Experience
2018: Independent Consultant, Inger Mollerup Regulatory Consulting. Experienced in:
- Regulatory strategies and plans: Building robust regulatory strategies and plans, facing regulatory reality, interpreting Agency feed-back, navigating the regulatory landscape and optimising Agency negotiations.
- Supporting international global harmonisation by training and presentation on ICH guidelines, first and foremost ICH E17 and ICH Q5E.
- Biosimilars: has actively contributed to regulatory guidelines and pathways for biosimilars, has in-depth understanding and experience of the scientific basics for biosimilar guidelines. Experienced in applying this in advocacy as relevant and in understanding how biosimilar guidelines are applied in the real world.
- Support of international convergence on biosimilar regulations by training both industry and regulatory authorities on biosimilar regulations and scientific basis for data requirements
2017 – 2018: Senior Regulatory Consultant, Regulatory Affairs, Novo Nordisk A/S
- Drives development of strategies for regulatory advocacy. Conducts training on biosimilars both within Novo Nordisk and at international conferences or traning courses. Supports key affiliates in the efforts to enhance interactions and engagement with their health authority.
2015 – 2016: Head of Region Pacific CMR (Clinical, Medical and Regulatory), Novo Nordisk
- Coordinated and led aspects of drug development in Region Pacific: Canada, Japan/Korea and Australia
2014 – 2015: Corporate Vice President, RA Insight, Novo Nordisk A/S
- Project management and regulatory responsibility for conducting and reporting the interim analysis for the Cardiovascular Outcomes Trial DEVOTE, to support US FDA regulatory approval of Novo Nordisk’s next generation insulins, Tresiba® and Ryzodeg®. To maintain the integrity of the ongoing trial while the interim analysis was conducted, submitted, and acted upon by the FDA, and also until completion of the full trial, only a small team working in seclucion was unblinded to the interim results.
2009 – 2014: Corporate Vice President, Regulatory Affairs, Novo Nordisk A/S
- Regulatory oversight and responsibility for the insulin degludec franchise including CMC, nonclinical and clinical areas leading to marketing authorisations in EU, US, Japan and a number of additional countries. Has in this capacity overseen a number of license application and approval projects with multiple agency consultations and interactions in several regions of the world including USA (incl. Advisory Committee preparations), EU, Japan, China, Canada, India, Latin America and Southeast Asia.
2004 – 2009: Vice President, Regulatory Affairs, Novo Nordisk A/S
- Regulatory oversight and responsibility for new products including CMC, nonclinical and clinical areas. Products covered included both coagulation factors and insulins. Responsibilities included ensuring approvals of Clinical Trial Applications and developing regulatory strategies targeting global regulatory approvals.
2003 – 2004: Project Vice President, NovoSeven Support, Novo Nordisk A/S
- Leads global development and life cycle management efforts for NovoSeven encompassing line extensions, 2nd generation processes, optimisation of product profitability
- Responsibility covers development, documentation, regulatory approval and implementation
2000 – 2002: Vice President, Protein Process Development, Novo Nordisk A/S
- Leads functional area of Protein Process Development (6 departments, 130 people) encompassing cell culture and downstream processes, analytical development and virology. Major projects in this period: rFVIIa, Insulin analogues, Glucagon Like Peptides
- Responsible for development, documentation, scale-up, process validation and transfer of processes to production
- Responsible for state-of-the-art biologics GMP pilot plants including manufacture of drug substance for clinical supplies
- Built strong leadership team and trained 4 new dept. managers
- Established 2 new departments to ensure the performance as the area grew
- Developed short and long term strategies for technology development within cell culture and downstream process development. More than 3 new initiatives started in this field with industry and university partners.
Full CV
2018: Independent Consultant, Inger Mollerup Regulatory Consulting. Experienced in:
- Regulatory strategies and plans: Building robust regulatory strategies and plans, facing regulatory reality, interpreting Agency feed-back, navigating the regulatory landscape and optimising Agency negotiations.
- Supporting international global harmonisation by training and presentation on ICH guidelines, first and foremost ICH E17 and ICH Q5E.
- Biosimilars: has actively contributed to regulatory guidelines and pathways for biosimilars, has in-depth understanding and experience of the scientific basics for biosimilar guidelines. Experienced in applying this in advocacy as relevant and in understanding how biosimilar guidelines are applied in the real world.
- Support of international convergence on biosimilar regulations by training both industry and regulatory authorities on biosimilar regulations and scientific basis for data requirements
2017 – 2018: Senior Regulatory Consultant, Regulatory Affairs, Novo Nordisk A/S
- Drives development of strategies for regulatory advocacy. Conducts training on biosimilars both within Novo Nordisk and at international conferences or traning courses. Supports key affiliates in the efforts to enhance interactions and engagement with their health authority.
2015 – 2016: Head of Region Pacific CMR (Clinical, Medical and Regulatory), Novo Nordisk
- Coordinated and led aspects of drug development in Region Pacific: Canada, Japan/Korea and Australia
2014 – 2015: Corporate Vice President, RA Insight, Novo Nordisk A/S
- Project management and regulatory responsibility for conducting and reporting the interim analysis for the Cardiovascular Outcomes Trial DEVOTE, to support US FDA regulatory approval of Novo Nordisk’s next generation insulins, Tresiba® and Ryzodeg®. To maintain the integrity of the ongoing trial while the interim analysis was conducted, submitted, and acted upon by the FDA, and also until completion of the full trial, only a small team working in seclucion was unblinded to the interim results.
2009 – 2014: Corporate Vice President, Regulatory Affairs, Novo Nordisk A/S
- Regulatory oversight and responsibility for the insulin degludec franchise including CMC, nonclinical and clinical areas leading to marketing authorisations in EU, US, Japan and a number of additional countries. Has in this capacity overseen a number of license application and approval projects with multiple agency consultations and interactions in several regions of the world including USA (incl. Advisory Committee preparations), EU, Japan, China, Canada, India, Latin America and Southeast Asia.
2004 – 2009: Vice President, Regulatory Affairs, Novo Nordisk A/S
- Regulatory oversight and responsibility for new products including CMC, nonclinical and clinical areas. Products covered included both coagulation factors and insulins. Responsibilities included ensuring approvals of Clinical Trial Applications and developing regulatory strategies targeting global regulatory approvals.
2003 – 2004: Project Vice President, NovoSeven Support, Novo Nordisk A/S
- Leads global development and life cycle management efforts for NovoSeven encompassing line extensions, 2nd generation processes, optimisation of product profitability
- Responsibility covers development, documentation, regulatory approval and implementation
2000 – 2002: Vice President, Protein Process Development, Novo Nordisk A/S
- Leads functional area of Protein Process Development (6 departments, 130 people) encompassing cell culture and downstream processes, analytical development and virology. Major projects in this period: rFVIIa, Insulin analogues, Glucagon Like Peptides
- Responsible for development, documentation, scale-up, process validation and transfer of processes to production
- Responsible for state-of-the-art biologics GMP pilot plants including manufacture of drug substance for clinical supplies
- Built strong leadership team and trained 4 new dept. managers
- Established 2 new departments to ensure the performance as the area grew
- Developed short and long term strategies for technology development within cell culture and downstream process development. More than 3 new initiatives started in this field with industry and university partners.
Full CV