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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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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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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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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Comparative assessment of the transduction efficiency and safety associated with the delivery of AAV9-GFP vector via lumbar puncture to cynomolgus macaques with and without anti-AA... von Guibinga, Ghiabe H., Do, Janet, Chu, Binh, Gu, Yin, Kikkawa, Rie, Li, Xiaoguang, Ozsolak, Fatih, MacLachlan, Timothy

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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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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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Inhibition of Choroidal Neovascularization in a Nonhuman Primate Model by Intravitreal Administration of an AAV2 Vector Expressing a Novel Anti-VEGF Molecule von Lukason, Michael, DuFresne, Elizabeth, Rubin, Hillard, Pechan, Peter, Li, Qiuhong, Kim, Ivana, Kiss, Szilard, Flaxel, Christina, Collins, Margaret, Miller, Joan, Hauswirth, William, MacLachlan, Timothy, Wadsworth, Samuel, Scaria, Abraham

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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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In Vino, Curationis? von MacLachlan, Timothy

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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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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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Nonclinical Evaluation of GMA161-An Antihuman CD16 (FcγRIII) Monoclonal Antibody for Treatment of Autoimmune Disorders in CD16 Transgenic Mice von Flaherty, Meghan M., MacLachlan, Timothy K., Troutt, Misty, Magee, Tomas, Tuaillon, Nadine, Johnson, Syd, Stein, Kathryn E., Bonvini, Ezio, Garman, Richard, Andrews, Laura

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Nonclinical Studies that Support Viral Vector-Delivered Gene Therapies: An EFPIA Gene Therapy Working Group Perspective von Bolt, Michael W., Whiteley, Laurence O., Lynch, Jessica L., Lauritzen, Brian, Fernández de Henestrosa, Antonio R., MacLachlan, Timothy, Ulrich, Peter, Philip, Binu K., Mahalingaiah, Prathap Kumar, Fuller, Claudette L., Compton, David R.

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Corrigendum to “Inflammation and immunogenicity limit the utility of the rabbit as a nonclinical species for ocular biologic therapeutics” [Regul. Toxicol. Pharmacol. (2017) 221–23... 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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Storm forecasting: additional lessons from the CD28 superagonist TGN1412 trial: 1 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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Insulin-like growth factor factor binding protein-2 is a novel mediator of p53 inhibition of insulin-like growth factor signaling von Grimberg, Adda, Coleman, Carrie M, Shi, Zonggao, Burns, Timothy F, MacLachlan, Timothy K, Wang, Wenge, El-Deiry, Wafik S

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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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