Driven by the expertise of Key Academic Opinion Leaders our individual disease state communities are collaborative spaces driving open conversation between experts, regulatory agencies, patient advocacy groups, and our Industry Partners.
TARGET PharmaSolutions was formed in February 2015, inspired by the success of HCV-TARGET, a case study of the TARGET model in hepatitis C. The HCV-TARGET case study was established in 2011 by Dr. Michael Fried (University of North Carolina) and Dr. David Nelson (University of Florida). It has enrolled over 10,000 patients at 58 sites across North America and Europe.
The evidence generated from HCV-TARGET has multiple applications, for instance it has been used by regulators to monitor post-marketing drug safety, by sponsors to support label expansion and to fulfill multiple post marketing commitments. In addition it has helped inform national and international treatment guidelines, been used in payer dossiers, and has resulted in numerous high impact scientific presentations and publications.
To date, there have been over 21 publications of the HCV-TARGET data with over 90 unique authors.
A Growing Problem
The increasing emphasis on real world utilization of medication (safety and efficacy) has resulted in growing numbers of regulatory mandated Phase 4 clinical trials, this has resulted in a rise in spending of over $1B in the last 5 years alone. Current post-market requirements (PMR) and post-marketing commitment (PMC) studies are costly, slow to initiate, slow to enroll, unable to uncover new safety signals, and are not powered to increase confidence in outcomes.
Understanding the complete natural history of diseases has also become increasingly important for physicians, payers, and pharmaceutical manufacturers. The insights garnered from a comprehensive understanding can help physicians augment treatment and identify new areas of prevention and control, help payers understand the true economic burden of disease, and help pharmaceutical manufacturers understand the true utilization of therapies across heterogeneous populations.
The TARGET Solution
TARGET PharmaSolutions was formed to provide a more efficient and cost effective approach to understanding the natural history of diseases and fulfilling post marketing commitments. By leveraging disease state specific “collaborative communities” centered around the insights of Key Academic Opinion Leaders along with, regulatory agencies, and patient advocacy groups we are able to:
Streamline Regulatory Requirements
- Satisfies Post Marketing Requirement and Post Marketing Commitments in a timely manner at the fraction of the cost of Phase 4 clinical trials.
- Quickly assesses efficacy of risk evaluation and management strategies mandated by regulatory agencies cutting down on the time and investment needed.
Enhance Commercial Opportunity
- Our dataset is transparent and easy to access. All industry partners can query information about their own or competitive products for internal planning purposes (e.g. Patient Segmentation, Compliance and Utilization)
Increase Academic/Clinical and Regulatory Interactions
- KOLs drive the analysis and dissemination of data at scientific meetings and in publications this ensures that all of our information is vetted by leading industry experts
- Industry Partners interact with regulatory agencies, KOLs and community advocates as Steering Committee members
All data is 21 CFR Part 11 compliant, monitored at 3 levels, and meets CDISC standards. Additionally, WHO DRUG and MedDRA standards are incorporated to ensure the highest quality and utility of data.
We employ an extremely inclusive collaboration model that leverages a variety of profiles including Key Academic Opinion leaders, regulatory agencies and patient advocacy groups. This collaborative model forms the centerpiece of our approach ensuring that our findings are informed by the contributions of multiple experts from a variety of categories.
TARGET PharmaSolutions has four communities underway: TARGET-NASH, TARGET-PBC, TARGET-HCC, TARGET-IBD.