Genentech: Sandhya Girish | Senior Director and Senior Scientist, Global Head Oncology, Clinical Pharmacology

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Scientists / Our Scientists

"Working at Genentech is a dream come true; you are in the midst of talented, passionate and extremely bright scientists who constantly motivate and inspire you to accomplish more. I feel fortunate to have the opportunity to implement clinical pharmacology and quantitative strategies and in bringing potential new treatment options to the forefront of patient care."

Years at Genentech

Publications

Awards & Honors

I have more than 20 years of pharmaceutical industry experience in the discovery, development and approval of large and small molecules, including antibody-drug conjugates (ADCs/TDCs) with a focus on quantitative clinical pharmacology, PK/PD, drug metabolism, and translational sciences . As the Senior Director of Oncology, my group currently provides global clinical pharmacology support for all gRED oncology molecules in our portfolio both marketed and those in various stages of clinical development. In addition I serve as a member and Chair of Clinical Pharmacology Leadership Group (CPLG), International Consortium for Innovation and Quality (IQ). During my 12-year tenure at Genentech, I have held varying levels of seniority starting out as a scientist/individual contributor on project teams, senior scientist, pharmacology sub team cross functional leader, clinical pharmacology group leader and Associate Director.

Prior to Genentech, I was a Senior Scientist with Novartis and Genesoft Pharmaceuticals where I provided strategic support in drug discovery and development for oncology and infectious diseases. I have also been a study director and a co-principal investigator for pharmacokinetics and drug metabolism studies at Stanford Research Institute (SRI) International.

Featured Publication

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.

Clin Pharmacokinet. 2013 Aug;52(8):657-72.

Lu D, Joshi A, Wang B, Olsen S, Yi JH, Krop IE, Burris HA, Girish S.

View Abstract

Catabolic fate and pharmacokinetic characterization of trastuzumab emtansine (T-DM1): an emphasis on preclinical and clinical catabolism.

Curr Drug Metab. 2012 Sep 1;13(7):901-10.

Shen BQ, Bumbaca D, Saad O, Yue Q, Pastuskovas CV, Khojasteh SC, Tibbitts J, Kaur S, Wang B, Chu YW, LoRusso PM, Girish S.

View Abstract

As the Senior Director of Oncology, Clinical Pharmacology our group provides strategic clinical pharmacology support for all gRED oncology molecules in our portfolio, including small molecules (cobimetinib, vismodegib, erivedge etc), monoclonal antibodies (bevacizumab, trastuzumab, and pertuzumab) and antibody drug conjugates (ADCs/TDCs such as ado-trastuzumab emtansine), cancer immunotherapy (Atezolizumab, etc) and heme-oncology (Venetoclax, Polatuzumab Vedotin, etc) molecules. In collaboration with clinical scientists and other researchers we continue to implement conventional, adaptive and innovative Phase I/II and III trial designs to inform drug development and enable decision making. My group also oversees the regulatory submissions in support of new drug/biologics approval which includes the clinical pharmacology strategy for the submission and the prescribing information. We ensure that preclinical, post approval and research data are appropriately integrated with clinical pharmacology and modeling and simulation strategy to ensure that right dose/schedule/route decisions are made in support of the new drug entity or new platforms (eg. ADC, T-cell dependent bispecifics or cancer vaccines). We also take pride in characterizing the pharmacokinetics (drug disposition, absorption, metabolism and elimination) of drugs and integrating state of the art modeling strategies to better understand drug exposure and response (safety/efficacy) relationships and determining any dose adjustments needed for special populations (eg, pediatrics, elderly, organ impairment, ethnicity etc) for various projects across multiple therapeutic areas. Additionally, our group is passionate about implementing quantitative approaches to drug development for novel combinations including cancer immunotherapy (CIT) and heme-oncology molecules.

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: 07248741

Dan Lu; Tong Lu; Rong Shi; Leonid Gibiansky; Priya Agarwal; Colby S. Shemesh; Randy Dere; Uzor Ogbu; Jamie Hirata; Pascal Chanu; Sandhya Girish; Jin Yan Jin; Chunze Li; Dale Miles

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

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Sandhya Girish

Senior Director and Senior Scientist, Global Head Oncology, Clinical Pharmacology

Featured Publication

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.

Catabolic fate and pharmacokinetic characterization of trastuzumab emtansine (T-DM1): an emphasis on preclinical and clinical catabolism.