Tom Gelzleichter
Senior Fellow / Toxicologist, Safety Assessment
"The only way you survive is you continuously transform into something else. It’s this idea of continuous transformation that makes for an innovation company."
24
Years at Genentech
26
Publications at Genentech
Following completion of postdoctoral training in toxicology, I joined Genentech as a Scientist in 1999. At that time, Genentech was emerging as a biotechnology powerhouse in the pharmaceutical industry and was renowned for innovative approaches to drug development. I have been fortunate to have served as a project team toxicologist where I designed and implemented non-clinical safety studies to support drug research and development efforts. This includes development of drugs for various disease classes including oncology, immunology, pulmonary, cardiovascular and metabolic diseases. I currently serve as Therapeutic Area Lead for metabolic disease and legacy programs and act as an advisor for the Global Technical Development organization.
Featured Publication
Combined administration of RG7652, a recombinant human monoclonal antibody against PCSK9, and atorvastatin does not result in reduction of immune function or change in bile acid composition.
Toxicol. Sci. 140(2), 470-80.
Gelzleichter TR, Halpern W, Erwin R, Baruch A, Leabman M, Forrest AS, Satterwhite CM, Peng Kun, Chilton J, and Stevens D (2014).
My Focus
Design and implement studies to evaluate the preclinical safety of therapeutics for licensure by the Food and Drug Administration and non-US regulatory agencies.
Manage the activities of Development Sciences pharmacology subteams for several drug development efforts.
Genentech Research and Early Development (gRED) lead Subject Matter Expert (SME) in pharmacology-, safety- and immunogenicity-based risk assessment related to Product Technical Development (PTD) aspects (manufacturing, process control strategy, formulation development) of biologics. Various expert assessments enabled PTD organization to make science-based decisions that efficiently balance manufacturing considerations/needs with efficacy and safety concerns and to defend Roche/Genentech’s positions with global health authorities.
Genentech Publications
Expert Opinion on Investigational Drugs, ISSN: 17447658 13543784
Ya-Chi Chen; Jiajie Yu; Ciara Metcalfe; Tom De Bruyn; Thomas R. Gelzleichter; Vikram Malhi; Pablo Perez-Moreno; Xiaojing Wang
Journal of Medicinal Chemistry, ISSN: 15204804 00222623
Jun Liang; Jason R. Zbieg; Robert A. Blake; Jae H. Chang; Stephen Daly; Antonio G. DiPasquale; Lori S. Friedman; Thomas R. Gelzleichter; Matthew Gill; Jennifer M. Giltnane; Simon Goodacre; Jane Guan; Steven J. Hartman; Ellen Ingalla; Kategaya; James R. Kiefer; Tracy L. Kleinheinz; Sharada Labadie; Tommy Lai; Jun Li; Jiangpeng Liao; Zhiguo Liu; Vidhi Mody; Neville J. McLean; Ciara Metcalfe; Michelle Nannini; Jason Oeh; Martin G. O'Rourke; Daniel F. Ortwine; Yingqing Ran; Nicholas C. Ray; Fabien Roussel; Amy Sambrone; Deepak Sampath; Leah Schutt; Maia Vinogradova; John Wai; Tao Wang; Ingrid E. Wertz; Jonathan R. White; Siew Kuen Yeap; Amy Young; Birong Zhang; Xiaoping Zheng; Wei Zhou; Yu Zhong; Xiaojing Wang
Expert Opinion on Investigational Drugs, ISSN: 17447658 13543784
Ya-Chi Chen; Jiajie Yu; Ciara Metcalfe; Tom De Bruyn; Thomas R. Gelzleichter; Vikram Malhi; Pablo Perez-Moreno; Xiaojing Wang
Proceedings of the National Academy of Sciences of the United States of America, ISSN: 10916490 00278424
Amos Baruch; Chin Wong; Leslie Chinn; Vaze; Junichiro Sonoda; Thomas R. Gelzleichter; Shan Chen; Nicholas Lewin-Koh; Linda Morrow; Suresh Dheerendra; Richard Boismenu; Johnny Gutierrez; Eric Wakshull; Maria E. Wilson; Puneet S. Arora
Journal of Pharmacological and Toxicological Methods, ISSN: 1873488X
Dale Stevens; Lisa P. Wong; Leah Schutt; Thomas R. Gelzleichter
Journal of Pharmacological and Toxicological Methods, ISSN: 1873488X 10568719
Sharmila Rajan; Junichiro Sonoda; Timothy Tully; Ambrose Jon Williams; Feng Yang; Frank D. Macchi; Terry Hudson; Mark Chen; Shannon Liu; Nicole R. Valle; Kyra J. Cowan; Thomas R. Gelzleichter
Pulmonary Pharmacology and Therapeutics, ISSN: 15229629 10945539
Lin Pan; Thomas R. Gelzleichter; Yuan Chen; Cindy Burg; Susan L. Limb; Linda Nguyen
American Journal of Cardiology, ISSN: 18791913 00029149
Amos Baruch; Mosesova; John Davis; Nageshwar Budha; Alexandr Vilimovskij; Robert S. Kahn; Kun Peng; Kyra J. Cowan; Laura Pascasio Harris; Thomas R. Gelzleichter; Josh Lehrer; John C. Davis; Whittemore G. Tingley
mAbs, ISSN: 19420870 19420862
Sharmila Rajan; Danielle Mandikian; Amos Baruch; Thomas R. Gelzleichter; Dale Stevens; Junichiro Sonoda; Kyra J. Cowan; C. Andrew Boswell; Stefanich
American Journal of Cardiology, ISSN: 18791913 00029149
Amos Baruch; Mosesova; John Davis; Nageshwar Budha; Alexandr Vilimovskij; Robert S. Kahn; Kun Peng; Kyra J. Cowan; Laura Pascasio Harris; Thomas R. Gelzleichter; Josh Lehrer; John C. Davis; Whittemore G. Tingley
Pharmaceutical Biotechnology: Fundamentals and Applications, Third Edition,
Banmeet S. Anand; Rong Deng; Frank-Peter Theil; Jing Li; Shasha Jumbe; Thomas R. Gelzleichter; Fielder; Amita Joshi; Sara Kenkare-Mitra
Reproductive Toxicology, ISSN: 18731708 08906238
Hong Wang; Chris Schuetz; Akihiro Arima; Yutaka Chihaya; Gerhard F. Weinbauer; Gunnar Habermann; Jim J. Xiao; Cynthia Woods; Jane L. Grogan; Thomas R. Gelzleichter; Cain
EBioMedicine, ISSN: 23523964
Ganesh Kolumam; Mark Chen; Raymond K. Tong; Jose Zavala-Solorio; Lance Kates; Nicholas Van Bruggen; Ross; Shelby K. Wyatt; Vineela D. Gandham; Richard A. D. Carano; Diana Ronai Dunshee; Ai-Luen Wu; Benjamin Haley; Keith R. Anderson; Søren Warming; Xin Y. Rairdan; Nicholas Lewin-Koh; Yingnan Zhang; Johnny Gutierrez; Amos Baruch; Thomas R. Gelzleichter; Dale Stevens; Sharmila Rajan; Travis W. Bainbridge; Jean-Michel Vernes; Meng; James Ziai; Robert Soriano; Matthew J. Brauer; Yongmei Chen; Scott Stawicki; Hok Seon Kim; Laetitia Comps-Agrar; Luis; Christoph Spiess; Yan Wu; James A. Ernst; Owen P. McGuinness; Andrew S. Peterson; Junichiro Sonoda
The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment,
Thomas R. Gelzleichter; Eric Wakshull
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
Molecular Cancer Therapeutics, ISSN: 15357163 15388514
Elaine Mai; Zhong Zheng; Youjun Chen; Jing Peng; Christophe Severin; Ellen H. Filvaroff; Mally Romero; William Mallet; Surinder Kaur; Thomas R. Gelzleichter; Ihsan Nijem; Mark Merchant; Judy Young
Journal of Immunotoxicology, ISSN: 1547691X
Rafael Ponce; Thomas R. Gelzleichter; Helen G. Haggerty; Shawn Heidel; Matthew S. Holdren; Herve Lebrec; R. Daniel Mellon; Marc Pallardy
Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics,
Theresa Reynolds; Christina de Zafra; Amy H. Kim; Thomas R. Gelzleichter
Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics,
Thomas R. Gelzleichter
mAbs, ISSN: 19420862 19420870
Deborah L. Mortensen; Saileta Prabhu; Stefanich; Saloumeh Kadkhodayan Fischer; Thomas R. Gelzleichter; Baker; Jenny Jiang; Kristin Wallace; Suhasini Iyer; Fielder; Wendy Putnam
British Journal of Pharmacology, ISSN: 00071188 14765381
Stefanich; Dimitry Danilenko; Hong Wang; Sharon O'Byrne; Erickson; Thomas R. Gelzleichter; Hajime Hiraragi; Chiu; Ivelja; Surinc Er Jeet; Gadkari; Hwang; Franklin Fuh; Looney; Howell; Albert; Mercedesz Balazs; Refino; Sherman Fong; Suhasini Iyer; Marna Williams
British Journal of Pharmacology, ISSN: 00071188 14765381
Stefanich; Dimitry Danilenko; Hong Wang; Sharon O'Byrne; Erickson; Thomas R. Gelzleichter; Hajime Hiraragi; Chiu; Ivelja; Surinc Er Jeet; Gadkari; Hwang; Franklin Fuh; Looney; Howell; Albert; Mercedesz Balazs; Refino; Fong; Suhasini Iyer; Marna Williams
Regulatory Toxicology and Pharmacology, ISSN: 02732300 10960295
Rafael Ponce; Leslie Abad; Lakshmi Amaravadi; Thomas R. Gelzleichter; Elizabeth Gore; Green; Shalini Gupta; Danuta Herzyk; Christopher Hurst; Inge A. Ivens; Thomas Kawabata; Curtis Maier; Barbara Mounho; Bonita Rup; Gopi Shankar; Holly W. Smith; Peter Thomas; Daniel Wierda
Blood, ISSN: 00064971 00064971
Yu Lin Wei; Qian Gong; Dhaya Seshasayee; Zhonghua Lin; Qinglin Ou; Shiming Ye; Eric Suto; Jean Shu; Wyne P. Lee; Chingwei V. Lee; Fuh; Maya Leabman; Suhasini Iyer; Howell; Thomas R. Gelzleichter; Joseph Beyer; Dimitry Danilenko; Sherry Yeh; Laura DeForge; Allen Ebens; Jeffrey S. Thompson; Christine Ambrose; Mercedesz Balazs; Melissa A. Starovasnik; Flavius Martin
British Journal of Pharmacology, ISSN: 14765381 00071188
Kelley; Thomas R. Gelzleichter; Dong Xie; Wyne P. Lee; Darbonne; Ferhan Qureshi; Kim Kissler; Ezogelin Oflazoglu; Iqbal S. Grewal
American Journal of Pathology, ISSN: 00029440
Yulia Vugmeyster; Dhaya Seshasayee; Wesley S. Chang; Anahid Storn; Howell; Susan Sa; Tenea Nelson; Flavius Martin; Iqbal S. Grewal; Ellen Gilkerson; Ben Wu; Jeffrey S. Thompson; Barbara N. Ehrenfels; Song Ren; An Song; Thomas R. Gelzleichter; Dimitry Danilenko
Education
- Univeristy of California, Davis, PhD in Pharmacology and Toxicology – 1992
- University of California, Los Angeles, BA, Biological Sciences – 1984