Strategy  ♦  Clinical  ♦  Regulatory  ♦  Reimbursement

   Planning   →      R&D      →       Approval      →     Commercialization


Our clients range from small start-up companies to large multinational corporations in diagnostic and pharmaceutical development, equity and investment firms, and health care consulting firms.

The following are some of the questions that we have engaged in answering for our clients. Answers are always nuanced and depend on the specific product or environment – there is no “one size fits all” answer to most of the questions; we work with our clients to find the solution that is most appropriate for their products and markets and best suits their needs.


• Will a genetic test be required and under what circumstances?

• How can drug- and test development be strategically aligned and regulatory submissions for drug and test be coordinated?

• How can new therapies be submitted to the FDA allowing an accelerated review and approval of this new drug development strategy?

• How can the development of a diagnostic be aligned with the much longer, more complex development of a new drug therapy?

• We have a drug-test co-development project. Which Center at the FDA should we engage with first?

• Should we develop a LDT or should we aim for regulatory clearance of our new diagnostic?



• Assuming that the selection of the appropriate therapy will depend on a genetic analysis, what does this test look like, how will it be clinically implemented, and how will it be aligned with the development paths of the compounds for regulatory clearance?

• Who can we work with for conduction our clinical trials?



• How is the FDA regulatory landscape for XY and Z evolving?

• How will the FDA regulate algorithms and decision tools that help select the right therapy?

• Which regulatory pathways exist (e.g. breakthrough dedication, voluntary submission, pre-Subs, and others) that could accelerate product development?

• Does the FDA regulate laboratory developed tests (LDTs)?

• The IVDMIA approach appears abandoned, but what – if any – regulation will take its place?

• How will the FDA evaluate such products and can a mechanism be found that allows an iteration of such products on an ongoing basis without the need for new regulatory submission?



• How is the new reimbursement coding system evolving and how will it impact in vitro diagnostics?

• How should phase 1 and 2 studies be conducted to satisfy regulatory expectations and enable the stratification of the patient population using genetic biomarkers? Does it impact reimbursement?

• 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?

• Will payers see the benefit of a personalized approach to health care and how will it affect product development? How can or should we gain insight?

• How does a one-time (e.g. gene therapy) treatment get reimbursed assuming a life-long effect?

• Will reimbursement of the test automatically follow reimbursement of the drug?