Dr. Frank Driessler

Manage and develop the global medical affairs strategies for pipeline molecules and marketed products, in alignment with Novo Nordisk’s corporate values, strategies and objectives. Develop and maintain productive and appropriate relationships with individuals across the organization including cross-functional groups.

Supporting of EPCU clinical trials and programs, ensuring the project teams achieve operational excellence and successful execution of the PL and clinical operations and logistics strategy Responsibilities include managing phase I and phase IIa clinical trials with regards to study conduct, timelines, regulatory issues and stakeholder communications Preparing, participating and following up on trail master file audits using GCP, FDA and EU clinical trial directive guidance documents

Appointed as Project Manager for development of 4 strategic novel ROTEM® POC diagnostic reagents Leading stakeholder meetings to enable requirements for quality and distribution performance management across different departments Handled globally the ordering, distribution, and marketing for >12 medical diagnostic reagents Introduced unified barcode systems and implemented standards compliant barcode labels under EU and FDA regulation framework

Developed global strategic clinical assays plan (including site feasibility, site qualification and site initiation plan, site monitoring and documentation plan, site closing plan), and implemented global clinical assay protocols Executed the 1. Standardized Thromboelastometry study in 2 pivotal Phase 3 studies in 9 countries by managing >21 laboratories globally Ensured budget, timelines and record data/ experiments were communicated across different functional teams in written and oral forms

Established, managed and supervised the tissue and cell culture laboratory; Developed annual operations budget, designed training materials and research protocols for analytical tools and biochemical techniques assessing cellular activities; Collaborated with Principle Investigators, mentored PhD students, honor students and supervised research assistants (>10 stuff members) in molecular and genetic techniques;

Clinical Trial and Data Management (InFormTM, PMED® and SAE reporting) Clinical Study Logistics (DataLabs®, IVRS and IWRS) Regulatory Affairs (Guidelines and laws in clinical research)

Identified new biomarker function of Rsk2 and Fra1 in mesenchymal stem cell differentiation Trained and supervised employees and students in bone genetics Managed breeding and genotyping of 10+ genetically modified mouse strains