Genentech: Eric Stefanich | Senior Scientist and Group Leader, Preclinical and Translational PKPD (PTPK)

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Scientists / Our Scientists

"The path to longevity at Genentech involves having a strong mentor/role model, trusted network of colleagues, and exciting opportunities."

Years at Genentech

Publications

I am a Senior Scientist and Group Leader in the PTPK group within Development Sciences. I am accountable for the pharmacology strategy from early stage research through first in human clinical trials for large molecule therapeutics in the areas of Immunology, Metabolic disease, Infectious disease, and Neurology.

Overall I have been at Genentech for over 21 years and have extensive drug development experience including writing regulatory documents as well as interactions with Health Authorities in US, Canada and Europe. I have also been team leader for the Pharmacology sub-team supporting several projects.

Featured Publication

A Humanized Monoclonal Antibody Targeting the Beta7 Integrin Selectively Blocks Intestinal Homing of T Lymphocytes.

Br J Pharmacol. 2011 Apr; 162(8): 1855–1870.

Stefanich EG, Danilenko DM, Wang H, O0Byrne S, Erickson R, Gelzleichter T, Hiraragi H, Chiu H, Ivelja S, Jeet S, Gadkari S, Hwang O, Fuh F, Looney C, Howell K, Albert V, Balazs M, Refino C, Fong S, Iyer S, Williams M.

View Abstract

Translational pharmacokinetics and pharmacodynamics of an FcRn-variant anti-CD4 monoclonal antibody from preclinical model to phase I study.

Clinical Pharmacology & Therapeutics, 2011; 89 (2):283-290.

Zheng Y, Scheerens H, Davis JC Jr, Deng R, Fischer SK, Woods C, Fielder PJ, Stefanich EG.

View Abstract

Therapeutic area lead for Immunology, Metabolic disease, Infectious disease, and Neurology. Accountable for translational pharmacology from early stage research through first in human clinical trials for large molecule therapeutics.

Pharmacology sub-team leader for Immunology and Cancer Immunotherapy related therapeutics. Accountable for nonclinical activities related to development of new therapeutics from Research through clinical development. Represent Development Sciences on the project core team and support key development decisions.

PK Scientist for Immunology and Cancer Immunotherapy related therapeutics on Pharmacology sub team. Supported selection of lead clinical candidate and project exposure-efficacy relationship based on preclinical disease models and projected human pharmacology. Supported toxicology studies and developed rationale for first inhuman dosing for new therapeutics. Wrote sections of regulatory filings for global Phase I studies and conducted pre-IND/CTA meetings with FDA, Canadian and European Health Authorities.

Performed due diligence on business development deals relating to PKPD and clinical dose and dose schedule.

Group leader of three Scientist and four Principal Scientific Researchers.

Mitigating the risk of cytokine release syndrome in a Phase I trial of CD20/CD3 bispecific antibody mosunetuzumab in NHL: impact of translational system modeling

npj Systems Biology and Applications,

Iraj Hosseini; Kapil Gadkar; Eric Stefanich; Chi-Chung Li; Laura Sun; Yu-Waye Chu; Saroja Ramanujan

Nonclinical safety assessment of a human interleukin-22FC IG fusion protein demonstrates in vitro to in vivo and cross-species translatability

Pharmacology Research and Perspectives,

Donna Lee; Shelly Zhong; Rama Pai; Julie Rae; Sid Sukumaran; Eric Stefanich; Jeff Lutman; Estelle Doudement; Xiaoting Wang; Brandon Harder; Annemarie N. Lekkerkerker; Ann Herman; Wenjun Ouyang; Dimitry Danilenko

Pre-clinical and translational pharmacology of a human interleukin-22 IgG fusion protein for potential treatment of infectious or inflammatory diseases

Biochemical Pharmacology, ISSN: 18732968 00062952

Eric Stefanich; Julie Rae; Sid Sukumaran; Jeff Lutman; Annemarie N. Lekkerkerker; Wenjun Ouyang; Xiaoting Wang; Donna Lee; Dimitry Danilenko; Lauri Diehl; Kelly Loyet; Ann Herman

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Eric Stefanich

Senior Scientist and Group Leader, Preclinical and Translational PKPD (PTPK)

Featured Publication

A Humanized Monoclonal Antibody Targeting the Beta7 Integrin Selectively Blocks Intestinal Homing of T Lymphocytes.

Translational pharmacokinetics and pharmacodynamics of an FcRn-variant anti-CD4 monoclonal antibody from preclinical model to phase I study.