Genentech: Dan Lu | Senior Principal Scientist Development Modeling & Simulation, Development Sciences

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Scientists / Our Scientists

"I aim to deliver the right dose to the right patient by applying modeling and simulation approaches"

13

Years at Genentech

39

Publications at Genentech

I joined Genentech in March of 2009 after 2 years of work at Roche Palo Alto preclinical modeling and simulation group. Since joining Genentech, I have worked on both clinical pharmacology and modeling & simulation aspects to support drug development, mainly in the field of monoclonal antibodies and antibody drug conjugates for cancer treatment.

Featured Publication

Time-to-Event Analysis of Polatuzumab Vedotin-Induced Peripheral Neuropathy to Assist in the Comparison of Clinical Dosing Regimens.

CPT:PSP, CPT Pharmacometrics Syst Pharmacol. 2017 Jun;6(6):401-408.

Lu D, Gillespie WR, Girish S, Agarwal P, Li C, Hirata J, Chu YW, Kagedal M, Leon L, Maiya V, Jin JY.

I am focusing on applying the advanced modeling and simulation approaches to support drug development.

Model-Informed Therapeutic Dose Optimization Strategies for Antibody–Drug Conjugates in Oncology: What Can We Learn From US Food and Drug Administration–Approved Antibody–Drug Conjugates?

Clinical Pharmacology and Therapeutics, ISSN: 15326535 00099236

Michael Z. Liao; Dan Lu; Kagedal; Dale Miles; Divya Samineni; Stephanie N. Liu; Chunze Li

Application of a Two-Analyte Integrated Population Pharmacokinetic Model to Evaluate the Impact of Intrinsic and Extrinsic Factors on the Pharmacokinetics of Polatuzumab Vedotin in Patients with Non-Hodgkin Lymphoma

Pharmaceutical Research, ISSN: 1573904X 07248741

Dan Lu; Tong Lu; Rong Shi; Leonid Gibiansky; Priya Agarwal; Colby S. Shemesh; Randall Dere; Uzor Ogbu; Jamie Hirata; Pascal Chanu; Sandhya Girish; Jin Yan Jin; Chunze Li; Dale Miles

Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma

Leukemia and Lymphoma, ISSN: 10292403 10428194

Tong Lu; Leonid Gibiansky; Xiaobin Li; Chunze Li; Rong Shi; Priya Agarwal; Jamie Hirata; Dale Miles; Pascal Chanu; Sandhya Girish; Jin Yan Jin; Dan Lu

Physiologically Based Pharmacokinetic Model-Informed Drug Development for Polatuzumab Vedotin: Label for Drug-Drug Interactions Without Dedicated Clinical Trials

Journal of Clinical Pharmacology, ISSN: 15524604 00912700

Divya Samineni; Hao Ding; Fang Ma; Rong Shi; Dan Lu; Dale Miles; Jialin Mao; Chunze Li; Jin Jin; Matthew Wright; Sandhya Girish; Yuan Chen

Impact of Physiologically Based Pharmacokinetics, Population Pharmacokinetics and Pharmacokinetics/Pharmacodynamics in the Development of Antibody-Drug Conjugates

Journal of Clinical Pharmacology, ISSN: 15524604 00912700

Chunze Li; Shang-Chiung Chen; Yuan Chen; Sandhya Girish; Matts Kaagedal; Dan Lu; Tong Lu; Divya Samineni; Jin Yan Jin

Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma

Cancer Chemotherapy and Pharmacology, ISSN: 14320843 03445704

Rong Shi; Tong Lu; Grace Ku; Hao Ding; Tomohisa Saito; Leonid Gibiansky; Priya Agarwal; Xiaobin Li; Jin Yan Jin; Sandhya Girish; Dale Miles; Chunze Li; Dan Lu

An in vitro quantitative systems pharmacology approach for deconvolving mechanisms of drug-induced, multilineage cytopenias

PLoS Computational Biology, ISSN: 15537358 1553734X

Jennifer L. Wilson; Dan Lu; Nick Corr; Aaron Fullerton; James Lu

Pharmacokinetics of polatuzumab vedotin in combination with R/G-CHP in patients with B-cell non-Hodgkin lymphoma

Cancer Chemotherapy and Pharmacology, ISSN: 14320843 03445704

Colby S. Shemesh; Priya Agarwal; Tong Lu; Calvin Lee; Randall Dere; Xiaobin Li; Chunze Li; Jin Yan Jin; Sandhya Girish; Dale Miles; Dan Lu

Exposure–response analysis of venetoclax in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia: pooled results from a phase 1b study and the phase 3 MURANO study

Leukemia and Lymphoma, ISSN: 10292403 10428194

Rong Deng; Leonid Gibiansky; Tong Lu; Xiaobin Li; Dan Lu; Chunze Li; Sandhya Girish; Jue Wang; Michelle Boyer; Noopur Shankar; Kathryn Humphrey; Kevin J. Freise; Ahmed Hamed Salem; John F. Seymour; Kater; Dale Miles

Clinical pharmacology of vc-MMAE antibody–drug conjugates in cancer patients: learning from eight first-in-human Phase 1 studies

mAbs, ISSN: 19420870 19420862

Chunze Li; Cindy Zhang; Zao Li; Divya Samineni; Dan Lu; Wang; Shang-Chiung Chen; Rong Zhang; Priya Agarwal; Bernard M. Fine; Sandhya Girish

Integrated Two-Analyte Population Pharmacokinetic Model of Polatuzumab Vedotin in Patients With Non-Hodgkin Lymphoma

CPT: Pharmacometrics and Systems Pharmacology, ISSN: 21638306

Dan Lu; Tong Lu; Leonid Gibiansky; Xiaobin Li; Chunze Li; Priya Agarwal; Colby S. Shemesh; Rong Shi; Randall Dere; Jamie Hirata; Dale Miles; Pascal Chanu; Sandhya Girish; Jin Yan Jin

Bayesian Population Model of the Pharmacokinetics of Venetoclax in Combination with Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results from the Phase III MURANO Study

Clinical Pharmacokinetics, ISSN: 11791926 03125963

Rong Deng; Leonid Gibiansky; Tong Lu; Priya Agarwal; Hao Ding; Xiaobin Li; Smita Kshirsagar; Dan Lu; Chunze Li; Sandhya Girish; Jue Wang; Michelle Boyer; Kathryn Humphrey; Kevin J. Freise; Ahmed Hamed Salem; John F. Seymour; Kater; Dale Miles

Prediction of Human Pharmacokinetics of Antibody–Drug Conjugates From Nonclinical Data

Clinical and Translational Science, ISSN: 17528062 17528054

Chunze Li; Cindy Zhang; Rong Deng; Douglas Leipold; Dongwei Li; Brandon Latifi; Yuying Gao; Crystal Zhang; Zao Li; Dale Miles; Shang-Chiung Chen; Divya Samineni; Wang; Priya Agarwal; Dan Lu; Saileta Prabhu; Sandhya Girish; Amrita Kamath

Polatuzumab vedotin in combination with immunochemotherapy in patients with previously untreated diffuse large B-cell lymphoma: an open-label, non-randomised, phase 1b–2 study

The Lancet Oncology, ISSN: 14745488 14702045

Herve Tilly; Morschhauser; Nancy L. Bartlett; Amitkumar Mehta; Gilles Salles; Corinne Haioun; Javier Munoz; Chen; Kathryn S. Kolibaba; Dan Lu; Mark Yan; Elicia M. Penuel; Jamie Hirata; Calvin Lee; Jeff P. Sharman

Pharmacokinetics of trastuzumab emtansine (T-DM1) as a single agent or in combination with pertuzumab in HER2-positive breast cancer patients with recurrent or locally advanced metastatic breast cancer

Cancer Chemotherapy and Pharmacology, ISSN: 14320843 03445704

Dan Lu; Chunze Li; Matthew Riggs; Daniel Polhamus; Jonathan French; Priya Agarwal; Shang-Chiung Chen; Shweta Vadhavkar; Patre; Alexander Strasak; Angelica Quartino; Jin Yan Jin; Sandhya Girish

Polatuzumab vedotin or pinatuzumab vedotin plus rituximab in patients with relapsed or refractory non-Hodgkin lymphoma: final results from a phase 2 randomised study (ROMULUS)

The Lancet Haematology, ISSN: 23523026

Morschhauser; Ian W. Flinn; Ranjana H. Advani; Laurie H. Sehn; Catherine S. Diefenbach; Kathryn S. Kolibaba; Oliver W. Press; Gilles Salles; Herve Tilly; Chen; Sarit E. Assouline; Bruce D. Cheson; Dreyling; Anton Hagenbeek; Pier Luigi Zinzani; Surai Jones; Ji Cheng; Dan Lu; Elicia M. Penuel; Jamie Hirata; Michael Wenger; Yu-Waye Chu; Jeff P. Sharman

Time-to-Event Modeling of Peripheral Neuropathy: Platform Analysis of Eight Valine-Citrulline-Monomethylauristatin E Antibody–Drug Conjugates

CPT: Pharmacometrics and Systems Pharmacology, ISSN: 21638306

Kagedal; Divya Samineni; Gillespie; Dan Lu; Bernard M. Fine; Sandhya Girish; Chunze Li; Jin Y. Jin

Exposure–response analyses of trastuzumab emtansine in patients with HER2-positive advanced breast cancer previously treated with trastuzumab and a taxane

Cancer Chemotherapy and Pharmacology, ISSN: 14320843 03445704

Chunze Li; Wang; Shang-Chiung Chen; Russell D. Wada; Dan Lu; Xin Wang; Daniel Polhamus; Jonathan French; Shweta Vadhavkar; Alexander Strasak; Melanie Smitt; Amita Joshi; Meghna Samant; Angelica Quartino; Jin Y. Jin; Sandhya Girish

Platform model describing pharmacokinetic properties of vc-MMAE antibody–drug conjugates

Journal of Pharmacokinetics and Pharmacodynamics, ISSN: 15738744 1567567X

Kagedal; Leonid Gibiansky; Jian Xu; Xin Wang; Divya Samineni; Shang-Chiung Chen; Dan Lu; Priya Agarwal; Wang; Ola M. Saad; Neelima Koppada; Bernard M. Fine; Jin Y. Jin; Sandhya Girish; Chunze Li

Time-to-event analysis of polatuzumab vedotin-induced peripheral neuropathy to assist in the comparison of clinical dosing regimens

CPT: Pharmacometrics and Systems Pharmacology, ISSN: 21638306

Dan Lu; Gillespie; Sandhya Girish; Priya Agarwal; Chunze Li; Jamie Hirata; Yu-Waye Chu; Kagedal; Leon; Maiya; Jin Y. Jin

Assessment of Correlation Between Early and Late Efficacy Endpoints to Identify Potential Surrogacy Relationships in Non-Hodgkin Lymphoma: a Literature-Based Meta-analysis of 108 Phase II and Phase III Studies

AAPS Journal, ISSN: 15507416

Rui Zhu; Dan Lu; Yu-Waye Chu; Akiko Chai; Michelle Green; Nancy Zhang; Jin Y. Jin

Phase i study of the anti-CD22 antibody-drug conjugate pinatuzumab vedotin with/without rituximab in patients with relapsed/refractory B-cell non-hodgkin lymphoma

Clinical Cancer Research, ISSN: 15573265 10780432

Ranjana H. Advani; Lebovic; Chen; Mark Brunvand; Andre Goy; Julie E. Chang; Ephraim Hochberg; Sreeni Yalamanchili; Robert S. Kahn; Dan Lu; Priya Agarwal; Randall Dere; Hsin-Ju Hsieh; Surai Jones; Yu-Waye Chu; Bruce D. Cheson

Integrated Two-Analyte Population Pharmacokinetic Model for Antibody-Drug Conjugates in Patients: Implications for Reducing Pharmacokinetic Sampling

CPT: Pharmacometrics and Systems Pharmacology, ISSN: 21638306

Dan Lu; Leonid Gibiansky; Priya Agarwal; Randall Dere; Chunze Li; Yu-Waye Chu; Jamie Hirata; Amita Joshi; Jin Y. Jin; Sandhya Girish

Ethnic sensitivity assessment of the antibody–drug conjugate trastuzumab emtansine (T-DM1) in patients with HER2-positive locally advanced or metastatic breast cancer

Cancer Chemotherapy and Pharmacology, ISSN: 14320843 03445704

Chunze Li; Wang; Dan Lu; Jin Y. Jin; Yuying Gao; Kiyoshi Matsunaga; Yuriko Igawa; Ihsan Nijem; Michael W. Lu; Alexander Strasak; Nataliya Chernyukhin; Sandhya Girish

Phase 1b/2a study of trastuzumab emtansine (T-DM1), paclitaxel, and pertuzumab in HER2-positive metastatic breast cancer

Breast Cancer Research, ISSN: 1465542X 14655411

Ian E. Krop; Shanu Modi; Patricia M. LoRusso; Pegram; Ellie Guardino; Betsy Althaus; Dan Lu; Alexander Strasak; Anthony Elias

A survey of new oncology drug approvals in the USA from 2010 to 2015: A focus on optimal dose and related postmarketing activities

Cancer Chemotherapy and Pharmacology, ISSN: 14320843 03445704

Dan Lu; Tong Lu; Mark Stroh; Richard A. Graham; Priya Agarwal; Luna Musib; Chi-Chung Li; Bert L. Lum; Amita Joshi

Semi-mechanistic multiple-analyte pharmacokinetic model for an antibody-drug-conjugate in cynomolgus monkeys

Pharmaceutical Research, ISSN: 1573904X 07248741

Dan Lu; Jin Y. Jin; Sandhya Girish; Priya Agarwal; Dongwei Li; Saileta Prabhu; Randall Dere; Ola M. Saad; Denise Nazzal; Neelima Koppada; Ramanujan; Chee Ng

Safety and activity of the anti-CD79B antibody-drug conjugate polatuzumab vedotin in relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia: A phase 1 study

The Lancet Oncology, ISSN: 14745488 14702045

Palanca-Wessels; Myron S. Czuczman; Gilles Salles; Sarit E. Assouline; Laurie H. Sehn; Ian Flinn; Manish R. Patel; Randeep Sangha; Anton Hagenbeek; Ranjana H. Advani; Herve Tilly; Olivier Casasnovas; Oliver W. Press; Sreeni Yalamanchili; Robert S. Kahn; Randall Dere; Dan Lu; Surai Jones; Cheryl L. Jones; Yu-Waye Chu; Morschhauser

Physiologically Based Pharmacokinetic Modeling as a Tool to Predict Drug Interactions for Antibody-Drug Conjugates

Clinical Pharmacokinetics, ISSN: 11791926 03125963

Yuan Chen; Divya Samineni; Sophie Mukadam; Harvey Wong; Shen; Dan Lu; Sandhya Girish; Cornelis E. Hop; Jin Y. Jin; Chunze Li

Population pharmacokinetics of trastuzumab emtansine (T-DM1), a HER2-targeted antibody-drug conjugate, in patients with HER2-positive metastatic breast cancer: Clinical implications of the effect of covariates

Cancer Chemotherapy and Pharmacology, ISSN: 14320843 03445704

Dan Lu; Sandhya Girish; Yuying Gao; Wang; Joo-Hee Yi; Ellie Guardino; Meghna Samant; Melody A. Cobleigh; Mothaffar F. Rimawi; Pier Franco Conte; Jin Y. Jin

Model-based meta-analysis for quantifying paclitaxel dose response in cancer patients

CPT: Pharmacometrics and Systems Pharmacology, ISSN: 21638306

Dan Lu; Amita Joshi; Li; Nancy Zhang; Melanie Ren; Yuying Gao; Russell D. Wada; Jin Y. Jin

An integrated multiple-analyte pharmacokinetic model to characterize trastuzumab emtansine (T-DM1) clearance pathways and to evaluate reduced pharmacokinetic sampling in patients with HER2-positive metastatic breast cancer

Clinical Pharmacokinetics, ISSN: 03125963 11791926

Dan Lu; Amita Joshi; Wang; Steve Olsen; Joo-Hee Yi; Ian E. Krop; Howard A. Burris; Sandhya Girish

Strategies to address drug interaction potential for antibody-drug conjugates in clinical development

Bioanalysis, ISSN: 17576180 17576199

Dan Lu; Srikumar Sahasranaman; Yi Zhang; Sandhya Girish

Drug interaction potential of trastuzumab emtansine (T-DM1) combined with pertuzumab in patients with HER2-positive metastatic breast cancer

Current Drug Metabolism, ISSN: 13892002 18755453

Dan Lu; Howard A. Burris; Wang; E. Claire Dees; Javier Cortés; Amita Joshi; Manish Gupta; Joo-Hee Yi; Yu-Waye Chu; Ted Shih; Liang Fang; Sandhya Girish

Clinical pharmacology of trastuzumab emtansine (T-DM1): An antibody-drug conjugate in development for the treatment of HER2-positive cancer

Cancer Chemotherapy and Pharmacology, ISSN: 03445704 14320843

Sandhya Girish; Manish Gupta; Wang; Dan Lu; Ian E. Krop; Charles L. Vogel; Howard A. Burris; Patricia M. LoRusso; Joo-Hee Yi; Ola M. Saad; Barbara Tong; Yu-Waye Chu; Scott N. Holden; Amita Joshi

Preclinical pharmacokinetics of MEHD7945A, a novel EGFR/HER3 dual-action antibody, and prediction of its human pharmacokinetics and efficacious clinical dose

Cancer Chemotherapy and Pharmacology, ISSN: 03445704 14320843

Amrita Kamath; Dan Lu; Priyanka Gupta; Denise Jin; Hong Xiang; Anne Wong; Cecilia Leddy; Lisa Crocker; Gabriele Schaefer; Mark X. Sliwkowski; Lisa A. Damico

Preclinical pharmacokinetics of MFGR1877A, a human monoclonal antibody to FGFR3, and prediction of its efficacious clinical dose for the treatment of t(4;14)-positive multiple myeloma

Cancer Chemotherapy and Pharmacology, ISSN: 03445704 14320843

Amrita Kamath; Dan Lu; Priyanka Gupta; Denise Jin; Yan Xin; Ann Brady; Jean-Philippe Stephan; Hao Li; Janet Y. Tien; Jing Qing; Lisa A. Damico

A guide to rational dosing of monoclonal antibodies

Clinical Pharmacokinetics, ISSN: 03125963 11791926

Shuang Bai; Karin Jorga; Yan Xin; Denise Jin; Zheng; Lisa A. Damico; Manish Gupta; Meina Tao Tang; David E. Allison; Dan Lu; Yi Zhang; Amita Joshi; Mark J. Dresser

Antibody delivery of drugs and radionuclides: Factors influencing clinical pharmacology

Therapeutic Delivery, ISSN: 20415990 20416008

Saileta Prabhu; C. Andrew Boswell; Douglas Leipold; Leslie A. Khawli; Dongwei Li; Dan Lu; Frank-Peter Theil; Amita Joshi; Bert L. Lum

Ohio State University, Ph.D. – 2006