadwick, S.G., Self, M.J., Mordechai, E., Adelson, M.E., Nickels, J.T. Jr., and Gygax, S.E.3. 2009. CgUpc2 is the master regulator of ergosterol biosynthetic genes in Candida glabrata. Antimicrob. Agents Chemother. Manuscript in preparation.

Gygax, S.E., Vermitsky, J.-P., Self, M.J., Chadwick, S.G., Mordechai, E., Adelson, M.E., and Trama, J.P.4. 2008. Antifungal Resistance of Candida glabrata Vaginal Isolates and the Development of a qRT-PCR-based Azole Susceptibility Assay. Antimicrob. Agents Chemother. 52(9): 3424-3426.

Gygax SE, Vermitsky JP, Self MJ, Mordechai E, Adelson ME, Trama JP5. . 2008. Antifungal resistance in vaginal Candida clini-cal isolates. Antimicrob Agents Chemother, manuscript under review.

Gygax SE, Schuyler JA, Kimmel LE, Trama JP, Mordechai E, Adelson, ME6. . 2006. Erythromycin and clindamycin resistance in Group B Streptococcal clinical isolates. Antimicrob Agents Chemother, 50(5):1875-7.

Gygax SE, Schuyler JA, Trama JP, Mordechai E, Adelson ME.7. 2007. The detection of erythromycin and clindamycin resistance genes in both Group B Streptococcal clinical isolates and cervicovaginal/rectal swabs. Microb Drug Resist, 13(2):119-123.

Vermitsky JP, Self MJ, Chadwick SG, Trama JP, Mordechai E, Adelson ME. 8. 2007. A survey of vaginal flora Candida species isolates from women of different age groups by use of species-specific PCR detection. J Clin Microbiol, 46(4):1501-1503.

Publications


Prasad A, Basu P, Mordechai E, Adelson ME, Gygax SE.1. . PBP4 Polymorphisms Generate Penicillin Tolerance in Group B Streptococcus. 109th American Society for Microbiology General Meeting. Philadelphia, PA. May 17-21, 2009.

Vermitsky JP, Self MJ, Chadwick SG, Katiyar SK, Edlind TD, Gygax SE.2. 2009. cAMP-PKA kinase Tpk3 negatively regulates Candida glabrata Pdr1. 109th American Society for Microbiology General Meeting. Philadelphia, PA. May 17-21, 2009.

Vermitsky JP, Katiyar S, Gygax SE, Edlind TD.3. Multidrug resistance transcription factor Pdr1 is activated by MAP kinase Slt2 and repressed by protein kinase A Tpk3 in the opportunistic yeast Candida glabrata. 2008 Yeast Genetics and Molecular Biology Meeting. Toronto, Canada. July 22-27, 2008.

Hilbert DW, Paulish TE, Libby EK, Pascal KE, Mordechai E, Adelson ME, Gygax SE, Trama JP.4. O Serotype, Virulence Factors, Plasmid Replicons, and Antibiotic Resistance of Rectal and Cervico-vaginal Escherichia coli Isolates. 108th American Society for Microbiology General Meeting. Boston, MA. June 1-5, 2008.

Prasad A, Mordechai E, Adelson ME, Gygax SE5. . Penicillin tolerance in Group B Streptococcus. 48th Annual Interscience Con-ference on Antimicrobial Agents and Chemotherapy. Washington, DC. October 25-28, 2008.

Edlind TD, Vermitsky JP, Pfaller M, Gygax SE, Katiyar S6. . Molecular mechanisms behind flucytosine resistance and azole-flucytosine antagonism in Candida glabrata. 9th American Society for Microbiology Conference on Candida and Candidiasis, Jersey City, NJ. March 24-28, 2008.

Katiyar S, Vermitsky JP, Gygax SE, Edlind TD7. . Anatomy of Candida glabrata PdR1, master regulator of azole resistance: evidence for activation by MAP kinase SIt2. 9th American Society for Microbiology Conference on Candida and Candidiasis, Jersey City, NJ. March 24-28, 2008.

Vermitsky JP, Self MJ, Katiyar S, Mordechai E, Adelson ME, Edlind TD8. , Gygax SE. The cAMP protein kinase a signal transduction pathway negatively regulates Pdr1, the master regulator of azole resistance in Candida glabrata. 9th American Society for Microbiology Conference on Candida and Candidiasis, Jersey City, NJ. March 24-28, 2008.

Gygax SE, Prasad A, Schuyler JA, Trama JP, Mordechai E, Adelson ME9. . Penicillin tolerance in Group B Streptococcus. 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, September 17-20, 2007.

Gygax SE, Schuyler JA, Trama JP, Adelson ME10. . A novel β-hemolysin/cytolysin expression phenotype in Group B Streptococcal clinical isolates. 107th American Society of Microbiology General Meeting, Toronto, Canada, May 21-25, 2007.

Gygax SE, Prasad A, Schuyler JA, Trama JP, Mordechai E, Adelson ME11. . Penicillin tolerance in Group B Streptococcus. 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA. September 26-30, 2006.

Gygax SE, Schuyler JA, Trama JP, Mordechai E, Adelson ME12. . Erythromycin and clindamycin resistance in Group B Streptococcus clinical isolates. 45th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington DC, December 16-19, 2005.

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Pharmacogenomics DivisionGenomic sequencing initiatives have laid the ground work for sophisticated proteomic approaches aimed at uncovering gene product structure/function relationships. Potential chemotherapeutic targets for many human diseases will undoubtedly surface from these studies. Moreover, proteomic analyses of the genomes from pathogenic microorganisms should uncover novel drug targets. The mission of the Pharmacogenomics Team is to identify and characterize novel gene products, and evaluate their efficacy as targets for combating human diseases, such as, atherosclerosis, cancer, diabetes, and fungal mycoses.

Joseph T. Nickels, Ph.D. - Pharmacogenomics Division Team Leader

2006 – Editorial Board: Analytical Biochemistry.• 1999-2006 Director, Graduate Program in Molecular and Cellular Biology and Genetics, Drexel • University College of Medicine.2005-2007 Associate Professor, Department of Biochemistry and Molecular Biology, Drexel • University College of Medicine.1999-2002 Basil O’Connor Scholar, March of Dimes Foundation.• 1997-2005 Assistant Professor, Department of Biochemistry and Molecular Biology, Drexel • University College of Medicine.1994-97 Postdoctoral Fellow, New Jersey Commission on Cancer Research.• 1993-97 Post-doctoral fellow, Department of Molecular Biology, Princeton University, Advisor: Jim • Broach, Ph.D. Studied ceramide signaling and the role of ceramide-activated protein phosphatase (CAPP) in regulating the yeast cell cycle.1989-93 Ph.D. Microbiology and Molecular Genetics, UMDNJ/Rutgers University. Studied • phosphoinositide signaling in the yeast S. cerevisiae. Advisor: George Carman, Ph.D.Adhoc manuscript reviewer • Journal of Biological Chemistry, Genetics, Molecular and Cellular Biology, Microbiology, Eukaryotic Cell, Current Biology, Molecular Biology of the Cell, Biochmica and Biochim Biophys Acta.Adhoc grant reviewer Canadian Research Council, National Science Foundation, Swiss Research • Foundation.Member of Genetics Society of America, American Association for the Advancement of Science, • American Society for Microbiology, American Society for Biochemistry and Molecular Biology.Currently isolating novel antifungal targets through uncovering the molecular basis for induced • sterol gene expression in response to blocks in sterol biosynthesis in several yeast species.Isolating novel protein phosphatase 2A (PP2A) targets through elucidating the role of PP2A and • CAPP in cell cycle regulation and endocytosis. These targets may have future potential as drug targets for cancer and diabetes. Exploring the role of the putative lipid transporter, Arv1, in sterol trafficking, cardiovascular disease, • and polarized growth in yeast and humans.

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Christina Gallo, B.S.Ph.D. candidate in Molecular & Cell Biology & Genetics from Drexel University College of Medicine.• Graduate thesis work focused on understanding the transcriptional mechanisms regulating sterol • biosynthesis in Saccharomyces cerevisiae.Thesis advisor: Joseph T. Nickels, Ph.D.• B.S. in Molecular Biology from Lehigh University.• ïIdentification of inhibitors for the fungal transcription factors, Upc2/Ecm22 to prevent pathogenic • fungal growth.Identification of inhibitors for the lipid transporter, Arv1, to prevent pathogenic fungi growth.• Characterize the role of fungal Arv1 in virulence.• Characterize the role of fungal Upc2 in virulence.•

Lyndi M. Rice, Ph.D.Post-doctoral Research at the Wistar Institute studying the role of histone modifications in genomic • silencing in Schizosaccharomyces pombe and the effects of histone variant incorporation into the HSV-1 genome during lytic infection. Mentor: Shelley Berger, Ph.D.Ph.D. in Molecular & Cell Biology & Genetics from Drexel University College of Medicine in May, • 2005. Dissertation: “The Regulation of Pre-Meiotic DNA replication in Saccharomyces cerevisiae”. Mentor: Joseph T. Nickels, Ph.D.B.S. in Biology from Indiana University of Pennsylvania, 2000.• Development of a human genetic diagnostic panel to determine which host genes influence predis-• position/resistance to cardiovascular disease.Examining the role of PP2A in regulating cholesterol metabolism in humans.• Identification of small molecules regulating PP2A to attenuate cholesterol homeostasis.• Development of an Arv1 knockout mouse model to study the role of Arv1 in lipid-mediated meta-• bolic disorders

Paula McCourt, Ph.D.

Ph.D. in Molecular & Cell Biology & Genetics from Drexel University College of Medicine. • Dissertation: “Novel Functions of Protein Phosphatase 2A in Saccharomyces cerevisiae”.Ph.D. supervisor: Joseph T. Nickels, Ph.D.• B.A. in Biology from Holy Family University. Undergraduate Senior Project: “Isolation of Antibiotic • Resistant Gram-negative Bacteria from the Delaware River”. Development of a human genetic diagnostic panel to determine which host genes influence • predisposition/resistance to fungal mycoses.Development of a fungal genetic diagnostic panel to determine fungal resistance.• Identification of inhibitors for the lipid transporter, Arv1, to prevent pathogenic fungi growth.• Characterize the role of fungal Arv1 in virulence.• Member of the Genetics Society of America.•

Tina Okomski, M.S.M.S. Graduate of Thomas Jefferson University, Department of Bioscience Technologies.• B.S. from Thomas Jefferson University, Department of Bioscience Technologies.• Diagnositc analysis of SREBP transcription factor phosphorylation state as a biomarker for • cardiovascular risk and/or disease

Characterization of the PP2AñCIP2A interaction.•

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Michelle Villasmil, B.S. Ph.D. candidate in Molecular & Cell Biology & Genetics at Drexel University College of Medicine. • Supervisor: Joseph T. Nickels, Ph.D.• B.S. in Molecular Genetics from the University of Rochester. • B.A. in Spanish from the University of Rochester .• Currently pursuing a structure/function analysis of Arv1 Homology Domain (AHD), in the putative • lipid transporter, Arv1, and defining its role in sterol trafficking.Determining role of Arv1 in polarized cell growth in • S. cerevisiae.Determining the molecular role of human Arv1 in sterol and sphingolipid homeostasis and • ascertaining its potential as a chemotherapeutic target for cardiovascular disease.

PublicationsMorgan J, McCourt P, Rankin L, Swain E, Rice LM, Nickels Jr. JT1. . 2009. Altering sphingolipid metabolism in yeast cells lacking the amphiphysin ortholog, Rvs161, re-initiates sugar transporter endocytosis. Eukaryot Cell. In press.

McCourt P, Morgan J, Nickels Jr JT. 2. 2009. Stress-induced ceramide-activated protein phosphatase can compensate for loss of amphiphysin-like activity in Saccharomyces cerevisiae and functions to reinitiate endocytosis. J Biol Chem. In press.


McCourt PC, Nickels JT1. . Molecular Analysis of the Candida albicans Arv1 Ortholog of Saccharomyces cerevisiae. American Society of Microbiology Meeting. Philadelphia, PA. May 17-21, 2009.

Rice LM, Nickels JT. 2. PP2A is required for SREBP2 transcription factor activity. Keystone Symposia – Metabolism and Cardiovascular Risk. September 23-28, 2008

1. Villasmil ML, Bower M, Ansbach A, Nickels JT. The putative lipid transporter, Arv1, is required for mating in Saccharomyces cerevisiae. Yeast Genetics and Molecular Biology Meeting, Toronto, Canada. July 22-27, 2008.

2. Gallo C, Bower M, Shirzadi R, Nickels JT. The SRE-dependant and –independent transcriptional regulation of sterol gene expression in Saccharomyces cerevisiae. Yeast Genetics and Molecular Biology Meeting, Toronto, Canada. July 22-27, 2008.

Jocelyn Nolt, B.S.Ph.D. candidate in Molecular & Cell Biology & Genetics at Drexel University College of Medicine: • Supervisor: Joseph T. Nickels, Ph.D.Currently characterizing the role of protein phosphatase 2A (PP2A) in meiosis using the budding • yeast, Saccharomyces cerevisiae as a model system.Isolating novel cell cycle targets of PP2A in yeast and humans.• B.S. in Biochemistry & Molecular Biology from Dickinson College, Carlisle, PA. • Member of the Genetics Society of America and The American Society for Microbiology.•

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Clinical Assay Development Division The Development Division within the Research and Development Department of MDL is comprised of four general categories: Blood-Borne Pathogens, Obstetrics/Gynecology/Urinary Tract Infections, Pediatric Infectious Diseases and Cytogenetics. The aim of the first three divisions is to identify potential pathogenic agents clinically germane to their respective focus of interest. Once identified, diagnostic tests are designed for their identification in clinical specimens sampled using MDL’s proprietary OneSwab®, UroSwab® and NasoSwab™ technologies, as well as other medias, including blood, synovial and cerebrospinal fluids and ThinPrep. Dividing the pathogenic agents clinically allows MDL to concentrate their efforts upon medically relevant infectious agents that meet the needs of both the physician and the individual through our extensive testing menus and rapid reporting times. MDL’s goal is to aid the physician in planning their course of treatment. Antibiotic resistance is a naturally occurring phenomenon that renders certain antibiotics, oftentimes the treatment of choice, useless. As antibiotic resistant agents are identified, MDL modifies its testing procedures to include reflexive testing that enables physicians to modify their treatment strategies. Such advanced diagnostic testing is already available for ciprofloxacin-resistant Neisseria gonorrhoeae, clindamycin and erythromycin resistant Group B Streptococcus, amantadine-resistant influenza A, and clarithromycin-resistant Helicobacter pylori. Cytogenetics represents a new area of focus for MDL. Within this group, tests are being designed and validated for the identification of carriers of inheritable diseases. Initial tests under development are those most common in Ashkenazi Jewish populations. Our initial release screens for Cystic Fibrosis carrier status in OneSwab® and buccal swabs and tests for Huntington’s Disease, Fragile X, Bloom and Canavan’s Syndromes, Familial Dysautonomia, Fanconi’s Anemia, Gaucher, Niemann-Pick and Tay-Sachs Disease are currently under development and will be released soon.

Molecular Diagnostic Assay Development

Kathryn T. Iacono, Ph.D. - Clinical Team Leader

• Ph.D. Graduate of Temple University School of Medicine, Philadelphia, Pennsylvania

• B.S. Muhlenberg College, Allentown, Pennsylvania.

• Work within MDL’s Developmental Team in the selection and validation of all diagnostic tests. Also work in conjunction with the Quality Control/Quality Assurance Division for the maintenance of state licensure and compliance through the critical review of the scientific data reported in validation reports for individual tests.

Melanie M. Feola, B.S. - Clinical Coordinator• B.S. in Microbiology from the University of the Sciences in Philadelphia, Pennsylvania.

• Masters of Business Administration from the University of Phoenix.

• Member of American Society of Microbiology.

• Oversees the Pediatrics, Blood-Borne, and OB/GYN-Urology team leaders in training of new staff and supervision of routine laboratory operations.

• Develops and validates diagnostic assays from the Development division for transfer to the Clinical Laboratory.

Jessica Zimmerman, B.S. - OB/GYN & UTI Team Leader • B.S. in Biology from the University of the Sciences in Philadelphia, P.A.

• Currently involved in development of new clinical diagnostic assays for the OB/GYN market.

• Participated in Nutraceutical Research as an undergraduate.

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Rob Mason, B.S. - Blood-Borne Pathogen Team Leader• B.S. Degree from the Richard Stockton State College of New Jersey.

• Oversees the development and validation of assays targeting various blood-borne pathogens.

Christine Hancock, B.S.B.S. Graduate of Thomas Jefferson University, College of Health Professions, Department of •Bioscience TechnologiesDevelops and validates diagnostic OB/GYN tests to transfer to the Clinical Laboratory•

Adam Green, B.A.• B.A. in Biology from Rutgers University in Camden.

• Develops and validates diagnostic assays from the molecular biology division for transfer to the Clinical Laboratory.

Christina Overmyer, B.S. - Pediatric Infectious Disease Team Leader • B.S. Degree from Cook College - Rutgers University.

• Genotyping Technician at Orchid Biosciences.

• Supervisor/Research IV at Rutgers University Cell & DNA Repository.

• Involved in the development of new clinical assays for the Pediatric Infectious Disease market.

Diana E. Gonzalez, B.S. • B.S. in Biology from Rider University Lawrenceville, New Jersey.

• Participated in undergraduate research studying immune system suppression in the peritoneal cavity of mice, in vivo and in vitro.

• Recently transferred from the Clinical Department into R&D’s Pediatrics and Infectious Diseases development team, where she currently works to develop and validate assays for transfer to the Clinical Department.

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Sergey Balashov, Ph.D. - Cytogenetics Team Leader• Ph.D. Graduate of the Institute of Biochemistry and Physiology of Microorganisms

of Russian Academy of Sciences, Pushchino, Russia. Studied bacterial plasmids of biodegradation.

• Postdoctoral training on bacterial mutagenesis at the University of Medicine and Dentistry of New Jersey.

• Research position at the Public Health Research Institute. Studied antibiotic resistance in fungi.

• Extensive experience in advanced molecular techniques and assay development.

• Currently involved in the development of new clinical assays for prenatal diagnostics and genetic screening.

Katie Trifiletti, B.S.• B.S. in Biology with a focus on Neuroscience from Stony Brook University.

• Participated in undergraduate research studying the morphology and evolutionary divergence of tropical Drosophila.

• Currently involved in developing assays for prenatal detection of genetic diseases.

Lohitha Konduru, B.S.B.S. in Biology from Rutgers University, New Brunswick, New Jersey.•Presently working in the development and validation of assays for diagnosis of various •genetic diseases.

Justine Legbedze, B.S.B.S. in Public Health from Rutgers University in New Brunswick, New Jersey.•Currently involved in the development and validation of assays for the Veterinary Medicine •development team.

Elizabeth Tollar, B.S.Graduated form Cornell University, Ithaca, NY with a B.S. in Genetic and Molecular •Engineering.One year’s experience in studying the mutation of the “dumpy” gene in drosophila •Melanogaster.Currently working on identifying host genes whose translational expression is affected •during HPV infection that will serve as biomarkers of cervical cancer onset and progression.

Advanced Diagnostics Development Genetic carrier screening represents a new area of focus for MDL. Within this group, tests are being designed and validated for the identification of carriers of inheritable diseases. Our initial release screens for Cystic Fibrosis carrier status in OneSwab® and buccal swabs. Recently developed test are those most common in Ashkenazi Jewish populations. MDLs new Ashkenazi Jewish genetic panel screens for genetic determinants of Bloom and Canavan’s Syndromes, Familial Dysautonomia, Fanconi’s Anemia, Gaucher, Niemann-Pick, and Tay-Sachs Diseases. Tests for Huntington’s Disease, Torsion Dystonia, Factor XI deficiency, and Sickle Cell Anemia are the newest additions to our genetic carrier screening menu.

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Publications

1. Eskow E, Rao RV, Mordechai E. 2001. Concurrent infection of the central nervous system by Borrelia burgdorferi and Bartonella henselae: Evidence for a novel tick-borne disease complex. Arch Neurol, 58:1357-1363.

2. Eskow E, Adelson ME, Rao RV, Mordechai E. 2003. Evidence for disseminated Mycoplasma fermentans in New Jersey residents with antecedent tick attachment and subsequent musculoskeletal symptoms. J Clin Rheumatol, 9:77-87.

3. Tilton RC. 2003. New tests for Lyme disease. Clin Microbiol Newsl, 25(19):145-149.

4. Adelson ME, Rao RV, Tilton RC, Cabets K, Eskow E, Fein L, Occi JL, Mordechai E. 2004. Prevalence of Borrelia burgdorferi, Bartonella species, Babesia microti, and Anaplasma phagocytophila in Ixodes scapularis collected in northern New Jersey. J Clin Microbiol, 42:2799-2801.

5. Meer-Scherrer L, Adelson ME, Mordechai E, Lottaz B, Tilton RC. 2004. Babesia microti infection in Europe. Curr Microbiol, 48(6):435-7.

6. Adelson ME, Feola M, Trama JP, Tilton RC, Mordechai E. 2005. Simultaneous detection of herpes simplex virus types 1 and 2 by Real-Time PCR and Pyrosequencing. J Clin Virol, 33(1):25-34.

7. Drisko J, Bischoff B, Giles C, Adelson ME, Rao RV, McCallum R. 2005. Evaluation of 5 probiotic products for bacteria by DNA extraction and PCR analysis. Dig Dis Sci, 50(6):1113-7.

8. Meer-Scherrer L, Adelson ME, Mordechai E, Tilton RC. 2006. Neuroborreliosis associated with Alzheimer’s disease. Curr Microbiol, 52(4):330-2.

9. Stemmer SM, Adelson ME, Trama JP, Cohen JL, Mordechai E. 2008. Prevalence of Neisseria gonorrhoae, Chlamydia trachomatis and Trichomonas vaginalis in a clinical laboratory setting. Manuscript submitted.


1. Mordechai E, Adelson ME, Cabets K, Eskow E, Fein L, Occi J. Pivotal role of PCR in the detection of coinfections. 15th International scientific conference on Lyme disease and other tick-borne disorders, Farmington, CT, April 6-7, 2002.

2. Drisko J, Bischoff B, Giles C, Adelson ME, Rao RV, McCallum R. Evaluation of 5 probiotic products for bacteria by DNA extraction and PCR analysis. Digestive Disease Week 2003, American Gastroenterological Association, Orlando, FL, May 17-22, 2003.

3. Adelson ME, Feola M, Stemmer SM, Mordechai E. Diagnosis of Neisseria gonhorrhea, Chlamydia trachomatis and Trichomonas vaginalis by Real-Time PCR. American College of Obstetricians and Gynecologists 52nd Annual Clinical Meeting, Philadelphia, PA, May 1-5, 2004.

4. Adelson ME, Feola M, Mordechai E. Development of a Real-Time PCR assay for the simultaneous detection of herpes simplex virus types 1 and 2 with confirmation by Pyrosequencing technology. American Society for Microbiology 104th General Meeting, New Orleans, LA, May 23-27, 2004.

5. Naurath EF, Mohr EL, Adelson ME, Stemmer SM, Mordechai E, Trama JP. Detection and quantification of Gardnerella vaginalis by Real-Time PCR. American College of Obstetricians and Gynecologists 53rd Annual Clinical Meeting, San Francisco, CA, May 7–11, 2005.

6. Feola M, Laskowski R, Choi D, Trama JP, Mordechai E, Adelson ME. Detection and confirmation of the urogenital Mycoplasmas, Ureaplasma urealyticum, Mycoplasma hominis, and Mycoplasma genitalium by Real-Time PCR and Pyrosequencing. American Society of Microbiology 105th General Meeting, Atlanta, GA, June 5–9, 2005.

7. Adelson ME, Rao RV, Trama JP, Mordechai E. Evaluation of UTM-RT for the molecular detection of a plurality of OB/GYN related pathogens. 45th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy Meeting, Washington DC, December 16-19, 2005.

8. Nguyen T, Feola M, Mordechai E, Stemmer SM, Adelson ME. Bacterial vaginosis: Development of a Real-Time PCR assay for the detection of Mobiluncus species and Bacteroides fragilis. Annual Clinical Meeting of the American College of Obstetricians and Gynecologists, Washington DC, May 8-10, 2006.

9. Lim C, Kimmel L, Nuesa J, Mordechai E, Stemmer SM, Adelson ME. Robotic PCR detection of human papillomavirus genotypes in cervicovaginal swab and urine specimens. 54th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists, Washington DC, May 8-10, 2006.

10. Feola M, Nguyen TT, Entwistle J, Zimmerman JA, Mordechai E, Adelson ME. Trichomonas vaginalis sequence heterogeneities may necessitate multiple Real-Time PCR detection assays.106th American Society of Microbiology General Meeting, Orlando, FL, May 21-25, 2006.

11. Entwistle J, Feola M, Rao RV, Zimmerman JA, Trama JP, Mordechai E, Adelson ME. Molecular detection of a plurality of pathogens in UTM-RT. 9th Annual European Society for Clinical Virology Meeting, Birmingham, United Kingdom, September 3-6, 2006.

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12. Entwistle J, Feola M, Mordechai E, Adelson ME. Real-Time PCR detection of polyomaviruses BK and JC in Urine. 9th Annual European Society for Clinical Virology Meeting, Birmingham, United Kingdom, September 3-6, 2006.

13. Valois-Cruz F, Loa CC, Mordechai E, Tilton RC, Adelson ME. Simultaneous detection and identification of Bartonella henselae and Bartonella quintana by a duplex Real-Time PCR and Pyrosequencing assay. Association for Molecular Pathology 2006 Annual Meeting, Orlando, FL, November 16-19, 2006.

14. Walsh P, Overmyer CL, Gofman L, Nguyen T, Michaelson S, Pusavat J, DeSalvia L, Gonzalez D, Feola M, Nguyen KA, Iacono KT, Mordechai E, Adelson ME. Pediatric respiratory infectious disease analysis: UTM-RT versus flocked swab nasal collections. The 23rd Clinical Virology Symposium, Clearwater, Florida, April 29-May 2, 2007.

15. Biggs C, Overmyer CL, Gofman L, DeSalvia L, Gonzalez D, Feola M, Iacono KT, Mordechai E, Adelson ME. Prevalence of pediatric respiratory infections in a suburban Philadelphia hospital. The 23rd Clinical Virology Symposium, Clearwater, Florida, April 29-May 2, 2007.

16. Zimmerman J, Feola M, Mordechai E, Adelson ME. Detection and quantification of Actinomyces israelli in cervicovaginal specimens by Real-Time PCR. 107th American Society for Microbiology General Meeting, Toronto, Canada, May 21-25, 2007.

17. Mason R, Feola M, Mordechai E, Adelson ME. Hepatitis B virus subtype determination through Pyrosquencing. 107th American Society for Microbiology General Meeting, Toronto, Canada, May 21-25, 2007.

18. Walsh P, Lim-Overmyer CL, Gofman L, DeSalvia L, Gonzalez D, Feola M, Nguyen A, Pusavat J, Nguyen TA, Pham K, Michaelson S, Iacono KT, Mordechai E, Adelson ME. Comparison of three nasal collection specimen methods for the detection of pediatric respiratory infectious disease. Association for Molecular Pathology 2007 Annual Meeting, Los Angeles, California, November 7-10, 2007.

19. Balashov S, Mordechai E, Adelson ME. Development of a new test for cystic fibrosis mutation screening. Association for Molecular Pathology 2007 Annual Meeting, Los Angeles, CA, November 7-10, 2007.

20. Biggs C, Overmyer CL, DeSalvia L, Gonzalez D, Gofman L, Feola M, Iacono KT, Mordechai E, Adelson ME. Geographic distribution of pediatric respiratory infections: A bi-coastal analysis. Molecular Medicine, Lake Buena Vista, FL. March 27-30, 2008.

21. Biggs C, Overmyer CL, DeSalvia L, Gonzalez D, Gofman L, Feola M, Iacono KT, Mordechai E, Adelson ME. A comparison of nasopharyngeal and midturbinate region sampling for the detection of respiratory infections. 24th Clinical Virology Symposium, Daytona Beach, FL. April 27-30, 2008.

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Serological diagnostic assays are employed by laboratories to determine if an individual has been exposed to a pathogen. This infection could have been very recent (acute) or in the distant past. Our ability to better detect and diagnose infectious diseases is vital to successful vaccination development and treatment efforts. The mission of the Antigen Discovery Team is to develop, through the use of molecular, microbiological, and immunological techniques, cost-effective serological assays that would provide healthcare professionals assays with greater diagnostic sensitivity and specificity over existing tests.

Antigen Discovery Division

John G. Hoey, Ph.D. - Division Head/Team LeaderPh.D. in Cell and Molecular Biology from the City University of NY Graduate School and University • Center.

Graduate work was done under the mentorship of Ray H. Gavin, Ph.D., and focused on the • identification and characterization of a non-muscle contractile system associated with basal bodies in Tetrahymena.

Postdoctoral fellowship at the National Heart, Lung, and Blood Institute of the National Institutes of • Health. Postdoctoral project involved the cloning and expression of Myosin I Heavy Chain Kinase from Acanthamoeba.

Sr. Research Associate position in the Laboratory of Experimental Pathology at West Virginia • University School of Medicine. Research involved the identification and cloning of the heavy metal response gene Metallothionein (MT)-3 from normal and carcinoma-derived human kidney cells. Originally named growth inhibitory factor (GIF) and thought to be a brain-specific member of this gene family, MT-3 is intriguing because of its ability to inhibit the growth of neuronal cells in culture, and because of its deficiency in Alzheimer’s diseased (AD) brain tissue. This deficiency has been proposed to be involved in the formation of neurofibrillary tangles (NFT) in the neuropathology of AD.

Previous positions as Sr. Scientist within the Gene Isolation Laboratory at NaPro Biotherapeutics • (now Tapestry Pharmaceuticals), and Research Assistant Professor at the Mary Babb Randolph Cancer Center of West Virginia University School of Medicine.

Currently investigating the human antibody response to • Bartonella henselae antigens.

Recently developed an IgM ELISA for serological diagnosis of acute infection with • Bartonella henselae.

Oversee, advise, and direct all projects being done by the Antigen Discovery team. •

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Lisa P. Huang, Ph.D.Research Associate, Weill Medical College of Cornell University, NYC. Conducted research • on limb regeneration, cell differentiation, and cancer pharmacology.Postdoctoral Fellow, Stanford University School of Medicine, Palo Alto, CA. Studied • in vivo and in vitro functions of Granulysin to develop novel antibiotics and new oncogenic therapeutics.Ph.D. in Molecular Virology, Purdue University, West Lafayette, IN.• B.S., University of Science and Technology of China (USTC).• Membership: American Association of Immunologists; American Society for Virology; and • RNA Society.Award: Andrews Fellowship; Travel Award for American Society for Virology Annual Meeting.•

Denise Dimitrov, M.S M.S. in Bioscience Technology - Thomas Jefferson University, College of Health Professions.• Masters Thesis: “Cloning and expression of novel • Anaplasma phagocytophilum peptide reactive with patient antisera”.B.S. in Bioscience Technology - Thomas Jefferson University, College of Health Professions.• Currently involved in development of diagnostic assays for • Anaplasma phagocytophilum.

Crystal Mazur, M.S.M.S. from the University of Florida in Medical Sciences. Thesis: Optimization of methods for • phage display using single-chain variable fragment phagemid libraries.B.S. from the University of Florida, magna cum laude, in Microbiology and Cell Sciences • with a minor in Chemistry. Thesis: Characterization of temperature sensitive Vaccinia virus mutants from E11 and E6 complementation groups.Currently developing diagnostic assays for cancer detection.•

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Publications

1. Loa CC, Adelson ME, Mordechai E, Raphaelli I, Tilton RC. 2004. Serological diagnosis of human babesiosis by IgG enzyme-linked immunoabsorbent assay. Curr Microbiol, 49:385-389.

2. Mogilyansky E, Loa CC, Adelson ME, Mordechai E, Tilton RC. 2004. Comparison of western immunoblots and the C6 Lyme antibody test for the laboratory detection of Lyme disease. Clin Diagn Lab Immunol, 11(5):924-929.

3. Loa CC, Mordechai E, Tilton RC, Adelson ME. 2006. Production of recombinant Bartonella henselae 17 kDa protein for antibody-capture enzyme-linked immunosorbent assay. Diagn Microbiol Infect Dis, 55(1):1-7.

4. McCool TL, Hoey JG, Montileone F, Goldenberg HB, Mordechai E, Adelson ME. 2008. Discovery and analysis of Bartonella henselae antigens for use in clinical serological assays. Diagn Microbiol Infect Dis, 60(1):17-23.


1. Loa CC, Adelson ME, Mordechai E, Raphaelli I, Tilton RC. Antibody-capture enzyme-linked immunosorbent assay for human babesiosis. American Society for Microbiology 104th General Meeting, New Orleans, LA, May 23-27, 2004.

2. McCool TL, Loa CC, Mordechai E, Adelson ME. Identification of antigenic Bartonella henselae proteins. American Society of Microbiology 105th General Meeting, Atlanta, GA, June 5–9, 2005.

3. Loa CC, Mordechai E, Tilton RC, Adelson ME. Purification and antigenicity of Bartonella henselae 17 kDa protein expressed in Escherichia coli. American Society of Microbiology 105th General Meeting, Atlanta, GA, June 5–9, 2005.

4. Loa CC, Valois-Cruz F, Goldenberg H, Mordechai E, Tilton RC, Adelson ME. Detection of human parvovirus-specific antibodies by VP1 and VP2 protein-based serological assays. 22nd Clinical Virology Symposium, Clearwater Beach, FL, April 30 - May 3, 2006.

5. Mogilyansky E, Manderbaugh K, Mason R, Mordechai E, Adelson ME. Comparison of automated ELISA-based clinical virology assays on the Mago Plus Aptus automated EIA processor and the Nexgen Four. 22nd Clinical Virology Symposium, Clearwater Beach, FL, April 30 - May 3, 2006.

6. McCool TL, Montileone FL, Goldenberg HB, Loa CC, Mordechai E, Adelson ME. Discovery of potential Bartonella henselae antigenic proteins using a two-dimensional proteomic approach. 106th American Society of Microbiology General Meeting, Orlando, FL, May 21-25, 2006.

7. Valois-Cruz F, Loa CC, Mordechai E, Tilton RC, Adelson ME. Experiences on the development of continuous in vitro culture for Babesia microti. 106th American Society of Microbiology General Meeting, Orlando, FL, May 21-25, 2006.

8. Goldenberg HB, Valois-Cruz F, Hoey JH, Mordechai E, Adelson ME. Identification of Babesia microti antigens for use in a diagnostic assay. 107th American Society of Microbiology General Meeting, Toronto Canada, May 21-25, 2007.

9. Venit H, Valois-Cruz F, Hoey J, Mordechai E, Adelson ME. Identification of Babesia microti antigens for use in diagnostic test. 107th American Society for Microbiology General Meeting, Toronto, Canada, May 21-25, 2007.

10. Brunner M, Gallagher GE, Valois-Cruz F, Buchan R, Hoey JG, Mordechai E, Adelson ME. Cambridge Healthtech Institute’s second annual Baculovirus Technology Meeting, Boston, MA, September 19-20, 2007.

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VENENUM BIODESIGN L.L.C. is a high-throughput screening organization dedicated to the discovery and identification of novel therapeutic products through the use of genetic, genomic and proteomic platforms in conjunction with rational drug design. Venenum has a collection of over 70,000 small, non-peptide molecules that includes natural products, FDA-approved drugs, the NIH Clinical Collection, and focused libraries such as ATP analogs. Our goal is to use this collection to identify novel modulators (inhibitors or enhancers) for targets proposed by MDL’s R&D groups, as well as, external collaborators. Eventually Venenum’s services will be available for outside contracts.

The members of Venenum include Ilana Stroke, Ph.D. and Michael McQueney, Ph.D.

Ilana Stroke, Ph.D.

Ph.D. graduate of Yale University Department of Molecular Biophysics and Biochemistry•Postdoctoral work at Institut Pasteur (mobile introns in yeast mitochondria) and State University •of New York at Stony Brook (pheromone response in yeast)Senior Principal Scientist at Pharmacopeia•Extensive experience with high throughput screening and lead compound optimization for drug •discovery, molecular biology, and yeast geneticsCurrently involved in establishing high throughput screens for agents modulating targets in •therapeutic areas including infectious disease and cancer

Michael S. McQueney, Ph.D.

Ph.D. in Bioorganic Chemistry from the University of Maryland, College Park. Discovered and •characterized the first P-C bond forming enzyme, phosphoenolpyruvate mutase. Post-doctoral Fellow, Fox Chase Cancer Center, National Institutes of Health •Postdoctoral Fellowship. Elucidated the free energy profile for the reaction catalyzed by S-Adenosylmethionine Synthetase using Steady-state and Pre-steady state kinetics.Adhoc manuscript reviewer, Applied and Environmental Microbiology.•Member of the Society for Biomolecular Screening.•2009 Assistant Manager, Venenum Biodesigns, LLC. Currently helping to equip and staff •Venenum Biodesign, and developing assays for high throughput screening.

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Mission Statement

Welcome to HUMIGEN, LLC: The Institute for Genetic Immunology. (HUMIGEN)

HUMIGEN is an independent basic research organization whose mission is to understand the relationship between human health, the genetics of the immune system, and disease pathogenesis and outcome.

HUMIGEN was formed in January 2007 with a role to bring a long-term program of basic and translational research into being that would address neglected areas of human immunology and the genetics of immune response.

Our goal is to understand how the immune system works, to explain how genetic variations influence its functions, to use this information to probe disease biology and to identify disease mechanisms along with genetic markers that modify disease susceptibility. Our ultimate goal is to contribute to prevention and treatment of immune system-mediated conditions.

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HUMIGEN, LLC: The Institute for Genetic Immunology

HUMIGEN is a basic research organization whose mission is to understand the relationship between human health, the genetics of the immune system and the development and severity of disease. Genetics determines obvious physical traits such as hair, skin and eye color. Less obviously, a person’s genetic makeup contributes significantly to how their immune system responds to pathogens, transplanted organs or cancer. In infection, this can make the difference between a long or short disease course and in some cases determine whether there will be a fatal outcome or not. Understanding the role of immune system genetics will soon help define treatments for disease and tailor them to individual patients. Susceptibility and severity to autoimmune diseases is also profoundly influenced by immune system genetics. Malignant diseases too, including the common solid tumors, by genetics. Understanding how these genetic variables contribute to disease will bring new diagnostic and treatment options to affected individuals and their families. HUMIGEN is contributing to this understanding.

HUMIGEN is focusing its research in Genetic Immunology and Genomin Immunoepidemiology. These research disciplines are being applied into diseases and conditions whose pathology lies with the immune system including asthma, Irritable Bowel Disease (IBD), pregnancy failure, and infertility. These research topics allow us to bring functional genetic and epidemiologic techniques to bear an impact human diseases.

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Grant Gallagher, B.Sc. (Hons), Ph.D.Director of HUMIGEN, LLC: The Institute for Genetic Immunologyand Head of the Genetic Immunology Laboratory.

Ph.D. graduate of the Department of Immunology at University of Strathclyde, Glasgow, • Scotland; thesis title: “The construction of functional human T-cell hybrids”.

Previous appointments include faculty positions as Lecturer at University of Strathclyde • Department of Immunology (1986-1990), Reader at University of Glasgow Department of Surgery (1990 - 2001) and Professor at University of Medicine and Dentistry of New Jersey, Department of Oral Biology (2001 - 2006).

Adjunct appointments include Associate Scientist at the Beatson Institute for Cancer • Research (1990 - 1993), Director for Research at the UMDNJ Center for BioDefense (2003 - 2006), and Adjunct Professor in the Department of Molecular Biology at UMDNJ School of Osteopathic Medicine.

Co-Editor of “• Genes and Immunity”, published by the Nature Publishing Group.

Mentor of ten M.Phil., eight Ph.D., and thirteen post-doctoral graduates.•

Author of 80 peer-reviewed publications, 92 published abstracts and 11 book chapters.•

Currently directing the HUMIGEN Team of 5 individuals in understanding the functional • genetics of human cytokines, the functional analysis of immunoregulatory proteins, and the immunogenetic analysis of human autoimmune disease.

M. Tevfik Dorak, B.A. (Hons), M.D., Ph.D. Head of the Genomic Immunoepidemiology Laboratory.

Trained as a medical doctor (Hacettepe University, Turkey, 1982) and completed a • residency in internal medicine.Involved in genetic research since 1991. Graduated with a Ph.D. entitled “A Search for a • Leukemia Susceptibility Genes in the HLA Complex” completed at the University of Wales College of Medicine in 2000.Adjunct Associate Professor in the Department of Molecular Biology at UMDNJ School of • Osteopathic Medicine.Previous appointments include Research Fellowships at Glasgow Leukemia Research • laboratory and the University of Wales (Department of Haematology), Research Assistant Professorships at the University of Tennessee Department of Surgery (Memphis) and University of Alabama Department of Epidemiology (Birmingham), and Principal Research Associate at the University of Newcastle (United Kingdom).Author of more than 50 peer-reviewed journal publications and nine book chapters, has • made over 100 conference presentations and edited a book entitled “Real-Time PCR”.Member of the Editorial Board of • Genes & Immunity and Open Leukemia Journal.Currently Head of Genomic Immunoepidemiology Laboratory at HUMIGEN, directing a • team of two research associates to study the complex genetics of immunological diseases with an emphasis on immune system-related genes and the gender effect, and the non-HLA genes of the HLA complex for their relationships with conserved extended HLA haplotypes.

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Joyce Eskdale, B.Sc. (Hons). Scientist, Genetic Immunology Laboratory.

Graduated from University of Strathclyde, Glasgow, Scotland, with a B.Sc. (Hons) in Biochemistry.• Five years’ experience in molecular diagnostics of human diseases, including thalassemias, sickle-• cell anaemia, leukaemia & bone marrow transplantation and Duschenne muscular dystrophy.Thirteen years’ experience in immunology and molecular immunology, particularly the application • of human cytokine genetics to susceptibility and severity of human autoimmune, malignant and inflammatory disorders such as RA, SLE, pancreatitis and gastric & colorectal cancers.Author on 33 peer-reviewed publications (eight as first author), 45 published abstracts and 4 book • chapters.Involved in the functional genetics of human cytokines, the functional analysis of immunoregulatory • proteins and the immunogenetic analysis of human autoimmune disease.

Charronne Davis, B.A.Research Associate, Genomic Immunoepidemiology Laboratory.

Graduated from Cornell University, Ithaca, NY with a B.A. from the Department of Biological • Sciences.Two years’ experience of studying genetic expression using molecular biology techniques such as: • quantitative PCR, cloning and restriction digestion amongst others.Currently working on the discovery and analysis of novel variants of DNA repair genes that are • encoded within the HLA complex, and iron-related genes involved in the immune response.

Thuy N. Do, B.A., Ph.D. Scientist, Genomic Immunoepidemiology Laboratory.

Graduated from Drew University, Madison, NJ with a B.A. in Biology (minor: Biochemistry).• Graduated from the University of Medicine and Dentistry of New Jersey with a Ph.D. from the • Department of Pharmacology/Physiology and a certificate for course work completion from the Bioinformatics program. Thesis title: “Regulation of D1 dopamine receptor expression.”First author of three publications in the Journal of Neurochemistry.• Post-doctoral work on biomarker discovery at Prospect Biosystems, LLC with a New Jersey • Technology Fellowship.Expertise in cell-based assays, Western blot, RNase Protection Assay (RPA), real time RT-PCR, • molecular cloning, promoter reporter assays, gene recombineering and other molecular techniques.Currently working on genotype-phenotype correlations and the functional assessment of genetic • associations found in immunological diseases.

Grant E. Gallagher, B.S.Research Associate, Genetic Immunology Laboratory.

Graduated from Rutgers University with a B.S. in Biochemistry, senior research project title: • “Development of a B. henselae diagnostic ELISA”.Worked with MDL in the Antigen Discovery group developing diagnostic ELISAs.• Expertise in genetic library construction and screening, plasmid construction and cloning, PCR, • protein purification, ELISA, and other molecular techniques.Currently working on the relationship between epithelial cells, dendritic cells, and T-cells.•

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Michelle Miles, B.A.Administrative Assistant, HUMIGEN, LLC: The Institute for Genetic Immunology.

Graduated from Rowan University, Glassboro, NJ with a B.A. in English from the College of Arts and • Sciences and received a NJ Certificate of Eligibility with Advanced Standing for a Teacher of English in Secondary Education.Two years experience as a substitute and full-time teacher of English utilizing reading, writing and • communication strategies as per NJ state education standards in English.Five years’ office experience utilizing customer service, communication, technology, research and • writing skills.Currently serving as editorial assistant to Dr. Grant Gallagher, the co-editor of “• Genes & Immunity”.Coordinate meetings, schedules and travel for HUMIGEN members.•

Nicholas J. Megjugorac, B.S. (Hons), Ph.D.Scientist, Genetic Immunology Laboratory/Cellular Immunology Laboratory.

Graduated from the College of New Jersey in Ewing, NJ with a B.S. (Hons) in Biology.• Ph.D. for study of dendritic cell and viral immunology from the Graduate School of Biomedical • Sciences at the University of Medicine and Dentistry in Newark, NJ; Dissertation: “Characterization of plasmacytoid dendritic cells.”Postdoctoral work at the NJ Center for BioDefense on the human host response to viral and bacterial • select agents.Adjunct Assistant Professor, UMDNJ Graduate School; Course co-coordinator in M.Sc. program • Concentration in Bioterrorism and Homeland Security.Currently investigating the relationship between epithelial cells, dendritic cells, and T-cells•

Rachael Siegel, B. Sc. (Hons), Ph.D.Scientist, Genetic Immunology Laboratory

Graduated from Rutgers University, New Brunswick, NJ, with a B.Sc. (Hons) in Biology and • Evolutionary Anthropology.Graduated from The Rockefeller University, New York, NY, with a Ph.D, in Biological Science. Thesis • title: “The Dual Role of OCA-B in B Cell Development.”Postdoctoral work on Non-coding RNAs in Chronic Lymphocytic Leukemia at The Institute for • Cancer Genetics of Columbia University, with a fellowship from The Leukemia and Lymphoma Society.First author of a publication in • Cell and co-author of publications in the Journal of Biological Chemistry and Proceedings of the National Academy of Science.Experienced in the regulation of gene expression and cellular signaling.•

Current work involves analysis of immune cell signaling.•

Yick Loi (Raymond) Yu, Ph.D.Scientist, Genetic Immunology Laboratory

Graduated from Hong Kong University of Science and Technology with a B.Sc. in Biology.• Graduated from Hong Kong University of Science and Technology with a Ph.D., Thesis title: • “Molecular understanding of ray morphogenesis in Caenorhabditis elegans.”First author and co-author of publications in the • EMBO Journal, Blood, and Molecular and Cellular Biology.Post-doctoral work on signal transductions and transcriptional regulation at Albert Einstein College • of Medicine with the Harry Eagle Postdoctoral Fellowship.Expertise in cellular signaling and gene transcriptional regulation.• Comprehensive experience in various areas including molecular biology, cell culture techniques • and animal handling.

Currently working on IL-23R isoforms and theirs signaling.•

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Inventor(s) TitleFiling Date

Application No.

Gallagher, G., Eskdale, J., Sriniuas, S., Dai, J., Megjugorac, N.

A method of treating diseases and disorders with IFN-lambda

10/27/08 12/290,052

Dorak, M.T., Uciski-Akkaya, E., Use of killer cell lectin-like receptor K1 gene (KLRK1/NKG2D) polymorphisms in assessing sex-specific materno-feto recognition

4/14/09 12/386,106

Gallagher, G., Kan, Shih-hsin, Mancini, G.

Novel insert variant of IL-23 Receptor Transcript. Multiple Splice form of human Il-23 receptor vairants and expression system thereof

4/14/09 12/386,146

Gallagher G, Yu R, Kan S, Mancini G.Splice Variants of Human IL-23 Receptor (IL-23R) mRNA and Use of a Delta 9 Isoform in Predicting Inflammatory Bowel Diseases.

4/14/09 12/386,146

Dorak MT, Ucisik-Akkaya E, Do TN,

Davis C, Morrison B. Single Nucleotide Polymorphisms as Genetic Markers for Childhood Leukemia

6/3/09 12/455,520

Intellectual Property

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HUMIGEN members are active in research. Although HUMIGEN was formed in 2007, we bring a strong breadth and depth of expertise to the Institute. Here are our primary research papers from the last few years.

HUMIGEN – Genetic Immunology Laboratory

Publications:

2009Dai J, Megjugorac NJ, Gallagher GE, Yu RYL, Gallagher G1. . 2009. IFN-l1 (IL-29) inhibits GATA3 expression and suppresses Th2 responses in human naive and memory T-cells. Blood, In press.

20081. Gallagher G, Eskdale J, Sabat R, Wolk K. 2008. Interleukin-19. in: “Class-II Cytokines” A. Zdanov, editor,

Transworld Research Network, p127-144.2. Gallagher G, Moraes MO, Anaya J-M. 2008. Tumor Necrosis Factor and related genes. in: “Genetic

susceptibility to infectious diseases.” Kaslow RA, McNicholl JM & Hill AVS Editors, Oxford University Press, p190-208.

3. Kan SH, Mancini G, Gallagher G. 2008. Identification and characterization of multiple splice forms of the human interleukin-23 receptor alpha chain in mitogen-activated leukocytes. Genes Immun, 9:631-639.

4. Mancini G, Kan SH, Gallagher G. 2008. A novel insertion variant of the human IL-23 receptor-alpha chain transcript. Genes Immun, 9:556-559.

5. Srinivas S, Dai J, Eskdale J, Gallagher GE, Megjugorac N, Gallagher J. 2008. Interferon lambda-1 (IFN-l1 / IL-29) preferentially down regulates IL-13 over other Th2 cytokine responses in vitro. Immunol, 125:492-502.

6. Ding BB, Yu JJ, Yu RY, Mendez LM, Shaknovich R, Zhang Y, Cattoretti G, Ye BH. 2008. Constitutively activated STAT3 promotes cell proliferation and survival in the activated B-cell subtype of diffuse large B-cell lymphomas. Blood, 111(3):1515-23.

7. Laube DM, Denominationalism A, Kashleva H, Eskdale J, Gallagher G, Diamond G. 2008. Differential regulation of innate immune response genes in gingival epithelial cells stimulated with Aggregatibacter actinomycetemcomitans. 2008. J Periodontal Res, 43:116-123.

8. Olabisi OA, Soto-Nieves N, Nieves E, Yang TT, Yang X, Yu RY, Suk HY, Macian F, Chow CW. 2008. Regulation of transcription factor NFAT by ADP-ribosylation. Mol Cell Biol, 28(9):2860-71.

9. Sahay S, Pannucci NL, Mahon GM, Rogriguez PL, Megjugorac NJ, Kostenko EV, Ozer HL, Whitehead IP. 2008. The RhoGEF domain of p210 Bcr-Abl activates RhoA and is required for transformation. Oncogene, 27(14):2064-71.

10. Yang TT, Yu RY, Agadir A, Gao GJ, Campos-Gonzalez R, Tournier C, Chow CW. Integration of protein kinases mTOR and extracellular signal-regulated kinase 5 in regulating nucleocytoplasmic localization of NFATc4. 2008. Mol Cell Biol, 28(10):3489-501.

20071. Pekarek V, Srinivas S, Eskdale J, Gallagher G. 2007. Interferon lambda-1 (IFN-lambda1/IL-29)

induced ELR(-) CXC chemokine mRNA in human peripheral blood mononuclear cells, in an IFN-gamma independent manner. Genes Immun, 8:177-180.

2. Jordan WJ, Eskdale J, Srinivas S, Pekarek V, Kelner D, Rodia M, Gallagher G. 2007. Human interferon lambda-1 (IFN-lambda1/IL-29) modulates the Th1/Th2 response. Genes Immun, 8:13-20.

3. Jordan WJ, Eskdale J, Boniotto M, Rodia M, Kelner D, Gallagher G. 2007. Modulation of the human cytokine response by interferon lambda-1 (IFN-lambda1/IL-29). Genes Immun, 8:13-20.

4. Megjugorac N, Jacobs E, Izaguirre A, George TC, Gupta G, Fitzgerald-Bocarsly P. 2007 Interactions of Plasmacytoid Dendritic Cells with HSV-infected Monocyte-derived Dendritic Cells Lead to the Induction of IFN-alpha. Immun Invest, 36(5-6):739-61.

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20061. Boniotto M, Jordan WJ, Eskdale J, Tossi A, Antcheva N, Crovella N, Connell N, Gallagher G. 2006.

Human beta-defensin 2 induces a vigorous cytokine response in peripheral blood mononuclear cells. Antimicrob Agents Chemother, 50:1433-1441.

2. Fanning S, George T, Fend D, Feldman S, Megjugorac N, Izaguirre A, Fitzgerald-Bocarsly, P. 2006. Receptor cross-linking on human plasmacytoid dendritic cells leads to the regulation of IFN-alpha production J Immunol, 177(9):5829-39.

3. Siegel R, Kim U, Patke A, Yu X, Ren X, Tarakhovsky A, Roeder RG. 2006. Nontranscriptional regulation of SYK by the coactivator OCA-B is required at multiple stages of B cell development. Cell, 125:761-74.

4. Yang TT, Suk HY, Yang X, Olabisi O, Yu RY, Durand J, Jelicks LA, Kim JY, Scherer PE, Wang Y, Feng Y, Rossetti L, Graef IA, Crabtree GR, Chow CW. 2006. Role of transcription factor NFAT in glucose and insulin homeostasis. Mol Cell Biol, 26(20):7372-87.

5. Yu X, Siegel R, Roeder RG. 2006. Interaction of the B cell-specific transcriptional coactivator OCA-B and galectin-1 and a possible role in regulating BCR-mediated B cell proliferation. J Biol Chem, 281:15505-16.

Abstracts & Presentations:

2009Gallagher G.1. Modulation of the Th2 response by IL-19 and interferon lambda (IFN-λ1). American Association of Immunologists 96th Annual Meeting. Seattle, WA. May 8-12, 2009.Gallagher GE, Gallagher G2. , Megjugorac NJ. Modulation of human pDC function by IFN-λ1 (IL-29). American Association of Immunologists 96th Annual Meeting. Seattle, WA. May 8-12, 2009.Megjugorac NJ, Gallagher GE, Gallagher G.3. Reciprocal control of IL-4 and IFN-λ1 (IL-29); mechanisms for the control of Th2 polarization. American Association of Immunologists 96th Annual Meeting. Seattle, WA. May 8-12, 2009.Siegel R, Eskdale J, Gallagher G4. . Characterization of IFN-λ1 (IL-29) gene regulation and analysis of inter-individual variation of IFN-λ1 levels. American Association of Immunologists 96th Annual Meeting. Seattle, WA. May 8-12, 2009.

2008Gallagher G, Gallagher GE, Dai J, Megjugorac NJ. 1. Coordinated expression of IFN-lambda 1 and IL-4, a novel feedback loop leading to the reduction of Th2 responses. International Cytokine Society. Montréal, Québec Canada. October 12-16, 2008.Dai J, Megjugorac NJ, Gallagher G. 2. IFN-lambda 1 (IL-29) suppresses the differentiation of human naive and memory Th2 cells without inhibiting their proliferation. International Cytokine Society. Montréal, Québec Canada. October 12-16, 2008.Megjugorac NJ, Gallagher GE, Dai J, Gallagher G. 3. Production of and response to IFN-λ1 by plasmacytoid dendritic cells. International Cytokine Society. Montréal, Québec Canada. October 12-16, 2008.

2007Kan SH, Eskdale J, Gallagher G. 1. Activation-dependent splice variants of the human IL-23 receptor. 6th Annual Advances in the Inflammatory Bowel Diseases. Aventura, FL. December 6-9, 2007.Eskdale J, Babad J, Kan SH, Gallagher G. 2. Genetic studies at the human IL-19 gene locus. International Cytokine Society, San Francisco, CA. October 26-30, 2007.Srinivas S, Babad J, Eskdale J, Kan SH, Gallagher G. 3. Interferon lambda (IL-29) downregulates the human Th2 response. International Cytokine Society, San Francisco. October 26-30, 2007.

2006Gallagher G, Eskdale J. 1. IL-19 and IFN-lambda, new cytokines that modulate the human Th2 response. 5th Annual Advances in the Inflammatory Bowel Diseases. Miami Beach, FL. December 1-3, 2006.Pekarek V, Srinivas S, Eskdale J, Gallagher G. 2. Interferon lambda-1 (IFN-λ1/IL-29) Induces ELR-CXC chemokine mRNA in human peripheral blood mononuclear cells, in an IFN-γ independent manner. 5th Annual Advances in the Inflammatory Bowel Diseases. Miami Beach, FL. December 1-3, 2006.

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HUMIGEN - Genomic Immunoepidemiology Laboratory

Publications

20091. Dorak MT. 2009. Gene-Environment Interactions in Childhood Cancer. In: Nriagu J (Ed): Encyclopedia

of Environmental Health. Elsevier BV, Amsterdam, Netherlands. In Press2. Ucisik-Akkaya E, Dorak MT. 2009. A study of natural killer cell lectin-like receptor K1 gene (KLRK1 /

NKG2D) region polymorphisms in a European population sample. Tissue Antigens, 73:177–183.3. Magnanti BL, Dorak MT, Parker L, Craft AW, James PW, McNally RJ. 2009. Geographical analysis

of thyroid cancer in young people from Northern England: Evidence for a sustained excess amongst females in Cumbria. Eur J Cancer, 45:1624-9.

4. Wang JH, Zheng X, Ke X, Dorak MT, Shen J, Boodram B, O’Gorman M, Hershow R, Beaman K, Cotler SJ, Rong L. 2009. Ethnic and geographical differences in HLA associations with the outcome of hepatitis C virus infection. Virol J, 6:46

5. Do TN, Ucisik-Akkaya E, Davis CF, Morrison BA, Dorak MT. 2009. TP53 R72P, MDM2 SNP309 and DAXX polymorphisms in modification of childhood acute lymphoblastic leukemia susceptibility. Cancer Genet Cytogenet, In press.

6. Dorak MT, MacKay RK, Relton CL, Worwood M, Parker L, Hall AG. 2009. Hereditary Hemochromatosis Gene (HFE) Variants are Associated with Birth Weight and Childhood Leukemia Risk. Pediatr Blood Cancer, In press.

20081. Martin MP, Dorak MT, Carrington M. 2008. Killer Immunoglobulin-like and related receptors: Genes,

variation, and pathophysiologic mechanisms. In: Kaslow RA & Hill AV (Eds). Genetic Susceptibility to Infectious Diseases, Oxford University Press, pp. 89-106.

2. Magnanti BL, Dorak MT, Parker L, Craft AW, James PW, McNally RJ. 2008. Sex-specific incidence and temporal trends in solid tumours in young people from Northern England, 1968-2005. BMC Cancer, 8:89.

3. Magnanti BL, Dorak,MT, Parker L, Craft AW, James PW, McNally RJ. 2008. Sex-specific incidence and temporal trends in leukaemia and lymphoma in young people from Northern England, 1968-2005. Haematologica, 93:1438-40.

20071. Dorak MT, Pearce MS, Hammal DM, McNally, RJQ, Parker L. 2007. Examination of gender effect in

birth weight and miscarriage associations with childhood cancer. Cancer Causes & Control, 18:219-228.

2. Dorak MT. 2007. Genotyping with PCR: how to choose the right approach? The Scientist, 21:70-72.3. Dorak MT, McNally RJQ, Parker L. 2007. Childhood acute lymphoblastic leukemia and infections

(letter). American Journal of Epidemiology, 166:364-54. Dorak MT. 2007. Role of Natural Killer Cell and Killer Immunoglobulin-like Receptor Polymorphisms. In:

Beksac M (Ed): Methods in Molecular Medicine, Vol. 134: Bone Marrow and Stem Cell Transplantation. Humana Press, Totowa, New Jersey.123-144.

5. Pearce MS, Hammal DM, Dorak MT, McNally RJQ, Parker L. 2007. Paternal occupational exposure to electro-magnetic fields as risk factors for cancer in children and young adults. A case-control study from the North of England. Pediatric Blood & Cancer, 49:280-6.

20061. Dorak MT, Shao W, Machulla HKG, Lobashevsky ES, Tang J, Park MH, Kaslow RA. 2006. Conserved

extended haplotypes of the major histocompatibility complex: further characterization. Genes & Immunity, 7:450-67.

2. Dorak MT. 2006. HFE H63D variant and leukemia. Leukemia & Lymphoma, 47:2269-79.3. Dorak MT (Ed). 2006. Real-Time PCR (Advanced Methods Series). Taylor and Francis, Oxford, UK 4. Pearce MS, Hammal DM, Dorak MT, McNally RJQ, Parker L. 2006. Paternal occupational exposure to

pesticides and/or herbicides as risk factors for cancer in children and young adults. A case-control study from the North of England. Archives of Environmental and Occupational Health, 61:138-44.

5. Shao W, Lazaryan A, Dorak MT, Penman-Aguilar A, Wilson CM, Margolick JB, Goedert JJ, Prins M, Tang J, Kaslow RA. 2006. Cohort- and time-specific associations of CTLA4 genotypes with HIV-1 disease progression. AIDS, 20:1583-90.

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2009:

Ucisik-Akkaya E, Davis CN, Do TN,1. Dorak MT. Immunoregulatory Gene Polymorphisms and Childhood Leukemia Susceptibility. 35th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. San Francisco, CA, November 2-6, 2009.Do TN, Davis CF, Ucisik-Akkaya E, Morrison BA, Dorak2. MT. Molecular Mechanism of a Sex-specific Risk Association of an Interferon Regulatory Factor 4 Polymorphism with Childhood Acute Lymphoblastic Leukemia. 35th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. San Francisco, CA, November 2-6, 2009.Davis CN, Ucisik-Akkaya E, Do TN, Dorak MT3. . Polymorphisms of Iron Regulatory Genes with Immune Functions are Associated with Childhood Leukemia Susceptibility. 35th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. San Francisco, CA, November 2-6, 2009.

2008:

Magnanti BL, Dorak MT, Parker L, McNally RJ.1. Sex-specific temporal trends in the incidence of cancer in children and young adults in Northern England. Children with Leukaemia Scientific Conference P.07. Institute of Child Health, London, England. April 29-30, 2008.Magnanti BL, Dorak MT, Parker L, McNally RJ2. . Sex-specific analyses of thyroid cancer incidence in Northern England. Children with Leukaemia Scientific Conference, P.08. Institute of Child Health, London, England. April 29-30, 2008. Magnanti BL, Dorak MT, Parker L, McNally RJ3. . Critical review and pooled analysis of sex-specific results in childhood cancer studies. National Cancer Research Institute Cancer Conference. Birmingham, UK. October 5-8, 2008. Dorak MT4. , Oguz FS, Ozdilli K, Kekik C, Carin M, Gedikoglu G. HLA-DR ancestral lineages and childhood leukemia susceptibility. 33rd Annual Meeting of the American Society for Histocompatibility and Immunogenetics. Minneapolis, MN. October 8-12 2007.MacKay RK,5. Dorak MT. Haplospecific markers for HLA-DRB3 and -DRB4 ancestral lineages. 33rd Annual Meeting of the American Society for Histocompatibility and Immunogenetics. Minneapolis, MN. October 8-12, 2007.Dorak MT6. , MacKay R, Relton CL, Worwood M, Parker L, Hall AG. Iron-related Gene Variants Increase Childhood Leukemia Risk and Birth Weight. 57th Annual Meeting of the American Society for Human Genetics. San Diego, CA, October 23-27, 2007Davis C, Dorak MT7. . An analysis of the extended HLA class I region gene HFE and flanking genes. 34th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. Toronto, Canada. October 27-31, 2008. Ucisik-Akkaya E, Morrison BA, Davis C, Do T, Dorak MT8. . Update on conserved extended haplotypes and possible identification of the ancestral MHC haplotype. 34th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. Toronto, Canada. October 27-31, 2008. Morrison BA, Ucisik-Akkaya E, Flores H, Dorak MT9. . Similarities between multiple sclerosis and childhood leukemia HLA complex associations. 34th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. Toronto, Canada. October 27-31, 2008. Ucisik-Akkaya E, Morrison BA, Gorodezky C, Dorak MT10. . HLA class III region genes HSPA1L/A/B polymorphisms and childhood leukemia risk. 34th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. Toronto, Canada. October 27-31, 2008. Ucisik-Akkaya E, Morrison BA, Alaez C, Dorak MT11. . Extended HLA class II region genes RXRB and DAXX polymorphisms in childhood leukemia. 34th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. Toronto, Canada. October 27-31, 2008. Morrison BA, Davis C, Ucisik-Akkaya E, Dorak MT12. . MHC associations in childhood leukemia: identification of heterozygote advantage 34th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. Toronto, Canada. October 27-31, 2008. Ucisik-Akkaya E, Dorak MT13. . Polymorphisms of natural killer cell receptor NKG2D and childhood leukemia susceptibility. 34th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. Toronto, Canada. October 27-31, 2008.

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Morrison BA, Dorak MT.14. Two proto-oncogenes located in the HLA class III region (PBX2 and NOTCH4) show associations with childhood leukemia 34th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. Toronto, Canada. October 7-31, 2008.Morrison BA, Dorak MT15. . Complete sequencing of HLA-DQA1 3UTR and correlations with ancestral lineages. 34th Annual Meeting of the American Society for Histocompatibility and Immunogenetics. Toronto, Canada. October 27-31, 2008.Davis C, Do T, Dorak MT16. . Polymorphisms of iron-related genes and childhood leukemia risk. 58th Annual Meeting of the American Society for Human Genetics. Philadelphia, PA. November 11-15, 2008 Dorak MT, Ucisik-Akkaya E, Davis C, Morrison BA, Do T.17. Genetic associations in childhood leukemia and interactions with sex. 58th Annual Meeting of the American Society for Human Genetics. Philadelphia, PA. November 11-15, 2008Ucisik-Akkaya E, Davis C, Morrison BA, Do T, Dorak MT18. . Markers for sex-specific prenatal selection. 58th Annual Meeting of the American Society for Human Genetics. Philadelphia, PA. November 11-15, 2008Do T, Ucisik-Akkaya E, Davis C, Morrison BA, Dorak MT19. . TP53 R72P polymorphism and childhood leukemia susceptibility. 58th Annual Meeting of the American Society for Human Genetics. Philadelphia, PA. November 11-15, 2008.

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