Rupa Guha

Translational oncology scientist with 10+ years of combined industry and academic experience driving antibody and small molecule programs from target validation through IND clearance. PhD research generated the preclinical efficacy and mechanistic data package that enabled FDA IND clearance for AG01, a first-in-class anti-progranulin antibody now in Phase I for advanced solid tumors (NCT05627960). Industry track record includes leading biomarker strategy and in vivo pharmacology for bispecific antibody programs, managing CRO partnerships, and contributing regulatory-aligned documentation to multiple IND submissions.

Co-inventor on U.S. Patent 9,498,507 B2.

Research Scientist (Postdoctoral) at UCSF, Department of Radiation Oncology (2023-01 – Present)

• Investigating mechanisms of therapeutic resistance in TNBC using 8 engineered cell line models, focusing on MAP3K8-driven stress-adaptive signaling, in combination studies with radiation and chemotherapy, identifying clinically actionable resistance nodes and combination strategies.
• Characterizing small molecule inhibitors and PROTAC/targeted protein degraders against stress-response signaling pathways (MAP3K8), including gene regulation analysis of MAP3K8 transcriptional control via IL-1 signaling.
• Analyzing clinical significance using clinical datasets from drug-resistant tumors, integrating bioinformatics (R programming) with functional in vitro validation.
• Screened drug combinations targeting parallel signaling pathways in KRAS G12C colorectal cancer models, evaluating synergy and resistance mechanisms to guide translational combination strategies.

Senior Scientist I at Hengenix (Henlius US) (2022-01 – 2022-12)

• Directed translational biomarker strategy for 2 bispecific antibody candidates in a immuno-oncology program, designing pharmacodynamic endpoints to be integrated into the clinical protocol.
• Designed and executed humanized tumor model efficacy studies, generating dose-response and PK/PD data that informed lead candidate prioritization and go/no-go decisions.
• Collaborated cross-functionally with clinical and discovery teams to align preclinical data with IND filing strategy and clinical development timelines. Authored regulatory-aligned preclinical study summaries for IND.

Staff Scientist at ABL, Inc. (CRO) (2020-01 – 2021-12)

• Led development, optimization, and qualification of immunogenicity and functional immune assays (immune cell coculture, cytokine release, ELISpot, FluoroSpot, multi-parameter flow cytometry) supporting IND submissions across oncology and viral vaccine programs.
• Served as scientific liaison between ABL and 4+ sponsor companies, aligning bioanalytical assay design and validation strategy with FDA regulatory expectations and GLP requirements.
• Contributed to successful NIH grant proposal for vaccine development study.
• Achieved 98% on-time study completion rate, managing concurrent timelines for multiple sponsors.

Industry Scientist at Piramal Life Sciences Ltd & Sun Pharma Advanced Research Center (2005-01 – 2011-12)

• Conducted IND-enabling in vivo pharmacology, GLP toxicology and genotoxicity studies across rodent and non-rodent models spanning multiple small molecule drug discovery and development programs, contributing data to 2 U.S. IND submissions.
• Developed and implemented efficacy studies for small molecule candidates, generating dose-response, tolerability, and preliminary PK data for 5+ preclinical programs.
• Co-inventor on U.S. Patent 9,498,507 B2 for Viracure (PP-9706642), an antiviral therapeutic that completed a Phase II clinical trial (CTRI/2011/05/001706). The research resulted in peer-reviewed publications and international conference presentations (ICAAC 2010, 2012).
• Collaborated with medicinal chemistry, DMPK & formulation teams to optimize lead compounds for IND-enabling.
• Collaborated with 3 cross functional teams to support FDA regulatory communications, contributed crucial preclinical pharmacology/ toxicology data to U.S. IND submission packages.

Ph.D. in Toxicology (Cancer Biology) – University of Maryland, Baltimore (2013-08 – 2020-01)