# Vicarius Leadership Team – Executive Profiles

Pre-Approval Regulatory Affairs

### Professional Experience

FB Pharma Consultancy, Founder & Consultant, United Kingdom

Vice President, International Regulatory Affairs, Biogen

Vice President, Clinical Operations and Data Management, Biogen

Head of Clinical Research and Project Planning, Scherer DDS

Clinical Research Manager, Glaxo

Clinical Research Scientist, Upjohn

### Regulatory Consultant

• Provided consultancy services to clients to help achieve approvals of their products in the EU during appeal, overturning previously negative CHMP opinions, achieving one conditional approval, one exceptional approval and one full approval.
• Provided advice for clients on strategic and operational aspects of clinical development programs for the EU.

### Biogen

• Achieved a positive CHMP opinion for conditional approval of Fampyra, overturning a previously overwhelmingly negative CHMP opinion
• Achieved approval of Tysabri in EU and many follow-on markets with a good label and reasonable risk management plan to manage the risk of PML
• Successfully managed major deviations and recalls
• Achieved approvals for clinical trials in over 40 countries
• Set regulatory strategy for biologics, small molecules, and for the start of a Biosimilars business.

### Education

Diploma in Company Direction, Institute of Directors, UK

D.Phil., University of York, UK

B.Sc., Biology, University of York

British

English

## Member Profiles

• President and CEO
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• Post-Approval Regulatory Affairs
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• Chief Compliance Officer
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• Vice President, Market Access
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• Head of Business Development,
• Legal & External Affairs
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• Chief Medical/Scientific Officer
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• Chief Financial Officer
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• Vice President,
• Head of Commercial Strategy
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