Research Associate Clinical Trials

Durgadevi Ravillah PhD

Senior Research Associate

Case Western Reserve University, Comprehensive Cancer Centre ***********.****@*****.*** +1-405-***-****

Professional Summary: Self- motivated and highly experienced researcher (Over 10 years) with a demonstrated success in early drug discovery and translational research with an overarching goal to support successful development of novel cancer treatments from preclinical models to clinical trials in the fields of rare cancer diseases as well as Immuno-oncology. Expertise in identifying novel therapeutic targets and biomarkers, validating the lead/potentialcandidates using multi-omics approaches and testing drug efficacy in both in vitro and in vivo (Xenograft and Patient derived models). Proven success in progressing drug candidates from preclinical models to clinical trials resulting in securing over $18M in research funding. Proficiency in experimental design and managing scientific projects by meeting aggressive deadlines, strong problem-solving skills and ability to work independently and collaboratively across cross functional teams to drive outcome for impactful research besides presenting impactful research findings at International Conferences as well as high impact journal publications. Education

PhD, Experimental Pathology University of Oklahoma Health Sciences Centre, OK 2013

Thesis: "HDAC2 in Colon Tumor Progression and as Potential Target for Chemoprevention and Treatment"

MBA, Health Care Services Management Oklahoma Christian University, OK 2009

Key Skills

Drug Discovery & Development: Preclinical evaluation studies (Xenograft and Patient derived models) to evaluate lead drug candidate including small molecule inhibitors, therapeutic target identification, novel nanobody Antibody Drug Conjugate (ADC) in vitro and in vivo testing, CAR-T/NK design, development in vitro and in vivo testing, mechanism of action and dose-response studies.

Oncology & Immuno-oncology: Cancer treatments, biomarker discovery, gastrointestinal cancers (Esophagus, stomach and colon), hematological malignancy including Multiple Myeloma.

Molecular & Cellular Biology: Aseptic cell culture techniques (primary and cancer cell lines), DNA and RNA extraction and purification, TOPO cloning, CRISPR/Cas9 gene editing, stable cell line generation using TET-ON Dox inducible shRNA, Lentiviral transduction, viral packaging and lentivirus production using primary cell lines, determining optimal MOI using viral titre (infection units per ml), and non-viral methods including transient transfection using siRNA, Lipid Nanoparticles (LNPs), LNA- gapmers, Electroporation, DNA damage calorimetric assays, Immunohistochemistry, Immunofluroscence, cell line development

(including PDX-derived), 3D organoid cultures, generating organoids from human iPSCs, isolation of PBMNCs, plasmacytoid Dendritic cells from patients, stable line generation flow cytometry, western blotting, qPCR.

In Vivo Models: GEMM (knock-in, knock-out), patient-derived xenografts (PDX), immune- deficient models (therapy resistant or immune-oncology mouse models), standard cemoprevention models (APC min/+), drug administration (oral, IP, IV, SC), administration of carcinogens (AOM, MNU, colitis agents such as DSS, bile acid such as DCA in diet/water), in vivo imaging, breeding and genotyping (SNP validation by sanger sequencing and Pyrosequencing- SNP genotyping and quantification of DNA methylation at specific CpG sites). Highly experienced in drafting and amending IACUC protocols, serving as Exposure control officer abiding to CHP guidelines.

Research & Project Management: Experimental design, scientific project management, aggressive deadline management, manuscript drafting, coordinated and led cross-functional teams including internal research team members and collaborated with external CROs to execute preclinical studies that supported Investigational New Drug applications.

Regulatory: Familiarity with cGMP, SOPs, early-stage clinical trial documentation.

Data Analysis: Next- Generation sequencing (SOLiD platform), FlowJo, ImageJ, GraphPad Prism, cell cycle analysis using GUAVA MUSE, cell imaging analysis using Celleste Software, Incucyte Sarotorius live cell analysis, statistical analysis (t-test, Fisher's exact, Benjamini Hochberg correction), RNA sequencing analysis (Whole Transcriptome differential gene expression analysis), bioinformatics tools (NCBI, UCSC, GTEx), Benchling tools ( crispr.mit.edu,CHOPCHOP), proficient in using Endnote. Professional experience

Senior Research Associate Case Western Reserve University, Cleveland, OH March 2016 – Present

Drug Candidate Evaluation: Directed drug development efforts for gastrointestinal cancers by screening novel nanobodies, identifying lead candidates with target specificity, and evaluating their anti-tumor potential using in vitro and in vivo models.

Translational Research: Designed and Developed a novel gene-edited(CRISPR/Cas9) Genetically Engineered Mouse Model (GEMM) for familial BE/EAC, mimicking genetic and phenotypic human disease aspects. These preclinical models enabled translational research into early-stage biomarkers and therapeutic strategies.

Biomarker Discovery: Pioneered the identification of novel long intergenic noncoding RNAs

(LincRNAs) as potential biomarkers for the early detection of esophageal and gastric cancers using multi-omics approach.

Clinical-Stage Drug Development: Assessed the efficacy of small molecule inhibitors targeting key oncogenic pathways (TGFβR1, Ephb2/MYC) and identified novel predictive biomarkers for anti-TGFβR1 treatment response, contributing to a rationale for clinical trials.

Drug Resistance Mechanisms: Performed Preclinical studies to evaluate the response and resistance mechanisms of ALK5 inhibitors in Esophageal cancer models Mentorship: Trained and mentored junior scientists on experimental design and advanced laboratory techniques.

Inventory: Developed and deposited the patient-derived tumor xenograft (PDX) line, CW1474

(CRL3529), into the American Type Culture Collection (ATCC). Temporary industry experience Quality Control ORA Clinical Jan 2016 – Feb 2016 and Aug 2015 – Sep 2015

Implemented and documented Current Good Manufacturing Practice (cGMP) protocols for labeling investigational drugs used in early-stage clinical trials.

Ensured compliance with standard operating procedures (SOPs) and quality assurance practices for documentation.

Additional experience Volunteer Researcher Boston Children's Hospital, Boston, MA Sept 2015 – Nov 2015 and April 2015 – Aug 2015

Investigated molecular mechanisms underlying cardiac dysfunction and regeneration using both in vitro and in vivo models, contributing to translational research for pediatric patients. Postdoctoral Research Fellow Dana Farber Cancer Institute, Boston, MA, March 2014 – March 2015

Mechanism of action studies: Deciphered the role of the ubiquitin-proteasome pathway in multiple myeloma, determining proteasome activity and evaluating the mechanism of action of novel therapeutics in myeloma cell lines.

Quantified the efficacy of Mel-flufen, a novel alkylating agent, demonstrating its ability to overcome drug resistance in multiple myeloma using multiple in vitro assays (cytotoxicity, viability, immunofluorescence). Developed in vivo xenograft models to evaluate the dose- response effects and relative efficacy of immunomodulatory drugs.Analyzed complex interactions between tumor cells and bone marrow accessory cells (plasmacytoid dendritic cells) using advanced flow cytometry to identify potential therapeutic strategies. Graduate Research Assistant University of Oklahoma Health Sciences Centre, OK August 2009 – December 2013

Chemopreventive studies and Mechanism of action: Leveraged Next-Generation Sequencing to identify the relevance of HDAC2 overexpression in human colon tissues and cell lines, contributing to the understanding of colon tumor progression. Led preclinical studies in rat and mouse models (AOM-induced colon carcinogenesis, APC min/+) to assess the preventive and suppressive efficacy of HDAC inhibitors. Determined the molecular effects of targeting HDAC2 on key signaling pathways in preclinical cancer models. Publications: https://scholar.google.com/citations?user=8rLvVVkAAAAJ&hl=en. Presentations &Awards

Invited Platform Speaker (twice): Presented research on Mutations In Xanthene Dehydrogenase

(Xdh) Associated With Inherited Susceptibility To Barrett's Neoplasia and Transgenic Mouse Model Based On Vsig10l, The First Susceptibility Gene For Familial Barrett’s Esophagus at the Digestive Diseases Week (DDW) Annual Meeting (2019, 2023). Certificate of Recognition: Early Career Investigator for Platform Presentation at DDW (2019). Travel Awards: Case Comprehensive Cancer Centre Trainee Travel Awards (2019, 2023). Media

Featured Research: Multiple news articles published by Case Western Reserve University and Science Daily regarding discoveries in esophageal cancer therapeutics and biomarkers.

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