MEDICAL & SAFETY MONITORING
- 40 years as a physician.
- 30 years in clinical trials for drug development.
- 20 years as medical/clinical entrepreneur.
Anesthesiology, Clinical Pharmacology, Surgery, Internal Medicine, Regulatory Affairs. Deep experience in regulatory affairs and project management including finding and contracting investigators and pharmacies as well as liaising with IEC and regulatory bodies. Graduated MD from University of Uppsala Medical School, Sweden. Specialty in Anesthesia and Intensive Care Medicine. Associate professor in Anesthesiology and Intensive Care Medicine at Uppsala University. With research focused on clinical pharmacology and pain management, has published 40 papers and contributed chapters to four books on pain. Fluent in Swedish and English, with basic understanding of German.
European Clinical Trials – Arandi Development AB, a division of akta PD
Consults pharma and medical technology companies, providing medical monitoring as well as 24/7 safety physician and medical advisor. Writes clinical development plans and regulatory and EC applications. Has medical responsibility for three international MCT (medium-chain triglycerides) in Type 1 diabetes and rheumatoid arthritis. Developed two clinical trial protocols for validation of medical device (Smartphone app) for patient-managed, physician-supervised, diabetic monitoring of medication, physical exercise, and food consumption. Developed early phase clinical trials program for an NCE under development for chronic neuropathic pain for a Swedish pharma company.
European Commission Pain Expert
Current appointed independent expert to the Innovative Medicines Initiative Joint Undertaking, a pan-European public/private collaboration to support faster discovery and development of better medicines, supported by the European Commission and participating biopharma companies, to evaluate research proposals on Topic 9, Pain.
SEDOC Pharmaceutical Medicine AB, Scandinavia
Managing director, chairman, and owner of contract research organization. Provided advanced clinical development services to international pharma and medical device companies in areas of clinical drug development, clinical trials management, clinical data management, pharmacovigilance, and outsourcing of research staff.
Senior Medical Advisor, Pharmacia Hospital Care AB
Responsible for all medical and safety issues occurring in Phases 1 to 3 development of two anesthetic drugs, desflurane (Suprane®) and eltanolone.
Medical Review Officer, Medical Products Agency of Sweden
Reviewed clinical sections of NDAs and IND applications in various therapeutic areas.
Medical Advisor and Director of Clinical Research, Astra Pain Control AB
Responsible for clinical research and development of the topical anesthetic EMLA™ and a mixed agonist antagonist opioid analgesic (dezocine). Project team leader for preclinical NCE project (compound: sameridine) under development for neuraxial blockades. Compound reached Phase 2 trials.