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Hire Thomas D.

United States

USD 150 /hr

Biotech R&D Consultant | Translational Study Design & In Vivo Model Development Strategy Expert

Profile Summary

I am a translational pharmacology and in vivo strategy consultant with over 15 years of experience advancing oncology, immuno-oncology, and autoimmune programs from early discovery through IND-enabling studies. My background bridges technical execution and program strategy—designing, leading, and performing preclinical studies that generate reproducible, clinically meaningful data. I work with emerging biotech teams to develop in vivo programs, establish CRO or contract vivarium partnerships, and build the scientific and operational foundation needed to move candidates confidently toward the clinic. Core Expertise & Services In Vivo Pharmacology & Model Development: Design and execution of tumor, immune, and inflammatory models, including syngeneic, CDX/PDX, orthotopic, fibrosis, and autoimmune platforms. Proven success developing models that reflect clinical biology and drive translational insight. Translational Study Design & PK/PD Strategy: Define dose ranges, schedules, and biomarker integration to support robust PK/PD interpretation and clinical translation. Preclinical Operations & Vivarium Setup: Guide biotech teams through CRO selection, vendor evaluation, and contract vivarium establishment, including protocol frameworks, workflow design, and compliance setup. Regulatory & IND-Enabling Support: Author and review IACUC protocols, SOPs, and study summaries supporting IND submissions; ensure regulatory alignment and inspection readiness. Hands-On Scientific Execution: Actively available for in vivo study execution, animal dosing and sampling, imaging, necropsy, and tissue processing across oncology, fibrosis, and autoimmune models. CRO Oversight & Study Direction: Provide end-to-end management of external studies—protocol development, execution oversight, data review, and integrated interpretation. Data Synthesis & Communication: Deliver concise, data-driven summaries, presentations, and decision frameworks that bridge discovery and development teams. Selected Achievements Directed in vivo pharmacology and translational strategy for six IND-enabling programs advancing into clinical development. Developed a radiation-induced pulmonary fibrosis (RIPF) model using the SmART+ IGRT platform and SmART-ATP software, combining focal lung irradiation, longitudinal µCT imaging, and histopathologic validation—now a reference model supporting fibrosis and oncology programs. Built and led pharmacology functions at Fate Therapeutics, supporting T-cell, NK-cell, and autoimmune therapy pipelines through model innovation and translational study design. Managed CRO and sponsor collaborations to deliver high-quality data, streamline project initiation, and ensure on-time, scientifically rigorous outcomes. Mentored and trained in vivo teams in study design, execution, and analysis to elevate technical and operational performance. Technical & Analytical Competencies In vivo execution: multi-species dosing (IV, IP, SC, PO, IT), tumor induction, immune profiling, fibrosis induction, necropsy, tissue harvest, and sample processing. Imaging & instrumentation: µCT/CT, IVIS, and SmART+ IGRT systems for focal irradiation and image-guided preclinical studies. Data & analysis: GraphPad Prism, ImageJ, SigmaPlot, Pathcore, translational data visualization and interpretation. Operational systems: Benchling, Smartsheet, SharePoint, Veeva Vault, Provantis, SciNote, MS Project. Regulatory documentation: IND submissions, IACUC and SOP development, GLP/AAALAC compliance, QA/QC practices. How I Work Engagements range from single-study design consults to long-term strategic support and hands-on in vivo execution. I frequently help clients identify suitable CRO partners, establish internal vivarium workflows, and design preclinical programs aligned with their mechanism and regulatory goals. Deliverables include study protocols, operational plans, vendor assessments, and decision-grade data summaries for regulatory or investor review. Ideal Partners Emerging biotech teams advancing oncology, immuno-oncology, or autoimmune therapeutics. Sponsors building or outsourcing in vivo capabilities. CROs or contract vivaria expanding preclinical services. Investors or consultants requiring translational due diligence and scientific validation. Availability Based in San Diego, available for remote strategy work and on-site, hands-on study execution. I collaborate with clients to design, execute, and interpret studies that accelerate development while ensuring scientific rigor and translational relevance.

Subject Matter Expertise

• ☆ Animal Science
• ☆ Animal Biotechnology
• ☆ Animal Welfare
• ☆ Molecular Biology
• ☆ Biomarkers
• ☆ Cell Biology
• ☆ Statistics
• ☆ Study Design
• ☆ Immunohistochemistry
• ☆ Drug Development
• ☆ Preclinical ADME/PK/PD
• ☆ Preclinical Research
• ☆ Preclinical Pharmacology
• ☆ In vitro Preclinical Toxciology
• ☆ In vivo Preclinical Toxicology
• ☆ Oncology
• ☆ Immunotherapy
• ☆ Autoimmune Disease
• ☆ Lupus
• ☆ Business Strategy
• ☆ Project Management

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing, General Proofreading & Editing, Translation

Research Feasibility Study, Gap Analysis, Gray Literature Search, Scientific and Technical Research

Consulting Business Strategy Consulting, Operations Consulting, Scientific and Technical Consulting

Data & AI Image Processing, Image Analysis, Data Visualization, Data Processing

Product Development Product Evaluation, Quality Assurance & Control (QA/QC), Product Compliance

Work Experience

Senior Manager / Senior Scientist

Fate Therapeutics (United States)

January 2020 - August 2025

Project Manager / Team Leader / Client Liaison

MI Bioresearch

April 2014 - June 2019

Research Associate II

MPI Research (United States)

May 2007 - August 2014

Education

Bachelor's of Science (Industrial Organizational Psychology)

Western Michigan University

January 2004 - April 2007

Certifications

• Certification details not provided.

Publications

JOURNAL ARTICLE

(2025). A novel CD3ε fusion receptor allows T cell engager use in TCR-less allogeneic CAR T cells to improve activity and prevent antigen escape . MOLECULAR THERAPY.

(2025). FT836, a Novel MICA/B-targeting CAR T-cell Therapy Engineered to Eliminate the Need for Conditioning Chemotherapy with Broad Activity Across Solid Tumor Indications. MOLECULAR THERAPY.

(2025). Targeting UPAR With Multiplexed-Engineered iPSC-Derived CAR T Cells to Reverse Age- and Insult-Related Fibrotic Disease. MOLECULAR THERAPY.

(2024). Novel a3-MICA/B-Specific CAR T-Cell Immunotherapy Demonstrates Ubiquitous Targeting of Cancer Cells and Resistance to Immune-Surveillance Evasion. MOLECULAR THERAPY.

(2023). A chimeric antigen receptor uniquely recognizing MICA/B stress proteins provides an effective approach to target solid tumors . MED.

(2022). COMBINING FT536, A PAN-TUMOR TARGETING CAR NK CELL THERAPY, WITH CD16 ENGAGERS PROVIDES A COORDINATED TARGETING STRATEGY TO OVERCOME TUMOR HETEROGENEITY . JOURNAL FOR IMMUNOTHERAPY OF CANCER.

(2022). Detection of genetically engineered iPSC-derived natural killer cells in blood and tissue. CANCER RESEARCH.

(2022). FT536: A First-of-Kind, Off-the-Shelf CAR-iNK Cell Product Candidate for Solid Tumors Designed to Specifically Target MICA/B Stress Proteins and Overcome Mechanisms of Tumor Evasion. MOLECULAR THERAPY.

(2022). OFF-THE-SHELF IPSC-DERIVED CAR-T CELLS TARGETING KLK2 DEMONSTRATE PROLONGED TUMOR CONTROL AND SURVIVAL IN XENOGRAFT MODELS OF PROSTATE CANCER . JOURNAL FOR IMMUNOTHERAPY OF CANCER.

(2022). PRECLINICAL IN VIVO MODEL DEVELOPMENT: HIGHLIGHTING SUCCESS AND DISCUSSING XENOGRAFT ADVANCEMENTS, A STEP CLOSER TO PREDICTING PATIENT OUTCOMES . JOURNAL FOR IMMUNOTHERAPY OF CANCER.

(2022). Quadruple gene-engineered natural killer cells enable multi-antigen targeting for durable antitumor activity against multiple myeloma . NATURE COMMUNICATIONS.

(2022). TARGETING COLD TUMORS USING IPSC-DERIVED CAR T CELLS DIRECTED TO THE IMMUNE CHECKPOINT MOLECULE AND TUMOR-ASSOCIATED ANTIGEN B7-H3 . JOURNAL FOR IMMUNOTHERAPY OF CANCER.

(2022). iPSC-Derived CD38-Null NK Cells in Combination with CD38-Targeted Antibody Represent a Novel Therapeutic Strategy to Avoid Host Immune Cell Rejection for Off-the-Shelf Cell-Based Cancer Immunotherapy. MOLECULAR THERAPY.

(2022). iPSC-Derived CD38-Null NK Cells in Combination with CD38-Targeted Antibody: A Dual Therapeutic Strategy to Enable ADCC and Eliminate Host Immune Cells in Multiple Myeloma . BLOOD.

(2021). FT536 PATH TO IND: UBIQUITOUS TARGETING OF SOLID TUMORS WITH AN OFF-THE-SHELF, FIRST-OF-KIND MICA/B-SPECIFIC CAR-INK CELLULAR IMMUNOTHERAPY . JOURNAL FOR IMMUNOTHERAPY OF CANCER.

(2021). FT536: Preclinical development of a novel off-the-shelf CAR-MICA/B NK cell immunotherapy combined with radiation and antibody treatments as a first-of-kind pan-cancer targeting strategy. CANCER RESEARCH.

(2021). Harnessing features of adaptive NK cells to generate iPSC-derived NK cells for enhanced immunotherapy . CELL STEM CELL.

(2021). Off-the-Shelf, Multiplexed-Engineered iPSC-Derived NK Cells Mediate Potent Multi-Antigen Targeting of B-Cell Malignancies with Reduced Cytotoxicity Against Healthy B Cells . BLOOD.

(2021). Off-the-Shelf, iPSC-Derived CAR-NK Cells Multiplexed-Engineered for the Avoidance of Allogeneic Host Immune Cell Rejection. BLOOD.

(2017). Focal radiation enhances paclitaxel therapy in a mouse model of triple negative breast cancer . CANCER RESEARCH.

(2017). Image-guided focal irradiation in syngeneic preclinical oncology mouse models . CANCER RESEARCH.