Swamy Kumar Polumuri, Ph.D.

**** ****** *****, ***********, ** 21029

Phone: 443-***-****

Email: adkcls@r.postjobfree.com

Citizenship: USA

Summary

Highly motivated and innovative scientist with a strong track record success in toxicology (the role of aggregates and impurities in harnessing unwanted immunogenicity of therapeutic proteins (e.g. IVIG) and monoclonal antibodies (e.g. Avastin).

Strong academic background in pharmacology, cell signaling (molecular biology), virology (Zika) and drug (Amoxicillin and Flucloxacillin)-induced allergy and autoimmune diseases.

Hand on experience on various preclinical animal disease models and biomarkers.

Excellent writing and verbal communicating skills, with supervisory experience and project management skills.

Ability to design and execute projects independently with interpersonal relationships with fellow workers in highly collaborative teamwork.

With my background, I am interested in applying my research experience and scientific knowledge to review of scientific information related to microbiological, immunological product development, Research and Development studies.

Professional Experiences

Researcher (contractor) 2015- present

Office of Biotechnology Products, OPQ, CDER, FDA

Analysis of HLA-DR immunopeptidomes towards understanding the mechanism of drug-induced adverse effects such as allergy.

Identify the drug induced epitopes (peptides) through HLA immunopeptidomes by using Mass Spectrometry. These peptides were screened for T cell activation to understand the drug induced allergy in contributing specific HLA types.

Participated in the development of mouse models of ZIKA infection to test potency and efficacy of ZIKA vaccines.

Developed assays to identify host cell and process derived innate immune response modulating impurities (IIRMI) and aggregates in synthetic and recombinant proteins.

Performed immunogenicity assessment of aggregated therapeutic proteins and antibodies (IVIG and Avastin) using in vitro and in vivo methodologies.

Developed models and biomarkers capable of identifying the synergistic interaction between impurities and aggregates in biologics.

Managed several research projects including planning and executing experiments, analysis of data and presenting to research community as well as writing the manuscripts for the publications.

Published first-authored paper in Nature-Scientific Reports and three co-authored papers with collaborations.

Awarded by FDA in 2018, for “Excellence in Laboratory Science” for the contribution a member of the immunogenicity risk of innate immune response modulation impurities: assessment and control (CDER) for identifying contribution of process of process-related innate immune response modulating impurities to immunogenicity risk of peptides and proteins.

Oral presentation on “Aggregates of IVIG or Avastin, but not HSA, modify the response to model innate immune response modulating impurities” in CDER Day on October 25, 2018.

Research Associate 2007- 2015

Department of Microbiology and Immunology,

University of Maryland at Baltimore

Mentor: Dr. Stefanie N. Vogel, Ph.D. Professor

•Served as a scientific expert, act as a reviewer for the Journal of Infection and Immunity.

•Independently designed and executed research project to "Delineate the role of IL-33 gene regulation in macrophages stimulated by a bacterial toxin (Bordetella pertussis adenylate cyclase toxin (ACT), viral infection and TLR agonists.

•Participated in multiple collaborative projects which are designed to study the signaling pathways leading to endotoxin tolerance and differentiation unraveling the mechanisms underlying mycobacterial Hsp65-induced protection against arthritis.

•Supervised lab technicians, undergraduate students and summer interns.

•Served as an expert in resolving problems, modifying existing procedures for improvement, developed new technology and standards relevant to their research area.

Postdoctoral fellow 2004 – 2007

Department of Microbiology and Immunology

University of Maryland at Baltimore

Mentor: Dr. Stefanie N. Vogel, Ph.D. Professor

•Worked on the NIH funded project “Differentiative signals for macrophage activation.” Identified the role of phosphatidylinositol-3 kinase in transcriptional regulation of TLR-induced IL-12 and IL-10 by FcγR ligation in murine macrophages.

Postdoctoral fellow 2000-2003

Department of Microbiology and Immunology

University of Maryland at Baltimore

Mentor: Dr. Dan H Schulz, Ph.D. Professor

•Worked on the NIH funded project to understand the biology of the Na+/Ca2+ exchanger(NCX), specifically to study the function of alternatively spliced isoforms of the Na+/Ca2+ exchanger using HEK transient transfection.

Scientist (Microbiology) 1996-2000

Agharkar Research Institute (Department of Science and Technology, Govt. of India) Pune, Maharashtra, India

Defined the role of Thiobacilli cultures on reduction of soil PH in alkaline soils to increase the crop productivity.

Published a first authored article and co-supervised several graduate students in the department.

Educational Background and Honors

Ph.D. Microbiology (Minors in Biochemistry and Molecular biology) 1990-1996

Indian Agricultural Research Institute, New Delhi, India

Received Senior Research Fellowship from Indian Agricultural Research Institute, New Delhi for doctoral program.

Qualified the National Educational Test (NET) conducted by Council of Scientific Industrial Research and University Grants Commission (CSIR-UGC), Department of Education, Government of India to carry out higher studies with fellowships in 1989.

M. Sc. Microbiology (Minor in biochemistry) 1985-1989

Indian Agricultural Research Institute, New Delhi, India

Received Junior Research Fellowship from Indian Agricultural Research Institute, New Delhi for post-graduate studies.

B.Sc. Chemistry (Minors in Zoology and Botany) 1982-1985

Andhra University, India

Scientific Technical Experience

Microbiology: Preparation of different media and other culture reagents; Collection of microorganisms; Maintaining microorganisms; Making specialized plates to grow the bacteria.

Protein aggregates characterization of therapeutic proteins: Preparing therapeutic protein aggregates (both monoclonal or polyclonal antibodies and recombinant proteins) with various stress conditions and characterization of protein aggregates by various methods, optical density, SDS-PAGE, FlowCam, and MFI. Tested these aggregated proteins for immunogenicity and interaction other receptor in cell-based assays.

Cell culture: Culture and maintenance of primary cells namely macrophages and cardiomyocytes; Isolating Human PBMC and monocytes from the Blood. Maintenance of stable cell lines namely HEK 293, RAW 264.7 cells, Hela, and C6 Glioma cells.

Molecular biology: Isolation of plasmid and restriction enzyme analysis; Purification of plasmid DNA by CsCl density gradient; Cloning and sub-cloning of different genes, as well as construction of luciferase promoters for promoter analysis; Point mutations in different genes by site directed mutagenesis; Sequence analysis; Isolation of RNA from tissues, making cDNA and measuring the mRNA by using quantitative, real time -PCR analysis(RT-PCR); Electrophoretic Mobility Shift Assay (EMSA); Chromatin immunoprecipitation (ChIP) analysis; Isolation and purification of recombinant proteins expressed in different cell lines and bacteria; SDS-PAGE, Detection of several phosphorylated proteins by western blotting to know various signaling events in the cell; Immunoprecipitation of proteins and its interaction with other proteins; immunopeptidome studies, Mass spectrometry, multicolor flow cytometry, cell sorting, Luminex assay, ELISA, mRNA measurement by Nanostring.

Animal handling: Mouse colony maintenance and handling of mice; Subcutaneous and intraperitoneal injections of mice and collection of peritoneal macrophages from mice, Infection with bacteria and virus (Zika) in mouse models, dissecting different organs from mouse (brain, liver, spleen, eye and ovaries or testis), etc. Measuring bacterial load and conducting viral titers; by serial dilutions in plate count for Bacteria and TCID50 for the virus. Bacterial and viral quantification by RT-PCR in infected animal samples as well as in in-vitro stimulated cells.

Bioinformatic analysis programs: BLAST, Primer Express for designing primers for RT-PCR, Ensemble gene the web, Xcalibur™ Software, Peaks X program, Primer 3, web cutter, etc.

Computer skills: Microsoft office suite (word, excel, power point & outlook), Adobe Photoshop, Statistical analysis and graphing software (GraphPad PRISM), Microarray data mining and pathway analysis software (Ingenuity Pathway analysis), Reference management and publishing software (Reference Manager, EndNote).

Other skills: Writing and evaluating technical reports, progress reports, and study protocols; Scientific records review and management; Preparation of scientific articles for publication. Experience and expertise in working with multiple animal models using a variety of techniques to study the cellular and humoral immune responses. Experience and knowledge in the authoring and authorization of Institutional Animal Care and Use Committee (IACUC) protocols.

Supervisory experience

•Supervised the summer interns (4), graduate students (4), postdoctoral fellows and technical staffs (2) in the laboratory.

Memberships

1)Society for Leukocyte Biology: 2006-present

2)International Endotoxin and Innate Immunity Society: 2006-present

Presentations in FDA:

Presented talk on “Aggregation and innate immune response modulating impurities” at Laboratory of Immunology Meeting (LIM) in FDA on 12/20/2016.

Presented a talk on “Role of cAMP-PKA pathway in alternatively activated Macrophage Polarization” at Macrophage interest group (MIG) in FDA on 06/24/2015.

Oral presentation on “Aggregates of IVIG or Avastin, but not HAS, modify the response to model innate immune response modulating impurities” in CDER Day on October 25, 2018.

Research Publications

https://www.ncbi.nlm.nih.gov/pubmed/?term=polumuri

1)Polumuri SK, Lydia A. Haile, Derek D.C. Ireland, and Daniela Verthelyi (2018) Aggregates of IVIG or Avastin, but not HSA, modify the response to model innate immune response modulating impurities. Sci Rep. 2018 Jul 31;8(1):11477. doi: 10.1038/s41598-018-29850-4.

2)Polumuri SK, Ramesh Chandra, Tristan Dyson, Shirey KA, Padmaja Gade, Dhananjaya V. Kalvakolanu and Stefanie N. Vogel (2018). Role of cAMP-PKA pathway in Macrophages activations (under preparation)

3)Lydia A Haile, Roshni Rao, Polumuri SK, Arepally GM, Keire DA, Daniela Verthelyi, Sommers C (2017) PF4-HIT antibody (KKO) complexes activate broad innate immune and inflammatory responses. Thromb Res. 2017 Sep 21; 159:39-47

4)Lydia A Haile, Polumuri SK, Logan Kelly-Baker, Dmitry Kryndushkin, Rajesh Rajaiah, Israely Tomer, V. Ashutosh Rao, Daniela Verthelyi (2017) Application of a cell-based assay to detect IIRMIs in interferon beta products produced by different manufacturing platforms. Sci Rep. 2017 Sep 5;7(1):10490.

5)Lydia A Haile, Montserrat Puig, Polumuri SK, Jill Ascher, Daniela Verthelyi (2016) In vivo effect of innate immune response modulating impurities (IIRMIs) on the skin milieu using a macaque model: Impact on product immunogenicity, J Pharm Sci. 2016 Dec 3. pii: S0022-3549(16)41836-8

6)Prasun Guha, Gargi Bandyopadhyaya, Polumuri SK, Saranya Chumsri, Padmaja Gade, Dhananjaya V. Kalvakolanu and Hafiz Ahmed (2014) Nicotine Promotes Apoptosis Resistance of Breast Cancer Cells and Enrichment of Side Population Cells with Cancer Stem Cell Like Properties via a Signaling Cascade Involving Galectin-3, α9 Nicotinic Acetylcholine Receptor and STAT3, Breast Cancer Research and Treatment, 145(1):5-22.

7)Darren J. Perkins, Polumuri SK, Meghan E. Pennini, Wendy Lai, and Stefanie N. Vogel (2013) Macrophage reprogramming through TLR2 confers viral resistance via TRAF-3 enhanced interferon production, PLoS Pathog. 2013 Jul;9(7):e1003479. doi: 10.1371/journal.ppat.1003479. Epub 2013 Jul 11.

8)Rajesh Rajaiah, Darren J. Perkins, Polumuri SK, Aiping Zhoa, Achsah D. Keegan and Stefanie N. Vogel (2013) Dissociation of Endotoxin Tolerance and differentiation of Alternatively Activated Macrophages, J Immunol. 190(9):4763-72

9)Panicker LM, Miller D, Park TS, Patel B, Azevedo JL, Awad O, Masood MA, Veenstra TD, Goldin E, Stubblefield BK, Tayebi N, Polumuri SK, Vogel SN, Sidransky E, Zambidis ET, and Feldman RA.(2012) Induced pluripotent stem cell model recapitulates pathologic hallmarks of Gaucher. Proc Natl Acad Sci U S A.109(44):18054-9.

10) Polumuri SK, Jayakar GG, Shirey KA, Roberts ZJ, Darren J. Perkins, Paula M. Pitha and Vogel SN (2012) Transcriptional Regulation of Mouse IL-33 by TLR and Non-TLR Agonists, J Immunol. 189(1):50-60.

11) Rajaiah R, Puttabyatappa M., Polumuri SK and Moudgil KD (2011) Interleukin-27 and interferon-gamma are involved in regulation of autoimmune arthritis, J Biol Chem. 286(4):2817-25.

12) Satpute SR, Rajaiah R, Polumuri SK and Moudgil KD (2009) Tolerization with Hsp65 induce protection against adjuvant-induced arthritis by modulating the antigen-directed interferon-gamma, interleukin-17 and antibody responses, Arthritis Rheum. 60(1):103-13.

13) Polumuri SK, Toshchakov V, and Vogel SN (2007) Role of Phosphatidylinositol-3 kinase in transcription regulation of TLR-induced IL-12 and IL-10 by FcγR ligation in murine macrophages, J Immunology 179(1): 236-246.

14) Cuesta N, Nhu QN, Zudaire E, Polumuri SK, Cuttitta F and Vogel SN (2007) Interferon Regulatory Factor-2 (IRF-2) Regulates Macrophage Apoptosis through a STAT1/3 and Caspase-1-Dependent Mechanism, J. Immunology 178(6): 3602-11.

15) Pyrski M, J-H. Koo, Polumuri SK, Ruknudin A, Margolis JW, Schulze DH and Margolis FL (2007) sodium calcium exchanger expression in the mouse and rat olfactory systems, J. Comp. Neurology 501(6):944-958.

16) Schulze DH, Pyrski MM, Ruknudin A, Margolis JW, Polumuri SK and Morgolis FL (2002) Sodium-Calcium exchanger in olfactory tissues. Ann. N Y Acad. Sci. 976:67-72.

17) Schulze DH, Polumuri SK, Gille T, Ruknudin A. (2002) Functional regulation of alternatively spliced Na+/Ca2+ exchanger (NCX1) isoforms. Ann. N Y Acad. Sci. 976:67-72.

18) Polumuri SK, Ruknudin A, McCarthy MM, Perrot-sinal TS and Schulze DH (2002) Sodium calcium exchanger NCX1, NCX2, and NCX3 transcripts in developing rat brain. Ann N Y Acad. Sci. 976:187-96.

19) Polumuri SK, Ruknudin A and Schulze DH (2002) RnaseH and its effects on PCR. Biotechniques 32:1224-1225.

20) Polumuri SK and Panknikar KM (1999) Reduction of soil PH using Thiobacillus cultures. In: Biohydrometallurgy and the environment towards the mining of 21st Century, Process Metallurgy 9B, Elsevier, pp717-723.

Research Abstracts and Proceedings

1)Polumuri SK, Lydia Haile, Roshni Rao and Daniela Verthelyi (2017) Aggregation and innate immune response modulating impurities, IMMUNOLOGY 2017™ in Washington, D.C (May 12-16, 2017)

2)Polumuri SK, Lydia Haile and Daniela Verthelyi (2016) Aggregation and innate immune response modulating impurities: Impact on the immunogenicity of therapeutic proteins. Immunology interest Group NIH, IIG 2016(September 7-8, 2016)

3)Polumuri SK, Lydia Haile and Daniela Verthelyi (2015) Aggregation and innate immune response modulating impurities: Impact on the immunogenicity of therapeutic proteins. Immunology interest Group NIH, IIG 2015(September 9-10, 2015)

4)Leelamma M. Panicker, Diana Miller, Tea Soon Park, Brijesh Patel, Judi L. Azevedo, Ola Awad, Vivek Bose, M. Athar Masood, Timothy D. Veenstra, Ehud Goldin, Barbara Stubblefield, Nahid Tayebi, SK Polumuri, Stefanie N. Vogel, Ellen Sidransky, Elias T. Zambidis, and Ricardo A. Feldman (2012) Induced Pluripotent Stem Cells, ‘A Disease in a Dish’ Model for Types 1, 2 and 3 Gaucher Disease. The 5th Annual Maryland Stem Cell Research Symposium (Oct 4-5, 2012) Annapolis, MD, USA.

5)Polumuri SK, Jayakar GG, Roberts ZJ, Shirey KA, Thomas KE, Fitzgerald KA and Vogel SN (2008) Role of IRF-3 in Transcriptional Regulation of Mouse IL-33 by TLR and Non-TLR Agonists, The international endotoxin and innate immunity society, 10th Biennial Meeting, July, 30- August 2, Edinburgh University, Scotland, United Kingdom.

6)Polumuri SK, Toshchakov V, and Vogel, SN (2006) Role of Phosphatidylinositol-3 kinase in transcription regulation of TLR-induced IL-12 and IL-10 by FcγR ligation in murine macrophages, the joint meeting of the society for leukocyte biology and the international endotoxin and innate immunity society, November 9-11, San Antonia, Texas. USA. (Received Student/Post-Doctoral Fellow Travel Grant)

7)Roberts ZJ Toschchakov V Cuesta N, Thomas KE, Polumuri SK, Rallabhandi P and Ching LM and Vogel SN (2004) Utilization of known TLR signaling pathways in the activation of murine macrophages by the inflammatory anti-tumor agent, 5,6-dimethylxanthenone 4-acetic acid (DMXAA). The 37th Annual Meeting of the Society for Leukocyte Biology, Oct. 21-23, Westin Harbour Castle, Toronto, Ontario, Canada.

8)Polumuri SK, Ruknudin A, Gille T, Shoenfelt J and Schulze DH (2003) Alternatively Spliced Isoforms of Rat NCX1 Shows Functional Differences When Expressed in 293HEK Cells. 47th Annual Meeting of the Biophysical Society (USA) March 1-5, San Antonio, Texas. USA.

9)Polumuri SK, Ruknudin A and Schulze DH (2001) Determining the relative level of Transcripts for genes in a multigene family, Cellular and Molecular Physiology of Sodium – calcium exchange, October 10-14, The Banff Center for Conferences, Banff, Alberta, Canada.

10)Schulze DH, Ruknudin A, Margolis JW, Polumuri SK and Margolis FL (2001) Sodium calcium exchangers in Olfactory tissue. Cellular and Molecular Physiology of Sodium – calcium exchange, October 10-14, The Banff Center for Conferences, Banff, Alberta, Canada.

11)Pyrski MM, Margolis JW, Polumuri SK, Bell. G, Ruknudin A, Schulze DH and Margolis. FL (2002) Expression of Na+/Ca+/(K+) exchangers in olfactory receptor neurons (ORNS) AChemS 24th Annual Meeting, April 24-28. Sarasota, FL. USA.

12)Ruknudin A, Polumuri SK and Schulze DH (2001) Phosphorylation modulates the activity of the mammalian and Drosophila Na+/Ca+ exchangers. AHA Research Symposium, May 5, Dallas, Texas, USA.

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