As President and Founder of Lucy Rose and Associates, LLC, Lucy provides in-depth strategic consulting services to nearly 300 pharmaceutical and biotech companies around the world. Lucy’s 30-year career experience in for-profit, non-profit, government, and patient care settings, coupled with her innovative approach to training and strategy, provides the depth of knowledge and technical expertise necessary to equip pharmaceutical companies to excel in a rapidly changing future.

Strategic Life Sciences Consulting

Senior Leadership “Signature” Partnerships

• Enterprise risk management
• Intentional drug development for clinical success
• Due diligence assessments
• Patient engagement programs
• US and global advertising and promotion regulatory considerations

            Drug Development (“Backwards Planning”) for Commercial Success

• Clinical trials design (overall development program) counsel for maximizing the label for commercial success – including outcomes, such as: patient satisfaction, adherence, and compliance
• Strategic regulatory direction regarding the creation of realistic promotional programs and expectations

Peri-launch Strategy Development

• Authoritative guidance supporting the development of a realistic marketing strategy (and claims) based on clinical trials and PI
• Regulatory expert guidance and participation in internal “Mock OPDP” comprehensive meetings on claim development and support
• Communications strategy considerations
• Medical Meetings considerations
• Ad/Promo launch materials review

Post-launch Evaluative Consulting

• Enlightened consulting on new program and tactic viability (for instance, patient involvement and social media) and regulatory maximization
• Astute review and insight regarding new promotional materials and claims

Process Improvement Consulting

• Evaluation of current, and creation of future, “best practices” promotional review process, utilizing an overall, beginning to end, systems approach