Kenneth Munroe Email and Phone Number

In vitro analysis of immune effector function such as multiplex cytokine panels or circulating drug measurement, from disease models using plate-based assays, including ELISA, MSD and Gyrolab xPlore platforms. Conduct isolation of immune effector cells or in vitro cell differentiation for adoptive transfer or ex vivo assays. Performs in vitro drug screens on cancer cell lines.

Development and execution of ex vivo and in vitro assays to measure general and targeted immune responses, in mouse tumor models

• Used flow cytometry to determine binding efficiency of antibody candidates to antigen targets on cultured primary cells• Evaluated the anti-proliferative effects of small molecule payload of cultured primary cells using CellTiter Glo as readout

Utilized in vitro and in vivo experience to manage and conduct discovery projects supporting proprietary novel compounds • AAV gene therapy of a monogenic brain metabolic disorder• Performed in vivo AAV capsid selection to determine whether the AAV candidates crosses the blood brain barrier• Evaluated on-target and off-target reporter gene or transgene expression from AAV candidates • Utilized two-stage CD34+ HSC liquid culture to screen novel small molecules for hemoglobin induction activity• Led development of a congenic mouse transplant model to screen for enhanced donor cell engraftment• Principal investigator of in vivo studies including IACUC protocol authorship• Evaluated the potential chemosensitivity of mobilized acute myeloid leukemia cells in xenograft mouse models• Led development of disseminated, xenograft models of hematopoietic malignancies• Conducted in vitro screens for cytotoxicity of novel compounds as single agents and as combinatorial therapies• In vitro characterization of antibody-drug conjugates including binding, internalization and cytotoxicity profiles• Conducted in vivo studies in-house and managed collaborations with external CROs to examine the efficacy and safety of antibody drug conjugates (ADCs) in xenograft models

Evaluated immunosuppressing strategies in mouse models to generate data supporting long-term enzyme replacement therapy in humans. Tested the effect of TGFβ neutralization on decreasing metastasis in mouse tumor models.• Lead a project to determine the role of TGFβ neutralization on the recruitment of myeloid derived suppressor cells and tumor associated macrophages to the tumor site.• Responsible for the assessment of the mechanism of action of neutralization of TGFβ on tumor immunosurveillance through cytolytic assays, effector cell immmunophenotyping and Lumminex multiplex cytokine assay.• Evaluated the proliferative response of a large panel of syngeneic cancer cell lines to TGFβ stimulation.• Provided supportive data and assisted in writing a FDA Clinician’s Technical Report for clinical treatment of CRIM-negative infants.• Responsible for assisting in mouse study design and conducting mouse studies testing several approved and experimental drugs to attenuate the immune response to recombinant enzymes.• Performed assays including ELISA, proliferation assays and immmunophenotyping to determine the effect of test drugs to decrease immune-specific responses to recombinant enzymes.• Investigated the role of B cell subsets in a primary immune response to recombinant human enzymes in mouse models.• Developed and optimized assays used in immunomodulation studies.• Trained and mentored several college-aged Co-Operative students.

Applied immunology expertise to conduct studies and experiments to determine the efficacy of vaccines using the QS-21 adjuvant. • Coordinated ELISA and CTL assays in pre-clinical studies combining the adjuvant QS-21 with various excipients.• Responsible for determining the efficacy of CD1+ antigen presentation from a guinea pig animal model using flow cytometry, proliferation and CTL assays. • Participated in the testing phase II clinical trial sera samples by ELISA and an opsonophagocytic killing assay to evaluate the efficacy of a vaccine against Streptococcus pneumonia. • Developed procedures, including immunofluorescent staining and bacterial purification of the causative agent of human granulocytic ehrlichiosis (now identified as Anaplasma phagocytophilum).• Assisted the Radiation Safety Officer insuring compliance with the site radiation license.

Supported vaccine development using a proprietary adjuvant targeting HIV and tuberculosis in NIH grant funded studies. • Fully responsible for performing immunoassays including, proliferation, CTL, ELISA and immmunostaining on samples collected from Mycobacterium avium mouse studies.• Cultured M. avium in HT-29 cells and utilized acid fast staining to confirm infection.• Developed and optimized a method for using recombinant vaccinia HIVIIIb gp160 infected autologous antigen presenting cells to stimulate a T-cell effector cell activity.• Performed CTL and proliferation assays from effector cells derived from whole blood or spleen.• Formulated drugs and vaccines for in-life studies.

Conducted animal and ex vivo studies for independent clients in a contract research organization. • Determined anti-viral drug efficacy ex vivo and in vivo. • Isolated SIV and HIV on transformed lymphocytes from PBMCs and bone marrow biopsies.• Ran serum chemistry panels using automated and semi-automated analyzers.• Maintained and derived murine VSMC lines and murine T cells.• Tested compounds for potential carcinogenicity by means of dosed feed, oral gavage and skin paint.