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

Scientists / Our Scientists

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

15

Years at Genentech

47

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.

Clinical pharmacology strategies to accelerate the development of polatuzumab vedotin and summary of key findings

Advanced Drug Delivery Reviews, ISSN: 0169409X

Michael Z. Liao; Dan Lu; Tong Lu; Leonid Gibiansky; Rong Deng; Divya Samineni; Randall Dere; Andy Lin; Jamie Hirata; Shen; Donglu Zhang; Dongwei Li; Chunze Li; Dale Miles

Complex PK-PD of an engineered IL-15/IL-15Rα–Fc fusion protein in cynomolgus monkeys: QSP modeling of lymphocyte dynamics

European Journal of Pharmaceutical Sciences, ISSN: 18790720 09280987

Dan Lu; Rajbharan Yadav; Patrick Holder; Eugene Chiang; Shomyseh Sanjabi; Victor Poon; Matthew Bernett; Rajat Varma; Ke Liu; Irene Leung; Liz Bogaert; John Desjarlais; Vittal Shivva; Iraj Hosseini; Ramanujan

Integrated summary of immunogenicity of polatuzumab vedotin in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma

Frontiers in Immunology, ISSN: 16643224

Randall Dere; Richard L. Beardsley; Dan Lu; Tong Lu; Grace Ku; Gabriel Man; Van Nguyen; Surinder Kaur

Applying interpretable machine learning workflow to evaluate exposure–response relationships for large-molecule oncology drugs

CPT: Pharmacometrics and Systems Pharmacology, ISSN: 21638306

Gengbo Liu; James Lu; Hong Seo Lim; Jin Yan Jin; Dan Lu

Applying interpretable machine learning workflow to evaluate exposure–response relationships for large-molecule oncology drugs

CPT: Pharmacometrics and Systems Pharmacology,

Gengbo Liu; James Lu; Hong Seo Lim; Jin Yan Jin; Dan Lu

Performance of Cox proportional hazard models on recovering the ground truth of confounded exposure–response relationships for large-molecule oncology drugs

CPT: Pharmacometrics and Systems Pharmacology, ISSN: 21638306

Victor Poon; Dan Lu

Performance of Cox proportional hazard models on recovering the ground truth of confounded exposure–response relationships for large-molecule oncology drugs

CPT: Pharmacometrics and Systems Pharmacology,

Victor Poon; Dan Lu

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

Pharm-AutoML: An open-source, end-to-end automated machine learning package for clinical outcome prediction

CPT: Pharmacometrics and Systems Pharmacology, ISSN: 21638306

Gengbo Liu; Dan Lu; James Lu

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

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

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

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

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 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

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