Nick Staten

Nick Staten Email and Phone Number

Medical Devices & Imaging Agents: Pre-clinical & Clinical Development @
Nick Staten's Location
St Louis, Missouri, United States, United States
About Nick Staten

Innovative leader with a track record of success in medical/healthcare including medical devices, small molecule drugs, and biologics. Expertise in biotechnology, image-guided surgical devices, in vitro diagnostics (IVDs), medical device coatings, and theranostics. Entrepreneurial, efficient, and forward-thinking approached have led to successful progression of projects from Discovery through Clinical Development and Commercialization. FDA submissions including Investigational New Drug (IND), Premarket notification 510(k), de novo, and Combination Products. Design & execution of Preclinical & Clinical Studies. Working knowledge in Regulatory, Quality Management System (ISO 13485 standard & FDA Code of Federal Regulations (CFR) 21§ 820.30), Design Controls, full Product Design & Development, and Biocompatibility (ISO 10993), and Software as a Medical Device (SaMD).

Nick Staten's Current Company Details
Integro Theranostics (a Kingdom Capital portfolio company)

Integro Theranostics (A Kingdom Capital Portfolio Company)

Medical Devices & Imaging Agents: Pre-clinical & Clinical Development
Nick Staten Work Experience Details
  • Integro Theranostics (A Kingdom Capital Portfolio Company)
    V.P Product Development
    Integro Theranostics (A Kingdom Capital Portfolio Company) Jan 2020 - Present
    Greater St. Louis Area
    Developing new products for real-time intraoperative image-guided surgeries including cancer imaging agent LS301-IT (Leading Preclinical & Nonclinical Development; Design of NCT05900986 Clinical Study Objectives & Endpoints; Commercial Indications). Designing & developing augmented reality (AR), mixed reality (MR), and extended reality (XR) devices to visualize novel fluorescence tumor-targeting agents during surgery for complete removal of tumors. Exploring opportunities to incorporate… Show more Developing new products for real-time intraoperative image-guided surgeries including cancer imaging agent LS301-IT (Leading Preclinical & Nonclinical Development; Design of NCT05900986 Clinical Study Objectives & Endpoints; Commercial Indications). Designing & developing augmented reality (AR), mixed reality (MR), and extended reality (XR) devices to visualize novel fluorescence tumor-targeting agents during surgery for complete removal of tumors. Exploring opportunities to incorporate predictive analytics and artificial intelligence (e.g., machine learning, deep learning) into the operating room to improve patient treatment and care. Check us out: https://integrotheranostics.com/ Show less
  • Washington University School Of Medicine In St. Louis
    Medical/Healthcare Technologies
    Washington University School Of Medicine In St. Louis Dec 2016 - Jan 2020
    Greater St. Louis Area
    Applying industry experience to de-risk and develop novel medical devices, technologies, and therapeutics in the university for transfer to industry partners and translation to clinics, hospitals, and homes. Current products include: 1) Molecular imaging system including cancer viewing goggles (augmented/mixed reality) and tumor-specific contrast agent to aid in surgical removal of tumors, and 2) Unique medical device coatings that minimize tissue damage, blunt inflammation, reduce pain, and… Show more Applying industry experience to de-risk and develop novel medical devices, technologies, and therapeutics in the university for transfer to industry partners and translation to clinics, hospitals, and homes. Current products include: 1) Molecular imaging system including cancer viewing goggles (augmented/mixed reality) and tumor-specific contrast agent to aid in surgical removal of tumors, and 2) Unique medical device coatings that minimize tissue damage, blunt inflammation, reduce pain, and minimize infections. Additional early-stage development projects include novel drug combinations for new therapeutic uses in immuno-oncology, infectious diseases, autoimmune diseases, and wound care. Also, development of Regulatory strategy for Software as a Medical Device (SaMD) for artificial intelligence (machine & deep learning) and for wearables & smartphones (Apps). Show less
  • Kypha, Inc.
    V.P., Technology & Product Development
    Kypha, Inc. 2011 - Dec 2016
    S. Louis, Mo
    Responsible for development and implementation of Kypha's patented rapid diagnostic tests in a dozen clinical settings across the USA including clinics, ICUs, and reference testing labs. Also responsible for the portfolio of point-of-care Comp ACT Assays which are being developed for diagnosing and monitoring of acute infections, trauma, and auto-immune diseases. Applying FDA Regulatory requirements including Quality Management System and Design Controls while developing novel, rapid… Show more Responsible for development and implementation of Kypha's patented rapid diagnostic tests in a dozen clinical settings across the USA including clinics, ICUs, and reference testing labs. Also responsible for the portfolio of point-of-care Comp ACT Assays which are being developed for diagnosing and monitoring of acute infections, trauma, and auto-immune diseases. Applying FDA Regulatory requirements including Quality Management System and Design Controls while developing novel, rapid single-plex and multiplex diagnostic products for use in point-of-care IVDs, for analytical/process development, and for research purposes only. Products serve the medical, companion animal, and agriculture industries as well as the Dept. of Defense. Expertise with lateral flow, gravity flow, vacuum flow, and microfluidic/lab-on-a-chip platforms for detection of proteins and nucleic acids. Show less
  • Glg - Gerson Lehrman Group
    Council Member
    Glg - Gerson Lehrman Group 2003 - 2016
  • Pfizer
    Molecular & Protein Diagnostic Biomarker Development
    Pfizer 2003 - 2010
  • Pharmacia Corporation
    Genomics: High Throughput Cloning, Sequencing, And Gene Expression
    Pharmacia Corporation 2000 - 2003
  • Monsanto Company (Searle Pharmaceuticals)
    Oncology And Inflammation Biotherapeutics
    Monsanto Company (Searle Pharmaceuticals) 1994 - 2000
  • Monsanto Company
    Recombinant Proteins/Biologics/Biotherapeutics
    Monsanto Company 1985 - 1994

Nick Staten Skills

Assay Development Biotechnology Genomics Medical Diagnostics Biomarkers Protein Chemistry Drug Discovery Molecular Biology Business Development Product Development Biochemistry Biomarker Discovery Dna Sequencing Oncology Rapid Microfluidic Assays Lateral Flow Assay Clinical Diagnostics Multiplex Biomarker Diagnostic Product Development Biomarker Identification And Characterization New Technology Assessment And Development Biomarker Development Characterization Technology Evaluation Fda 510 And De Novo Submissions Design Verification And Validation Design Control Analytical And Clinical Validation Studies Quality Management System Contract Manufacturing Oem

Nick Staten Education Details

Frequently Asked Questions about Nick Staten

What company does Nick Staten work for?

Nick Staten works for Integro Theranostics (A Kingdom Capital Portfolio Company)

What is Nick Staten's role at the current company?

Nick Staten's current role is Medical Devices & Imaging Agents: Pre-clinical & Clinical Development.

What is Nick Staten's email address?

Nick Staten's email address is no****@****ail.com

What is Nick Staten's direct phone number?

Nick Staten's direct phone number is +131493*****

What schools did Nick Staten attend?

Nick Staten attended University Of Illinois At Urbana-Champaign.

What skills is Nick Staten known for?

Nick Staten has skills like Assay Development, Biotechnology, Genomics, Medical Diagnostics, Biomarkers, Protein Chemistry, Drug Discovery, Molecular Biology, Business Development, Product Development, Biochemistry, Biomarker Discovery.

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