Subramanian Kothandaraman

*** **** ****

Monroe, NY 10950

Email: aboco1@r.postjobfree.com

Phone: 845-***-**** (day)

845-***-**** (evening)

Objective:

Obtain a challenging position in Pharmaceuticals R & D utilizing my multi-

disciplinary expertise in Molecular Biology, antiviral studies, immunoassay

development, validation of cell-based assays, characterization and

optimization of biotherapeutic drug molecules and cGMP and cGLP experience

to support product development of therapeutic proteins and vaccines.

Expertise:

. Molecular Biology and Eukaryotic Gene Experssion

. Protein Conjugation Chemistry and Protein Bioanalysis

. Analytical Assay Development

. Automated assay work relevant to real-time PCR and immunoassay studies

. Authored and reviewed several Development protocols and Qualification

reports

. Manual & automated tissue culture using sterile technique and training in

instrument validation

Technical:

. Genome analysis using genomic and bioinformatic tools

. Designing antiviral strategies and analyzing antiviral targets

. Anti-drug antibody (ADA) assessments of protein-based drugs

. Method development of protein conjugations, purification and

characterization studies

. Utilization of new diagnostic molecular biology tools like Real-Time PCR

techniques

. To analyze the biosafety and genetic stability assessment of

biotechnology products

. Molecular, Biochemical and Biophysical characterization of therapeutic

proteins, monoclonal antibodies and vaccines

Education:

Ph.D (1997) Molecular Virology, University of Maryland, College Park,

MD

M.V.Sc (1988) Veterinary Microbiology, Tamil Nadu Veterinary and Animal

Sciences

University, Madras, India

B.V.Sc (1986) Veterinary Medicine, Tamil Nadu Veterinary and Animal

Sciences

University, Madras, India

Professional Experience:

2010- Now: Private Consultant

Responsibilities:

. Working with private consultants on current pharmaceutical research and

development activities in Vaccines and Biotechnology profession (analytical

development method validations studies and FDA requirements in adventitious

agent testing and HCP work)

. Involved actively in Biological and Pharmaceutical forums

2002- 2009: Senior Research Scientist II -Wyeth Vaccines

1999-2002: Post-Doctoral Research Scientist -Wyeth Infectious Disease and

Vaccines, Wyeth, NY

Responsibilities:

. Consent Decree commitment

. Development and implementation of assays to monitor the levels of process-

related impurities

. Transfer of test methods for release and stability test articles into the

QC laboratories

. Studies on FDA regulations on adventitious agents and contaminants in

vaccine samples

. Interaction with Early Phase and Formulation groups in therapeutic

protein and vaccine studies

. Molecular, Biochemical and Biophysical analysis of DNA vaccines and

stability studies

. Studies on host cell protein assays in purified recombinant proteins or

vaccine preparations

. Qualification of HIV recombinant vaccine studies & biochemical analysis

of HIV DNA studies

. Qualification of rLP2086, Neisseria meningococcal cGMP and cGLP vaccine

studies

. Evaluating antiviral strategies for RSV, VZV and MCMV and analysis of

viral gene products

. Quantitation of viral shedding for HSV-2 in experimental animal

infections by Real-Time PCR

. Trained in software programs for both biological and chemical analysis of

proteins

. Trained in chemical analysis of proteins using HPLC, LC/MS and MALDI-

TOF/MS

. Training of junior staff members and supervisory role in analytical

department.

Accomplishments:

. Developed quantitative and qualitative immunoassay to detect Host Cell

Protein

Contaminants in purified vaccine preparations

. Qualification of rLP2086, Neisseria meningococcal vaccine studies

(Identity, Purity, Stability,

ELISA and Bioveris & Meso Scale Discovery (MSD) systems for

quantification of proteins)

. Written cGMP and cGLP based Development protocols and Qualification

reports on HCP work, rLP2086 and HIV vaccine studies

. DNA vaccines using Biophysical and Biochemical techniques

. Qualification of HIV vaccine studies by QPCR and Plaque assay methods

. Vaccine development to support QC

. Experience in performing immunogenicity studies and interacted in PK

studies

. Interacted with process development groups on product stability studies

. Developed a PCR based detection for Mycoplasma in vaccine samples

. Transferred the PCR assay for Mycoplasma to Grange Castle to be used for

QPCR works

. Quantitation of viral shedding for HSV-2 in experimental animal

infections by QPCR

. Studies on FDA regulations on adventitious agents and contaminants in

vaccine samples

. Evaluating antiviral strategies for RSV, VZV and MCMV and analysis of

viral gene products

. Evaluating antiviral drug using specific antibodies for interference

studies in viral replication

. Antibody inhibition studies of antiviral drugs and assessment of the

drugs for antiviral studies

. Collaborated with other R&D in supporting testing of new drug candidates

during development

. Worked towards Consent Decree closure of change controls and IQ/OQ

procedures

. Served as safety officer for the Analytical Development Department.

1997-99: Post-Doctoral Fellow at Institute For Molecular Virology,

University of Wisconsin Madison, WI

. Designing antiviral strategies and analyzing antiviral targets in

Reovirus model

. Evaluating antiviral compounds using cathepsin blocking mechanism in

infected cells

. Studied genetic basis of persistent infections and apoptosis in viral

infections.

1990-97: Research Assistant -College of Veterinary Medicine, University of

Maryland, MD

. Molecular genomic studies of a Striped Bass Reo (SBR) virus and Bovine

and Human RSV

. Eukaryotic gene expression studies

1987-89: Graduate Research Assistant -Department of Microbiology, Madras

Veterinary College, India

. Studies on Rinderpest, a morblivirus infection in sheep and goats

1981-86: Veterinary Student -Madras Veterinary College, India

. Studies in Veterinary Science with relevance to Physiology, Pathology,

Microbiology and

Nutrition

Research Experience

. Molecular genetics, general microbiology, bacteriology, molecular

virology (Reovirus, Rotavirus, RSV, HBV, VZV, CMV, HSV and HIV) &

immunology

. Experience with cell culture techniques, virus purification, and plaque

assays

. Familiarity with drug development studies and combinatorial library

design

. Experience in developing anti-drug antibody assays and inhibitory studies

in viral replication

. Extensive experience in nucleic acid isolation, macromolecule

purification

. Good experience in genome library construction and genome analysis

. Knowledge in Southern blot, Northern blot analyses, various

electrophoresis techniques

. Validation of ELISA and cell based assays for protein biopharmaceuticals

. Experience in various immunological techniques like polyclonal antibody

production, ELISA, Western blot, fluorescent antibody technique, MSD and

Bioplex and hands-on technical experience in the development of RNA- and

DNA-based assays in clinical studies

. Experience in protein conjugation, purification and characterization

studies including antibody purification analysis studies, protein-protein

and protein-ligand interactions

. Experience in immunogenicity characterization studies involving SDS-PAGE,

2-D gel analysis

. Experience in analytical methods like HPLC and LC/MS and practical

understanding of MALDI-TOF/MS

. Experience in biophysical techniques like Analytical Ultracentrifugation,

fluorescence studies

. Experience in expression studies using E.coli, vaccinia, baculo virus

systems

. Generating and analysis of drug resistant mutants in cell culture

. Use of Meso Scale Discovery (MSD) systems to quantitate Neisseria protein

characterization studies and electrochemiluminescence assays

. Automated assay experience in immunoassay and real-time PCR work

Computer Skills:

. Good knowledge in use of various bioinformatics tools like Edit Sequence,

Gene Construction

Kit, Gene Manipulation, Map Draw, Meg Align, Oligo, Primer Select,

Protean search,

Sample Manager, Sequence Manipulation, Sequence Explorer, Sequencher, PC

Gene data

Analysis and blast search for genome analysis

Fellowships:

. Predoctoral graduate research assistantship, University of Maryland

. Agricultural fellowship award, Madras Veterinary College, Madras, India

Patent:

. Remedy For Virulent Viral Infections, Including Biological Threat Agents,

P99080US,

Wisconsin Alumni Research Foundation, University of Wisconsin at Madison

Publications

A. Articles in referred journals and Symposiums:

1. Visalli, R.J., Fairhurst, J., Kothandaraman, S., Buklan A. 2002. The

murine cytomegalovirus

m137 gene encodes a 38 kDa protein that is not required for

replication in vitro or in vivo

Virus Research: 84: 181-189.

2. Kothandaraman, S., Hebert M. Raines. R.T and Nibert M.L. 1998. No

evident role for

pepstatin A-sensitive aspartic proteinases in reovirus infections of

L or MDCK cells.

Virology: 251: 264-272.

3. McPhillips, T.M., Dinan, D., Subramanian, K and Samal, S.K. 1998.

Enhancement of

aquareovirus infectivity by treatment with proteases: Mechanism of

Action. J. Virol. 72 (4):

3387-3389.

4. Subramanian, K and Samal, S.K. 1997. Cloning and sequence analysis of a

non-structural

protein gene of an aquareovirus. Virus Gene. 15 (1): 83-86.

5. Subramanian, K., Lupiani, B., Samal, S.K., and Hetrick, F.M. 1997.

Molecular

Characterization of Aquareoviruses. NRIA International Workshop on New

Approaches to

Viral Diseases of Aquatic Animals, January 21-24 1997, Kyoto, National

Research Institute

of Aquaculture, Nansei, Watari, Mie 516-01, Japan.

6. Subramanian, K., Hetrick, F.M and Samal, S.K. 1997. Genogrouping of

aquareoviruses

Identification of a new genogroup. J. Gen. Virol. 78: 1385-1388.

7. Lupiani.B., Mallepeddi, S., Subramanian, K and Samal.S.K. 1997.

Characterization of the

gene coding the major outer capsid protein of an aquareovirus. J. Gen.

Virol. 78: 1379-1383.

8. Andrea, L.Shaw., Samal,S.K., Subramanian,K and Prasad,B.V.V. 1996.

Structure of

aquareovirus reveals interactions between T=1 and incomplete T=13

icosahedral capsid

layers. Structure. 4: 957-967.

9. Lupiani,B., Subramanian,K and Samal,S.K. 1995. Aquareoviruses. Annual

Rev Fish Dis. 5:

175-208.

10. Samal,S.K., Subramanian,K and Lupiani,B. 1995. Characterization of two

aquareovirus

proteins. Vet. Res. 26: 388-393.

11. Subramanian,K., McPhillips.T.H. and Samal,S.K. 1994. Characterization

of the

polypeptides and determination of the genome coding assignments of an

aquareovirus

Virology. 205: 75-81.

12. Lupiani,B., Subramanian,K., Hetrick,F.M and Samal,S.K. 1993. A genetic

probe for the

identification of the turbot aquareovirus in infected cell cultures.

Dis.Aquatic. Org. 15: 187-

192.

13. Subramanian,K., Lupiani,B., Hetrick,F.M and Samal,S.K. 1993. Detection

of aquareovirus

RNA in fish tissues by nucleic acid hybridization with a cloned DNA

probe. J. Clin.

Microbiol. 31: 1612-1614.

14. Hetrick,F.M., Samal,S.K., Lupiani,B., Dopazo,C.P., Subramanian,K., and

Mohanty,S.B.

1992. Members of the family Reoviridae found in aquatic animals.

Proceedings of the OJI

International Symposium on Salmonid Diseases, Hokkaido University

Press, Sapporo, Japan.

p. 33-40.

15. Samal.S.K., Subramanian,K., Lupiani,B., Mohanty,S.B., and Hetrick,F.M.

1992.

Characterization of Structural and non-structural proteins of an

aquatic rotavirus. Second Int.

Symp. on Viruses of Lower vertebrates. Oregon State university,

Corvallis, OR. p. 243-251.

16. Samal,S.K., Dopazo,C.P., Subramanian,K., Lupiani,B., Mohanty,S.B and

Hetrick,F.M.

1991. Heterogeneity in the genome RNAs and the polypeptides of five

members of a novel

group of rotavirus-like viruses isolated from aquatic animals.

J.Gen.Virol. 72: 181-184.

B. Abstracts and Professional papers presented:

1. Long, D., Natuk.R., Strasser.J., Cooper.D., Kothandaraman, S.,

Gangolli.S., Pride.M.,

Kowalski.J., Tummolo.D., Abramovitz.A.S., Bernstein.D., Miskhin.E and

Zamb.T.

Evaluation of Baculovirus-derived subunit glycoprotein D vaccine

formulations in mouse

and guinea pit HSV-2 vaginal challenge models. Wyeth Research,

Infectious Diseases,

Pearl River, NY, USA. 27th International Herpesvirus Workshop, Cairns

Convention centre,

Australia 20-26 July 2002.

2. Kothandaraman, S and Visalli, R.J. Characterization of the ORF 54 gene

product of

Varicella- Zoster Virus. Wyeth Ayerst Research, Infectious Diseases,

Pearl River, NY, USA.

25th International Herpesvirus Workshop, Portland, Oregon, July 29-

August 4, 2000.

3. Kothandaraman, S., Harrison,S.J., Rich,D.R and Nibert,M.L. No evident

role for Cathepsin

D in mammalian reovirus infection. 17th Annual Meeting of the American

Society for

Virology, University of California British Columbia, July 11-15, 1998.

4. Dinan,D., McPhillips, T.H., Subramanian, K., and Samal,S.K. 1997. Study

of growth of

aquareovirus in fish and mammalian cells. 11th National Conference on

Undergraduate

Research, April 24-26, Austin, Texas.

5. Subramanian,K., Samal,S.K and Hetrick,F.M. Molecular Characterization

of

Aquareoviruses. International Workshop on New Approaches to Viral

Diseases of Aquatic

animals, National Research Institute of Aquaculture, Nansei, Wateri,

Mie 516-01, Japan,

January 21-24, 1997, Kyoto.

6. Rockemann,D.D., Subramanian,K and Samal, S.K. Characterization of

aquareovirus

infection in selected mammalian cell lines. 10th International

Congress of Virology,

Jerusalem, Israel, August 11-16, 1996.

7. Samal,S.K., Subramanian,K and Lupiani,B. Structure and function of

Aquareovirus genes.

5Th International Symposium on dsRNA viruses. Zebra, Tunisia, March 18-

23, 1995.

8. Samal,S.K., Lupiani,B and Subramanian,K. Expression and

characterization of aquareovirus

proteins . 3rd International Symposium on Viruses of Lower

Vertebrates. Jouy-en-Josas,

France, March 14-17, 1995.

9. Subramanian,K., Lupiani,B., Samal,S.K and Hetrick,F.M. Gene probes for

the

identification of Aquareoviruses. International Congress on Quality

Veterinary Services For

the 21st Century, Kula Lumpur, November 15-17, 1994.

10. Lupiani,B., Subramanian,K., Samal,S.K and Hetrick,F.M. Genetic

analysis and genome

coding assignments of aquareoviruses. International Symposium on

Aquatic Animal Health,

Seattle, Washington, September 4-8, 1994.

11. Lupiani,B., Subramanian,K., Samal,S.K and Hetrick,F.M. Molecular

Studies of

Aquareoviruses. Eastern Fish Health Workshop, Blacksburgh, Virginia,

May 25-28, 1994.

12. Samal.S.K., Subramanian,K., Lupiani,B and Hetrick,F.M. Structural and

non-structural

proteins of aquareovirus and determination of the genome coding

assignments. 9Th

International Congress of Virology, Glasgow, August 8-13, 1993.

13. Subramanian,K., Hetrick,F.M and Samal,S.K. Analysis of aquareovirus

proteins

synthesized in infected cells. 12th Annual Meeting of the American

Society for Virology,

University of California Davis, California, July 10-14, 1993.

14. Samal,S.K., Subramanian,K., Lupiani,B and Hetrick,F.M. Genetic and

biochemical analysis

of aquareoviruses. 4th International Symposium on Double-Stranded RNA

viruses.

Scottsdale, Arizona. December 12-16 1992.

15. Hetrick,F.M., Dopazo,C.P., Subramanian,K and Samal,S.K. Detection of

fish viruses by

nucleic acid hybridization. Under the auspices of the U.S.-Ireland

Bilateral Agreement and in

association with BioResearch Ireland. Workshop on Biotechnological

Approaches to the

culture and the diseases of fish and shellfish. University College

Cork, Ireland, September

14-17, 1992.

16. Lupiani,B., Samal,S.K., Subramanian,K and Hetrick, F. Molecular

analysis of

aquareoviruses, 6th International Conference on diseases of fish and

shellfish of the

European Association of Fish Pathologists, Brest, France, September 5-

10, 1992.

17. Lupiani,B., Samal,S.K., Subramanian,K., Dopazo,C.P and Hetrick,F.M.

Gene probes for

the detection of fish pathogens in infected cell cultures. Joint

Meeting of the Australian and

New Zealand Microbiology Societies, Sydney, Australia, July 1992.

18. Lupiani,B., Subramanian,K., Samal,S.K., Baya,A and Hetrick,F.M.

Detection of

aquareovirus RNAs by nucleic acid hybridization techniques. 5th

International Conference of

the European Association of Fish Pathologists. Budapest, Hungary

August 25-29, 1991.

19. Samal,S.K., Lupiani,B., Subramanian,K., Dopazo,C., Marshall,S and

Hetrick,F.M.

Characterization of new members of the reoviridae found in finfish.

2nd International

Symposium on Viruses of Lower Vertebrates. Oregon State University,

Corvallis, Oregon,

July 29-31, 1991.

20. Hetrick,F., Samal,S., Lupiani,B., Subramanian,K and Mohanty,S. Members

of the family

Reoviridae found in Aquatic animals. OJI International Symposium on

Salmonid Diseases,

Sapporo, Japan, 1991.

21. Subramanian.K., Samal,S.K., Baya,A., Lupiani,B and Hetrick,F.M.

Detection of

aquareovirus RNAs in biological samples by nucleic acid hybridization

technique. American

Society for Virology, 10th Annual Meeting. Colorado State University,

Fort Collins. July 7-

11, 1991.

22. Samal,S.K., Lupiani,B., Subramanian,K., Dopazo,C.P., Marshall,S.H and

Hetrick,F.M.

Rotaviruses revisited. Eastern Fish Health Workshop. Matringsbourgh,

WV. June 1991.

23. Samal,S.K.., Subramanian,K., Lupiani,B., McPhillips,T.M and

Hetrick,F.M. Molecular

characterization of rotavirus-like viruses isolated from aquatic

animals. 3rd International

Symposium of Double-stranded RNA viruses. Kona Surf Resort, Hawaii.

December 1990.

C. Thesis and Dissertation:

Subramanian,K. Studies on Rinderpest in Sheep. M.V.Sc Thesis, Madras

Veterinary college, Madras, India, 1988.

Subramanian,K. Molecular characterization of the polypeptides of an

aquareovirus. PhD, Dissertation, University of Maryland, College Park,

1997.

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