J. Tibbitts

发表

Current strategies in the non-clinical safety assessment of biologics: New targets, new molecules, new challenges.

C. Grimaldi, J. Fikes, T. Maclachlan, 2018, Regulatory toxicology and pharmacology : RTP.

Conjugation site modulates the in vivo stability and therapeutic activity of antibody-drug conjugates

M. Sliwkowski, R. Scheller, L. Khawli, 2012, Nature Biotechnology.

A Mechanistic Pharmacokinetic Model Elucidating the Disposition of Trastuzumab Emtansine (T-DM1), an Antibody–Drug Conjugate (ADC) for Treatment of Metastatic Breast Cancer

L. Friberg, J. Tibbitts, B. Bender, 2014, The AAPS Journal.

American Association of Pharmaceutical Scientists National Biotechnology Conference Short Course: Translational Challenges in Developing Antibody-Drug Conjugates

B. Meibohm, Hong Zhao, H. Erickson, 2013, mAbs.

Pharmacokinetic Considerations for Antibody Drug Conjugates

J. Tibbitts, Kedan Lin, 2012, Pharmaceutical Research.

Biotherapeutics in non‐clinical development: Strengthening the interface between safety, pharmacokinetics‐pharmacodynamics and manufacturing

A. Kiessling, J. Tibbitts, L. Weir, 2018, Regulatory toxicology and pharmacology : RTP.

Mechanistic pharmacokinetic/pharmacodynamic modeling of in vivo tumor uptake, catabolism, and tumor response of trastuzumab maytansinoid conjugates

H. Erickson, J. Tibbitts, G. L. Lewis Phillips, 2014, Cancer Chemotherapy and Pharmacology.

Pharmacokinetics and ADME characterizations of antibody-drug conjugates.

J. Tibbitts, B. Shen, Kedan Lin, 2013, Methods in molecular biology.

Clinical Cancer esearch cer Therapy : Preclinical ineered Thio-Trastuzumab-DM 1 Conjugate with an roved Therapeutic Index to Target Human Epidermal R wth Factor Receptor 2 – Positive Breast Cancer

S. Spencer, P. Polakis, K. Parsons, 2010 .

Impact of drug conjugation on pharmacokinetics and tissue distribution of anti-STEAP1 antibody-drug conjugates in rats.

F. Theil, L. Khawli, Herman S. Gill, 2011, Bioconjugate chemistry.

Non-clinical Safety Evaluation of Biotherapeutics - Challenges, Opportunities and new Insights.

E. Tarcsa, L. de Haan, J. Tibbitts, 2016, Regulatory toxicology and pharmacology : RTP.

A phase I study of weekly dosing of trastuzumab-DM1 (T-DM1) in patients (pts) with advanced HER2+ breast cancer (BC)

M. Birkner, M. Beeram, H. Burris, 2008 .

Investigating the Nonclinical ADME and PK/PD of an Antibody–Drug Conjugate: A Case Study of Ado‐Trastuzumab Emtansine (T‐DM1)

J. Tibbitts, 2015 .

A phase I study of weekly dosing of trastuzumab-DM1 (T-DM1) in patients with advanced HER2+ breast cancer.

M. Birkner, H. Burris, S. Lutzker, 2009 .

High-content live-cell imaging assay used to establish mechanism of trastuzumab emtansine (T-DM1)--mediated inhibition of platelet production.

J. Italiano, J. Thon, J. Tibbitts, 2012, Blood.

Optimized Nonclinical Safety Assessment Strategies Supporting Clinical Development of Therapeutic Monoclonal Antibodies Targeting Inflammatory Diseases

F. Brennan, J. Tibbitts, A. Cauvin, 2014, Drug development research.

Practical approaches to dose selection for first-in-human clinical trials with novel biopharmaceuticals.

P. Andrews, J. T. Sullivan, J. Tibbitts, 2010, Regulatory toxicology and pharmacology : RTP.

Non-human primates in the PKPD evaluation of biologics: Needs and options to reduce, refine, and replace. A BioSafe White Paper

A. Kamath, Cheng-Pang Hsu, Hongbin Yu, 2022, mAbs.

Pharmacokinetic Considerations for Antibody Drug Conjugates

J. Tibbitts, Kedan Lin, 2012, Pharmaceutical Research.

Abstract 4494: A clinical candidate anti-mesothelin-MMAE antibody-drug conjugate (ADC) for therapy of mesothelin-expressing cancers

S. Spencer, L. Berry, D. French, 2014 .

Abstract 4502: Nonclinical characterization and tolerability of a surrogate anti-mesothelin-MMAE antibody-drug conjugate

S. Spencer, D. French, S. Ross, 2014 .

Toxicology of a Boronated Porphyrin in Dogs

J. Fike, K. Lamborn, A. Bollen, 1999, Photochemistry and photobiology.

Key factors influencing ADME properties of therapeutic proteins: A need for ADME characterization in drug discovery and development

L. Khawli, J. Tibbitts, R. Graff, 2015, mAbs.

Jay Tibbitts, J. Tibbitts, 2003, Toxicologic pathology.

Trastuzumab emtansine (T-DM1): a novel agent for targeting HER2+ breast cancer.

M. Sliwkowski, H. Burris, J. Tibbitts, 2011, Clinical breast cancer.

Catabolic fate and pharmacokinetic characterization of trastuzumab emtansine (T-DM1): an emphasis on preclinical and clinical catabolism.

P. LoRusso, S. Girish, J. Tibbitts, 2012, Current drug metabolism.

Phase I study of trastuzumab-DM1, an HER2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer.

Suzanne F. Jones, M. Sliwkowski, M. Beeram, 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Antitumor Activity of Targeted and Cytotoxic Agents in Murine Subcutaneous Tumor Models Correlates with Clinical Response

Harvey Wong, Cornelis E C A Hop, F. Theil, 2012, Clinical Cancer Research.

Clinical Cancer esearch cer Therapy : Preclinical ineered Thio-Trastuzumab-DM 1 Conjugate with an roved Therapeutic Index to Target Human Epidermal R wth Factor Receptor 2 – Positive Breast Cancer

M. Sliwkowski, R. Scheller, S. Spencer, 2010 .

The effect of immune-complex formation on the distribution of a novel antibody to the ovarian tumor antigen CA125

L. Khawli, S. Ross, J. Tibbitts, 2010 .

Preclinical safety profile of trastuzumab emtansine (T-DM1): mechanism of action of its cytotoxic component retained with improved tolerability.

S. Girish, J. Beyer, J. Tibbitts, 2013, Toxicology and applied pharmacology.

Toxicology of BOPP in Large Animals

J. Fike, K. Lamborn, A. Bollen, 2001 .

Plasma pharmacokinetics and tissue biodistribution of boron following administration of a boronated porphyrin in dogs.

J. Fike, J. Tibbitts, J R Fike, 2000, Journal of pharmaceutical sciences.

Toxicology and Pharmacokinetics of BOPP in a Canine Model

J. Fike, J. Tibbitts, S. Kahl, 1996 .

Effects of Anti-VEGF on Pharmacokinetics, Biodistribution, and Tumor Penetration of Trastuzumab in a Preclinical Breast Cancer Model

M. Sliwkowski, F. Theil, L. Khawli, 2012, Molecular Cancer Therapeutics.

Modeling the efficacy of trastuzumab-DM1, an antibody drug conjugate, in mice

M. Sliwkowski, D. Dugger, N. Jumbe, 2010, Journal of Pharmacokinetics and Pharmacodynamics.

A Mechanistic Pharmacokinetic Model Elucidating the Disposition of Trastuzumab Emtansine (T-DM1), an Antibody–Drug Conjugate (ADC) for Treatment of Metastatic Breast Cancer

L. Friberg, J. Tibbitts, B. Bender, 2014, The AAPS Journal.

A phase I study of trastuzumab-DM1 (T-DM1), a first-in-class HER2 antibody-drug conjugate (ADC), in patients (pts) with advanced HER2+ breast cancer (BC)

M. Birkner, M. Beeram, H. Burris, 2008 .

A phase I study of trastuzumab-MCC-DM1 (T-DM1), a first-in-class HER2 antibody-drug conjugate (ADC), in patients (pts) with HER2+ metastatic breast cancer (BC)

A. Tolcher, M. Beeram, H. Burris, 2007 .

The Effect of Different Linkers on Target Cell Catabolism and Pharmacokinetics/Pharmacodynamics of Trastuzumab Maytansinoid Conjugates

B. Gunter, J. Pinkas, H. Erickson, 2012, Molecular Cancer Therapeutics.

Nonclinical safety testing of biopharmaceuticals--Addressing current challenges of these novel and emerging therapies.

Peter Ulrich, Frank R Brennan, L. de Haan, 2015, Regulatory toxicology and pharmacology : RTP.

Development of a Translational Physiologically Based Pharmacokinetic Model for Antibody-Drug Conjugates: a Case Study with T-DM1

D. Rock, D. Shah, J. Tibbitts, 2017, The AAPS Journal.

2118 POSTER A phase I study of trastuzumab-DM1, a first-in-class HER2 antibody-drug conjugate, in patients with HER2+ metastatic breast cancer

M. Beeram, H. Burris, S. Lutzker, 2007 .

Abstract A11: Antitumor activity of targeted and cytotoxic agents in xenograft models correlates with clinical response: A pharmacokinetic-pharmacodynamic analysis.

L. Friedman, H. Wong, E. Choo, 2011 .

Multivalent Fcγ-receptor engagement by a hexameric Fc-fusion protein triggers Fcγ-receptor internalisation and modulation of Fcγ-receptor functions

F. Fallah-Arani, D. Humphreys, M. Malmqvist, 2017, Scientific Reports.

Multivalent Fcγ-receptor engagement by a hexameric Fc-fusion protein triggers Fcγ-receptor internalisation and modulation of Fcγ-receptor functions

F. Fallah-Arani, D. Humphreys, M. Malmqvist, 2017, Scientific Reports.

Semi‐mechanistic Population Pharmacokinetic Model of Multivalent Trastuzumab Emtansine in Patients with Metastatic Breast Cancer

J. Harrold, D. Mager, D. Mager, 2012, Clinical pharmacology and therapeutics.

Engineered Thio-Trastuzumab-DM1 Conjugate with an Improved Therapeutic Index to Target Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer

M. Sliwkowski, S. Spencer, P. Polakis, 2010, Clinical Cancer Research.

Development of a Translational Physiologically Based Pharmacokinetic Model for Antibody-Drug Conjugates: a Case Study with T-DM1

D. Rock, D. Shah, J. Tibbitts, 2017, The AAPS Journal.

Trastuzumab-MC-vc-PAB-MMAF: The effects of the Drug:Antibody Ratio (DAR) on efficacy, toxicity and pharmacokinetics.

Damon L. Meyer, M. Sliwkowski, D. Dugger, 2007 .

Abstract A136: Nonclinical disposition, metabolism, and in vitro drug-drug interaction assessment of DM1, a component of trastuzumab emtansine (T-DM1).

S. Girish, L. Salphati, J. Halladay, 2011 .

Non-clinical Safety Evaluation of Biotherapeutics - Challenges, Opportunities and new Insights.

E. Tarcsa, L. de Haan, J. Tibbitts, 2016, Regulatory toxicology and pharmacology : RTP.