Kenneth Swart

About Kenneth Swart

Experience:• >40 Years’ experience in all aspects of clinical trials with emphasis on bioanalytical and biomarker services.• Management of PAREXEL’s World Wide Bioanalysis and Biomarker Laboratories including responsibility for P&L, budget, quality systems and personnel.• Responsible for bioanalytical and biomarker services.• Established analytical services for clinical studies for Hoechst Pharmaceuticals in SA• Co-founder of a full service CRO in 1985 with responsibility of implementing a bioanalytical services division (bought by PAREXEL in Implemented PAREXEL’s biomarker services in 2008.• Assist clients on biomarker selection for clinical trials as well as development and validation of methods. • Scientific development of PAREXEL laboratories.• Business development for clinical, biosimilar, bioanalytical and biomarker services.• Professor in Bioanalytical and establish a school of bioanalytical chemistry• Lecturing in Pharmacology, chemistry and bioanalytical chemistry.• Consultancy for review and drafting of responses to regulatory questions on bioanalysis regarding sponsor’s submission reports.• Supervision, management and review of data of bioanalytical and biomarker studies performed at other laboratories on sponsor’s behalf.• Received in 2008 an award from the National Science and Technology Forum for outstanding contribution to Science, Engineering and Innovation in South Africa. • Published over 39 articles in Peer reviewed Journals • Served on the Editorial Advisory Board of the Journal of Chromatographia.Specialties: Budgeting, business development, financial management, GLP, LC-MS/MS, lecturer, marketing, quality control, research, sales, scientific, strategic, validation, workflow analysis, scientific writing, bioanalysis and biomarkers.

Experience

1. SVP Bioanalytical and Biotherapeutic Sciences at Inotiv

   Inotiv

   Dec 2021 — Present · Durham, NC, US

Education

• University of the Free State

  PhD, M.Med.Sc, BSc(Hon), BSc, Pharmacology, Bioanalytical chemistry, Chemistry and physiology

  1973 — 1987

• Grey College

  Matriculated

  1967 — 1971

Skills

• Quality System
• V&V
• Management: Bioanalytical Laboratories
• Clinical Development
• Good Clinical Practice (Gcp)
• Glp : Pharmaceutical
• Product Development
• Biomarkers
• Life Sciences
• Strategy
• Research: Pharmaceutical and Chemistry
• Consultancy: Bioanalysis and Biomarkers
• Biotechnology
• CRO
• Chromatography
• Budgets
• Management
• Laboratory
• Drug Development
• Bioanalysis
• Gcp
• Research
• Business Development
• Chemistry
• Clinical Research
• Pharmaceutics
• Validation
• Glp
• Science
• System Validations: Laboratory Software
• Quality Systems: Bioanalysis and Biomarkers
• Lifesciences
• Quality Management
• R&D
• Budgeting: Bioanalytical Laboratory
• Oncology
• Method Development and Validation: Drugs and Biomarkers
• Clinical Trials
• Pharmaceutical Industry
• Sop