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Immunogenicity & Immune Safety Testing, Risk Assessment & Mitigation Planning

Bioanalytical & Ligand Binding Assays

Protein / Peptide Therapeutics

Regulatory & Quality

CMC Support

Clinical Trials Statistics & Outcomes Research

Careers Analytics Consultants IT / SAS Programmers		About Us Fact Sheet History Management Rocco Brunelle, M.S. Ronald R. Bowsher, Ph.D. Wendell C. Smith, Ph.D. Mission		CMC Support Manufacturing & Regulatory Support Preformulation, Formulation, & Analytical Methods Dev.

Clinical Trials Statistics & Outcomes Research Analysis of Observational Data Drug Safety - Demonstration of Risk vs. Benefit Incremental Cost-Effectiveness (ICE) Analysis PK/PD Support Statistical Analyst & Programming Support Statistical Support for all phases of Clinical Trials		Clinical Drug Development, Pharmacokinetics & Modeling, & Regulatory & Quality Audit Conduct & Responses Clinical Drug Development Clinical Pharmacology, Pharmacokinetics & Modeling GLP Compliance - SOPs, Quality Reviews and System Validations Regulatory Sciences Technical Writing		Bioanalytical & Ligand Binding Assays Bioanalytical Statistics & Design-of-Experiments (DOE) CRO Lab Selection & Bioanalytical Life-Cycle-Management Ligand Binding Assays Method Validation

About Us Fact Sheet History Management Rocco Brunelle, M.S. Ronald R. Bowsher, Ph.D. Wendell C. Smith, Ph.D. Mission Bioanalytical & Ligand Binding Assays Bioanalytical Statistics & Design-of-Experiments (DOE) CRO Lab Selection & Bioanalytical Life-Cycle-Management Ligand Binding Assays Method Validation Careers Analytics Consultants IT / SAS Programmers Clinical Drug Development, Pharmacokinetics & Modeling, & Regulatory & Quality Audit Conduct & Responses Clinical Drug Development Clinical Pharmacology, Pharmacokinetics & Modeling GLP Compliance - SOPs, Quality Reviews and System Validations Regulatory Sciences Technical Writing Clinical Trials Statistics & Outcomes Research Analysis of Observational Data Drug Safety - Demonstration of Risk vs. Benefit Incremental Cost-Effectiveness (ICE) Analysis PK/PD Support Statistical Analyst & Programming Support Statistical Support for all phases of Clinical Trials CMC Support Manufacturing & Regulatory Support Preformulation, Formulation, & Analytical Methods Dev. Contact Services Request Immunogenicity, Immune Safety Testing, & Risk Assessment & Mitigation Anti-Drug Antibody (ADA) Assay Development & Validation Preclinical / Clinical Immunogenicity Risk Assessment & Mitigation Planning Preclinical Safety Testing / Immunotoxicology Statistics for Screening & Confirmatory Cut-Points Protein / Peptide Therapeutics & Biosimilars ADME of Protein / Peptide Biotherapeutics Biosimilars / Biocomparables Insulin / Insulin Analogues LC-MS Analysis PK Data Analysis Preclinical Toxicology / IND Support Team Consultants Bioanalytical & Ligand Binding Assays Clinical Drug Development, Pharmacokinetics & Modeling, & Regulatory & Quality Clinical Drug Development Clinical Pharmacology, Pharmacokinetics & Modeling Quality Compliance Regulatory Science Clinical Trials Statistics & Outcomes Research CMC Support Dan Wierda, Ph.D. Dennis Bowsher, M.D. Erik Foehr, Ph.D. Gordon Arbuthnot Immunogenicity, Immune Safety Testing, & Risk Assessment & Mitigation Immune Safety Testing / Immunotoxicology Immunogenicity Immunogenicity Statistics Risk Assessment & Mitigation Jeff Sailstad, B.S. Marian Kelley, M.A. Mark Staples, Ph.D. Nagy Farid, Ph.D. Paul Gesellchen, Ph.D., RAC Protein / Peptide Therapeutics & Biosimilars LC-MS Analysis Richard Bergstrom, Ph.D. Robert Obenchain, Ph.D. Rose Sekulovich, Ph.D. Staff Andy Sponsler, M.S. Ed Hacker, B.S. Kristin Hardymon, M.A. Philip Bowsher, B.S. Shanna Northrup Thank you Thank you		About Us Fact Sheet History Management Rocco Brunelle, M.S. Ronald R. Bowsher, Ph.D. Wendell C. Smith, Ph.D. Mission Bioanalytical & Ligand Binding Assays Bioanalytical Statistics & Design-of-Experiments (DOE) CRO Lab Selection & Bioanalytical Life-Cycle-Management Ligand Binding Assays Method Validation Careers Analytics Consultants IT / SAS Programmers Clinical Drug Development, Pharmacokinetics & Modeling, & Regulatory & Quality Audit Conduct & Responses Clinical Drug Development Clinical Pharmacology, Pharmacokinetics & Modeling GLP Compliance - SOPs, Quality Reviews and System Validations Regulatory Sciences Technical Writing Clinical Trials Statistics & Outcomes Research Analysis of Observational Data Drug Safety - Demonstration of Risk vs. Benefit Incremental Cost-Effectiveness (ICE) Analysis PK/PD Support Statistical Analyst & Programming Support Statistical Support for all phases of Clinical Trials CMC Support Manufacturing & Regulatory Support Preformulation, Formulation, & Analytical Methods Dev. Contact Services Request Immunogenicity, Immune Safety Testing, & Risk Assessment & Mitigation Anti-Drug Antibody (ADA) Assay Development & Validation Preclinical / Clinical Immunogenicity Risk Assessment & Mitigation Planning Preclinical Safety Testing / Immunotoxicology Statistics for Screening & Confirmatory Cut-Points Protein / Peptide Therapeutics & Biosimilars ADME of Protein / Peptide Biotherapeutics Biosimilars / Biocomparables Insulin / Insulin Analogues LC-MS Analysis PK Data Analysis Preclinical Toxicology / IND Support Team Consultants Bioanalytical & Ligand Binding Assays Clinical Drug Development, Pharmacokinetics & Modeling, & Regulatory & Quality Clinical Drug Development Clinical Pharmacology, Pharmacokinetics & Modeling Quality Compliance Regulatory Science Clinical Trials Statistics & Outcomes Research CMC Support Dan Wierda, Ph.D. Dennis Bowsher, M.D. Erik Foehr, Ph.D. Gordon Arbuthnot Immunogenicity, Immune Safety Testing, & Risk Assessment & Mitigation Immune Safety Testing / Immunotoxicology Immunogenicity Immunogenicity Statistics Risk Assessment & Mitigation Jeff Sailstad, B.S. Marian Kelley, M.A. Mark Staples, Ph.D. Nagy Farid, Ph.D. Paul Gesellchen, Ph.D., RAC Protein / Peptide Therapeutics & Biosimilars LC-MS Analysis Richard Bergstrom, Ph.D. Robert Obenchain, Ph.D. Rose Sekulovich, Ph.D. Staff Andy Sponsler, M.S. Ed Hacker, B.S. Kristin Hardymon, M.A. Philip Bowsher, B.S. Shanna Northrup Thank you Thank you		About Us Fact Sheet History Management Rocco Brunelle, M.S. Ronald R. Bowsher, Ph.D. Wendell C. Smith, Ph.D. Mission Bioanalytical & Ligand Binding Assays Bioanalytical Statistics & Design-of-Experiments (DOE) CRO Lab Selection & Bioanalytical Life-Cycle-Management Ligand Binding Assays Method Validation Careers Analytics Consultants IT / SAS Programmers Clinical Drug Development, Pharmacokinetics & Modeling, & Regulatory & Quality Audit Conduct & Responses Clinical Drug Development Clinical Pharmacology, Pharmacokinetics & Modeling GLP Compliance - SOPs, Quality Reviews and System Validations Regulatory Sciences Technical Writing Clinical Trials Statistics & Outcomes Research Analysis of Observational Data Drug Safety - Demonstration of Risk vs. Benefit Incremental Cost-Effectiveness (ICE) Analysis PK/PD Support Statistical Analyst & Programming Support Statistical Support for all phases of Clinical Trials CMC Support Manufacturing & Regulatory Support Preformulation, Formulation, & Analytical Methods Dev. Contact Services Request Immunogenicity, Immune Safety Testing, & Risk Assessment & Mitigation Anti-Drug Antibody (ADA) Assay Development & Validation Preclinical / Clinical Immunogenicity Risk Assessment & Mitigation Planning Preclinical Safety Testing / Immunotoxicology Statistics for Screening & Confirmatory Cut-Points Protein / Peptide Therapeutics & Biosimilars ADME of Protein / Peptide Biotherapeutics Biosimilars / Biocomparables Insulin / Insulin Analogues LC-MS Analysis PK Data Analysis Preclinical Toxicology / IND Support Team Consultants Bioanalytical & Ligand Binding Assays Clinical Drug Development, Pharmacokinetics & Modeling, & Regulatory & Quality Clinical Drug Development Clinical Pharmacology, Pharmacokinetics & Modeling Quality Compliance Regulatory Science Clinical Trials Statistics & Outcomes Research CMC Support Dan Wierda, Ph.D. Dennis Bowsher, M.D. Erik Foehr, Ph.D. Gordon Arbuthnot Immunogenicity, Immune Safety Testing, & Risk Assessment & Mitigation Immune Safety Testing / Immunotoxicology Immunogenicity Immunogenicity Statistics Risk Assessment & Mitigation Jeff Sailstad, B.S. Marian Kelley, M.A. Mark Staples, Ph.D. Nagy Farid, Ph.D. Paul Gesellchen, Ph.D., RAC Protein / Peptide Therapeutics & Biosimilars LC-MS Analysis Richard Bergstrom, Ph.D. Robert Obenchain, Ph.D. Rose Sekulovich, Ph.D. Staff Andy Sponsler, M.S. Ed Hacker, B.S. Kristin Hardymon, M.A. Philip Bowsher, B.S. Shanna Northrup Thank you Thank you

About Us Fact Sheet History Management Rocco Brunelle, M.S. Ronald R. Bowsher, Ph.D. Wendell C. Smith, Ph.D. Mission Bioanalytical & Ligand Binding Assays Bioanalytical Statistics & Design-of-Experiments (DOE) CRO Lab Selection & Bioanalytical Life-Cycle-Management Ligand Binding Assays Method Validation Careers Analytics Consultants IT / SAS Programmers Clinical Drug Development, Pharmacokinetics & Modeling, & Regulatory & Quality Audit Conduct & Responses Clinical Drug Development Clinical Pharmacology, Pharmacokinetics & Modeling GLP Compliance - SOPs, Quality Reviews and System Validations Regulatory Sciences Technical Writing Clinical Trials Statistics & Outcomes Research Analysis of Observational Data Drug Safety - Demonstration of Risk vs. Benefit Incremental Cost-Effectiveness (ICE) Analysis PK/PD Support Statistical Analyst & Programming Support Statistical Support for all phases of Clinical Trials CMC Support Manufacturing & Regulatory Support Preformulation, Formulation, & Analytical Methods Dev. Contact Services Request Immunogenicity, Immune Safety Testing, & Risk Assessment & Mitigation Anti-Drug Antibody (ADA) Assay Development & Validation Preclinical / Clinical Immunogenicity Risk Assessment & Mitigation Planning Preclinical Safety Testing / Immunotoxicology Statistics for Screening & Confirmatory Cut-Points Protein / Peptide Therapeutics & Biosimilars ADME of Protein / Peptide Biotherapeutics Biosimilars / Biocomparables Insulin / Insulin Analogues LC-MS Analysis PK Data Analysis Preclinical Toxicology / IND Support Team Consultants Bioanalytical & Ligand Binding Assays Clinical Drug Development, Pharmacokinetics & Modeling, & Regulatory & Quality Clinical Drug Development Clinical Pharmacology, Pharmacokinetics & Modeling Quality Compliance Regulatory Science Clinical Trials Statistics & Outcomes Research CMC Support Dan Wierda, Ph.D. Dennis Bowsher, M.D. Erik Foehr, Ph.D. Gordon Arbuthnot Immunogenicity, Immune Safety Testing, & Risk Assessment & Mitigation Immune Safety Testing / Immunotoxicology Immunogenicity Immunogenicity Statistics Risk Assessment & Mitigation Jeff Sailstad, B.S. Marian Kelley, M.A. Mark Staples, Ph.D. Nagy Farid, Ph.D. Paul Gesellchen, Ph.D., RAC Protein / Peptide Therapeutics & Biosimilars LC-MS Analysis Richard Bergstrom, Ph.D. Robert Obenchain, Ph.D. Rose Sekulovich, Ph.D. Staff Andy Sponsler, M.S. Ed Hacker, B.S. Kristin Hardymon, M.A. Philip Bowsher, B.S. Shanna Northrup Thank you Thank you