Copenhagen Metropolitan Area
I am offering consultancy services within Clinical Pharmacology, project management, clinical drug development plans and strategies and submission activities. I have more than 25 years of experience within global clinical development within diabetes, obesity, and oncology. Hanne has worked as senior director within clinical pharmacology scientist on various projects and prepared the global development plans during phase 1 to phase 3b and lead several drug products to the regulatory approval. Preparing study protocols, interpreting clinical pharmacology study results, preparing story lines for clinical study reports, regulatory interaction packages and summaries for the clinical pharmacology parts of a submission dossiers. I have been involved in numerous health authority interactions and Q&A process with health authorities during development and submissions. Hence, I have a deep understanding of regulatory requirement and project management. Furthermore, I have extensive experience in contributing to publication strategies and is author on more than 75 full manuscripts. Skilled in biotechnology, evaluating business development and in-licensing due diligence activities for early as well as late-stage drug products, and understanding the value chain end-to-end. Designing the right early human trials to enable early readout and decision. I can drive development of Clinical Pharmacology competencies by mentoring and sharing knowledge (has been hosting 2 days course in clinical pharmacology strategy and excellence).
For the last 20 years in Novo Nordisk I have been working as senior clinical pharmacologist expert and director/manager for a Clinical Pharmacology department. I have been responsible for developing the global clinical pharmacology strategy for more than 7 development projects, including securing 5 successful NDA/BLA submissions and launches. Worked out the strategy and story-line of a clinical pharmacology qualifying program, in conjunction with a decision to progress the projects into Phase 2, Phase 3 and BLA/NDA submissions ( including responsibility for ensuring a robust and successful clinical pharmacology submission packages). During this I have interacted with a significant number of internal and external stakeholders, across the R&D value chain, with key opinion leader, as well as regulatory agencies. I experience with all aspects from early to late clinical pharmacology phases. I have extended experience with designing clinical pharmacology development programs for exploring mechanism, PK/PD properties, obtaining regulatory approval with as highly competitive label as possible and scientific publications for promotion. I am experienced interactions with regulatory authorities and negotiating PK/PD sections of Labels, e.g. FDA, EMA, CDE in China, PMDA in Japan. In addition, I have experience with FDA advisory committee meeting. I have five years of managerial experience, latest as Director of the Insulin Clinical Pharmacology department. Major driver in ensuring clinical pharmacology competency development and innovation. I am proactively setting directions, taking ownership and educate/motivate the team to work for joint objectives.
Within oncology, conducting clinical phase 2a trials within e.g colon cancer, primary hepatic cellular carcinoma; Myelodysplastic Syndromes; breast cancer