Michael Hugh-Bloch

Therapeutic Expertise: Renal Denervation, Hypertension (Medical Device, Combination Product) -Project Lead for 2 regulatory Scientific Advice Meetings (MHRA and MPA) -Built-up a strong and efficient clinical affairs team for Europe -Successful expedited set-up of Phase II PoC and Phase III pivotal trial

Therapeutic Expertise: Haematology, Orphan Diseases (Phase IV studies) - Led a Key Opinion Leader (KOL) satisfaction survey project utilizing a customer feedback index - Provided medical and clinical scientific expertise, developed and executed EMEA Medical Affairs strategy and supported individual country teams on local strategic planning and execution

Therapeutic Expertise: Haematology, Orphan Diseases - Implemented a KOL management tool in EMEA and a KOL landscape survey and analysis for a newly launched product

Therapeutic Expertise: Haematology, Orphan Diseases, Vaccines (Phase I - III studies) - Successfully transitioned, implemented and closed an acquired international phase II/III study in haematology/orphan disease leading to successful BLA and EMA submission - Set-up and implemented several international phase III haematology studies and a phase I orphan disease study

Therapeutic Expertise: Oncology, Neurology), Orthopedics , Phase I-III studies - Headed Clinical Operations team in Austria - Rolled out new CRO model and improved collaboration with GCDU/Medical Affairs, GBUs and Affiliates - Planned and managed operational performance, setting and achieving all time, cost and quality targets - Local expert on site and study management, advising on country feasibility, site selection and submissions

- Set-up and successfully implemented a first-in-man study, assumed overall strategic responsibility for paediatric phase I/IIa study in Latin America and managed phase III and IIIb - Successfully project managed international pivotal phase III study, providing final clinical study report within deadlines, and overall clinical project lead on a key first-in-man product development program

- Project managed international clinical trials to confirm progress against development plans and strategic goals, tracked project budget and milestones; and hosted international meetings

Clinical Development, Project Management, Medical Affairs

Pharmaceutical Chemistry