William Current Email & Phone Number

Core regulatory competencies developed during 15 years as a regulatory professional, 14 years of drug discovery research, and 13 years of academic research:• Regulatory-clinical-marketing strategy for drug development teams (begin with the end in mind)• Clinical study design aimed at optimizing desire labeling • Briefing document processes aimed at key messages supported by scientific rationale• Planning and strategy development for FDA meetings (e.g., Pre-IND, EOP2, and Pre-NDA meetings), and other agency interactions• Planning and strategy for US Advisory Committee meetings• Regulatory strategy and key messaging for US and EU marketing authorization applications• Guiding team members to develop clear concise responses (containing key messages) to regulatory agency questions arising from marketing authorization reviews• Detailed, critical review of clinical and regulatory documents (protocols, final reports, cover letters, briefing documents, presentations, etc), • Interpretation of FDA policy and guidance – advising teams on strategy for compliance• US label development (e.g., physician and patient package inserts; cartons, and containers)• US promotional materials development, review and approval • Regulatory due diligence for drug in-licensing • Proactive crisis management of key events during drug development• Therapeutic area experience (Both Large and small Molecule): Endocrine, Infectious Disease (anti-bacterial, fungal, viral), Critical Care-Pulmonary, Dermatology, Auto-Immune)