Genentech: Kate Peng | Senior Scientist, BioAnalytical Sciences, Assay Development and Technology Department of Development Sciences

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Scientists / Our Scientists

"Genentech is a unique place. It has been extremely rewarding for me to work in a cross-functional environment with incredibly dedicated and talented colleagues to identify solutions for unmet medical needs."

11

Years at Genentech

19

Publications

1

Awards & Honors

I joined the BioAnalytical Research & Development department at Genentech in 2007 after working in the biotech industry for three years. I am currently a Senior Scientist in the Assay Development and Technology group within the BioAnalytical Sciences department. During my time at Genentech, I have gained experience and expertise in developing bioanalytical strategies and methods to enable appropriate assessment of the pharmacokinetics, immunogenicity and pharmacodynamics of protein biotherapeutics, interact with health authorities as well as retain knowledge of both nonclinical and clinical drug development.

Featured Publication

Critical role of bioanalytical strategies in investigation of clinical PK observations, a Phase I case study.

MAbs. 2014;6(6):1500-8.

Peng K. Xu K, Liu L, Hendricks R, Delarosa R, Erickson R, Budha NR, Leabman M, Song A, Kaur S, Fischer SK.

Develop bioanalytical strategies, methods and technologies enabling assessment of the pharmacokinetics, pharmacodynamics and immunogenicity of protein biotherapeutics from early development to clinical as well as post-marketing studies, with a focus on immunological diseases. Support regulatory filings by drafting filing documentations (IND, CTA, BLA) and interacting with healthy authorities on bioanalytical related discussions.

Characterization of IL-17AA and IL-17FF in rheumatoid arthritis and multiple sclerosis

Bioanalysis, ISSN: 17576199

Cheryl Schofield; Sally Fischer; Michael Townsend; Sofia Mosesova; Kate Peng; Francesca Setiadi; An Song; Amos Baruch

Specific Immune Response to Phospholipase B-Like 2 Protein, a Host Cell Impurity in Lebrikizumab Clinical Material

AAPS Journal, ISSN: 15507416

Sally Fischer; Melissa Cheu; Kate Peng; John Lowe; James Araujo; Elaine Murray; Mcclintock; John Matthews; Patty Siguenza; An Song

Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials

The Lancet Respiratory Medicine, ISSN: 22132619

Nicola A. Hanania; Phillip Korenblat; Kenneth R Chapman; Eric D Bateman; Petr Kopecky; Pierluigi Paggiaro; Akihito Yokoyama; Julie Olsson; Sarah Gray; Cecile Holweg; Mark Eisner; Charles Asare; Sally Fischer; Kate Peng; Wendy Putnam; John Matthews

Pre-existing Antibody: Biotherapeutic Modality-Based Review

AAPS Journal, ISSN: 15507416

Boris Gorovits; Adrienne Clements-Egan; Mary Birchler; Meina Liang; Heather Myler; Kate Peng; Shobha Purushothama; Manoj Rajadhyaksha; Laura Salazar-Fontana; Crystal Sung; Li Xue

Bioanalytical challenges and improved detection of circulating levels of IL-13

Bioanalysis, ISSN: 17576199

Fang Cai; Hans Hornauer; Kate Peng; Cheryl Schofield; Heleen Scheerens; Alyssa Morimoto

Modeling and Simulation to Support Phase 2 Dose Selection for RG7652, a Fully Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9

AAPS Journal, ISSN: 15507416

Nageshwar Budha; Maya Leabman; Jin Y. Jin; D. Russell Wada; Amos Baruch; Kate Peng; Whittemore Tingley; John Davis

Critical role of bioanalytical strategies in investigation of clinical PK observations, a phase I case study

mAbs, ISSN: 19420870

Kate Peng; Keyang Xu; Luna Liu; Robert Hendricks; Reginald Delarosa; Rich Erickson; Nageshwar Budha; Maya Leabman; An Song; Surinder Kaur; Sally Fischer

Combined administration of RG7652, a recombinant human monoclonal antibody against PCSK9, and atorvastatin does not result in reduction of immune function

Toxicological Sciences, ISSN: 10960929

Tom Gelzleichter; Wendy Halpern; Roy Erwin; Amos Baruch; Maya Leabman; Abigail S. Forrest; Christina M. Satterwhite; Kate Peng; Jennifer Chilton; Dale Stevens

Evaluation of two commercial omalizumab/free IgE immunoassays: Implications of use during therapy

Current Medical Research and Opinion, ISSN: 14734877

Dana Baker; Kate Peng; Melissa Cheu; Sally Fischer

Response to Becher and Strohner comment regarding Baker DL et al. Evaluation of two commercial omalizumab/free IgE immunoassays: Implications of use during therapy. CMRO 2014;30:913-22

Current Medical Research and Opinion, ISSN: 14734877

Dana Baker; Kate Peng; Melissa Cheu; Sally Fischer

When assay format matters: A case study on the evaluation of three assay formats to support a clinical pharmacokinetic study

AAPS Journal, ISSN: 15507416

Kate Peng; Dana Baker; Sue Brignoli; Janis Cabuhat; Sally Fischer

Mechanistic Pharmacokinetic-Pharmacodynamic Modeling of BACE1 Inhibition in Monkeys: Development of a Predictive Model for Amyloid Precursor Protein Processings

Drug Metabolism and Disposition, ISSN: 00909556

Xingrong Liu; Harvey Wong; Kimberly Scearce-Levie; Ryan Watts; Melis Coraggio; Young Shin; Kate Peng; Kristin Wildsmith; Jasi Atwal; Jason Mango; Stephen Schauer; Kelly Regal; Kevin W. Hunt; Allen A. Thomas; Mike Siu; Joe Lyssikatos; Gauri Deshmukh; Marcel Hop

Increased rheumatoid factor interference observed during immunogenicity assessment of an Fc-engineered therapeutic antibody

Journal of Pharmaceutical and Biomedical Analysis, ISSN: 07317085

James Araujo; Marcel Zocher; Kristin Wallace; Kate Peng; Sally Fischer

A therapeutic antibody targeting BACE1 inhibits amyloid-β production in vivo

Science Translational Medicine, ISSN: 19466234

Jasi Atwal; Yongmei Chen; Cecilia Chiu; Deborah Mortensen; Bill Meilandt; Yichin Liu; Chris Heise; Kwame Hoyte; Wilman Luk; Yanmei Lu; Kate Peng; Ping Wu; Lionel Rouge; Yingnan Zhang; Bob Lazarus; Kimberly Scearce-Levie; Weiru Wang; Yan Wu; Marc Tessier-Lavigne; Ryan Watts

Clinical immunogenicity specificity assessments: A platform evaluation

Journal of Pharmaceutical and Biomedical Analysis, ISSN: 07317085

Kate Peng; Ketevan Siradze; Valerie Quarmby; Sally Fischer

A novel homogeneous Biotin-digoxigenin based assay for the detection of human anti-therapeutic antibodies in autoimmune serum

Journal of Immunological Methods, ISSN: 00221759

Julia Qiu; Yong Ying; Michael Fox; Kate Peng; Sock-Cheng Lewin-Koh; Daniel Coleman; Jeremy Good; John Lowe; Amena Rahman; Jihong Yang; Jenny Jiang; Valerie Quarmby; An Song

Effects of RG7652, a Monoclonal Antibody Against PCSK9, on LDL-C, LDL-C Subfractions, and Inflammatory Biomarkers in Patients at High Risk of or With Established Coronary Heart Disease (from the Phase 2 EQUATOR Study)

American Journal of Cardiology, ISSN: 18791913

Amos Baruch; Sofia Mosesova; John Davis; Nageshwar Budha; Alexandr Vilimovskij; Robert S. Kahn; Kate Peng; Kyra Cowan; Laura Harris; Tom Gelzleichter; Josh Lehrer; John C. Davis; Whittemore Tingley

Model-based clinical pharmacology profiling and exposure-response relationships of the efficacy and biomarker of lebrikizumab in patients with moderate-to-severe asthma

Pulmonary Pharmacology and Therapeutics, ISSN: 15229629 10945539

Rui Zhu; Yanan Zheng; Nathanael L. Dirks; Shweta Vadhavkar; Jin Yan Jin; Kate Peng; Cecile Holweg; Julie Olsson; John Matthews; Wendy Putnam

Widespread brain distribution and activity following i.c.v. infusion of anti-β-secretase (BACE1) in nonhuman primates

British Journal of Pharmacology, ISSN: 14765381 00071188

Daniela Yadav; Janice Maloney; Kristin Wildsmith; Reina Fuji; Bill Meilandt; Hilda Solanoy; Yanmei Lu; Kate Peng; Blair Wilson; Pamela Chan; Kapil Gadkar; Andrew Kosky; Marisa Goo; Ann Daugherty; Jessica Couch; Thomas Keene; Karen Hayes; Lisa Jungbauer Nikolas; Deanna Lane; Robert Switzer; Eric L. Adams; Ryan Watts; Kimberly Scearce-Levie; Saileta Prabhu; Lisa Shafer; Deepak R Thakker; Keith Hildebrand; Jasi Atwal

University of California, Berkeley, Ph.D. in Metabolic Biology – 2001

AAPS award for outstanding contributions to AAPS Immunogenicity 101 eLearning Series – 2014