TARGET PharmaSolutions was formed in February 2015, based on the success of HCV-TARGET, a case study of the model in Hepatitis C. Formed in 2011 by Dr. Michael Fried (University of North Carolina) and Dr. David Nelson (University of Florida), there are over 10,000 patients enrolled at 58 sites worldwide. The FDA has entered into a Memo of Understanding with HCV-TARGET and is an active participant on the advisory committee directing the clinical analysis. Through the utilization of this data, one sponsor has expanded their label and others have mitigated costly Phase IV commitments.

A Growing Problem

With increased emphasis on real world utilization (safety and efficacy), there have been an increased number of Phase 4 trials mandated by regulatory bodies around the world which has resulted in an increase in spending of over $1B in the last 5 years alone.   Currently, post-marketing requirement (PMR) and post-marketing commitment (PMC) studies are:

  • Costly (CRO costs, site costs, drug opportunity costs, looks at only one drug)
  • Slow to initiate
  • Slow to enroll
  • Underpowered to increase confidence in outcomes or to uncover new safety signal

The TARGET Solution

As a result of these inefficiencies, TARGET PharmaSolutions was formed to provide a more effective and efficient solution to Post Marketing commitments. Through “collaborative communities” within individual disease states, TARGET is able to do the following:

Streamline Regulatory Requirements

  • Satisfy Post Marketing Requirements/Post Marketing Commitment at a fraction of the cost and in less time
  • Assess efficacy of risk evaluation and management strategies mandated by regulatory agencies in a timely manner

Enhance Commercial Opportunity

  • Dataset is transparent: All industry partners can query information about their own or competitor drugs for internal planning (e.g. Comparative effectiveness, Compliance and Utilization, Patient Segmentation)
  • Drug is prescribed and paid for using normal commercial process

Increase Academic/Clinical and Regulatory Interactions

  • Key opinion leaders drive the analysis and dissemination of post-marketing data at scientific meetings and publications
  • Industry Partners interact with regulatory agencies, key opinion leaders, and community advocates as members of Steering Committee