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1.

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.

Toxicol Pathol ; 50(1): 118-146, 2022 01.

Artículo en Inglés | MEDLINE | ID: mdl-34657529

2.

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.

Regul Toxicol Pharmacol ; 123: 104939, 2021 Jul.

Artículo en Inglés | MEDLINE | ID: mdl-33961952

3.

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.

Regul Toxicol Pharmacol ; 121: 104872, 2021 Apr.

Artículo en Inglés | MEDLINE | ID: mdl-33485926

4.

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.

Biologicals ; 56: 67-83, 2018 Nov.

Artículo en Inglés | MEDLINE | ID: mdl-30150108

5.

Applying a weight of evidence approach to the evaluation of developmental toxicity of biopharmaceuticals.

Rocca, Meredith; Morford, LaRonda L; Blanset, Diann L; Halpern, Wendy G; Cavagnaro, Joy; Bowman, Christopher J.

Regul Toxicol Pharmacol ; 98: 69-79, 2018 Oct.

Artículo en Inglés | MEDLINE | ID: mdl-30009863

6.

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.

Toxicol Pathol ; 43(7): 959-83, 2015 Oct.

Artículo en Inglés | MEDLINE | ID: mdl-26239651

7.

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.

Toxicol Pathol ; 38(7): 1138-66, 2010 Dec.

Artículo en Inglés | MEDLINE | ID: mdl-20926828

8.

Charting a clear path: the ASGCT Standardized Pathways Conference.

Kiem, Hans-Peter; Baum, Christopher; Bushman, Frederic D; Byrne, Barry J; Carter, Barrie J; Cavagnaro, Joy; Malech, Harry L; Mendell, Jerry R; Naldini, Luigi M; Sorrentino, Brian P; Williams, David A; Flotte, Terence R.

Mol Ther ; 22(7): 1235-1238, 2014 Jul.

Artículo en Inglés | MEDLINE | ID: mdl-24981438

9.

The application of ICH S6 to the preclinical safety evaluation of plasma derivative therapeutic products.

Lewis, Richard M; Cavagnaro, Joy.

Biologicals ; 38(4): 494-500, 2010 Jul.

Artículo en Inglés | MEDLINE | ID: mdl-20359910

10.

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.

Regul Toxicol Pharmacol ; 58(2): 243-51, 2010 Nov.

Artículo en Inglés | MEDLINE | ID: mdl-20558225

11.

Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals.

Martin, Pauline L; Breslin, William; Rocca, Meredith; Wright, David; Cavagnaro, Joy.

Birth Defects Res B Dev Reprod Toxicol ; 86(3): 176-203, 2009 Jun.

Artículo en Inglés | MEDLINE | ID: mdl-19462404

12.

Toxicity testing of a novel riboflavin-based technology for pathogen reduction and white blood cell inactivation.

Reddy, Heather L; Dayan, Anthony D; Cavagnaro, Joy; Gad, Shayne; Li, Junzhi; Goodrich, Raymond P.

Transfus Med Rev ; 22(2): 133-53, 2008 Apr.

Artículo en Inglés | MEDLINE | ID: mdl-18353253

13.

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.

MAbs ; 10(1): 1-17, 2018 01.

Artículo en Inglés | MEDLINE | ID: mdl-28991509

14.

It's All About the Dose.

Cavagnaro, Joy A.

Hum Gene Ther ; 32(7-8): 335-340, 2021 04.

Artículo en Inglés | MEDLINE | ID: mdl-33891505

15.

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.

Nucleic Acid Ther ; 26(4): 210-5, 2016 08.

Artículo en Inglés | MEDLINE | ID: mdl-26981618

16.

Regulatory acceptance of animal models of disease to support clinical trials of medicines and advanced therapy medicinal products.

Cavagnaro, Joy; Silva Lima, Beatriz.

Eur J Pharmacol ; 759: 51-62, 2015 Jul 15.

Artículo en Inglés | MEDLINE | ID: mdl-25814257

17.

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.

Clin Lymphoma Myeloma Leuk ; 15 Suppl: S167-9, 2015 Jun.

Artículo en Inglés | MEDLINE | ID: mdl-26297272

18.

Considerations for assessment of reproductive and developmental toxicity of oligonucleotide-based therapeutics.

Cavagnaro, Joy; Berman, Cindy; Kornbrust, Doug; White, Tacey; Campion, Sarah; Henry, Scott.

Nucleic Acid Ther ; 24(5): 313-25, 2014 Oct.

Artículo en Inglés | MEDLINE | ID: mdl-25137397

19.

Oligo safety working group exaggerated pharmacology subcommittee consensus document.

Kornbrust, Doug; Cavagnaro, Joy; Levin, Arthur; Foy, Jeffrey; Pavco, Pamela; Gamba-Vitalo, Christina; Guimond, Alain.

Nucleic Acid Ther ; 23(1): 21-8, 2013 Feb.

Artículo en Inglés | MEDLINE | ID: mdl-23289535

20.

Preclinical safety evaluation of biotechnology-derived pharmaceuticals.