Clinical Medical

Elizabeth A. Reap, Ph.D.

** ******** ***** ***** ******, NC 27713 919-***-**** *******@*****.*** https://www.linkedin.com/in/elizabeth-a-reap-05848b18/

Director of Immunology

A knowledgeable and hands-on senior scientist with over 20 years of experience in research and development as well as significant expertise in pre-clinical / clinical analytical assay development and testing, organizational guidance and staff mentoring and leadership. Strong scientific background in Clinical trials in Immunology disease. Recognized for developing and leading several successful immunotherapy translations and viral vaccine projects while maintaining effective communication with team scientists and organizational figureheads. Credited with dozens of academic and industry publications and presentations.

Laboratory Operations

Analytical Assay Development

Policies & Procedures

Monitoring Immune Response

Expertise in optimizing viral vectors

Set up BSL2 assays to characterize and predict the immune response

IND-enabling reporting

Clinical / Pre-Clinical Trials

Analysis & Reporting

Assay validation

Deep knowledge writing scientific documents, SOPs and protocols

Safety and Toxicology studies

Team Leadership & Supervision

Quality Assurance & Control

GMP, GLP expertise

Expertise in multicolor flow cytometry, ELISPOT and ELISA assays

PROFESSIONAL EXPERIENCE

SHATTUCK LABS, Durham, NC 2020-present

Director of Non-Clinical Development

Responsible for analytical assay development for receptor occupancy, PK, ADA and GLP Tox studies and pre-clinical studies for several novel bi-functional fusion proteins.

Responsible for GLP Tox studies working directly with CROs designing pk and pd studies

Responsible for translational science and analysis of clinical data measured by flow cytometry and ELISA

Responsible for interpretation of clinical data to company in presentations and papers

Assay development for detecting novel bi-functional fusion proteins and receptor occupancy

Assist in translation of products from bench to clinic

CHARLES RIVER LABORATORIES, Morrisville, NC 2018-2020 Discovery Oncology, Study Director

Responsible for multiple studies with high impact clients from big pharma, start-up biotech, and academics. Bringing state-of-the-art knowledge of immunotherapy and vaccine pre-clinical and clinical trials to CRL.

Successfully Maintains a study load of over 40 studies a fast-paced premier CRO

Directs and coordinates all aspects of study design, in vivo life portion and reporting

Expertise in oncology pre-clinical models for testing efficacy and PK for immunotherapy and viral vaccines

Leads Safety and Toxicology and IND-enabling studies

Direct client contact establishing relationships with over 35 career scientists and leaders in the field

Leads and mentors technical and in vitro teams

DUKE BRAIN TUMOR IMMUNOTHERAPY PROGRAM, Dept. of Neurosurgery, Duke University Medical Center 2010-2018

Director of Immune Monitoring

Served as co-leader of Immune Monitoring Core D within the department’s Brain Spore grant-funded project. Served as Director of Immune Monitoring in the DBTIP. Played a critical role in other NIH-funded program projects to combat brain tumors. Responsible for the supervision and mentorship of research associates as well as all departmental incoming graduate / medical students that facilitated the transfer of knowledge necessary to ensure projects’ continuity.

Established and maintained a dedicated GLP immune monitoring laboratory to drive productivity within a team-oriented, next-gen scientific environment. Spearheaded immune monitoring for pre-clinical and clinical studies, including assays for EGFRVIII-CAR, checkpoint inhibitors / glioma, synthetic long peptides, neoantigens and more

Developed and utilized high-dimensional flow cytometry panels to facilitate the testing and analysis of clinical / pre-clinical samples. Designed pre-clinical studies to disseminate immunotherapy objectives / results to clinic officials.

Published a recent first author clinical trial paper on efficacy of polyfunctional T cells in glioma

Authored sections of regulatory submission documents and IND-enabling studies

Spearheaded correlative studies from brain tumor specimens to identify biomarkers needed for survival.

ALPHAVAX HUMAN VACCINES, Research Triangle Park, NC 2005-2010

Director of Applied Immunology

Led the company’s Research Department’s immunology core, directives and all immune monitoring in support of company sponsored clinical vaccine trials during the timeframe. Managed, directed and participated in all Applied Immunology Laboratory operations to ensure the development and performance of immunological assays for all departmental research and preclinical studies company sponsored clinical trials. Provided mentorship to five research associate direct reports.

Delivered guidance and advice regarding research strategies, training objectives, and quality control directly to company figureheads. Participated in QA proficiency panels for cellular immunology assays.

Wrote pre-clinical sections of Investigators Brochures and INDs

Broad expertise in immunological assay development and validation.

Gathered, interpreted and published data from Phase I / II clinical trials via ELISpot, ELISA and ICS. Demonstrated the ability to oversee multiple projects and initiatives while ensuring ongoing productivity and long-term success.

Prepared and presented research findings at major scientific meetings and in various refereed medical journals.

Prior experience as Senior Research Scientist with Research Group (1999-2005), Research Assistant Professor with University of North Carolina at Chapel Hill (1996-1999), Postdoctoral Research Fellow with the Laboratories of Drs. Philip L. Cohen and Robert A. Eisenberg (1990-1996), Doctoral Candidate with Clemson University (1985-1990), and Laboratory Technician with Loyola Medical Center (1981-1985).

PROFESSIONAL AFFILIATIONS

American Association of Immunology Society for Neuro-Oncology American Association for Cancer Research EQAPOL

EDUCATION & CREDENTIALS

Post-Doctoral Fellowship, University of North Carolina – Chapel Hill, Chapel Hill, NC

Doctorate of Philosophy, Microbiology, Clemson University, Clemson, SC

Bachelor of Science, Biology, St. Mary's College, Notre Dame, IN

LSR II Flow Cytometry Course, BD Biosciences CFAR Polychromatic ICS Workshop, Duke University, 2009 & 2013 ELISpot Seminar, Duke University, 2005, 2013, 2015

SELECTED PUBLICATIONS

Price LS, Adamow M, Attig S, Fecci P, Norberg P, Reap E, Janetzki S, McNeil LK. Gating Harmonization Guidelines for Intracellular Cytokine Staining Validated in Second International Multiconsortia Proficiency Panel Conducted by Cancer Immunotherapy Consortium (CIC/CRI). Cytometry A. 2020 Oct 22. doi: 10.1002/cyto.a.24244. Epub ahead of print. PMID: 33090656.

Reap EA, Suryadevara CM, Batich KA, Sanchez-Perez L, Archer GE, Schmittling RJ, Norberg PK, Herndon JE, Healy P, Congdon KL, Gedeon PC, Campbell OC, Swartz AM, Riccione KA, Yi JS, Hossain-Ibrahim MK, Saraswathula A, Nair SK, Dunn-Pirio AM, Broome TM, Weinhold KJ, Desjardins A, Vlahovic G, McLendon RE, Friedman AH, Friedman HS, Bigner DD, Fecci PE, Mitchell DA, Sampson JH. Dendritic Cells Enhance Polyfunctionality of Adoptively Transferred T Cells That Target Cytomegalovirus in Glioblastoma. Cancer Research. 2018;78(1):256-64. doi: 10.1158/0008-5472.can-17-0469.

Gururangan S, Reap EA, Schmittling R, Kocak M, Reynolds R, Grant G, Onar-Thomas A, Baxter P, Pollack IF, Phillips P, Boyett J, Fouladi M, Mitchell D. Regulatory T cell subsets in patients with medulloblastoma at diagnosis and during standard irradiation and chemotherapy (PBTC N-11). Cancer Immunology, Immunotherapy. 2017;66(12):1589-95. doi: 10.1007/s00262-017-2051-6.

Batich KA, Reap EA, Archer GE, Sanchez-Perez L, Nair SK, Schmittling RJ, Norberg P, Xie W, Herndon JE, Healy P, McLendon RE, Friedman AH, Friedman HS, Bigner D, Vlahovic G, Mitchell DA, Sampson JH. Long-term Survival in Glioblastoma with Cytomegalovirus pp65-Targeted Vaccination. Clinical Cancer Research. 2017;23(8):1898-909. doi: 10.1158/1078-0432.ccr-16-2057

Saraswathula A, Reap EA, Choi BD, Schmittling RJ, Norberg PK, Sayour EJ, Herndon JE 2nd, Healy P, Congdon KL, Archer GE, Sanchez-Perez L, Sampson JH: Serum elevation of B lymphocyte stimulator does not increase regulatory B cells in glioblastoma patients undergoing immunotherapy. Cancer Immunology, Immunotherapy : CII. 2016. 65(2), 205–211. doi: 10.1007/s00262-015-1784-3.

Mitchell DA, Batich KA, Gunn MD, Nair SK, Sanchez-Perez L, Congdon KL, Reap EA, Archer GE, Desjardins A, Friedman AH, Friedman HS, Herndon JE 2nd, Coan A, McLendon RE, Reardon DA, Vredenburgh JJ, Bigner DD, Sampson, JH. Tetanus toxoid and CCL3 improve DC vaccines in mice and glioblastoma patients. Nature. 2015 19; 519(7543):366-9

Suryadevara CM, Verla T, Sanchez-Perez L, Reap EA, Choi BD, Fecci PE, Sampson JH. Immunotherapy for malignant glioma. Surg. Neurol. Int. 2015 Feb. 13 PMCID: PMC4338494

Choi BD, Gedeon PC, Herndon JE 2nd, Archer GE, Reap EA, Sanchez-Perez L, Mitchell DA, Bigner DD, Sampson JH. Human regulatory T cells kill tumor cells through granzyme-dependent cytotoxicity upon retargeting with a bispecific antibody. Cancer Immunol Res. 2014 Sep;1(3):163. doi: 10.1158/2326-6066.CIR-13-0049

Sampson JH, Choi BD, Sanchez-Perez L, Suryadevara CM, Snyder DJ, Flores CT, Schmittling RJ, Nair SK, Reap EA, Norberg PK, Herndon JE 2nd, Kuan CT, Morgan RA, Rosenberg SA, Johnson LA, EGFRvIII mCAR-modified T-cell therapy cures mice with established intracerebral glioma and generates host immunity against tumor-antigen loss. Clin Cancer Res. 2014 Feb 15;20(4):972-84. doi: 10.1158/1078-0432.CCR-13-0709. Epub 2013 Dec 18

Sanchez-Perez L, Choi BD, Reap EA, Sayour EJ, Norberg P, Schmittling RJ, Archer GE, Herndon JE 2nd, Mitchell DA, Heimberger AB, Bigner DD, Sampson JH. BLyS levels correlate with vaccine-induced antibody titers in patients with glioblastoma lymphodepleted by therapeutic temozolomide. Cancer Immunol Immunother. 2013 Jun;62(6):983-7. doi: 10.1007/s00262-013-1405-y. Epub 2013 Apr 17.

Morgan RA, Johnson LA, Davis JL, Zheng Z, Woolard KD, Reap EA, Feldman SA, Chinnasamy N, Kuan CT, Song H, Zhang W, Fine HA, Rosenberg SA. Recognition of glioma stem cells by genetically modified T cells targeting EGFRvIII and development of adoptive cell therapy for glioma. Hum Gene Ther 2012 Oct;23(10):1043-53. doi: 10.1089/hum. Epub 2012 Sep 24.

Sampson JH, Schmittling RJ, Archer GE, Congdon KL, Nair SK, Reap EA, Desjardins A, Friedman AH, Friedman HS, Herndon JE 2nd, Coan A, McLendon RE, Reardon DA, Vredenburgh JJ, Bigner DD, Mitchell DA. A pilot study of IL-2Rα blockade during lymphopenia depletes regulatory T-cells and correlates with enhanced immunity in patients with glioblastoma. PLoS One. 2012;7(2):e31046. doi: 10.1371/journal.pone.0031046. Epub 2012 Feb 27

Bernstein DI, Reap EA, Katen K, Watson A, Smith K, Norberg P, Olmsted RA, Hoeper A, Morris J, Negri S, Maughan MR, and Chulay JD.Randomized double-blind, Phase 1 trial of an alphavirus replicon for cytomegalovirus in CMV seronegative adult volunteers. Vaccine 2009; 28:484-493

Reap EA, Dryga SA, Morris J, Rivers B, Norberg PK, Olmsted RA, and Chulay JD. Cellular and Humoral Immune Responses to Alphavirus Replicon Vaccines Expressing Cytomegalovirus pp65, IE1, and gB Proteins. Clinical and Vaccine Immunology 2007 14(6): 748-755

Reap EA, Morris J, Dryga SA, Maughan M, Talarico T, Esch RE, Negri S, Burnett B, Graham A, Olmsted RA, and Chulay JD. Development and Preclinical Evaluation of an Alphavirus Replicon Particle Vaccine for Cytomegalovirus. Vaccine 2007 25(42),: 7441-7449

Hubby B, Talarico T, Maughan M, Reap EA, Berglund P, Kamrud KI, Copp L, Lewis W, Cecil C, Norberg P, Wagner J, Watson A, Negri S, Burnett BK, Graham A, Smith JF, and Chulay JD. Development and Preclinical Evaluation of an Alphavirus Replicon Vaccine for Influenza. Vaccine 2007,25(48): 8180-8189

Cohen PL, Caricchio R, Abraham V, Camenisch TD, Jennette JC, Roubey RA, Earp HS, Matsushima G, and Reap EA. Delayed Apoptotic Cell Clearance and Lupus-Like Autoimmunity in Mice Lacking the C-Mer Membrane Tyrosine Kinase. Journal of Experimental Medicine 2002,196(1): 135-140

Davis NL, West A, Reap E, MacDonald G, Collier M, Dryga S, Maughan M, Walker C, McGrath K, Cecil C, Ping LH, Frelinger J, Olmsted R, Keith P, Swanstrom R, Williamson C, Johnson P, Montefiori D, and Johnston RE. Alphavirus Replicon Particles as Candidate HIV Vaccines”, International Union of Biochemistry and Molecular Biology (IUBMB) 2002 Life 53(4-5): 209-211.

Scott RS, McMahon EJ, Pop SM, Reap EA, Caricchio R, Cohen PL, and Earp HS,, Phagocytosis and Clearance of Apoptotic Cells is Mediated by MER. Nature 2001 411(6843): 207-211

Richards HB, Reap EA, Shaw M, Satoh M, Yoshida H, and Reeves WH.B Cell Subsets in Pristane-Induced Autoimmunity.Current Topics in Microbiology and Immunology 2000 252,: 201-207

Serody JS, Cook DN, Kirby SL, Reap E, Shea TC, and Frelinger JA. Murine T Lymphocytes Incapable of Producing Macrophage Inhibitory Protein-1 are Impaired in Causing Graft-Versus-Host Disease Across a Class I but not Class II Major Histocompatibility Complex Barrier. Blood 1999 93(1): 43-50

Maldonado MA, Kakkanaiah V, MacDonald GC, Chen F, Reap EA, Balish E, Farkas WR, Jennette JC, Madaio MP, Kotzin BL, Cohen PL, and Eisenberg RA. The Role of Environmental Antigens in the Spontaneous Development of Autoimmunity in MRL-lpr Mice.Journal of Immunology, 1999 162(11): 6322-6330.

Booker JK, Reap EA, and Cohen PL.Expression and Function of Fas on Cells Damaged by Gamma-Irradiation in B6 and B6/lpr Mice. Journal of Immunology 1998 161(9): 4536-4541

Caricchio R, Reap EA, and Cohen PL. Fas/Fas Ligand Interactions are Involved in Ultraviolet-B-Induced Human Lymphocyte Apoptosis. Journal of Immunology 1998,161(1),: 241-251.

Sobel ES, Kakkanaiah VN, Schiffenbauer J, Reap EA, Cohen PL, and Eisenberg RA. Novel Immunoregulatory B cell Pathways Revealed by lpr-+ Mixed Chimeras Journal of Immunology 1998, 160(3): 1497-1503.

Reap EA, Roof K, Maynor K, Borrero M, Booker J, and Cohen PL. Radiation and Stress-Induced Apoptosis: a Role for Fas/Fas Ligand Interactions. Proceedings of the National Academy of Sciences for the United States of America 1997,94(11): 5750-5755.

Creech EA, Nakul-Aquaronne D, Reap EA, Cheek RL, Wolthusen PA, Cohen PL, and Eisenberg RA. MHC Genes Modify Systemic Autoimmune Disease. The Role of the I-E Locus. Journal of Immunology 1996,156(2): 812-187

Reap EA, Piecyk ML, Oliver A, Sobel ES, Waldschmidt T, Cohen PL, and Eisenberg RA. Phenotypic Abnormalities of Splenic and Bone Marrow B Cells in lpr and gld Mice. Clinical Immunology and Immunopathology 1996 78(1): 21-29

Ajmani AK, Satoh M, Reap E, Cohen PL, and Reeves WH. Absence of Autoantigen Ku in Mature Human Neutrophils and Human Promyelocytic Leukemia Line (HL-60) Cells and Lymphocytes Undergoing Apoptosis. Journal of Experimental Medicine 1995 181(6): 2049-2058

Reap EA, Felix NJ, Wolthusen PA, Kotzin BL, Cohen PL, and Eisenberg RA. Bcl-2 Transgenic Lpr Mice Show Profound Enhancement of Lymphadenopathy. Journal of Immunology 1995,155(11): 5455-5462

Reap EA, Leslie D, Abrahams M, Eisenberg RA, and Cohen PL Apoptosis Abnormalities of Splenic Lymphocytes in Autoimmune lpr and gld Mice. Journal of Immunology 1995,154(2),: 936-943

Eisenberg RA, Sobel ES, Reap EA, Halpern MD, and Cohen PL. The Role of B Cell Abnormalities in the Systemic Autoimmune Syndromes of lpr and gld Mice. Seminars in Immunology 1994, (1): 49-54

Reap EA, Sobel ES, Cohen PL, and Eisenberg RA. Conventional B Cells, not B-1 Cells, are the Source of Autoantibodies in Chronic Graft-Versus-Host Disease. Journal of Immunology 1993,151(12):7316-7323

Reap EA, Sobel ES, Cohen PL, and Eisenberg RA. Conventional B Cells, Not B-1 Cells, are Responsible for Producing Autoantibodies in lpr Mice. Journal of Experimental Medicine 1993,177(1): 69-78

Reap EA, and Lawson JW. Stimulation of the Immune Response by Dimethylglycine, a Nontoxic Metabolite.Journal Laboratory and Clinical Medicine 1990115(4):481-486

O'Connell JB, Reap EA, and Robinson JA. The Effects of Cyclosporine on Acute Murine Coxsackie B3 Myocarditis Circulation 1986, 73(2):353-9

Costanzo-Nordin MR, Reap EA, O'Connell JB, Robinson JA, and Scanlon PJ. A Nonsteroid Anti-Inflammatory Drug Exacerbates Coxsackie B3 Murine Myocarditis Journal of the American College of Cardiology 1985, 6(5):1078-1082

SELECTED PRESENTATIONS

Reap EA, Watson AD, Norberg PK, Cecil C, Dornsife RE, Kamrud KI, and Smith J, Evaluation of the Immunogenicity of an Alphavirus Replicon Particle Vaccine Expressing the SARS-CoV Spike (S) Glycoprotein in Non-Human Primates 2007, Program #B191, Abstract #73, Journal of Immunology 178, B191, Miama,FL

Reap, E., Norberg, P., Watson, A., Cecil, C., Wagner, J., Kamrud, K., and J. Smith. Evaluation of Cellular Immune Responses Induced in Mice by AlphaVirus Replicon Particle Vaccines for SARS-CoV#B192, Abstract #74, Journal of Immunology 178, B19, Miama,FL.

Maughan, M., Reap, E., Dempsey, J., Reid, R., Dinka, K., Pancorbo, B., Wagner, J., Norberg, P., Rivers, B., Dryga, S., and Olmsted, R. Preclinical Immunogenicity Studies of an Alphavirus Replicon Vector Multi-Genic HIV-1 Vaccine for South Africa, Aids Vaccine 2003, September 18-21, New York, New York

Morris,J.S., Reap, E.A., Reid, R.A., Norberg, P.K., Rivers, B.A., Chulay, J.D., Olmsted, R.A., and S.A. Dryga. Development of an AlphaVirus Replicon Vector Vaccine for Human CMV. American Society for Virology 22nd Annual Meeting 2003, University of California Davis, CA

Reap, E., Reid, R., West, A., Maughan, M., Dryga, S., Caley, I., Norberg, P., Dinka, K., Pancorbo, B., Raaf, E., Keith, P., and R. Olmsted. Preclinical Immunogenicity on Pilot Lots of a Prototype VEE Replicon Vaccine for South Africa. AIDS Vaccine Meeting 2001, Philadelphia, PA

Reap EA, Roof K, Maynor K, and Cohen P, Markedly Diminished Radiation-Induced Lymphocyte Apoptosis in lpr Mice Suggests a Role for Fas in Eliminating Damaged Cells, Annals of the New York Academy of Sciences 1997,815: 116-118

Reap EA, Sobel ES, Cohen PL, and Eisenberg RA,, The Role of CD5+ B Cells in the Production of Autoantibodies in Murine Systemic lupus Erythematosus, Annals of the New York Academy of Sciences1992 651: 588-590.

SELECTED PATENTS

Chulay JD, Dryga S, Reap EA, Olmsted RA, Morris JS, “Alphavirus-Based Cytomegalovirus Vaccines”, US Patent 7,419,674, September 2, 2008.

REFERENCES AVAILABLE ON REQUEST

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