Chuck Caldwell Email and Phone Number

Leading a team of subject matter experts to develop translational biomarker strategies supporting the development of Pfizer's early-stage clinical programs. Ensuring innovative strategies will enable program de-risking, data-driven decision making, finding the right dose, and selecting the right patients for treatment. Working across functions to develop, revise, and streamline processes for efficient operational execution.

• Supporting Seagen's oncology clinical trials by designing and executing translational strategies with a focus on early-stage, first-in-human trials of antibody-drug conjugates, immunotherapies, and bispecific T cell engagers• Developing growing team of direct reports to execute translational strategies for early-stage assets. • Advising governance and program teams on biomarker strategies to support molecule development, launch, lifecycle management • Facilitating collaborations between clinical biomarkers and research to inform early data for clinical program translation, reverse translation.• Leading efforts for biomarker technology standardization, evaluation, and implementation across programs

Supporting Seagen's clinical trials by designing and executing biomarker strategies to understand mechanisms related to drug response, resistance, and efficacy - with the overall goal of moving developed drug candidates through clinical stages. Devising scientifically sound biomarker plans and communicating data and program impacts to project teams and working with translational, clinical, and regulatory groups. Collaborating closely with Clinical Development Operations, Biometrics, and Bioinformatics functions to manage timely testing and data analysis of clinical trial samples. Maintaining state of the art knowledge of biomarker approaches to support Seagen's current and emerging pipelines in oncology and immune oncology fields.

•Manage team of biological and data scientists to design and execute biomarker strategies supporting clinical trials for small and large pharma companies•Supervise staff at the direct report or team project level who are working in areas to identify, interpret and provide data and strategies in support of client focused assay, clinical trial support, and clinical/companion diagnostic development•Lead internal research & development projects that ensure Flagship assay and data capabilities are up to date with client expectations and market needs•Formed collaborations with industry and academic partners to expand scientific presence and synergistic capabilities

•Consulted for academic and pharmaceutical clients on tissue-based immune oncology biomarker strategies to support retrospective or prospective analysis of patient clinical trial samples•Worked with histotechnicians, data analysts, and pathologists to develop assays and image analysis solutions to support clinical studies•Oversaw internal execution of biomarker and analytical strategies •Assisted sales team to engage potential new clients and discuss their scientific needs for characterization of drug efficacy and patient response•Worked in tandem with a multi-disciplinary team of pathologists, biologists, analysts, software engineers, and technicians to complete projects•Contributed to patents, white papers, publications, posters, and other scientific communications as requested

•Investigated clinical application of biomarkers in the field of immune oncology such as STING, HVEM, PVR, IDO1, PD-L1, CD73, CTLA4, and related proteins•Worked cross-functionally with pathologists and technologists to design and execute research studies•Collaborated with histotechnologists to develop IHC biomarker assays in a CLIA-certified lab containing platforms from major vendors (Roche, Dako, Leica)•Developed multiplexed IHC panels for both fluorescent and brightfield applications to investigate costimulatory pathways in immune oncology•Utilized HTG EdgeSeq platform to assay targeted genomic panels of RNA expression and their biomarker utility in cancer diagnosis•Used Leica Bond autostainer platform to automate peptide-based IHC developed at the University of Missouri. Networked with Companion DX Engineers and Product Managers to gain industry support for IHC development•Investigated tumor biomarkers using emerging technologies such as the Proximity Detection, Discovery DNA Extraction, and RNAscope platforms•Networked with researchers, clinicians, and companies to form collaborations, secure contracts, and obtain samples for biomarker investigations

• Researched oncology diagnostic applications of peptide-based nanotechnologies in a translational research focused lab• Developed IHC and flow cytometry assays on cell lines and clinical samples using proprietary anti-PDL1 peptide• Worked with pathologists to compare peptide-based PDL1 diagnostic to FDA-approved antibodies in a clinical setting• Developed PD-L1 targeted magnetic resonance probe for in vivo imaging of PD-L1• Performed experiments in mouse models analyzing PDL1 peptide targeting in tumors• Conjugated anti-HMGA2 aptamer to nucleolin antibody to deliver aptamer to retinoblastoma cell lines and performed cytotoxicity assays on the construct• Designed epidermal growth factor (EGF)-peptide-conjugated gold nanorods and developed methods to detect binding to EGF receptors (EGFR) in cell cultures• Created gold nanorod-based IHC platform for investigating EGFR and cMET biomarkers in tissue sections using novel microscopy techniques• Received multiple rounds of funding from the Wallace H. Coulter Translational Partnership to fast-track nanorod IHC platform for commercialization• Founded Columbia Diagnostics, LLC to continue translational work on novel peptide-based diagnostics• Interacted with university tech transfer office and potential investors interested in licensing intellectual property

• Provided oversight on Coulter funded project aimed at developing a novel sensor for monitoring oxygen intake and apnea in newborns in a NICU setting• Met with team members, discussed project milestones and adherence to timelines• Strategized with university IRB, FDA consultants, and Coulter oversight committee• Analyzed market and potential industry partners for licensing and commercialization