Jens Harald Kongsø
Founder and CEO
MS in Economics
jhk@clinigma.com
About
Jens brings over 20 years of specialized expertise in health economics, market access, and pharmaceutical strategy to CLINIGMA®. As Founder and CEO, he leverages his extensive background across government regulatory analysis, Big Pharma HEOR leadership, and qualitative research to ensure that patient interview studies deliver compelling evidence for commercial and regulatory success.
Expertise
Health Economics and Outcomes Research Leadership
- Over 15 years of HEOR experience spanning Novo Nordisk and Janssen, leading global strategies for multiple therapeutic areas
- Extensive experience designing and executing PRO strategies for major pharmaceutical products including Xultophy®, FIAsp, and Semaglutide
- Expert in health economic modeling, network meta-analyses, and indirect treatment comparisons for regulatory submissions
- Proven track record managing HEOR aspects of Phase 2 and Phase 3 clinical trial programs
Regulatory and Market Access Expertise
- Deep understanding of regulatory requirements
- Specialized experience in pharmaceutical competition analysis and market access strategies across EU and US markets
- Expert in NICE interactions, scientific advisory meetings, and Health Technology Assessment requirements
Qualitative Research and Patient-Reported Outcomes
- Over 10 years of experience designing and participating in qualitative research studies
- Expert in PRO instrument development, validation, and implementation across multinational clinical trials
- Extensive experience conducting focus groups and large-scale web surveys across diverse populations
- Specialized knowledge in translating patient experience data into regulatory and commercial evidence
International Pharmaceutical Experience
- Senior roles at Novo Nordisk spanning insulin, GLP-1, and combination therapy development programs
- EMEA leadership experience at Janssen coordinating between global and operating country strategies
- Direct experience with FDA, EMA, and other international regulatory agencies
Strategic Business Development
- Founder and CEO since 2017, successfully building CLINIGMA® from startup to established clinical research organization
- Expert in identifying market opportunities and developing innovative solutions for pharmaceutical industry challenges
Publication and Thought Leadership
- Extensive publication record with presentations at major international conferences including ISPOR, ADA, EASD, and IDF
- Expert in scientific communication and dissemination of HEOR and qualitative research findings
- Regular presenter at clinical forums, investigator meetings, and advisory boards
Compliance
- Deep understanding of Good Clinical Practice (GCP) and regulatory compliance requirements
Jens's unique combination of regulatory experience, Big Pharma HEOR leadership, and entrepreneurial vision ensures that CLINIGMA® delivers patient interview studies that meet the highest standards while addressing real-world commercial and regulatory needs.
Publications
Kern, Werner & Meryl, B & Manghi, F & García-Hernández, P & Norwood, P & Jarlov, H & Kongsø, J & Lingvay, Ildiko. (2016). Insulin degludec/Liraglutid (IDegLira) verbesserte bei Patienten mit Typ 2 Diabetes (T2D) mit unzureichender Blutzuckereinstellung unter Insulin glargin (IGlar) plus Metformin (Met) die Leistungsfähigkeit und das Wohlbefinden (Patient Reported Outcomes): DUAL-V-Studie. Diabetologie und Stoffwechsel. 11. 10.1055/s-0036-1580789.
Freemantle, Nick & Mamdani, Muhammad & Vilsbøll, Tina & Kongsø, Jens & Kvist, Kajsa & Bain, Stephen. (2015). IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. Diabetes therapy: research, treatment and education of diabetes and related disorders. 6. 10.1007/s13300-015-0142-y.
Freemantle, N & Lingvay, Ildiko & Kongsø, JH & Abrahamsen, TJ & Bjorner, Jakob. (2015). Ideglira Improves Health Utility Compared with Insulin Glargine in Patients with Type 2 Diabetes. Value in Health. 18. A614. 10.1016/j.jval.2015.09.2135.
Freemantle, N. & Mamdani, M. & VilsbØll, T. & KongsØ, J.H. & Kvist, K. & Bain, Stephen. (2015). PDB11. Ideglira Versus other Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin “An Indirect Statistical Comparison”. Value in Health. 18. A54. 10.1016/j.jval.2015.03.318
Beck, Jane & Brod, Meryl & Pfeiffer, Kathryn & Clausen, Kasper & Skovgaard, Rasmus & Kongso, Jens. (2015). Insulin-taking behavior and memory problems among people with diabetes in five countries: findings from a web survey [Corrigendum]. Patient Intelligence. 10.2147/PI.S81252.
Hall, Rebecca & Willgoss, Tom & Humphrey, Louise & Kongsø, Jens. (2014). The effect of medical device dose-memory functions on patients’ adherence to treatment, confidence, and disease self-management. Patient Preference and Adherence. 8. 775. 10.2147/PPA.S61248.
Brod, Meryl & Kongso, J. & Bushnell, Donald. (2013). PDB76. The Impact of Memory Problems on Diabetes Treatment in the United Kingdom. Value in Health. 16. 10.1016/j.jval.2013.08.697.
Brod, Meryl & Kongso, J. & Bushnell, Donald. (2013). PDB107. The Impact of Memory Problems on Diabetes Treatment in Germany. Value in Health. 16. A449-A450. 10.1016/j.jval.2013.08.728.
Brod, Meryl & Pohlman, Betsy & Kongsø, Jens. (2013). Insulin Administration And The Impacts Of Forgetting A Dose For Patients. The patient. 7. 10.1007/s40271-013-0029-9.
Brod, Meryl & Kongso, J & Bushnell, Donald & Rotter, J & Xu, Z & Yang, L. (2013). The Impact Of Memory Problems On Diabetes Treatment In China. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. 16. A170. 10.1016/j.jval.2013.03.850.
Brod, Meryl & Christensen, Torsten & Kongsø, Jens & Bushnell, Donald. (2009). Examining and interpreting responsiveness of the Diabetes Medication Satisfaction measure. Journal of medical economics. 12. 309-16. 10.3111/13696990903337017.
Boulanger, Luke & Kongso, J. & Bouchard, J. & Christensen, Torsten & Fraser, Kimberly & Russell, M.. (2009). PDB28 EXCESS COSTS OF DIABETES MELLITUS AMONG MEDICARE RECIPIENTS IN A SKILLED NURSING FACILITY SETTING. Value in Health - VALUE HEALTH. 12. 10.1016/S1098-3015(10)73572-5.
Brod, Meryl & Kongsø, Jens & Lessard, Suzanne & Christensen, Torsten. (2008). Psychological insulin resistance: Patient beliefs and implications for diabetes management. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. 18. 23-32. 10.1007/s11136-008-9419-1.
Kongso, J. & Brod, Meryl & Lessard, S & Christensen, Torsten. (2008). PDB54 PSYCHOLOGICAL INSULIN RESISTANCE (PIR): PATIENT AND PHYSICIAN BELIEFS IMPACTING DIABETES MANAGEMENT. Value in Health. 11. 10.1016/S1098-3015(10)66702-2.
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