Ditte Boilesen

Loma Therapeutics develops best-in-class treatment for HPV cancers

Main tasks include: Ensuring progress and quality in the CMC process development of InProTher’s lead therapeutic cancer vaccine candidate at a CDMO Responsible for preparation of briefing material for Scientific Advice in collaboration with regulatory consultants Supervision of a PhD project investigating immune responses and tissue-biomarkers in blood and tumor-biopsies from cancer patients.

Industrial PhD at University of Copenhagen/InProTher APS. Topic: Developing therapeutic vaccines and immunotherapy against chronic HPV infection and HPV+ cancers A collaborative project between German, Danish and Indonesian universities and industry partners with the aim to develop and test a novel therapeutic vaccine for the treatment of HPV and HPV-associated cancers. The outcome of the project was, besides a number of publications, a patent on the vaccine design and a very positive Scientific Advice from the Danish health authorities in favor of progressing to first-in-human clinical trials. Through the project, I have developed as a project manager to ensure a structured and fruitful collaboration between all project partners. Concise and honest communication and discussion, as well as the combined strengths and skills of the interdisciplinary group of scientists, resulted in a successfully conducted project. Lastly, I have had the opportunity to supervise several master’s students. It has been the most rewarding experience to create a challenging yet supportive learning space, where the students have grown into independent researchers capable of taking ownership of their projects. Technical skills acquired include murine vaccine studies and engrafted tumor models as well as high-parameter flow cytometry. Transferrable skills developed include project management of an interdisciplinary and international team, and supervision of master students.

During three rotations of 8 months each, one of them in the UK, I have gained experience in various aspects of planning and conducting clinical trials, including working under GMP, GCP and local regulatory requirements, project management and organization of trainings and meetings. I understand the ultimate importance of patient safety and data quality that is inherent in all aspects of clinical trial planning and conduct. In terms of transferrable skills, I have learned the importance of a structured approach, transparent and timely communication and of building good relations with collaborators. First rotation: International trial manager working on the setup of a phase III study comparing Semaglutide once-weekly to a blinded control treatment for patients with type II diabetes. Second rotation: Clinical Research Associate/Monitor in UK South East region. Monitoring and managing sites for diabetes type II studies during recruitment, focused on delivering a high level of support to site staff and a smooth collaboration with the global trial management team, to ensure patient safety and high-quality data. Also involved in site-initiation visits and in site visits on other trials ranging from phase I to III. Third rotation: Clinical Trial Supplies project initiation and trial setup teams. Responsible for preparing trial drug manuals for doctors and nurses at trial sites, and involved in multiple improvement projects to ensure efficient collaboration between Trial Supplies teams and reduction of errors.

WHO Western Pacific Regional Office - department for HIV, Hepatitis and STIs