Information Management Accomplishments

 

A Mid-Sized Pharmaceutical Company

Goal: To address pivotal data and analysis issues for an NDA in oncology.

Result:

  • Identified and characterized issues of non-randomly missing primary efficacy data.
  • Defined overall strategy for communicating this issue to the FDA.
  • Devised sensitivity analyses to assess possible impact of the data gaps on primary efficacy result.
  • Summarized issues and results in Clinical Study Report.
  • The U.S. NDA filing was successful and was approved in 1Q2008.

 

 A Software Contractor to the US Military

Goal: To analyze strengths, weaknesses, opportunities, and threats for a company plan to enter the digital microscopy market.

Result:

  • Found the company’s strengths to be its ability to perform real-time zoom and pan, plus multi-level security and access.
  • Found the company’s weaknesses to be lack of brand recognition and the fact that they are late to market.
  • Discovered faster technology is possible with room for growth in this market; there are several business models to choose from and they have the opportunity to influence standards and acceptance criteria.
  • Detailed market challenges including constrained budgets, declining reimbursement , significant regulatory hurdles, and competitors who are strong and established equipment and platform companies with significant brand loyalty.

 

Gene Network Sciences - A Clinical Bio-Simulation Technology Platform Company

Goal: To establish strategic partnerships and associated business models. Support development of scientific advisory board, and mentor key personnel.

Result:

  • Identified applications within the pharmaceutical industry segmented by therapeutic area, drug development phases, and information types that would significantly benefit from client’s proprietary tools: patented algorithm based on Bayesian statistics and novel algebras.
  • Helped executives define and prioritize research and commercial programs.
  • Supported business development and deal structuring activities to prioritize client base, business leads, and to provide strategic introductions.
  • Prepared client for negotiations and participate in negotiations on behalf of client.
  • Evaluated and recommended collaboration, fee-for-service, and milestone-payment models.
  • Develop purpose and operating principles for a scientific advisory board.
  • Mentor executives to lead board meetings.