PACEOMICS aims to maximize the return on investments made in PM technology to secure greater patient benefits, lower health care costs, and waste fewer resources. It does so by bridging informational gaps between PM researchers, developers, safety regulators, health system payers and patients who require new and innovative treatments. PACEOMICS activities address issues across four broad thematic areas:
- Public and clinician perceptions of the social value of PM technologies and services. PACEOMICS research is characterizing and measuring Canadian social values for PM technologies to develop a value framework to support regulatory and reimbursement policy and decision-making.
- Health technology appraisal and evidence development for PM diagnostics and pharmacogenomics therapies. PACEOMICS is addressing technical challenges in research and development by asking: 1) how reimbursement decision-makers should assess the evidence for a PM technology and identify the best value reimbursement strategy for a given population; and 2) how developers of PM technologies should evaluate alternative research investment options to maximize the value of their commercial investment. This area of research incorporates the identified social values for both healthcare reimbursement decision-making and commercial research investment appraisal.
- The legal and regulatory environment. PACEOMICS is addressing the legal and regulatory environment for PM technologies and services, focusing on key challenges associated with the co-ordination of PM technologies through regulatory approval pathways and how the legal system may impact their uptake and utilization.
- PM technology development and intellectual asset management. PACEOMICS is addressing the translational hurdles in moving PM technologies through clinical development to market. It analyzes the incentives required to harness the necessary multi-disciplinary, multi-stakeholder, multi-national, and highly collaborative research and development required to capitalize on public and private sector investments. The research focuses on funding mechanisms and intellectual property (IP) rights.
The PACEOMICS Toolkit
The PACEOMICS Toolkit will assist the PM industry by reducing risks surrounding regulatory and reimbursement decisions and health care systems by proactively attracting the types of PM technology needed to improve health outcomes.
The Toolkit will comprise:
- Value frameworks for decision makers and regulators, based on social preferences;
- Analytical strategies to inform early to mid-stage research prioritization decisions and ‘go-no-go’ decisions on late-stage research investments; and
- Methods for evaluating the evidence for PM technologies and alternative patient access strategies.
- Further deliverables will include position papers with recommendations for regulatory frameworks and the advancement of technological development through public-private partnerships and the creative management of intellectual property, as well as public and media engagement.
PACEOMICS will research these four thematic areas based on six case-studies to ensure real-world relevance. The toolkit will be developed and tested using the six case studies. Read more… .