Current nonclinical testing paradigm enables safe entry to First-In-Human clinical trials: The IQ consortium nonclinical to clinical translational database
Monticello, Thomas M., Jones, Thomas W., Dambach, Donna M., Potter, David M., Bolt, Michael W., Liu, Maggie, Keller, Douglas A., Hart, Timothy K., Kadambi, Vivek J.
Published in Toxicology and applied pharmacology (01.11.2017)
Published in Toxicology and applied pharmacology (01.11.2017)
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Development challenges associated with rAAV-based gene therapies
Bolt, Michael W., Brady, Joseph T., Whiteley, Lawrence O., Khan, K. Nasir
Published in Journal of toxicological sciences (01.01.2021)
Published in Journal of toxicological sciences (01.01.2021)
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Factor XIa-specific IgG and a reversal agent to probe factor XI function in thrombosis and hemostasis
David, Tovo, Kim, Yun Cheol, Ely, Lauren K, Rondon, Isaac, Gao, Huilan, O'Brien, Peter, Bolt, Michael W, Coyle, Anthony J, Garcia, Jorge L, Flounders, Eric A, Mikita, Thomas, Coughlin, Shaun R
Published in Science translational medicine (24.08.2016)
Published in Science translational medicine (24.08.2016)
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Journal Article
The ‘totality-of-the-evidence’ approach in the development of PF-06438179/GP1111, an infliximab biosimilar, and in support of its use in all indications of the reference product
McClellan, Joseph E., Conlon, Hugh D., Bolt, Michael W., Kalfayan, Vatche, Palaparthy, Rameshraja, Rehman, Muhammad I., Kirchhoff, Carol F.
Published in Therapeutic Advances in Gastroenterology (01.06.2019)
Published in Therapeutic Advances in Gastroenterology (01.06.2019)
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Book Review
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Sex-related differences in retinal function in Wistar rats: implications for toxicity and safety studies
Tyszkiewicz, Cheryl, Hwang, Seo-Kyoung, Manickam, Balasubramanian, Jakubczak, Ben, Walters, Karen M, Bolt, Michael W, Santos, Rosemary, Liu, Chang-Ning
Published in Frontiers in toxicology (23.05.2023)
Published in Frontiers in toxicology (23.05.2023)
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Journal Article
Nonclinical Studies that Support Viral Vector-Delivered Gene Therapies: An EFPIA Gene Therapy Working Group Perspective
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.
Published in Molecular therapy. Methods & clinical development (11.12.2020)
Published in Molecular therapy. Methods & clinical development (11.12.2020)
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Journal Article
Small Molecule Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitors: Hit to Lead Optimization of Systemic Agents
Londregan, Allyn T, Wei, Liuqing, Xiao, Jun, Lintner, Nathanael G, Petersen, Donna, Dullea, Robert G, McClure, Kim F, Bolt, Michael W, Warmus, Joseph S, Coffey, Steven B, Limberakis, Chris, Genovino, Julien, Thuma, Benjamin A, Hesp, Kevin D, Aspnes, Gary E, Reidich, Benjamin, Salatto, Christopher T, Chabot, Jeffrey R, Cate, Jamie H. D, Liras, Spiros, Piotrowski, David W
Published in Journal of medicinal chemistry (12.07.2018)
Published in Journal of medicinal chemistry (12.07.2018)
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Journal Article
Evaluation of biomarkers for monitoring thrombogenic potential of FXaI16L
Bolt, Michael W, Hua, Fei, Brenneman, Karrie A, Graves, John E, Arkin, Steven, Criswell, Kay
Published in Blood coagulation & fibrinolysis (01.01.2020)
Published in Blood coagulation & fibrinolysis (01.01.2020)
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Journal Article
Liver‐Targeted Small‐Molecule Inhibitors of Proprotein Convertase Subtilisin/Kexin Type 9 Synthesis
McClure, Kim F., Piotrowski, David W., Petersen, Donna, Wei, Liuqing, Xiao, Jun, Londregan, Allyn T., Kamlet, Adam S., Dechert‐Schmitt, Anne‐Marie, Raymer, Brian, Ruggeri, Roger B., Canterbury, Daniel, Limberakis, Chris, Liras, Spiros, DaSilva‐Jardine, Paul, Dullea, Robert G., Loria, Paula M., Reidich, Benjamin, Salatto, Christopher T., Eng, Heather, Kimoto, Emi, Atkinson, Karen, King‐Ahmad, Amanda, Scott, Dennis, Beaumont, Kevin, Chabot, Jeffrey R., Bolt, Michael W., Maresca, Kevin, Dahl, Kenneth, Arakawa, Ryosuke, Takano, Akihiro, Halldin, Christer
Published in Angewandte Chemie International Edition (18.12.2017)
Published in Angewandte Chemie International Edition (18.12.2017)
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Journal Article
Nonclinical Evaluation of PF-06438179: A Potential Biosimilar to Remicade® (Infliximab)
Derzi, Mazin, Johnson, Theodore R., Shoieb, Ahmed M., Conlon, Hugh D., Sharpe, Penny, Saati, Andrew, Koob, Sarah, Bolt, Michael W., Lorello, Leslie G., McNally, Jim, Kirchhoff, Carol F., Smolarek, Teresa A., Leach, Michael W.
Published in Advances in therapy (01.11.2016)
Published in Advances in therapy (01.11.2016)
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Journal Article
Liver‐Targeted Small‐Molecule Inhibitors of Proprotein Convertase Subtilisin/Kexin Type 9 Synthesis
McClure, Kim F., Piotrowski, David W., Petersen, Donna, Wei, Liuqing, Xiao, Jun, Londregan, Allyn T., Kamlet, Adam S., Dechert‐Schmitt, Anne‐Marie, Raymer, Brian, Ruggeri, Roger B., Canterbury, Daniel, Limberakis, Chris, Liras, Spiros, DaSilva‐Jardine, Paul, Dullea, Robert G., Loria, Paula M., Reidich, Benjamin, Salatto, Christopher T., Eng, Heather, Kimoto, Emi, Atkinson, Karen, King‐Ahmad, Amanda, Scott, Dennis, Beaumont, Kevin, Chabot, Jeffrey R., Bolt, Michael W., Maresca, Kevin, Dahl, Kenneth, Arakawa, Ryosuke, Takano, Akihiro, Halldin, Christer
Published in Angewandte Chemie (18.12.2017)
Published in Angewandte Chemie (18.12.2017)
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Journal Article