Diane Rossi

Detail-oriented and passionate biopharmaceutical professional with exceptional critical-thinking and problem-solving abilities. Extensive experience in the biotechnology field, including experimental research, preclinical research, and commercial manufacturing. Expertise in diverse cellular and molecular analytical assays. Proven proficiency in developing and conducting cell-based assays for testing a wide range of therapeutics. Successfully managed Upstream Manufacturing, overseeing the MCB thawing and seed scale-up of the hRS7 mAb segment of the ADC TRODELVY®. Played a pivotal role as the Subject Matter Expert in two FDA pre-approval inspections, resulting in the successful approval of the triple-negative breast cancer drug TRODELVY®.

• Developed a novel cell-based assay to evaluate T-cell redirected toxicity
• Developed a completely serum-free mammalian Sp2/0-based host cell, SpESF-X10, with robust cell growth and enhanced protein yields compared to the parental cell line. After development, this cell line became our primary "in-house" host cell line
• Involved in the design and execution of a fluorescence microscopy experiment depicting anti-CD22 mediated trogocytosis of cell surface markers from Daudi cells to monocytes, for which the fluorescent image I generated was selected to be featured as the cover photo for Blood journal (Volume 122, issue 17)
• Winner of 2016 Edison Patent Award in field of Biotechnology for "T-cell redirecting bispecific antibodies for treatment of disease) - US Patent 9,315,567
• Author on 12 peer reviewed scientific publications
• Named on 20 US issued patents
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• 8,889,410, Mammalian cell lines for increasing longevity and protein yield from a cell culture
• 8,771,987, Mammalian cell lines for increasing longevity and protein yield from a cell culture
• 8,569,054, Mammalian cell lines for increasing longevity and protein yield from a cell culture
• 8,372,603, Mammalian cell lines for increasing longevity and protein yield from a cell culture
• 8,153,433, Mammalian cell lines for increasing longevity and protein yield from a cell culture
• 8,076,140, Mammalian cell lines for increasing longevity and protein yield from a cell culture
• 785,880, Mammalian cell lines for increasing longevity and protein yield from cell culture
• 7,608,425, Methods for protein expression in mammalian cells in serum-free medium
• 7,537,930, Mammalian cell lines for increasing longevity and protein yield from a cell culture
• 7,531,327, Methods and compositions for increasing longevity and protein yield from a cell culture
• 9,382,329, Disease therapy by inducing immune response to Trop-2 expressing cells
• 9,315,567, T-cell redirecting bispecific antibodies for treatment of disease
• 10,308,688, T-cell redirecting bispecific antibodies for treatment of disease
• 10,245,321, Combination therapy for inducing immune response to disease
• 10,239,938, T-cell redirecting bispecific antibodies for treatment of disease
• 10,183,992, T-cell redirecting bispecific antibodies for treatment of disease
• 10,111,954, Combination therapy for inducing immune response to disease
• 9,879,088, Disease therapy by inducing immune response to Trop-2 expressing cells
• 9,682,143, Combination therapy for inducing immune response to disease
• 9,670,286, Disease therapy by inducing immune response to Trop-2 expressing cells

• IMMU-140, a Novel SN-38 Antibody-Drug Conjugate Targeting HLA-DR, Mediates Dual Cytotoxic Effects in Hematologic Cancers and Malignant Melanoma, Mol Cancer Ther, 01/2018, 10.1158/1535-7163.MCT-17-0354, 29133623
• Combination Therapy with Bispecific Antibodies and PD-1 Blockade Enhances the Antitumor Potency of T Cells, Cancer Res, 10/2017, 10.1158/0008-5472.CAN-16-3431, 28819027
• Synthetic Lethality Exploitation by an Anti-Trop-2-SN-38 Antibody-Drug Conjugate, IMMU-132, Plus PARP Inhibitors in BRCA1/2-wild-type-Negative Breast Cancer, Clin Cancer Res, 07/2017, 10.1158/1078-0432.CCR-16-2401, 28069724
• Redirected T-cell killing of solid cancers targeted with an anti-CD3/Trop-2-bispecific antibody is enhanced in combination with interferon-α, Mol Cancer Ther, 10/2014, 10.1158/1535-7163.MCT-14-0345, 25053819
• A new class of bispecific antibodies to redirect T cells for cancer immunotherapy, MAbs, 03/2014, 10.4161/mabs.27385, 24492297
• Trogocytosis of multiple B-cell surface markers by CD22 targeting with epratuzumab, Blood, 10/2013, 10.1182/blood-2012-12-473744, 23821660
• Evaluation of a novel hexavalent humanized anti-IGF-1R antibody and its bivalent parental IgG in diverse cancer cell lines, PLoS One, 08/2012, 10.1371/journal.pone.0044235, 22952934
• Preclinical studies on targeted delivery of multiple IFNα2b to HLA-DR in diverse hematologic cancers, Blood, 08/2011, 10.1371/journal.pone.0044235, 21680794
• A new mammalian host cell with enhanced survival enables completely serum-free development of high-level protein production cell lines, Biotechnol Prog, 05/2011, 10.1002/btpr.584, 21473000
• A bispecific antibody-IFNalpha2b immunocytokine targeting CD20 and HLA-DR is highly toxic to human lymphoma and multiple myeloma cells, Cancer Res, 10/2010, 10.1158/0008-5472.CAN-10-2126, 20876805
• A new method to produce monoPEGylated dimeric cytokines shown with human interferon-α2b, Bioconjug Chem, 10/2009, 10.1021/bc9001773, 19736932