OUR CURRENT AREAS OF FOCUS
TARGET-NASH is critical for the scientific and regulatory community to better understand the natural history of disease, including long term outcomes across populations.
TARGET-PBC is critical to enhance the understanding of the natural history of PBC by answering crucial questions involving the safety and efficacy of approved and off-label therapies.
TARGET-HCC is critical to provide more comprehensive clinical data from defined patient populations in academic and community practices to advance this area of significant unmet medical need.
TARGET-IBD is critical to better understand real world, longitudinal data where the robust pipeline of new chemical entities and biosimilar entrants will have a profound effect on patient management.
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.
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.
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:
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.