Rapid Response Supporting In-Licensure (United States)


Charge

A major global pharmaceutical company is evaluating a CNS product recently approved in the United States for a CNS-related condition, in a nonoral formulation.  Specific project objectives included:

  • Understanding potential barriers to adoption
  • Sizing the segment that would be appropriate for, and in need of, a nonoral formulation, which is considered by the development team as the target for the product
  • Determining how the product would compete with other non-oral solids (eg, inhaled formulations) in late-stage development for a similar condition, a question that is critically important to the medical reviewer on the client’s business development team

 

Methodology

A research plan was designed for this project reflecting experts in the field and potential users of the product; the timeframe reflected the client’s needs. For this project, Cello Health Advantage used their proprietary Matrix Intelligence Process,®, a system of analyzing and synthesizing multiple inputs into a concise set of learnings and recommendations. The Matrix Intelligence Process for this project was as follows:CASE-STUDY-2
Only 7 days were available to answer the questions listed in the objectives above.  To that end, a kick-off conference call was immediately held with the client to gain approval of the methodology, which consisted of the following:

  • 60-minute TeleWeb interviews with experts; the expert list was created by Cello Health Advantage in 1 day and shared with the client; the list was created based on our rigorous approach of matching individuals with a minimum of 3 of the following 7 criteria:
    • Have studied and published in the condition.
    • Hold key positions in appropriate specialty associations, or on appropriate workgroups or committees related to the condition.
    • Widely respected in their specialty and by affiliated specialties.
    • Have participated in consensus panels, guideline committees, or advisory boards sponsored by the NIH and other government bodies on this or related subject areas.
    • Are or have been a principal investigator in major, relevant NIH-sponsored studies on the condition.
    • Have been an author/editor of related textbook chapters or relevant key medical journals.
    • Head of a department considered most prestigious in neurosciences, and particularly in this condition.
  • 45-minute TeleWeb interviews with 5 community-based neurologists.
  • 45-minute TeleWeb interviews with 5 community-based primary care physicians.

One page of prework and the blinded product profile were provided to the experts and community-based physicians to efficiently use the time during the interviews.  The prework requested information on the respondent’s adoption strategy of new products and impression of superiority among the products most commonly used to treat this condition today.

Deliverables

In addition to the research tools and the US-based expert list, which was available to the client for use in other projects, Cello Health Advantage delivered information on:

  • How and why current products are chosen to treat this condition
  • Detailed description of the patients who would be appropriate for nonoral medications
  • Detailed reaction to the product profile and reasons why
  • What might be expected in use of this asset when other nonoral formulations are approved in the US
  • A high-level summary of the opportunity assessment was provided to the client to share as part of a management presentationKey learnings were provided in a 1-hour presentation (24-PowerPoint slides), a 3-slide executive summary, and detailed backup slides with additional details on the respondent profiles and prework.productn2

Postmortem

Utilizing the information provided in this rapid response project, and the forecasts that were generated internally, the client ultimately licensed in the product.  Several additional rapid response assignments in CNS categories were awarded to Cello Health Advantage immediately following this project based on the quality of the deliverables and on-time, on-budget performance.

  • Cello Health Advantage Inc.

    Cello Health Advantage Offers You
    • US and global experience
    • Experience in ~100 therapeutic areas
    • Ability to work quickly
    And delivers on time, on target, and on budget
  • Locations

    Princeton
    475 Wall Street, Princeton
    New Jersey 08540

    Midland Park
    666 Godwin Avenue, Suite 230
    Midland Park
    New Jersey 07432

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