Kristine Holgersen

Education

PhD, February 2015, Novo Nordisk A/S and University of Copenhagen

MSc in Veterinary Medicine (DVM), August 2011, University of Copenhagen

Mathematical high school graduate, June 2004, Virum Gymnasium

Employment history

Jan 2019 - current: Postdoc at Comparative Pediatric and Nutrition, Department of Veterinary and Animal Science

• In vivo studies– evaluating the role of growth factors in a pig model of premature infants  including stable work,  study planning and analysis / interpretation of achieved data.
• Laboratory work– performing immunological in vitro techniques i.e.multicolor flow cytometry, histopathological analyses, immunohistochemistry, and QPCR

May 2015 - Nov. 2018: Compliance Consultant at Epista Life Science.

Projects at CMC Development and Biopharm (Via ITCO), Novo Nordisk A/S

• Validation activities - testing and qualification of computerized systems used in the GMP-regulated area for manufacturing drugs for clinical trials.
• Quality and compliance – ensure that production/laboratory systems and related documentation comply with regulatory requirements and NN QMS
• Data integrity – ensure data flow optimization and FDA CFR 21 part 11 compliance. 
• Documentation- preparation of validation deliverables like risk assessment, user requirement specification, validation plan/report, test protocols/reports. 
• O&M process: Establish Operation and Maintenance Processes and write Unit instructions 

April 2017- March 2018: Maternity Leave

Nov. 2014 – April 2015: Scientific assistant at University of Southern Denmark/Hospital of Southern Jutland. The Institute of Regional Health Research, Center Sønderjylland

• In vivo studies- establishment of an experimental mouse model of colitis with a humanized gut microbiota, including handling, injections, blood sampling, disease assessment, and necropsy.
• Laboratory work- DNA extraction and analysis of material from inflammatory bowel disease patients.
• Teaching- practical and theoretical courses in laboratory animal science for Bachelor-, Master- and PhD students.
• Project management- coordinating and planning research project between University of Southern Denmark, University of Copenhagen and the Novo Nordisk Foundation Center for Basic Metabolic Research.

Sep. 2011 –Oct. 2014: PhD student at the Novo Nordisk – LIFE In Vivo Pharmacology Centre (LIFEPHARM). Dept. of Immunopharmacology, Novo Nordisk A/S and Dept. of Veterinary Disease Biology, Faculty of Health and Medical Sciences, University of Copenhagen.

PhD project entitled Piroxicam-accelerated colitis in interleukin-10 knockout mice; an in vivo model mimicking human inflammatory bowel disease.

• In vivo studies– implementation and characterization of experimental mouse models of colitis and preclinical drug screening, including stable work, colonoscopy on mice, study planning and analysis / interpretation of achieved data.
• Laboratory work– performing immunological in vitro techniques i.e.ELISA, Bio-Plex, multicolor flow cytometry, histopathological analyses, immunohistochemistry, and cell stimulation assay.
• Paper publications/conferences- scientific dissemination in peer-reviewed journals and international conferences.
• Teaching and supervision- teacher and censor at University of Copenhagen and Novo Nordisk, and supervising laboratory technician trainees in practical experimental work and during their final project.
• Statistical analyses- performing correct parametric or non-parametric statistical analyses on collected dataset for publishing.
• Presentation– oral and poster presentation at several science/research days, as well as academic and project meetings at Novo Nordisk A/S and University of Copenhagen.

Sep. 2013- Dec. 2013: Academic Visitor at the University of Oxford.

Nuffield Department of Medicine, Translational Gastroenterology Unit, Powrie Laboratory.

• In vivo studies- preclinical testing of a new Novo compound in a mouse model of chronic colitis.  
• Laboratory work- qPCR analyses, intracellular FACS analyses, single cell preparationfrom lamina propria lymphocytes/spleen/lymph node.
• Bacterial culturing- of sp. Helicobacter Hepaticus
• Study report- preparation and approval.

Summer 2010: Internship at University of Liverpool

Small Animal Teaching Hospital.

• Common veterinary work- diagnose and treat medical conditions of presented animal patients.
• Writing medical journals.
• Interviewing and communicating with clients/owners.

Summer 2009+ spring 2010: Veterinary nurse substitute at Gentofte Dyreklinik.

• Assisting with the treatment and care taking of sick animals.
• Performing explanatory laboratory tests, like blood, urine, and fecal analyses.  
• Answering the phone, appointment booking and general services for the clients.

1998- 2006: Lyngby Swimming club

I started as a competitive swimmer in 1998 and became a coach for different kinds of swimming teams with children, adults, families and non-ethnic Danish women.

Other scientific  skills

Poster and oral presentation; I have presented at several scientific congresses and academic meetings, incl.:

• Digestive Disease Week, Chicago 2014
• Congress of the European Crohn’s and Colitis Organisation (ECCO), Barcelona 2012/Vienna 2013
• European Medicines Research Training Network (EMTRAIN) PhD Workshop, Stevenage (GSK) 2013
• European Congress of Immunology, Glasgow 2012.

Training courses:

• Data Integrity. Requirement for a GMP-compliant Data Life Cycle. European Compliance Academy
• The 3-year In Vivo Pharmacology Research Training Programme. Faculty of Health and Medical sciences, University of Copenhagen as a collaboration with the pharmaceutical industry
• In Vivo Pharmacology - Biologic variation, reproducibility and predictability in preclinical drug testing in lab. animals. Faculty of Health and Medical sciences, University of Copenhagen
• Practical course in cellular immunology. Faculty of Health and Medical sciences, University of Copenhagen
• Statistics for Veterinarians. Faculty of Health and Medical sciences, University of Copenhagen
• Laboratory Animal Science - Cat. C Course. Faculty of Health and Medical sciences, University of Copenhagen.
• Home Office, ANIMALS (SCIENTIFIC PROCEDURES) ACT 1986, personal licence, UK Government.

Excellent Microsoft Office Skills (Excel, Powerpoint, Word, Adobe Acrobat, Outlook etc.)

Language skills; Danish is native and English is fluent (written and spoken).

Academic awards and honours:

• Runner-up, Best poster presentation, IVP annual meeting, Marts 2014.
• SHARE Young Scientist Research Award for outstanding achievement poster presentation, November 2011.

Personal references

• Thomas Lindebo Holm, PhD, Specialist in Pharmacology, Novo Nordisk A/S.

Novo Nordisk Park, DK-2760, Måløv, [email protected]

• Arne Tue Lehmann, Senior Project Manager, at CMC Business & IT Support, Novo Nordisk A/S, Smørmosevej 17-19, DK-2880, Bagsværd, [email protected]
• Axel Kornerup Hansen, Professor, Dept. Of Veterinary Disease Biology, University of Copenhagen, Thorvaldsensvej 57, DK-1870, Frederiksberg, [email protected]