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505(b)(2) – Part 2: The Assessment: Clinical Marketing Assessment

Competitive Products Review/Clinical Marketing Assessment     

This section includes an assessment of the existence of a medical need and the ability of the proposed drug to compete with existing and pipeline agents.  At Camargo we deeply believe that good science = good business.  In practice, this means that simply getting FDA approval isn’t enough.  The drug must meet a need for a physician and patient.  If the drug meets this test, then it should be reimbursed, be attractive to the distribution system (when priced right) and be profitable.

This section provides:

  • Insight into the market
  • Pipeline overview
  • – Products in development
  • – Clinical trials in progress (CenterWatch)
  • Competitor’s Strategy
  • – Pricing
  • Patents
  • – Diversification
  • – In-licensing

This section is tailored to the clients’ needs.  Depending on the question(s) to be addressed, Camargo may seek information from key opinion leaders and other experts in the field. We may conduct surveys of physicians, pharmacists, distributors or patients.  Primary data can come from prescription databases (i.e., IMS), from SEC filings, US government reports and databases (Pediatric example, Healthcare Cost and Utilization Project, Center for Disease Control (Caution: 600 page PDF!), epidemiology published studies  and many other sources.