Torben Halkier

Background

About Torben Halkier

Before I joined Ascendis Pharma in 2011, I build and headed protein analytical and characterization laboratories three times. My conviction about the value of a proactive strategy for the analysis and characterization of protein product candidates combined with scientific excellence were the two cornerstones of my laboratories successful achievements. In January 2004 an independent consultant ranked my group to be among the ten best laboratories in the world working with analysis and characterization of protein pharmaceuticals. After joining Ascendis Pharma, my tasks changed to working solely through CMOs/CROs, but my basic convictions and thoughts remain the same - scientific excellence and proactiveness - and remain successful. I have significant experience with the CMC-part of pre-clinical and clinical development of biopharmaceuticals, including knowledge of regulatory requirements and guidelines. I have played major roles in outsourcing of CMC tasks; including major technology transfers and troubleshooting. I have thus a lot of experience in interacting with international project partners, CMO's, and CRO's. I have extensive experience in writing regulatory documents for all clinical phases as well as for registrations in both the U.S.A. and Europe. I headed the steering committee that ensured the successful submission and approval of Ascendis Pharma's first BLA. My skill set covers the following expertise areas: Detailed analysis and characterization of protein products Writing of regulatory documents at any level in any region Writing of technical reports Pre-clinical and clinical development of biopharmaceuticals including tech transfers and troubleshooting International relationship management of partners, CMOs/CROs across five continents Outsourcing strategy and management Teamwork and collaboration in global organizations Documentation of scientific data Due diligence and auditing Line, project, and project portfolio management I think strategically, and I am known for my ability to execute. My analytical mindset combined with a keen eye for critical details helps me to quickly extract the important facets of a broad picture. I pride myself of my ability to communicate clearly and precisely both written and orally. Honesty, credibility, empathy, fairness, and respect for other person's opinions are key words for the way I interact with people. I have a natural authority and an inherent ability for leadership. I work well with and within teams. I am a hard working, self-motivating individual with a humorous mind and an excellent memory.