Do I need a companion diagnostic?
A careful assessment of the design of the clinical study and of the benefit/risk for the patient population will help guide whether a companion diagnostic is required. An interaction with FDA, CHMP, or PMDA is encouraged.
Do I need an IDE (Investigative Device Exemption) before starting my drug study?
Perhaps---an assessment of the design of the clinical study in which the diagnostic is being used along with the assessment of benefit/risk should be done. For the US, there are mechanisms to seek feedback from FDA prior to initiating a clinical study.
How late in drug development is it too late to include a companion diagnostic?
It largely depends on the quality of information obtained in your drug development thus far. Often, there are risk mitigation measures that can be taken to potentially prevent regulatory bodies from holding up approval of the drug product based on status of the companion diagnostic.
When should I engage FDA?
Regulatory bodies should be considered important partners to successfully advance drug development programs. Timing of engagement and form of engagement are dependent on a variety of factors. For example, if you should have questions about an unprecedented trial design or if you are studying a new class of drugs, it is prudent to seek input early. If you are studying a drug in a therapeutic area where there are a number of existing marketed agents and the study design for a drug development program is more common, pursuit of written comments from FDA may be acceptable. A consultation with you to discuss the merit of when and how to engage regulatory bodies will allow us to sort through the most appropriate approach(es) for you.
Should I have a pre-IND meeting with FDA?
There are a number of considerations to weigh when determining if a pre-IND meeting might be warranted. For example:
- Is the development program likely to be a fast track to market (e.g. moving quickly from Phase 1 to Phase 3)?
- Is there a high likelihood for the drug to be co-developed with a companion diagnostic?
- Is the drug a biological which has risk of initiating an unwanted immune-inflammatory cascade?
- Is the drug being studied in a disease area where there is a lack of well-established clinical study endpoints?
- Is the drug of a novel mechanism of action where there is little to no clinical experience for the novel class of drug?
- Do you plan to introduce a new health outcomes measure as part of your drug development program?
- Do you have a question regarding safe dosing in the context of your drug's toxicology profile?
Regulatory bodies can be very helpful in providing input and guidance. They often can provide insights based on information they have from other competitive drug programs or scientific literature.