Calluna Pharma appoints Margrethe Sørgaard as Senior Vice President of Clinical Operations and Pharmacovigilance
April 23, 2024 – Other, Pharmaceutical – Calluna Pharma, appointments, pharmacovigilance
First senior executive appointment made following Company launch to oversee strategic development of clinical programmes
23 April 2024 — Oslo, Norway — Calluna Pharma, a clinical stage company pioneering a breakthrough approach to treating inflammatory and fibrotic diseases, today announced the appointment of Margrethe Sørgaard to the position of senior vice president (VP) of Clinical Operations and Pharmacovigilance. Margrethe joins the company’s cross-functional R&D team following Calluna’s launch, to oversee the strategic development of the company’s clinical programmes in line with regulatory guidelines and safety requirements.
With over 25 years’ experience from different leading positions in clinical development and operation, medical affairs and drug safety/pharmacovigilance, Margrethe will play a pivotal role in supporting the development of Calluna’s clinical programmes including CAL101, the company’s lead product as it enters phase 2a clinical development.
As a senior VP of Clinical Operations and Pharmacovigilance, Margrethe will be responsible for clinical operation activities pertaining to product safety and pharmacovigilance, ensuring appropriate safety assessment and surveillance, compliant regulatory authority reporting and the development and implementation of risk management strategies. She will also oversee CRO activities and tasks related to patients’ safety in clinical studies.
Margrethe joins Calluna from BioInvent International AB where she was the senior director of Safety and PV, supporting product safety and assuring safety standards were compliant with global drug safety regulations. Prior to this, Margrethe was the VP and head of Clinical Development at Circio Holding ASA, and has previously gained experience in regulatory pre- and post-marketing processes and quality assurance, by serving as an EU Qualified Person for Pharmacovigilance (QPPV) while at Photocure ASA, and head of Unit for Safety Assessment and GCP/PhV inspector at the Norwegian Medicines Agency (NOMA). She holds an MSc in Biology (Physiology) from the University of Oslo, Norway.
Margrethe Sørgaard, senior vice president of Clinical Operations and Pharmacovigilance of Calluna Pharma, said: “I am thrilled to join Calluna’s team at such an exciting stage of the company’s development. Calluna’s ground-breaking approach in targeting upstream innate immune amplifiers has the potential to revolutionise treatment across a spectrum of diseases associated with chronic inflammation and fibrosis, improving patient outcomes and fulfilling unmet medical needs. I look forward to becoming an integral part of the development of our clinical programmes.”
John Montana PhD, CEO of Calluna Pharma, commented: “We are excited to have Margrethe join us at a time when we are preparing several of our innovative programmes for clinical trials. We look forward to leveraging Margrethe’s expertise in all aspects of clinical development and clinical operations, to help ensure Calluna’s clinical programmes run according to the company’s strategy, applicable legislation, regulations and guidelines, while prioritising patient safety.”
About Calluna Pharma
Calluna Pharma is a clinical stage company pioneering a breakthrough approach to treating inflammatory and fibrotic diseases by leveraging the body’s innate immune system. The company’s therapeutic approach targets upstream amplifiers of disease, offering potential applicability across a diverse array of medical conditions. Calluna has a robust pipeline of selective antibodies targeting immunological diseases with enhanced efficacy, including several first-in-class clinical candidates. Calluna Pharma was formed in 2023 following the merger of Oxitope Pharma and Arxx Therapeutics and is based in Oslo, Norway. Visit: www.callunapharma.com
