Drug Development
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Biosimilar clinical development
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Biological developments
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Clinical appraisal of new formulations and drug delivery systems
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Clinical phase II and III protocol design
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Clinical Trial Application support
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Close cooperation with toxicology Consultants
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Evaluation of phase II data, planning further development
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First-in-man protocol developments
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Member of independent Data Monitoring Committees
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New routes of administration
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Non-clinical pharmacology review and planning
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Non-clinical planning of various therapeutic areas
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Orphan Drug clinical and administrative support
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Paediatric Investigation Plan (PIP) clinical and administrative support
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Persuading a client to suspend clinical work and undertake further preclinical work
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Phase I CRO assessment, liaison and study placement
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Presentations on first-time-in-man studies, QT/QTc guidelines, clinical study design phases I, II and III, European drug licensing, anti-cancer regulation, pharmacovigilance.
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Primary reviewer for phase I dose-ranging PK, PD and safety data and advising on dose escalation
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Provision of due diligence reports
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Toxicology reviewing, gap analysis
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Writing and amending Investigator Brochures
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Writing Briefing Books and questions for Scientific Advice