- Creating value proposition relevant for payers
- Design of health economics and outcomes-based research projects
- Identification of real-world, payer focused research sites and opportunities
- Evaluation of reimbursement environment
- Does my pivotal trial, designed for regulatory purposes also provide useful information for payers? If not, how can I integrate/generate data that is of interest to payers?
- Is a health economic and outcomes research (HEOR) study needed to convince payers about the value of the product? How should this study be designed and where can it be conducted?
- What is in the pipeline for indication X? Can I competitively position my product, e.g. using a biomarker?
- Will reimbursement of the companion diagnostic test automatically follow reimbursement of the drug? Is it advisable to develop a companion diagnostic and what are potential other options?
- Analysis of US reimbursement opportunities for Crohn’s Disease, NASH and NAFLD diagnostics
- Health economic evaluation and payer strategy of novel renal therapy
- Identification of market access strategy for new diagnostic via integrated health systems
- Product positioning for new microbiome company
- Population-based screening for pharmacogenetic applications, integration into national health care
“Opus Three assisted our company over a period of 4 years in determining path to market, product priorities, and regulatory strategy. Their extensive and up-to-date knowledge of the global regulatory environment and the clinical evidentiary demands was excellent, and enabled the company to successfully navigate the changing healthcare landscape as a young technology-based company.”
“Opus Three provided sure-footed guidance for a plan to obtain FDA approval for a new infectious disease diagnostic, and the clinical studies required to compile the necessary data.”
“Dr. Frueh has provided our company with extremely useful guidance in exploring the commercialization of a Genetic Test for Depression. His pragmatic detailed strategic advice has been coupled with magnanimous personal network connections, at the highest levels of this sector.”