Medical Clinical Research

Sue S. Cross

**********@*****.***

**** ******** ***** ****** ****** phone: 703-***-****

Manassas, VA 20110 Home: 703-***-****

Executive Summary

Sue Cross, Ph.D., CTPM, CCRA, Microbiologist (Virologist)

Clinical research management experience includes work on medical devices and drugs for treatment of both chronic and acute wounds. Management tasks included document development (protocols, consent forms, HIPAA forms, and CRFs), document maintenance, developing and teaching training courses as related to the conduct of specific clinical trials, maintaining personnel contact for providing answers to specific questions on a clinical trial about procedures, equipment, supplies, sample collection, sample time lines, and sample. Virology programs which were created were supported for the most part by Spanish corporations and institutes and focused on the discovery of new drugs effective against HIV and influenza viruses. Virology projects in biodefense had major emphasis on viruses that could be utilized as bioweapons. Documents needed to operate these programs included government permits, international permits, patent applications, scientific publications, detailed data analysis, and biorepository creation and maintenance.

Professional competencies

•Scientific writing (Protocols, SOPs, and related scientific documents)

•Creating biorepository databases and maintaining biorepositories according to rules and regulations for handling and storage of all types of samples including infectious agents and human samples from clinical trials.

•Development of projects related to virus research

•Set up new laboratories for virus research

•Laboratory management and project management

•Trained to work with viruses and bacteria at a biosafety level 3 (BSL-3 agents are strictly controlled and must be registered with all appropriate government agencies)

•Generating scientific data from research, processing data, and creating databases for data storage

•Data analysis

•International communications for data analysis and distribution

•Computer skills: Microsoft Office (Word, Excel, Access, PowerPoint, and Outlook), FoxPro, FreezerWorks, CryoTrack, development of Excel macros for data processing, and courses in visual basic, C+, and C++

•Tissue culture expert

•Expert in aseptic techniques

•Expert skills for propagation of many strains of DNA and RNA viruses and development of assays identification using techniques for PCR, DNA and RNA extractions, ELISA, CPE and others

Professional Experience

Scientific Consultant January 2015 to present

With the forced closing of the Diagnostic and Translational Research Center by the Henry M. Jackson Foundation, my work has centered on working with a small number of scientists from this laboratory and my original supervisor to establish a small laboratory that continues the scientific research on medical devices for wound treatment. During this period certifications were earned as a clinical research associate and as a clinical trial program manager. Publication of clinical trial data was completed in 2016.

Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD

Clinical Research Associate and Biorepository Manager January 2012 to September 2014

I.Clinical Research Associate

•Supervised CRA and performed responsibilities of a CRA for a clinical trial on a medical device.

•Revised and provided editorial assistance for clinical research protocols.

•Prepared informed consent documents, CRFs for field use, replies to IRB comments after consultation with the principal investigator and the team members, Statements of Work for collaborators, training documents for medical personnel for sample collection, handling, shipping and storage, new SOPs, yearly updates on all laboratory SOPs, permits required by APHIS, CDC, and DOC, risk assessments for infectious agents, and training procedures for handling infectious agents in the laboratory.

•Logistics: Identified sources for required equipment and supplies and assured delivery to site.

•Prepared literature reviews and background research and verified scientific references

•Obtained all documents from personnel listed on the clinical trial protocol for IRB submission.

•Worked at clinical site as team member to conduct training classes for protocols, check receipt of supplies, prepare subject folders, prepare site for conducting clinical procedures, set up field laboratory for collection and processing of tissue samples, closing out site when trial was completed, and completed accounting for IP.

•Assisted in the evaluation of the capability of the site to successfully manage and conduct the clinical study.

•Served as primary contact for clinical personnel at multiple sites including foreign countries.

•Data collection and analysis: Analyzed sample collection types and times for baseline and follow-up visits listed in protocol time tables for creating virtual databases to identify all possible samples to be collected for purposes of printing labels, creating chain of custody forms, and preparation of sample lists for shipping and storage of human samples. Reviewed clinical procedures listed in the time line of the protocol to use as a reference document for preparing a list of all materials and equipment required at each participating site. Organized clinical data for statistician for clinical analysis. Reviewed subject files for data validation.

II.Biorepository Management

•Used current available software for establishing biorepository databases to document the receipt, cataloguing, storage location, distribution for biological and chemical assays, and shipping of biological samples including clinical human samples of tissues and blood, bacteria, viruses, and fungal specimens.

•Standard Operating Procedures were written for the receipt, shipping, storage, access to all biological samples, and training personnel on the use of the database for sample labeling.

•Maintained documents for accountability of the stability and storage conditions of clinical trial materials and all other biological materials, performed regular inventories, and verified destruction of any materials and biological samples.

Armed Forces Institute of Pathology, Walter Reed Army Medical Center - Washington, DC

Chief, Virology February 2005 to March 2011

As Principal Investigator for a biodefense project, the production of live virus material and related viral products was done for viruses of significance to the program defined as select agents by CDC which have the potential to be used as bioweapons. The viral products were provided to different biodefense agencies to be used as reference agents for validation of instruments for the detection of the viruses. Security clearance and participation in the Army's Biological Personnel Responsibility Program was required for this work. The major work for this project was performed at the BSL-3 level. Databases were created and maintained using existing software for tracking the location of every single vial of material created, stored and shipped.

American Type Culture Collection, Manassas, VA

Virologist January 2003 to February 2005

The major responsibility was to establish the purity of any viral strain used for preparing new materials. Documentations included original histories, protocols, study methodologies, and data collected and analyzed, product sheets, and certificates of analysis. Authentication for purity was accomplished by a series of assays including FA, PCR, CPE, neutralization assays, or other assays

Aphios Corporation, Woburn, MA

Director of Virology and Consultant January 1997 to June 2002

Drug Discovery: As the Director of Virology, I was the principle investigator for the drug discovery program for new and novel compounds from marine sources active against HIV and influenza viruses. The work was supported by contracts from Instituto Biomar, S.A. located in Leon, Spain. All of my drug discovery work from 1990 on was supported by Instituto Biomar, S.A. and PharmaMar, S.A.

PharmaMar, Inc., Boston, MA

Senior Research Scientist September 1990 to December 1996

Drug Discovery: PharmaMar, Inc. was the US subsidiary of PharmaMar, S.A., located in Madrid, Spain. My job was to establish a virology laboratory and create computer programs and biological assays for receiving and testing samples from marine sources for antiviral activity against HIV viruses. As part of an international project, the USA program provided bioassays and data analysis to natural products chemists located in universities and organizations worldwide working with marine organisms to isolate new and novel compounds following the biological activity by in vitro testing.

SeaPharm, Inc. and Harbor Branch Oceanographic Institute, Fort Pierce, FL

Senior Research Scientist September 1984 to July 1990

Drug Discovery: Established laboratory, viral assays, and all document types required for the purpose of identifying antiviral activity in marine microorganisms and macroorganisms using in vitro bioassays to guide the natural products chemistry. This work resulted in scientific publications and patents for discovery of new and novel compounds.

Virginia Commonwealth University, Medical College of Virginia, Dept. of Pathology - Richmond, VA

Assistant Professor April 1975 to August 1984

With grant supported research medical and graduate students had research projects as summer interns and thesis research for those seeking graduate degrees. Virology and immunology classes were taught to medical students and graduate students.

Microbiological Associates, Inc., Bethesda, MD

Technician, graduate student (virology and animal research {rodent models}), post doctorate student (immunology {viral effects of herpes virus on T cell development and function}) February 1962 to March 1975

Education

PhD in Microbiology, The George Washington University, 1973

MS in Microbiology, The George Washington University 1967

BA in Chemistry, East Carolina University, 1961

Certifications

CTPM, Clinical Trial Program Manager certification earned December, 2014, Montgomery College

CCRA, ACRP certification, September, 2015, Expires October 30, 2017

Associations

Washington Academy of Science (Currently serve as the President-Elect for year 2016 to 2017)

ACRP

Publications and Patents of Sue Cross

Accepted for publication (July 2016)

Clinical Evaluation of a Bioelectric Dressing System for Acute Wound Management Authors: Housler, GJ, S Cross, V Marcel, DO Kennedy, M Husband, A Regiser, T Roberts, S Grubbs, D Dudewicz, N Setka, C Bay, ME Wendelken, MJ Izadjoo

Accepted for Publication in “The Journal of Special Operations Medicine”.

The clinical work focused on a clinically relevant problem in military healthcare, particularly military personnel presenting with acute soft tissue wounds and the use of an FDA approved wound care bandage to treat these wounds.

An Overview of the Efficacy of a Next Generation Electroceutical Wound Care Device

May 2016

Authors: Kim H, Park S, Housler G, Marcel V, Cross S, Izadjoo M

Published: Mil Med. 2016 May;181(5 Supl): 184-90. Doi: 10.7205/MILMED-D-15-00167

The research presented describes the efficacy evaluation of a wireless wound care device consisting of a matrix of alternating silver (Ag) and zinc (Zn) dots against both planktonic and biofilm forms of wound pathogens including multidrug resistant organisms.

Efficacy Evaluation of a Bioelectric Wound Dressing against Single Species Biofilms

April 2014

Authors: Hosan, K, S Cross, W Thomas, and M Izadjoo

Presented: Symposium on Advanced Wound Care, April 23-27, 2014, Orlando, FL

The results from the efficacy evaluation of a bioelectric wound dressing using single species biofilms showed that the biofilms could be disrupted with this dressing. This result is significant for the treatment of chronic wounds.

Evaluation of an Antimicrobial [AG+-Zn2+] Bioelectric Dressing on Foot Blisters of US Army Ranger Students at Fort Benning, GA.

May 16, 2014

Authors: Marcel, V, G Houssler, S Cross, W Thomas, and M Izadjoo

Presented: USU Research Days, May 15-16, 2014, Uniformed Services University, Bethesda, MD

A bioelectric wound dressing was evaluated on foot blisters in a clinical trial conducted at Fort Benning, GA.

Identification of Antiviral Drugs for Smallpox Virus

November 2009

Authors: Cross, S, M Alavi, and H Hu.

Presented: Chemical and Biological Defense Science and Technology Conference, WO12, pp441, Nov. 16-20, 2009.

The Spectrum library of 1999 compounds was screened for their potential to inhibit replication of the tissue culture adapted vaccinia virus strain Western Reserve (WR). The highest testing concentration in the screen was 100 micrograms. The hit rate was 2.4%. Positive samples could be grouped into categories based on chemical structures and activities including flavonoids, chemotherapy drugs, cardiac drugs, and anti-inflammatory drugs. Twenty three of the active compounds had other medical uses. Structure-activity relationships of chemical structures and inhibition of viral replication were shown in tests of isoflavone compounds.

Swine Influenza Diagnostic Capabilities at the Armed Forces Institute of Pathology.

March 2010

Authors: Shaak, T, M Alavi, S Cross, A Ravizee, H Pan, D Wear, and M Izadjoo

Presented: The Thirty-Eighth Annual Meeting of the Society of Armed Forces Medical Laboratory Scientists, March 21-25, 2010, San Diego, CA

During the H1N1 influenza pandemic in 2010 the virology laboratory worked with the staff at Walter Reed laboratory to isolate and classify influenza isolates taken from military personnel. Influenza virus was isolated from clinical samples and characterized by PCR and genetic analysis.

A Novel Non-nucleoside Compound with High in vitro anti-HIV-1 activity. Absolute Stereochemistry Determination.

1995

Authors: De la Fuente, JA, JJ Marugan, SS Cross, AF Mateos, S Gargia, and AA Menendiz Bioorganic & Med. Chem Let. 5:141-1474, 1995

The stereochemistry of a compound designated PM92131 that was active against HIV-1 was determined. The plus form was the most active form against HIV-1.

Fistularin-3 and 11-ketofistularin-3. Feline Leukemia Virus Active Bromotyrosine metbolites from the marine sponge Aplysina archeri.

1992

Authors: Gunasekera, SP and SS Cross Published: J. Nat. Prod. 55:509-512, 1992

Bromotyrosine metabolites from a marine sponge were antiviral compounds active against feline leukemia virus using an in vitro cell based assay and viral detection using ELIZA assays to quantitate activity and toxicity. The compounds were isolated by following the activity in purified fractions.

Halitunal, an Unusual Diterpene Aldehyde from the Marine Alga Halimeda tuna

1962

Authors: Koehn, FE, SP Gunasekera, DN Niel, and SS Cross Published: Tetrahedron Letters 32:169-172, 1992

Halitunal is an unusual diterpene aldehyde with a deep yellow color isolated from the marine alga Halimeda tuna. Halitunal was a major component in the alga. This compound was active against the A59 mouse coronavirus. Minor components of greater antiviral activity present in the fractions have not been purified or characterized.

A New Bis-(Indole) Alkalid frm a Deep-water Marine Sponge of the Genus Spongosorites

1992

Authors: Wright, AE, SA Pomponi, SS Cross, and P McCarthy Published: J. Org. Chem 57(17):4772-4775, 1992

An Antiviral Sesquiterpene Hydroquinone from the Marine Sponge Strongylophora hartmani

1991

Authors: Wright, AE SA Rueth and SS Cross Published: J. Nat. Prod. 54:1108-1111, 1991

A sesquiterpene hydroquinone isolated from the sponge Strongylophora hartmani was an antiviral compound active against influenza A virus. The isolation of the compound was a bioassay guided process.

The Chemistry and Biological Activity of Five Marine Sponges of the Genus Aplysina.

1991

Authors: Gunasekera, SP, SS Cross, RE Longley, and SA Pomponi Published: Progress on Natural Products 53-58, 1991

Chemical structures of compounds from sponges from the genus Aplysina are reviewed with reference made to the antifungal, antiviral, and antibacterial activity of the compounds. Weinbersterol Disulfates A and B, Antiviral Steroid Sulfates from the Sponge Petrosia weinbergi

1991

Authors: Sun, HH, SS Cross, M Gunasekera, and FE Koehn Published: Tetrahedron 47:1185-1190, 1191

Weinbersterol disulfates A and B were isolated by following the antiviral activity against feline leukemia virus in cell based assays where the presence or absence of virus was measured in by an ELIZA assay. Toxicity was determined for each compound using the ELIZA assay.

New Antiviral Sterol Disulfate Ortho Esters from the Marine Sponge Petrosia weinbergi

1991

Authors: Koehn, FE, M Gunasekera, SS Cross Published: J. Org. Chem 56:1322-1325, 1991

New antiviral sterol disulfate ortho esters were isolated from the sponge Petrosia weinbergi following the bioactivity against feline leukemia virus. The antiviral activity was so specific that it served as a taxonomic marker for the sponge.

3-amino-1-(2aminoimidazolyl)-prop-1-ene from the Marine Sponges Teichaxinella morchella and Ptilocaulis walpersi

1991

Authors: Wright, AE, SA Chiles, and SS Cross Published: J. Nat. Prod. 5496):1684-1686, 1991

A Nondisposable Microplate for Use with Organic Solvents

1989

Authors: Cross, SS, GT Faircloth, and MA Young Published: J. Tissue Culture Methods 12:57-59, 1989

A 96-well tissue culture plate was designed and manufactured that was resistant to organic solvents for drying samples dissolved in organic solvents for reconstitution in solutions compatible for testing in cell based assays.

Topsentin, Bromotopsentin, and Dihydrodeoxybromotopsentin. Antiviral and Antitumor bis(Indolyl)ilmidazoles from Caribbean Deep-water Sponges of the Family Halichondriidae. Structural and Synthetic Studies

1988

Authors: Gunasekera, SP, Y Kahman, SS Cross, MS Lui, SA Pomponi, and MC Diaz Published: Org. Chem. 53 5446-5453, 1988

Pure compounds of topsentin, bromotopsentin, and dihydrodeoxybromotopsentin were isolated from extracts of four related Caribbean deep-sea sponges. These compounds were found to inhibit the growth of P388 mouse leukemia cells and herpes simplex virus type 1 (HSV-1). In addition the synthesis of topsentin and analogues are described.

A New Cytotoxic and Antiviral Diterpene Isolated from Briareum abestinum

1987

Authors: Coval, SJ, SS Cross, G Bernardinelli, and C Jefford Published: J, Nat. Prod. 51(5):981-984, 1988

The Briareum abestinum diterpene was isolated by following the coronavirus antiviral activity of fractions in cell based assays. The diterpene was shown to have cytotoxic and antiviral activity. The structure of the compound was identified as a precursor to cholesterol.

Development of Rapid Assay for Screening Compounds for Antiviral Activty against RNA Viruses

1987

Authors: Cross, SS and T Lewis

Published: Coronaviruses: Advan. Exp. Med. Biol. 218:275-276, 1987

A strain of mouse hepatitis virus A59 (a coronavirus of mice) was used to develop a 24-hour assay for the detection of antiviral activity in samples of marine origin. The antiviral activity was used to guide the fractionation of marine extracts to isolate new and novel compounds for medical use.

Reiswigins A and B. Novel Antiviral Diterpenes from a Deepwater Sponge

1987

Authors: Kashman, Y, S Hirsch, F Koehn F, and S Cross Published: Tetrahedron Letters 28(45):5461-5464, 1987

The structures of reiswigins A and B were determined. Bioassay guided isolation was done when the crude sponge extracts showed strong antiviral activity against herpes simples virus type 1 (HSV-1) and a mouse coronavirus.

The Expression of Murine Leukemia Viruses in RFM Mice with Host versus Graft Disease Following the Perinatal Inoculation of (T6 x RFM)F1 Lymphohemopoietic Cells

1983

Authors: Cross, SS, G Brede, H S Tucker 3rd, M Maloney, JL Montour, RC Hard Jr. Publication: Infect. Immun. 41:570-577, 1983

The transfer of F1 cells into RFM recipients resulted in the development of host versus graft disease and the activation of ecotropic murine leukemia virus.

Biology of Mouse Thymic Virus, a Herpesvirus of Mice, and the Antigenic Relationship to Mouse Cytomegalovirus

1979

Authors: Cross, SS, JC Parker, WP Rowe, and MS Robbins Published: Infect. Immun. 26:118-1195, 1979

Mouse thymic virus is an endogenous herpesvirus in wild mice. This virus inoculated into newborn mice destroys the T cells in the thymus. Prior to this work the virus was identified by pathology only. Fluorescent antibody assays were developed for the detection of the virus by using serum from adult mice infected with the virus and tissue impressions from neonatal mice infected with the virus. Adult mice infected with mouse thymic virus developed antibodies, whereas newborn mice did not.

Neonatal Infection with Mouse Thymic Virus. Differential Effects on T Cells Mediating the Graft-versus-Host Reaction

1977

Authors: Cross, SS, HC Morse III, and R Asofsky Published: J. Immunol. 117:635-638, 1976

The differential effects on T cells mediating the graft-versus-host reaction in neonatal mice infected with mouse thymic virus was determined.

Rat coronavirus (RCV): A Prevalent, Naturally Occurring Pneumotropic Virus of Rats

1970

Authors: Parker, JC, SS Cross, and WP Rowe

Published: Arch. Gesamte Virusforsch. 31(3):293-302, 1970

Rat lung tissue extracts from rats with antibody to mouse hepatitis virus strains were inoculated into primary cortical rat kidney cells prepared from the kidneys of specific pathogen free rats. Rat coronavirus was isolated from the tissues. Cytopathic effects were observed in 24 to 48 hours. The coronavirus tissue culture virus propagated in the cortical rat kidney cells did not replicate in other tissue culture cell lines.

Some Antigenic Relationships of the Murine Parvoviruses: Minute Virus of Mice, Rat Virus, and H-1 Virus

1972

Authors: Cross, SS and JC Parker

Published: Proc. Soc. Exp. Biol. and Med. 139(1):105-108, 1972

Granted Patents of Sue Cross (Co-Inventor)

Biologically Active Compounds from Blue-Green Algae (#CA 2086918 C)

https://covalentdata.com January 2001

(Granted Patent) Novel bioactive compounds isolated from blue-green alga were found to have antitumor, antiviral, and immunomodulatory properties.

Antitumor and Antiviral Alkaloids (#CA 1340513 C)

https://covalentdata.com April 1999

(Granted Patent) This invention relates to antitumor and antiviral alkaloid compositions, a process of producing the compositions and a method for inhibiting tumors and viruses utilizing the compositions. The compositions are antitumor and antiviral bis-indole alkaloids.

Biologically Active Compounds from Blue-Green Algae (#EP 542891 B1)

https://covalentdata.com January 1995

(Patent granted) Novel bioactive compounds were isolated from blue-green alga and found to have antitumor, antiviral, and immunomodulatory properties.

Antiviral, Antitumor and Antifungal Compositions and Their Methods of Use (#CA 1327367 C)

https://covalentdata.com March 1994

(Granted Patent) This invention relates to novel compositions which are useful as antitumor, antiviral, and antifungal compositions, a process of producing the compositions and a method for inhibiting tumors, viruses and fungi utilizing the composition. The novel compounds are derived from a marine sponge, Theonella species.

Novel Antiviral and Anti-leukemia terpene Hydroquinones and Methods of Use (#US 5204367)

https://covlentdata.com April 1993

(Granted Patent) Novel terpene hydroquinones were isolated from the marine sponge Strongylophora hartmanii. The compounds were found to have antiviral and anti-leukemia activity.

Antiviral, Antitumor and Antifungal Compositions (#EP 299713 B1)

https://covlentdata.com November 1992

(Granted Patent) Compositions of marine compounds are listed with antiviral, antitumor and antifungal compositions.

Novel Antiviral Terpene Hydroquinones and Methods of Use (#US 5091412)

https://covlentdata.com February 1992

(Granted Patent) Novel terpene hydroquinones isolated from the marine sponge Stronglophora hartmanii and derivatives thereof were found to have antiviral activity. The terpene hydroquinone known as aureole has strong antiviral activity.

Biologically Active Compounds from Blue-green Algae (#US 5091368)

https://covlentdata.com February 1992

(Granted Patent) Novel compounds isolated from blue-green alga and derivatives have antitumor, antiviral, and immunomodulatory properties and can be used to treat human and animal tumors, inhibit viral growth, and provide immunomodulatory activity.

Sterol disulfates and Methods of Use (#US 5079239)

https://covlentdata.com January 1992

(Granted Patent) Novel sterol disulfates have been isolated from the marine sponge Petrosia weinbergii. These compounds and derivatives thereof have antiviral properties. One of the compounds was shown to be active against the HIV virus.

Novel Antiviral and Antitumor Terpene Hydroquinones and Methods of Use (#US 5051519)

https://covlentdata.com September 1991

(Granted patent) Novel terpene hydroquinones were isolated from the marine sponge Strongylophora hartmanii and found to have antiviral and antitumor activity.

Antiviral Compositions Derived from Marine Sponge Epipolasis reiswigi and Their Methods of Use (#US 4935439)

https://covlentdata.com June 1990

(Granted Patent) This invention relates to antiviral organic compositions and derivatives thereof, a process of producing the antiviral compositions, and a method for inhibiting viruses utilizing the compositions. More particularly, the compositions are derived from marine sponges of the genus Epipolasis.

Topsentin Compounds Effective Against Viruses and Certain Tumors (#US 4866084)

https://covlentdata.com September 1989

(Granted Patent) A new class of novel, biologically active bisindole alkaloid compounds, which have been named topsentins, pharmaceutical compositions containing them, methods of producing the compounds and methods of using them are disclosed,

Antiviral, Antitumor and Antifungal Compositions and Their Methods of Use (#US 4808590)

https://covlentdata.com February 1989

(Granted Patent) This invention relates to novel compositions which are useful as antitumor, antiviral and antifungal compositions, a process of producing the compositions and a method for inhibiting tumors, viruses and fungi utilizing the composition. The novel compositions are derived from the marine sponge Theonella species.

Antiviral Compositions (#US 4801606)

https://covlentdata.com January 1987

(Granted Patent) This invention relates to novel compositions which are useful as antitumor, antiviral and antifungal compositions, a process of producing the compositions and a method for inhibiting tumors, viruses and fungi utilizing the composition. More particularly, the novel compositions are derived from the marine sponge Theonella species.

Antiviral furanoditerpenoids (#US 4801607)

https://covlentdata.com January 1989

(Granted Patent) This invention relates to antitumor and antiviral furanoditerpenoid compositions, a process of producing the compositions and a method for inhibiting tumors and viruses utilizing the compositions. The new compositions are antitumor and antiviral franoterpenoids which are derived from marine organisms, i.e., the marine sponge Spongia species.

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