Genentech: Wendy Halpern | Senior Fellow - Pathologist, Safety Assessment Pathology, Development Sciences

Scientists / Our Scientists

"Committed to serving the underserved, with persistence fueled by curiosity."

17

Years at Genentech

30

Publications at Genentech

I joined Genentech as a Scientist/Pathologist in 2007, following seven years at a smaller biotechnology company. I am currently a Staff Scientist/Pathologist in Safety Assessment, supporting several programs from discovery through post-marketing as a team member or leader. Within Safety Assessment, I also lead strategic support of reproductive, developmental and juvenile toxicity across our portfolio, and contribute to strategies in other areas such as safety pharmacology and inhalation toxicology. My broad interests have allowed me to build a strong foundation around drug development and its regulation and implementation. I support and applaud efforts by Roche/Genentech to uphold high standards of science, sustainability, and commitment to the ethics and welfare in support of our medical advances.

Over my career thus far, I have been able to support programs intended for diseases across a broad range of therapeutic areas including immunology, oncology, infectious diseases, and metabolism, as a team member or leader. Over the past decade especially, I have increased my knowledge and contributions in specific areas of cardiovascular safety pharmacology, developmental and reproductive toxicology (DART) and support of pediatrics. In addition to roles on internal expert working groups, I have served on a number of efforts with external organizations such as the Biotechnology Industry Organization (BioSafe Leadership Committee and representative on ICH S11), the HESI DART technical committee, the Society of Toxicologic Pathology Scientific and Regulatory Policy Committee, and the American College of Veterinary Pathology Advocacy and Policy Committee. I am also a member of the Society for Birth Defects Research and Prevention and of the Safety Pharmacology Society. I have been a Diplomate of the American College of Veterinary Pathologists since 2002.

Isoform-selective TGF-β3 inhibition for systemic sclerosis

Med, ISSN: 26666359

Tianhe Sun; Jason A. Vander Heiden; Xia Gao; Jianping Yin; Salil Uttarwar; Wei-Ching Liang; Guiquan Jia; Rajbharan Yadav; Zhiyu Huang; Mayurranjan Mitra; Wendy Halpern; Hannah Bender; Hans D. Brightbill; Yan Wu; Patrick J. Lupardus; Thirumalai R. Ramalingam; Joseph R. Arron

HESI workshop summary: Interpretation of developmental and reproductive toxicity endpoints and the impact on data interpretation of adverse events

Birth Defects Research,

Green; Kluever; Connie Chen; Dobreniecki; Wendy Halpern; Bethany Hannas; Alan M. Hoberman; McNerney; Mitchell-Ryan; Shafer; Steven Van Cruchten; Tacey White

Preclinical and translational pharmacology of afucosylated anti-CCR8 antibody for depletion of tumour-infiltrating regulatory T cells

British Journal of Pharmacology, ISSN: 00071188

Gautham Gampa; Phillip Spinosa; Jennifer A. Getz; Yu Zhong; Wendy Halpern; Emel Esen; John Davies; Cassie Chou; Mandy Kwong; Yingyun Wang; Teresita L. Arenzana; Vittal Shivva; Mahrukh Huseni; Robert Hsieh; Jill Schartner; James T. Koerber; Sascha Rutz; Iraj Hosseini

Repeat-dose and embryo-fetal developmental toxicity of zinpentraxin alfa

Reproductive Toxicology, ISSN: 08906238

Gautham K. Rao; Sara F. Santagostino; Lisa Wong; Ayumi Inoue; Audrey Arjomandi; Rajbharan Yadav; Wendy Halpern

FDA and industry collaboration: Identifying opportunities to further reduce reliance on nonhuman primates for nonclinical safety evaluations

Regulatory Toxicology and Pharmacology, ISSN: 10960295 02732300

David Ackley; Joanne Birkebak; Jorg Blumel; Todd Bourcier; Christina de Zafra; Andrew Goodwin; Wendy Halpern; Danuta Herzyk; Sven Kronenberg; Robert Mauthe; Jacintha Shenton; Dana Shuey; Ronald L. Wange

General Design Considerations in Reproductive and Developmental Toxicity Studies

The Quintessence of Basic and Clinical Research and Scientific Publishing,

Wendy Halpern

Utilizing PK and PD Biomarkers to Guide the First-in-Human Starting Dose Selection of MTBT1466A: A Novel Humanized Monoclonal Anti-TGFβ3 Antibody for the Treatment of Fibrotic Diseases

Journal of Pharmaceutical Sciences, ISSN: 00223549

Rajbharan Yadav; Siddharth Sukumaran; Jeff Lutman; Mayur S. Mitra; Wendy Halpern; Tianhe Sun; A F. Setiadi; Margaret Neighbors; X Rebecca Sheng; Victor Yip; Shen; Chang Liu; Lyrialle Han; Ayse Meric Ovacik; Yan Wu; Sara Glickstein; Rebecca Kunder; Joseph R. Arron; Lin Pan; Amrita Kamath; Stefanich

Neutropenia in Cynomolgus Monkeys With Anti-Drug Antibodies Associated With Administration of Afucosylated Humanized Monoclonal Antibodies

Toxicologic Pathology, ISSN: 15331601 01926233

Adedeji; Fiona Zhong; Jennifer A. Getz; Zoe Zhong; Wendy Halpern

Surfactant protein D is a biomarker of influenza-related pediatric lung injury

Pediatric Pulmonology, ISSN: 10990496 87556863

Arindam Chakrabarti; Allen Nguyen; Margaret M. Newhams; Maikke B. Ohlson; Xiaoying Yang; Sheila Ulufatu; Shannon Liu; Summer Park; Min Xu; Jenny Jiang; Wendy Halpern; Veronica G. Anania; Jacqueline McBride; Carrie M. Rosenberger; Adrienne G. Randolph

Surfactant protein D is a biomarker of influenza-related pediatric lung injury

Pediatric Pulmonology, ISSN: 10990496

Arindam Chakrabarti; Allen Nguyen; Margaret M. Newhams; Maikke B. Ohlson; Xiaoying Yang; Sheila Ulufatu; Shannon Liu; Summer Park; Min Xu; Jenny Jiang; Wendy Halpern; Veronica G. Anania; Jacqueline McBride; Carrie M. Rosenberger; Adrienne G. Randolph

Nonclinical toxicology development of a novel antibody antibiotic conjugate for treating invasive Staphylococcus Aureus infections

Toxicology and Applied Pharmacology, ISSN: 10960333 0041008X

Nicola J. Stagg; Paula Katavolos; Kirsten Achilles Poon; Shelly Zhong; Nina Ljumanovic; Amrita Kamath; Hao Cai; Montserrat Carrasco-Triguero; Wendy Halpern

Current Trends of Practices in Nonclinical Toxicology: An Industry Survey

International Journal of Toxicology, ISSN: 1092874X 10915818

Simon Authier; William J Brock; Wendy Halpern; Stephanie N Harris; David Jones; Timothy McGovern; Pamela D McGovern; Michael K. Pugsley

The Role of Pathology in Evaluation of Reproductive, Developmental, and Juvenile Toxicity

Haschek and Rousseaux's Handbook of Toxicologic Pathology: Volume 1: Principles and Practice of Toxicologic Pathology,

Christopher J. Bowman; Wendy Halpern

Atypical presentation and pathogenesis of a macaque lymphocryptoviral-associated B-cell lymphoma in a cynomolgus monkey

Veterinary Clinical Pathology, ISSN: 1939165X 02756382

Adedeji; Vimala Vemireddi; Niraj K. Tripathi; Durinck; Jonathan M. Maher; Domagoj Vucic; Wendy Halpern

In vivo assessment of antibody-dependent enhancement of influenza B infection

Toxicological Sciences, ISSN: 10960929 10966080

Gautham K. Rao; Prell; Steven T. Laing; Stefanie C M Burleson; Allen Nguyen; Jacqueline McBride; Crystal Zhang; Daniel Sheinson; Wendy Halpern

Physiology of the neonatal gastrointestinal system relevant to the disposition of orally administered medications

Drug Metabolism and Disposition, ISSN: 1521009X 00909556

April Neal-Kluever; Jeffrey Fisher; Lawrence Grylack; Satoko Kakiuchi-Kiyota; Wendy Halpern

Resolution of unexpected pregnancy-related findings in a rat embryofetal development and toxicokinetic study of monoclonal antibodies specific for hCMV

Birth Defects Research, ISSN: 24721727

Paula Katavolos; Prell; Doris Zane; Rong Deng; Wendy Halpern

Applying a weight of evidence approach to the evaluation of developmental toxicity of biopharmaceuticals

Regulatory Toxicology and Pharmacology, ISSN: 10960295 02732300

Meredith Rocca; LaRonda L. Morford; Diann Blanset; Wendy Halpern; Joy A. Cavagnaro; Christopher J. Bowman

Placental and fetal effects of onartuzumab, a Met/HGF signaling antagonist, when administered to pregnant cynomolgus monkeys

Toxicological Sciences, ISSN: 10960929 10966080

Prell; Noel Dybdal; Akihiro Arima; Yutaka Chihaya; Ihsan Nijem; Wendy Halpern

Use of Severity Grades to Characterize Histopathologic Changes

Toxicologic Pathology, ISSN: 15331601 01926233

Kenneth A. Schafer; John Eighmy; James D. Fikes; Wendy Halpern; Renee R. Hukkanen; Gerald G. Long; Emily K. Meseck; Daniel J. Patrick; Michael S. Thibodeau; Charles E. Wood; Sabine Francke

Scientific and Regulatory Policy Committee Points to Consider Review: Inclusion of Reproductive and Pathology End Points for Assessment of Reproductive and Developmental Toxicity in Pharmaceutical Drug Development

Toxicologic Pathology, ISSN: 15331601 01926233

Wendy Halpern; Mehrdad Ameri; Christopher J. Bowman; Michael R. Elwell; Michael L. Mirsky; Julian Oliver; Karen S. Regan; Amera K. Remick; Vicki L. Sutherland; Kary E. Thompson; Claudine Tremblay; Midori Yoshida; Lindsay Tomlinson

Perspective on a Modified Developmental and Reproductive Toxicity Testing Strategy for Cancer Immunotherapy

International Journal of Toxicology, ISSN: 1092874X 10915818

Prell; Wendy Halpern; Gautham K. Rao

Developmental and Reproductive Toxicity Testing

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment,

Gerhard F. Weinbauer; Christopher J. Bowman; Wendy Halpern; Gary Chellman

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

Thomas R. Gelzleichter; Wendy Halpern; Roy Erwin; Amos Baruch; Maya Leabman; Abigail S. Forrest; Christina Satterwhite; Kun Peng; Jennifer Chilton; Dale Stevens

Biopharmaceuticals

Haschek and Rousseaux's Handbook of Toxicologic Pathology,

Wendy Halpern; David Hutto

Integrated and translational nonclinical in vivo cardiovascular risk assessment: Gaps and opportunities

Regulatory Toxicology and Pharmacology, ISSN: 02732300 10960295

Brian R. Berridge; Peter K. Hoffmann; James R. Turk; Frank W Sellke; Gary Gintant; Gerald Hirkaler; Kevin Dreher; A. Eric Schultze; Dana Walker; Nick Edmunds; Wendy Halpern; James Falls; Marty Sanders; Syril D. Pettit

Biopharmaceuticals

Haschek and Rousseaux's Handbook of Toxicologic Pathology, Third Edition: Volume 1-3,

Wendy Halpern; David Hutto

Nonclinical Development of Multi-targeting Biopharmaceuticals

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics,

Prell; Donna W. Lee; Wendy Halpern; Anu V. Connor

Stems to gems: Impact of stem cell technology on engineered animal models

Veterinary Pathology, ISSN: 03009858 15442217

Wendy Halpern; Mark McArthur; Elizabeth Galbreath; Elizabeth Uhl; Wayne Buck; Elizabeth Whitley

A Phase 1b/2 trial of mapatumumab in patients with relapsed/refractory non-Hodgkin's lymphoma

British Journal of Cancer, ISSN: 00070920 15321827

Younes; Julie Vose; Zelenetz; Smith; Howard A. Burris; Stephen Ansell; Klein; Wendy Halpern; Miceli; Kumm; Fox; Myron S. Czuczman

University of New Mexico, Ph.D. in Biomedical Sciences – 1999
The Ohio State University, M.Sc. Veterinary Pathobiology – 1994
The Ohio State University College of Veterinary Medicine, D.V.M. – 1992
Amherst College, BA in Neuroscience and Psychology (double major) – 1988