Harmonizing standards for producing clinical-grade therapies from pluripotent stem cells
Andrews, Peter W, Cavagnaro, Joy, Deans, Robert, Feigal, Ellen, Horowitz, Ed, Keating, Armand, Rao, Mahendra, Turner, Marc, Wilmut, Ian, Yamanaka, Shinya
Published in Nature biotechnology (01.08.2014)
Published in Nature biotechnology (01.08.2014)
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Journal Article
Pre-clinical Specificity and Safety of UC-961, a First-In-Class Monoclonal Antibody Targeting ROR1
Choi, Michael Y, Widhopf, George F, Wu, Christina C.N, Cui, Bing, Lao, Fitzgerald, Sadarangani, Anil, Cavagnaro, Joy, Prussak, Charles, Carson, Dennis A, Jamieson, Catriona, Kipps, Thomas J
Published in Clinical lymphoma, myeloma and leukemia (01.06.2015)
Published in Clinical lymphoma, myeloma and leukemia (01.06.2015)
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Journal Article
Classic and evolving approaches to evaluating cross reactivity of mAb and mAb-like molecules – A survey of industry 2008–2019
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.
Published in Regulatory toxicology and pharmacology (01.04.2021)
Published in Regulatory toxicology and pharmacology (01.04.2021)
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Journal Article
Use of tissue cross-reactivity studies in the development of antibody-based biopharmaceuticals: history, experience, methodology, and future directions
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
Published in Toxicologic pathology (01.12.2010)
Published in Toxicologic pathology (01.12.2010)
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Journal Article
Report of the international conference on manufacturing and testing of pluripotent stem cells
Abbot, Stewart, Agbanyo, Francisca, Ahlfors, Jan-Eric, Baghbaderani, Behnam A., Bartido, Shirley, Bharti, Kapil, Burke, Carl, Carlsson, Bjorn, Cavagnaro, Joy, Creasey, Abla, DiGiusto, David, Francissen, Kathy, Gaffney, Andrew, Goldring, Christopher, Gorba, Thorsten, Griffiths, Elwyn, Hanatani, Tadaaki, Hayakawa, Takao, Heki, Tatsuo, Hoogendoorn, Karin, Kawamata, Shin, Kimura, Hironobu, Kirkeby, Agnete, Knezevic, Ivana, Lebkowski, Jane, Lin, Stephen, Lin-Gibson, Shen, Lubiniecki, Anthony, O'Shea, Orla, Pera, Martin, Petricciani, John, Pigeau, Gary, Ratcliffe, Anthony, Sato, Yoji, Schumann, Gerald G., Shingleton, William, Stacey (Chair), Glyn, Sullivan, Stephen, Svendsen, Clive N., Trouvin, Jean-Hugues, Vandeputte, Joris, Yuan, Bao-Zhu, Zoon, Kathryn
Published in Biologicals (01.11.2018)
Published in Biologicals (01.11.2018)
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Journal Article
Practical approaches to dose selection for first-in-human clinical trials with novel biopharmaceuticals
Tibbitts, Jay, Cavagnaro, Joy A., Haller, Christine A., Marafino, Ben, Andrews, Paul A., Sullivan, John T.
Published in Regulatory toxicology and pharmacology (01.11.2010)
Published in Regulatory toxicology and pharmacology (01.11.2010)
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Journal Article
American society of gene therapy (ASGT) ad hoc subcommittee on retroviral-mediated gene transfer to hematopoietic stem cells
Kohn, Donald B, Sadelain, Michel, Dunbar, Cynthia, Bodine, David, Kiem, Hans-Peter, Candotti, Fabio, Tisdale, John, Riviére, Isabelle, Blau, C.Anthony, Richard, Robert E, Sorrentino, Brian, Nolta, Jan, Malech, Harry, Brenner, Malcolm, Cornetta, Kenneth, Cavagnaro, Joy, High, Katherine, Glorioso, Joseph
Published in Molecular therapy (01.08.2003)
Published in Molecular therapy (01.08.2003)
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Journal Article
Clinical Expert Panel on Monitoring Potential Lung Toxicity of Inhaled Oligonucleotides: Consensus Points and Recommendations
Alton, Eric W., Boushey, Homer A., Garn, Holger, Green, Francis H., Hodges, Michael, Martin, Richard J., Murdoch, Robert D., Renz, Harald, Shrewsbury, Stephen B., Seguin, Rosanne, Johnson, Graham, Parry, Joel D., Tepper, Jeff, Renzi, Paolo, Cavagnaro, Joy, Ferrari, Nicolay
Published in Nucleic acid therapeutics (01.08.2012)
Published in Nucleic acid therapeutics (01.08.2012)
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Journal Article
Not reinventing the wheel: applying the 3Rs concepts to viral vector gene therapy biodistribution studies
MacLachlan, Timothy K, McIntyre, Maritza, Mitrophanous, Kyriacos, Miskin, James, Jolly, Douglas J, Cavagnaro, Joy A
Published in Human gene therapy. Clinical development (01.03.2013)
Published in Human gene therapy. Clinical development (01.03.2013)
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Journal Article
'Generic' or 'follow-on' biologics: scientific considerations and safety issues
Green, James D, Tsang, Lincoln, Cavagnaro, Joy A
Published in Expert opinion on biological therapy (01.10.2003)
Published in Expert opinion on biological therapy (01.10.2003)
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Journal Article
PEGylated Biopharmaceuticals: Current Experience and Considerations for Nonclinical Development
Ivens, Inge A, Achanzar, William, Baumann, Andreas, Brändli-Baiocco, Annamaria, Cavagnaro, Joy, Dempster, Maggie, Depelchin, B Olympe, Rovira, Armando R Irizarry, Dill-Morton, Laura, Lane, Joan H, Reipert, Birgit M, Salcedo, Theodora, Schweighardt, Becky, Tsuruda, Laurie S, Turecek, Peter L, Sims, Jennifer
Published in Toxicologic pathology (01.10.2015)
Published in Toxicologic pathology (01.10.2015)
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Journal Article
Considerations for the Characterization and Interpretation of Results Related to Alternative Complement Activation in Monkeys Associated with Oligonucleotide-Based Therapeutics
Henry, Scott P., Seguin, Rosanne, Cavagnaro, Joy, Berman, Cindy, Tepper, Jeff, Kornbrust, Douglas
Published in Nucleic acid therapeutics (01.08.2016)
Published in Nucleic acid therapeutics (01.08.2016)
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Journal Article
Scientific and Regulatory Policy Committee Points to Consider: Nonclinical Research and Development of In Vivo Gene Therapy Products, Emphasizing Adeno-Associated Virus Vectors
Hutt, Julie A, Assaf, Basel T, Bolon, Brad, Cavagnaro, Joy, Galbreath, Elizabeth, Grubor, Branka, Kattenhorn, Lisa M, Romeike, Annette, Whiteley, Laurence O
Published in Toxicologic pathology (01.01.2022)
Published in Toxicologic pathology (01.01.2022)
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Journal Article
Use of an animal model of disease for toxicology enables identification of a juvenile no observed adverse effect level for cyclocreatine in creatine transporter deficiency
Do, Minh-Ha Thi, Cavagnaro, Joy, Butt, Mark, Terse, Pramod S., McKew, John C.
Published in Regulatory toxicology and pharmacology (01.07.2021)
Published in Regulatory toxicology and pharmacology (01.07.2021)
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Journal Article
Safety testing of monoclonal antibodies in non-human primates: Case studies highlighting their impact on human risk assessment
Brennan, Frank R., Cavagnaro, Joy, McKeever, Kathleen, Ryan, Patricia C., Schutten, Melissa M., Vahle, John, Weinbauer, Gerhard F., Marrer-Berger, Estelle, Black, Lauren E.
Published in mAbs (02.01.2018)
Published in mAbs (02.01.2018)
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Journal Article
Oligo Safety Working Group Exaggerated Pharmacology Subcommittee Consensus Document
Kornbrust, Doug, Cavagnaro, Joy, Levin, Arthur, Foy, Jeffrey, Pavco, Pamela, Gamba-Vitalo, Christina, Guimond, Alain
Published in Nucleic acid therapeutics (01.02.2013)
Published in Nucleic acid therapeutics (01.02.2013)
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Journal Article
Conference Proceeding