Preclinical Safety Evaluation of AAV2-sFLT01— A Gene Therapy for Age-related Macular Degeneration von MacLachlan, Timothy K, Lukason, Michael, Collins, Margaret, Munger, Robert, Isenberger, Elisabete, Rogers, Cindy, Malatos, Shana, DuFresne, Elizabeth, Morris, James, Calcedo, Roberto, Veres, Gabor, Scaria, Abraham, Andrews, Laura, Wadsworth, Samuel

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Regulatory Consideration for the Nonclinical Safety Assessment of Gene Therapies von Moffit, Jeffrey S, Blanset, Diann L, Lynch, Jessica L, MacLachlan, Timothy K, Meyer, Kathleen E, Ponce, Rafael, Whiteley, Laurence O

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Classic and evolving approaches to evaluating cross reactivity of mAb and mAb-like molecules – A survey of industry 2008–2019 von MacLachlan, Timothy K., Price, Shari, Cavagnaro, Joy, Andrews, Laura, Blanset, Diann, Cosenza, Mary Ellen, Dempster, Maggie, Galbreath, Elizabeth, Giusti, Anna Maria, Heinz-Taheny, Kathleen Marie, Fleurance, Renaud, Sutter, Esther, Leach, Michael W.

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BRCA1 Directs a Selective p53-Dependent Transcriptional Response towards Growth Arrest and DNA Repair Targets von MacLachlan, Timothy K., Takimoto, Rishu, El-Deiry, Wafik S.

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Apoptotic Threshold is Lowered by p53 Transactivation of Caspase-6 von MacLachlan, Timothy K., El-Deiry, Wafik S.

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Nonclinical Safety Evaluation of scAAV8- RLBP1 for Treatment of RLBP1 Retinitis Pigmentosa von MacLachlan, Timothy K, Milton, Mark N, Turner, Oliver, Tukov, Francis, Choi, Vivian W, Penraat, Jan, Delmotte, Marie-Hélène, Michaut, Lydia, Jaffee, Bruce D, Bigelow, Chad E

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BRCA1 Effects on the Cell Cycle and the DNA Damage Response Are Linked to Altered Gene Expression von MacLachlan, Timothy K., Somasundaram, Kumaravel, Sgagias, Magda, Shifman, Yelena, Muschel, Ruth J., Cowan, Kenneth H., El-Deiry, Wafik S.

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The Bespoke Gene Therapy Consortium: facilitating development of AAV gene therapies for rare diseases von Brooks, P. J., Miller, Timothy M., Revah, Frédéric, Suh, Junghae, Garrison, Bradley R., Starke, Lawrence C., MacLachlan, Timothy K., Neilan, Edward G., Raychaudhuri, Gopa, Kassim, Sadik H., Dehdashti, Jean, Rutter, Joni L.

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P886: AFRICAN AMERICAN PATIENTS WITH SMOLDERING MULTIPLE MYELOMA MAY HAVE A LOWER RISK OF PROGRESSION COMPARED TO WHITE PATIENTS von Akhlaghi, T., Maclachlan, K., Korde, N., Mailankody, S., Lesokhin, A., Hassoun, H., Lu, S. X., Patel, D., Shah, U., Tan, C., Derkach, A., Lahoud, O., Landau, H. J., Shah, G. L., Scordo, M., Chung, D. J., Giralt, S. A., Usmani, S. Z., Landgren, O., Hultcrantz, M.

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S177: EVALUATING SERUM FREE LIGHT CHAIN RATIO AS A BIOMARKER FOR MULTIPLE MYELOMA von Akhlaghi, T., Maclachlan, K., Korde, N., Mailankody, S., Lesokhin, A., Hassoun, H., Lu, S. X., Patel, D., Shah, U., Tan, C., Derkach, A., Lahoud, O., Landau, H. J., Shah, G. L., Scordo, M., Chung, D. J., Giralt, S. A., Usmani, S. Z., Landgren, O., Hultcrantz, M.

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Nuclear magnetic resonance spectroscopy reveals the functional state of the signalling protein CheY in vivo in Escherichia coli von Hubbard, Julia A., MacLachlan, Lesley K., King, Gavin W., Jones, Joanna J., Fosberry, Andrew P.

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Challenges and opportunities for the future of monoclonal antibody development: Improving safety assessment and reducing animal use von Sewell, Fiona, Chapman, Kathryn, Couch, Jessica, Dempster, Maggie, Heidel, Shawn, Loberg, Lise, Maier, Curtis, Maclachlan, Timothy K, Todd, Marque, van der Laan, Jan Willem

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Industry experiences with immune-mediated findings in biotherapeutic nonclinical toxicology studies von MacLachlan, Timothy K., Kronenberg, Sven, Marshall, Nikki, Andrews, Laura, Berens, Shawn Jay, Brouta, Frederic, Fogal, Birgit, Freebern, Wendy, Herzyk, Danuta, Kamperschroer, Cris, Kiessling, Andrea, Schneidkraut, Marlowe, Maier, Curtis

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BRCA1 Transcriptionally Regulates Damaged DNA Binding Protein (DDB2) In the DNA Repair Response Following UV-Irradiation von Takimoto, Rishu, MacLachlan, Timothy K., Dicker, David T., Niitsu, Yoshiro, Mori, Toshio, El-Deiry, Wafik S.

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Inflammation and immunogenicity limit the utility of the rabbit as a nonclinical species for ocular biologic therapeutics von de Zafra, Christina L.Zuch, Sasseville, Vito G., Matsumoto, Steven, Freichel, Christian, Milton, Mark, MacLachlan, Timothy K., Farman, Cindy, Raymond, Iona, Gupta, Swati, Newton, Ronald, Atzpodien, Elke-Astrid, Thackaberry, Evan A.

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Repression of BRCA1 through a Feedback Loop Involving p53 von MacLachlan, Timothy K., Dash, Bipin C., Dicker, David T., El-Deiry, Wafik S.

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BRCA1 Augments Transcription by the NF-κB Transcription Factor by Binding to the Rel Domain of the p65/RelA Subunit von Benezra, Miriam, Chevallier, Nathalie, Morrison, Debra J., MacLachlan, Timothy K., El-Deiry, Wafik S., Licht, Jonathan D.

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BRCA1 signals ARF-dependent stabilization and coactivation of p53 von SOMASUNDARAM, K, MACLACHLAN, T. K, BURNS, T. F, SGAGIAS, M, COWAN, K. H, WEBER, B. L, EL-DEIRY, W. S

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Use of Tissue Cross-reactivity Studies in the Development of Antibody-based Biopharmaceuticals: History, Experience, Methodology, and Future Directions von Leach, Michael W., Halpern, Wendy G., Johnson, Carol W., Rojko, Jennifer L., MacLachlan, Tim K., Chan, Curtis M., Galbreath, Elizabeth J., Ndifor, Anthony M., Blanset, Diann L., Polack, Evelyne, Cavagnaro, Joy A.

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Storm forecasting: additional lessons from the CD28 superagonist TGN1412 trial von Horvath, Christopher, Andrews, Laura, Baumann, Andreas, Black, Lauren, Blanset, Diann, Cavagnaro, Joy, Hastings, Kenneth L., Hutto, David L., MacLachlan, Timothy K., Milton, Mark, Reynolds, Theresa, Roberts, Stan, Rogge, Mark, Sims, Jennifer, Treacy, George, Warner, Garvin, Green, James D.

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