I help therapeutic programs become development-ready by connecting disease biology, biomarker strategy, assay validation, and translational decision-making.
Translational R&D leader with 12+ years across oncology, preclinical drug discovery, biomarker development, molecular diagnostics, and early drug development.
Principal Scientist, Tessering Biosciences · Scientific Advisor, Episteme Prognostics · New York, NY
Arturo Orlacchio, PhD
About me
I work across target validation, mechanism-of-action studies, in vivo pharmacology, biomarker development, and analytical validation. My experience includes support for two New York State CLEP submissions and current responsibility for assay strategy, lead optimization, translational pharmacology, and nonclinical development planning.
I combine scientific depth with structured execution: experimental design, CRO and vendor coordination, reproducible data analysis, SOPs, QC frameworks, and development-focused documentation.
Translational & Preclinical Development
Model strategy, mechanism-of-action studies, in vivo pharmacology, lead-optimization support, and nonclinical planning.
Biomarkers & Molecular Diagnostics
Biomarker discovery, analytical validation, IHC, chromatin accessibility, NGS, liquid biopsy, and CDx-relevant assay development.
Rigorous Program Execution
Quality by Design, reproducible Python workflows, statistical process control, CRO coordination, SOPs, and QC systems.
Career
Translational scientist with 12+ years across oncology, preclinical drug discovery, biomarker development, and molecular diagnostics, with work in pancreatic, lung, and thyroid cancers and, currently, early small-molecule drug development.
Lead translational and preclinical strategy for an early-stage small-molecule drug-development program, defining assay strategy, lead-optimization studies, translational pharmacology, and the nonclinical roadmap toward candidate selection and IND-enabling development. Design and execute the in vitro pharmacology, ADME, and PK/PD studies that support lead optimization, characterizing compound potency, selectivity, and developability. Build the company's core R&D infrastructure: laboratory operations, external study coordination, vendor and CRO management, documentation systems, and reproducible experimental workflows.
Progressed from Senior Scientist to Principal Scientist before transitioning to an advisory role. Led the pancreatic cancer biomarker program, advancing two laboratory-developed tests, an IHC assay and a chromatin-accessibility (ATAC) assay, from discovery through analytical validation (pooled precision 3.28% CV; inter-operator ICC 0.989; performance evaluation in 29 clinically characterized PDAC specimens) and New York State CLEP submission. Authored SOPs, validation plans, and CLIA/CLEP-aligned QC frameworks that established validated input requirements, precision criteria, traceability controls, and objective assay acceptance thresholds. Coordinated a four-site prospective validation study extending the assay from resected tissue to fine-needle biopsy specimens, serving as point of contact for site investigators, assembling longitudinal clinical follow-up, and analyzing overall and progression-free survival. Continue to provide scientific and translational guidance as the platform advances toward the clinic.
Led preclinical drug-discovery efforts in pancreatic ductal adenocarcinoma (PDAC) to improve the efficacy of epigenetic therapies and immune checkpoint inhibitors. Built multi-cell co-culture systems modeling the tumor–immune microenvironment, executed orthotopic in vivo studies with survival endpoints, and integrated flow cytometry, cytokine profiling, and RNA-seq. Showed that low-dose dual epigenetic therapy combined with anti-PD1 reverses an HMA-induced suppressive myeloid phenotype and prolongs survival in an orthotopic PDAC model.
Led NSCLC studies that uncovered a previously unrecognized role for the CTLH E3 ubiquitin ligase complex (the RANBP9/RANBP10 "rheostat") in tumor progression and therapy resistance. Generated multiple GEMMs and 20+ stable isogenic cell lines powering mechanistic studies and high-throughput screening; findings established RANBP9/RANBP10 as candidate therapeutic targets and linked RANBP9 to platinum sensitivity and a PARP-inhibitor "BRCAness-like" vulnerability.
Identified AGC-family kinases, notably SGK1, as essential, AKT-independent drivers of PI3K-driven thyroid cancer survival. Established primary thyrocyte cultures, generated 20+ engineered cell lines, and supported 100+ in vivo and in vitro studies, including industry collaborations to screen and validate small-molecule kinase inhibitors.
Selected projects
Spanning translational oncology, biomarker and diagnostic development, immuno-oncology, and target discovery. Each case study highlights the scientific question, experimental approach, and evidence generated to inform translational or development decisions.
Development of Epigenetic Biomarkers and Diagnostic Platforms
Led the development and analytical validation of epigenetic biomarker assays for pancreatic cancer, centered on an ATAC-array platform measuring chromatin-accessibility signatures in clinically derived samples.
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Enhancing Epigenetic and Immunotherapy Efficacy in PDAC
Preclinical studies identifying and validating therapeutic targets for combination strategies involving epigenetic therapies and immune checkpoint inhibition.
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RANBP9 and RANBP10 Regulation of the CTLH Complex in NSCLC
Investigated how two paralogous scaffold proteins within the CTLH E3 ubiquitin ligase complex regulate non-small cell lung cancer cell growth.
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AGC Kinase Screening and PI3K Pathway Validation in Anaplastic Thyroid Cancer
A target-discovery program using genetic and pharmacological perturbation to identify AGC-family kinases with functional roles in PI3K signaling.
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Conditional Knockout Analysis of IWS1 in Mouse Development
Generated and characterized a conditional Iws1 knockout mouse model to investigate the in vivo function of this RNA polymerase II–associated transcription elongation factor.
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Computational Portfolio
CI-tested Python analysis workflows supporting preclinical decision-making: IC50/dose-response and drug-combination synergy, PK/PD and tumor-growth-inhibition modeling, Kaplan–Meier/Cox survival analysis, ROC/AUC, statistical process control (Westgard/Levey-Jennings), and RNA-seq/ATAC-seq exploratory analysis, with reference implementations on synthetic and public data.
Publications & scientific output
Author or co-author of 15 peer-reviewed publications and 15 conference presentations and posters, listed below; see Google Scholar for the complete record. Work spans translational oncology, tumor microenvironment biology, chromatin and epigenetic regulation, and preclinical cancer models.
Peer-reviewed publications
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Conference posters & presentations
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Let's connect
I'm open to research collaborations, scientific advising and consulting, speaking opportunities, and conversations with others working to make translational science more rigorous and reproducible.