Areas of Expertise

Financial Firms, Investors & Analysts

• Review of sales projections, financial model assumptions and market share predictions

• Understanding of new therapeutics – will they fulfill an unmet need?

• Evaluation of pipeline activities – assigning success criteria

• Connections to key opinion leaders in many therapeutic areas – ensure conversations are with the right people

• Evaluation of all steps of the orphan drug process and keys to positive outcomes

Pharma & Biotech Companies

• Understand the ins and outs of pursuing Orphan Drug Designation (ODD) including what it takes to get Orphan Drug exclusivity (ODE) or re-exclusivity

• Recognize how to identify questions, engage with data and execute HEOR projects to answer critical real-world questions

• Become well versed in best in class approaches to new product launches from pre-launch medical planning to post-approval

• Offer opinions on market access success or failure and best approaches to improve market access after approval

Consulting Firms

• Provide added expertise to your team members on detailed aspects of Phases 1-4 of product development

• Understand the nuances of building departments in medical affairs, clinical development, clinical operations and commercial (sales and marketing)

• Deeply grasp the drug development process and keys to success with FDA interactions