Michael E. Collison, Ph.D. Email & Phone Number

St Paul, Minnesota, United States

Responsible for reviewing, certifying and reporting drug and metabolite testing results for patient clinical samples in the pain management compliance testing program and for all clinical toxicology tests.

Greater Minneapolis-St. Paul Area

Standing Man, LLC provides new product R&D services to clients in medical device, clinical diagnostics, and pharmaceutical analysis industries.Standing Man develops and implements impactful, innovative, cGMP/cGLP-compliant solutions including: - new product research and development- existing product improvement- data and statistical analyses- technical white paper and report writing- intellectual property reviews, competitive analyses, due diligence- scientific project management- QA/QC compliance and documentation reviews- deviations and CAPA responses- SOP preparation and review- cleaning validations- oral and parenteral dosage formsPharmaceutical and chemical analysis and development expertise includes:- small molecule method development and validation- method transfers- analytical characterization of bulk APIs, reference standards, and drug products/dosage forms- cGMP/cGLP compliance- IND, NDA, CMC regulatory submissions- responses to inspections and audits- extractables and leachables analysesMedical device and clinical diagnostic expertise includes:- combination drug delivery devices (transcutaneous/iontophoretic, wearable/subcutaneous, and implantable)- human and veterinary point-of-care (POC) and near-patient diagnostics, - analysis of clinical samples including arterial and venous blood, capillary blood, serum, plasma, washed red blood cells (RBCs), urine, and interstitial fluid (ISF)- clinical analytes including blood gases, electrolytes, metabolites (glucose, blood urea nitrogen (BUN), creatinine, lactate), and nitric oxide- single-use and multi-use sensors- non-invasive, minimally invasive, and implantable sensors - macro and miniaturized planar electrochemical potentiometric and amperometric sensors and biosensors- self-assembled monolayers (SAMs) on glass, ceramic, metal, and electrode surfaces- control of surface coating, functionalization, and patterning of chemicals and biomolecules.

Roseville, Minnesota, Greater Minneapolis-St. Paul Area

Designed electrochemical sensor/biosensor Point-of-Care (POC) diagnostic tests for human and veterinary medicine customers. Developed single-use planar screen-printed sensors for the IRMA TruPoint POC system. IRMA analytes included hematocrit, blood gases (carbon dioxide, oxygen), electrolytes (hydrogen ion/pH, sodium, potassium, ionized calcium), and metabolites (glucose, creatinine, BUN/urea, lactate). Newly developed tests included the 3rd blood gas nitric oxide (NO) and its analogues S-nitrosylated hemoglobin (SNOHb) and iron-nitrosyl hemoglobin (HbFeNO). Blood NO, SNOHb, and HbFeNO link metabolic activity of tissue to hypoxic vasodilation regulation of local blood oxygen supply. Blood NO, SNOHb, and HbFeNO are recapitulating blood gas analysis as the triumvirate of NO, oxygen, and carbon dioxide gases.Developed scientific and R&D partnerships with subject matter experts (SMEs) in academia, industry, and government institutions. Partners included SMEs in: - NO physiology- planar electrode design and manufacturing- self-assembled monolayer (SAM) functionalization for regulating electrochemical, biological, and physical reactivities of sensor surfaces- microbiology for assuring cleanliness of laboratory, manufacturing, and ultrapure water distribution equipment.Wrote NIH (National Institutes of Health) SBIR grant proposals with SME partners.Managed and communicated scientific and R&D related timelines and performance metrics to executive leadership teams and investors.Supervised R&D scientists and interdisciplinary teams maintaining, improving, and troubleshooting manufacturing and existing product performance.Co-developed sensor algorithms, control circuits, user interface, and sensor test cartridges for next-generation IRMA TruPoint POC instrument.Provided QA/QC, continuous improvement, statistical, and sensor/instrument calibration support to meet product manufacturing and customer service needs.

Greater Minneapolis-St. Paul Area

Standing Man, LLC provides new product R&D services to clients in medical device, clinical diagnostics, and pharmaceutical analysis industries.See description above (2017 - present).

Eden Prairie, Minnesota, Greater Minneapolis-St. Paul Area

Directed a team of analytical scientists developing and validating cGMP-compliant small molecule analytical test methods to support formulation development, regulatory filings, product launch, and full-scale production of orally dissolving tablet pharmaceutical formulations. Managed project resources and timelines and reported progress against goals to management, executive leadership, and client company partners. Developed and validated methods including potency assays, impurity and related substance assays, tablet dissolution assays, and cleaning validation assays. Analytical techniques used included HPLC, GC, TLC, spectroscopy, titrimetry. Managed analytical method and technology transfers to QC laboratory.Designed and managed total analytical characterization, accelerated degradation, and extended stability studies.Established product specifications for quality, purity, strength, and stability of drug product formulations.Authored and reviewed technical SOPs.Provided analytical consulting to formulations scientists, new business development, and client company partners.

Greater Minneapolis-St. Paul Area

Standing Man, LLC provides new product R&D services to clients in medical device, clinical diagnostics, and pharmaceutical analysis industries.See description above (2017 - present).

Roseville, Minnesota, Greater Minneapolis-St. Paul Area)

Researched and developed single-use, point-of-care (POC) blood diagnostic tests for use on the IRMA TruPoint POC blood analysis system. The IRMA TruPoint introduced the world's first POC blood gas measurements. Annually, the IRMA TruPoint system provided millions of POC blood gas, electrolyte, and metabolite measurements to human and veterinary medicine customers in more than 50 countries around the globe.Developed electrochemical potentiometric and amperometric sensor and instrument systems for monitoring patient blood chemistries at the point-of-care.Led two biosensor development projects (glucose and lactate).Identified and corrected sensor and instrument failure modes and restored production and sales of Diametrics’ flagship disposable blood gas sensor cartridge product.Led a mutli-functional team of scientists, engineers, and statisticians in identifying shelf life limiters and extending shelf life of flagship disposable blood gas sensor cartridge products.Co-developed a combined blood gas and electrolyte sensor cartridge product.Developed quantitative return-on-investment financial models for biosensor product development projects.Developed market research on glucose test strip performance requirements of hospital critical care users.Co-developed and promoted corporate partnership between Johnson & Johnson and Diametrics to integrate the Lifescan test strip glucometer into Diametric’s point-of-care blood chemistry analyzer system.

Gaithersburg, Maryland

Researched and developed novel processes to immobilize and pattern biomolecules at gold electrode surfaces using nanoscale self-assembled monolayer (SAM) processes.Used electron beam (E-beam) deposition to fabricate highly reproducible, high purity, thin film metal coatings on substrates that included high purity silicon wafers, mica, and glass.Used wet chemistry and ultrasonic cleaning processes to produce ultra-clean substrate, bare metal, SAM functionalized, and biomolecule functionalized surfaces.Used photolithography to fabricate micron scale surface patterned alkylthiol SAMs and biomolecule functionalized SAMs.Used a variety of analytical techniques to test and characterize ultra clean substrates, high purity metal coatings, alkylthiol SAMs, and biomolecule functionalized surfaces. Analytical techniques included: - Optical and fluorescence microscopy - Atomic Force Microscopy (AFM) - Ellipsometry - Image analysis - Cyclic voltammetry (CV) - X-ray Photoelectron Spectroscopy (XPS) - Water-droplet contact angle wettability - Radio-labeled biomolecular binding assays - UV-Vis spectroscopy and microtiter plate UV-Vis assays - Fourier Transform Infrared Reflection Absorption Spectroscopy (FT-IRAS) - Biomolecule binding titrations

Indianapolis, Indiana

Directed a team of analytical scientists developing and validating analytical testing methods to support formulations development, regulatory submissions, product launches, and full-scale production of small molecule pharmaceutical products.Directed cGMP/cGLP-compliant analytical studies for IND and NDA regulatory filings.Represented analytical development function on corporate multidisciplinary product development teams that included drug discovery, process development, formulation, preclinical animal, toxicology, human clinical trial, regulatory, and marketing functions.As one of several senior scientists, established a new division of 42 analytical and formulations scientists and technicians. - New division was charged with reducing the time to first human dose for IND compounds - Included major analytical instrument evaluations and purchases.Performed total analytical characterization, accelerated degradation, and extended stability studies on bulk drug substances and dosage formsDeveloped new methods for validating the cleanliness of pharmaceutical manufacturing equipment and presented at national meeting establishing industry standard practices.Authored corporate guidelines for developing, validating and transferring pharmaceutical potency assays.Developed, validated, implemented, and transferred potency, impurity/related substances, tablet dissolution, and cleaning validation assays using a variety of analytical techniques (HPLC, GC, TLC, spectroscopy, radiometric, and others).Established product specifications for quality, purity, strength, and stability of bulk drugs and dosage forms.Established and characterized analytical reference standards for active pharmaceutical ingredients (APIs).Performed total analytical characterizations, accelerated degradation, and extended stability studies on bulk drug substances and dosage forms.Setup a division library for pharmaceutical analysis literature.

Bachelor'S Of Science (B.Sc.), Analytical Chemistry, 3.96/4.0

Bachelor's of Science, Analytical Chemistry, Research Advisor: Professor Mark A. Arnold Undergraduate Research: development of chemical.

Ph.D., Analytical Chemistry, 7.7/9.0

Thesis (advisor: Professor Mark E. Meyerhoff): "Advances in Potentiometric Chemical Sensing Systems for Clinical and Biochemical.