Journal Articles:
Mangelberger-Eberl, D., Cosenza, ME., et al. “Enhanced Prenatal and Postnatal Development Study in Marmoset Monkeys Following Administration of Felzartamab.” International Journal of Toxicology, vol. 43, no. 6, 11 Nov. 2024, pp. 561–578, https://doi.org/10.1177/10915818241289526.
Mary Ellen Cosenza (2024). Preclinical trends in developing genetically altered cell therapies. Cell & Gene Therapy Insights; 10(2), 215-221.
Mary Ellen Cosenza (2023, April 20). Navigating cell and gene therapy development challenges. Drug Discovery and Development. https://www.drugdiscoverytrends.com/navigating-cell-gene-therapy-development-challenges-accelerating-approvals/
Timothy K. MacLachlan, Shari Price, Joy Cavagnaro, Laura Andrews, Diann Blanset, Mary Ellen Cosenza, Maggie Dempster, Elizabeth Galbreath, Anna Maria Giusti, Kathleen Marie Heinz-Taheny, Renaud Fleurance, Esther Sutter, Michael W. Leach. Classic and evolving approaches to evaluating cross reactivity of mAb and mAb-like molecules – A survey of industry 2008–2019. Regulatory Toxicology and Pharmacology. Vol. 121: 2021.
Baldrick, P., Cosenza, M. E., Alapatt, T., Bolon, B., Rhodes, M., & Waterson, I. (2020). Toxicology Paradise: Sorting Out Adverse and Non-adverse Findings in Animal Toxicity Studies. International Journal of Toxicology. https://doi.org/10.1177/1091581820935089
Mary E. Cosenza. Book Review: Preserving the Promise: Improving the Culture of Biotech Investment. September 2017. International Journal of Toxicology; 36 (5): 413-416.
Richard M. Lewis, Mary Ellen Cosenza. Biologics and Manufacturing Changes. 2010. Regulatory Focus, Vol 16 Number 2:(25-29).
Richard M. Lewis, Mary Ellen Cosenza. Summary of DIA Workshop: Comparability Challenges: Regulatory and Scientific Issues in the Assessment of Biopharmaceuticals. 2010. Drug Information Journal, Vol 44. Number 4: (485-505).
Christine Haller, Mary Ellen Cosenza. Safety Issues Specific to Clinical Development of Protein Therapeutics. Clinical Pharmacology and Therapeutics on line. 2008. Nature Publishing.
Mary E. Cosenza. Safety Assessment of Biotechnology Derived Therapeutics. Preclinical Development Handbook – Toxicology, Chap 19 (295-711) 2008. Wiley & Sons.
Mary E. Cosenza. Implementation of ICH S6: US Perspective. Preclinical Safety Evaluation of Biopharmaceuticals, Part II (111-121): 2008. Wiley & Sons.
Mary E. Cosenza. Safety Assessment of Biotechnology – Derived Therapeutics. Preclinical Development Handbook – Toxicology, 19: (695-711).
Sushil K Thukral, Paul J. Nordone, Rong Hu, Leah Sullivan, Eric Galambos, Vincent D. Fitzpatrick, Laura Healy, Michael B. Bass, Mary E. Cosenza, and Cynthia A. Afshari. Prediction of Nephrotoxicant Action and Identification of Candidate Toxicity – Related Biomarkers. Toxicologic Pathology, 33 (343-355): 2005.
C.K. Edwards, III, Ph.D., S.W. Martin, Ph.D., J. Seely, Ph.D., O. Kinstler, Ph.D., S. Buckel, Ph.D., A.M. Bendele, D.V.M., Ph.D., M.E. Cosenza, Ph.D., U. Feige, Ph.D., T. Kohno, Ph.D. Design of PEGylated Soluble Tumor Necrosis Factor Receptor Type I (PEG sTNF-RI) for Chronic Inflammatory Diseases. Advanced Drug Delivery Reviews, 55(1315-1336): 2003.
B.B. Smith, M.E. Cosenza, A. Mancini, C. Dunstan, R. Gregson, S.W. Martin, S.Y. Smith, H. Davis. A Toxicity Profile of Osteoprotegerin in the Cynomolgus Monkey. International Journal of Toxicology, 22, #5(403-412): September/October 2003.
Larry W. Moreland, M.D.1, et. al. Phase I/II Trial Of Recombinant Methionyl Human Tumor Necrosis Factor Binding Protein Pegylated Dimer (TNFbp dimer) In Patients With Active Refractory Rheumatoid Arthritis. The Journal of Rheumatology, 27(601): March 2000.
C.C. Solorzano, A. Kaibara, P.J. Hess, P.D. Edwards, R. Ksontini, A. Abouhamze, S. McDaniel, J. Frazier, D. Trujillo, G. Kieft, J. Seely, T. Kohno, M.E. Cosenza, M. Clare-Salzler, S. L. D. Mackay, S. W. Martin, L. L. Moldawer, C. K. Edwards III. Pharmacokinetics, Immunogenicity, And Efficacy Of Dimeric TNFR Binding Proteins In Healthy and Bacteremic Baboon. J. Appl. Physiol, 84(3): 1998.
S.W. Martin, J.Frazier, J.Seely, A. Amicone, M.E. Cosenza, J.J. Rosenberg, T.Kohno, L.L Moldawer and C.K Edwards, III. A Genetically Modified tumor Necrosis Factor Receptor I (sTNF-RI) That Does Not Elicit Antibody Response in Primates. ACR Nov 1998.
C.K Edwards, III, J.Frazier, J.Seely, H Gaylord, S.W. Martin, A. Amicone, M.E. Cosenza, W. Boyle and T. Kohno. Assessment of the Major Antigenic Epitopes of the Recombinant Human Soluble p55 TNF Type I Receptor: design of a Novel Monomeric Non-immunogenic Analog, sTNF-RI. ACR Nov 1998.
E.N. Cheung, M. Cosenza, O. Lopez, M. Hayashi, G. Wariner, L.K. Roskos. Modeling of r-metHuG-CSF (SD/01) Mediated Granulopoiesis in Normal Animals With Mathematical Extrapolation to Neutropenic Settings; Blood 92 (10), Supplement 1 (Part 1 of 2), p. 379a 1998.
M.E. Cosenza and J. Bidanset. . Effects of Chlorpyrifos on Neuronal Development in Rat Embryo Midbrain Micromass Cultures, Veterinary and Human Toxicology. Vol. 37, Nov. 2, 1995.
M.E. Cosenza, J. Bidnaset, and D. Johnson. . Effects of Paraquat on the Midbrain Micromass Cell Culture System. In Vitro Toxicology. Vol. 7, No. 4, 1994.
Mary Ellen Cosenza (2024). Preclinical trends in developing genetically altered cell therapies. Cell & Gene Therapy Insights; 10(2), 215-221.
Mary Ellen Cosenza (2023, April 20). Navigating cell and gene therapy development challenges. Drug Discovery and Development. https://www.drugdiscoverytrends.com/navigating-cell-gene-therapy-development-challenges-accelerating-approvals/
Timothy K. MacLachlan, Shari Price, Joy Cavagnaro, Laura Andrews, Diann Blanset, Mary Ellen Cosenza, Maggie Dempster, Elizabeth Galbreath, Anna Maria Giusti, Kathleen Marie Heinz-Taheny, Renaud Fleurance, Esther Sutter, Michael W. Leach. Classic and evolving approaches to evaluating cross reactivity of mAb and mAb-like molecules – A survey of industry 2008–2019. Regulatory Toxicology and Pharmacology. Vol. 121: 2021.
Baldrick, P., Cosenza, M. E., Alapatt, T., Bolon, B., Rhodes, M., & Waterson, I. (2020). Toxicology Paradise: Sorting Out Adverse and Non-adverse Findings in Animal Toxicity Studies. International Journal of Toxicology. https://doi.org/10.1177/1091581820935089
Mary E. Cosenza. Book Review: Preserving the Promise: Improving the Culture of Biotech Investment. September 2017. International Journal of Toxicology; 36 (5): 413-416.
Richard M. Lewis, Mary Ellen Cosenza. Biologics and Manufacturing Changes. 2010. Regulatory Focus, Vol 16 Number 2:(25-29).
Richard M. Lewis, Mary Ellen Cosenza. Summary of DIA Workshop: Comparability Challenges: Regulatory and Scientific Issues in the Assessment of Biopharmaceuticals. 2010. Drug Information Journal, Vol 44. Number 4: (485-505).
Christine Haller, Mary Ellen Cosenza. Safety Issues Specific to Clinical Development of Protein Therapeutics. Clinical Pharmacology and Therapeutics on line. 2008. Nature Publishing.
Mary E. Cosenza. Safety Assessment of Biotechnology Derived Therapeutics. Preclinical Development Handbook – Toxicology, Chap 19 (295-711) 2008. Wiley & Sons.
Mary E. Cosenza. Implementation of ICH S6: US Perspective. Preclinical Safety Evaluation of Biopharmaceuticals, Part II (111-121): 2008. Wiley & Sons.
Mary E. Cosenza. Safety Assessment of Biotechnology – Derived Therapeutics. Preclinical Development Handbook – Toxicology, 19: (695-711).
Sushil K Thukral, Paul J. Nordone, Rong Hu, Leah Sullivan, Eric Galambos, Vincent D. Fitzpatrick, Laura Healy, Michael B. Bass, Mary E. Cosenza, and Cynthia A. Afshari. Prediction of Nephrotoxicant Action and Identification of Candidate Toxicity – Related Biomarkers. Toxicologic Pathology, 33 (343-355): 2005.
C.K. Edwards, III, Ph.D., S.W. Martin, Ph.D., J. Seely, Ph.D., O. Kinstler, Ph.D., S. Buckel, Ph.D., A.M. Bendele, D.V.M., Ph.D., M.E. Cosenza, Ph.D., U. Feige, Ph.D., T. Kohno, Ph.D. Design of PEGylated Soluble Tumor Necrosis Factor Receptor Type I (PEG sTNF-RI) for Chronic Inflammatory Diseases. Advanced Drug Delivery Reviews, 55(1315-1336): 2003.
B.B. Smith, M.E. Cosenza, A. Mancini, C. Dunstan, R. Gregson, S.W. Martin, S.Y. Smith, H. Davis. A Toxicity Profile of Osteoprotegerin in the Cynomolgus Monkey. International Journal of Toxicology, 22, #5(403-412): September/October 2003.
Larry W. Moreland, M.D.1, et. al. Phase I/II Trial Of Recombinant Methionyl Human Tumor Necrosis Factor Binding Protein Pegylated Dimer (TNFbp dimer) In Patients With Active Refractory Rheumatoid Arthritis. The Journal of Rheumatology, 27(601): March 2000.
C.C. Solorzano, A. Kaibara, P.J. Hess, P.D. Edwards, R. Ksontini, A. Abouhamze, S. McDaniel, J. Frazier, D. Trujillo, G. Kieft, J. Seely, T. Kohno, M.E. Cosenza, M. Clare-Salzler, S. L. D. Mackay, S. W. Martin, L. L. Moldawer, C. K. Edwards III. Pharmacokinetics, Immunogenicity, And Efficacy Of Dimeric TNFR Binding Proteins In Healthy and Bacteremic Baboon. J. Appl. Physiol, 84(3): 1998.
S.W. Martin, J.Frazier, J.Seely, A. Amicone, M.E. Cosenza, J.J. Rosenberg, T.Kohno, L.L Moldawer and C.K Edwards, III. A Genetically Modified tumor Necrosis Factor Receptor I (sTNF-RI) That Does Not Elicit Antibody Response in Primates. ACR Nov 1998.
C.K Edwards, III, J.Frazier, J.Seely, H Gaylord, S.W. Martin, A. Amicone, M.E. Cosenza, W. Boyle and T. Kohno. Assessment of the Major Antigenic Epitopes of the Recombinant Human Soluble p55 TNF Type I Receptor: design of a Novel Monomeric Non-immunogenic Analog, sTNF-RI. ACR Nov 1998.
E.N. Cheung, M. Cosenza, O. Lopez, M. Hayashi, G. Wariner, L.K. Roskos. Modeling of r-metHuG-CSF (SD/01) Mediated Granulopoiesis in Normal Animals With Mathematical Extrapolation to Neutropenic Settings; Blood 92 (10), Supplement 1 (Part 1 of 2), p. 379a 1998.
M.E. Cosenza and J. Bidanset. . Effects of Chlorpyrifos on Neuronal Development in Rat Embryo Midbrain Micromass Cultures, Veterinary and Human Toxicology. Vol. 37, Nov. 2, 1995.
M.E. Cosenza, J. Bidnaset, and D. Johnson. . Effects of Paraquat on the Midbrain Micromass Cell Culture System. In Vitro Toxicology. Vol. 7, No. 4, 1994.