J. Sims

发表

Challenges and approaches for the development of safer immunomodulatory biologics

M. Pirmohamed, S. Holgate, R. Weaver, 2013, Nature Reviews Drug Discovery.

The utility of the minipig as an animal model in regulatory toxicology.

J. Sims, G. Bode, P. Clausing, 2010, Journal of pharmacological and toxicological methods.

Assessment of biotechnology products for therapeutic use.

J. Sims, 2001, Toxicology letters.

A whole blood in vitro cytokine release assay with aqueous monoclonal antibody presentation for the prediction of therapeutic protein induced cytokine release syndrome in humans.

J. Sims, B. Wolf, Jennifer Krieg, 2012, Cytokine.

Pharmacokinetics, metabolism and distribution of PEGs and PEGylated proteins: quo vadis?

S. Prabhu, J. Sims, D. Tuerck, 2014, Drug discovery today.

6. Biological Therapeutics

J. Sims, P. Lloyd, 2013 .

Does Delayed Excretion of Therapeutic 131I-MIBG Interfere with a 123I-MIBG Diagnostic Scan 6 Weeks After the Therapy?

M. Guardia, J. Sims, M. Granger, 2020, The Journal of Nuclear Medicine Technology.

PEGylated Biopharmaceuticals

B. Schweighardt, L. Tsuruda, B. Reipert, 2015, Toxicologic pathology.

Final Paper Assessment of Metal Containments in Mangrove Leaves in Jobos Bay, Puerto Rico Clara Smith Marine Science Department University of Hawai‘i at Hilo Project ADVISORS

J. Sims, Lisa Parr, 2020 .

Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies

Jennifer Sims, Sebastian Spindeldreher, Roy Allenspach, 2010, mAbs.

Integrated pharmacokinetic, pharmacodynamic and immunogenicity profiling of an anti-CCL21 monoclonal antibody in cynomolgus monkeys

S. Dudal, J. Sims, G. Jarai, 2015, mAbs.

On setting the first dose in man: quantitating biotherapeutic drug-target binding through pharmacokinetic and pharmacodynamic models.

J. Sims, S. Tannenbaum, P. Lowe, 2010, Basic & clinical pharmacology & toxicology.

The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies.

Peter Lloyd, Jennifer Sims, Patrick Y Muller, 2009, Current opinion in biotechnology.

Development of ICT01, a first-in-class, anti-BTN3A antibody for activating Vγ9Vδ2 T cell–mediated antitumor immune response

S. Agaugué, D. Olive, R. Hoet, 2021, Science Translational Medicine.

Evaluation of dried blood spots for the quantification of therapeutic monoclonal antibodies and detection of anti-drug antibodies.

J. Sims, D. Sickert, P. Lloyd, 2013, Bioanalysis.

Development of the ICH Guidelines for Immunotoxicology Evaluation of Pharmaceuticals Using a Survey of Industry Practices

H. van Loveren, J. Sawada, J. W. van der Laan, 2005, Journal of immunotoxicology.

Storm forecasting: additional lessons from the CD28 superagonist TGN1412 trial

T. Maclachlan, M. Rogge, D. Blanset, 2012, Nature Reviews Immunology.

Storm forecasting: additional lessons from the CD28 superagonist TGN1412 trial

T. Maclachlan, M. Rogge, D. Blanset, 2012, Nature Reviews Immunology.

Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges

Jennifer Sims, Ian Ragan, Kathryn Chapman, 2016, mAbs.

The design of chronic toxicology studies of monoclonal antibodies: implications for the reduction in use of non-human primates.

Jennifer Sims, Paul Baldrick, Kathryn L Chapman, 2012, Regulatory toxicology and pharmacology : RTP.

The industry view on long-term toxicology testing in drug development of human pharmaceuticals.

J. Sims, G. Bode, P. Bentley, 2000, Pharmacology & toxicology.

The design of chronic toxicology studies of monoclonal antibodies: implications for the reduction in use of non-human primates.

Kathryn L Chapman, N. Pullen, C. Bowman, 2012, Regulatory toxicology and pharmacology : RTP.