Thinking of Launching a Companion Diagnostic? Ask Yourself These Questions

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For the last decade or so, much attention has been focused on personalized medicine; a modern approach that uses an individual’s genetic make-up to create a more targeted therapy or treatment. This advancement in genetics and biochemistry promises to bring to light the factors that explain why some patients largely benefit from therapy while others do not; and even in some cases go ahead to experience undesirable side effects.

To ensure better benefits for patients with the bonus of maximizing the potential of the companion diagnostic launch alongside a therapy, where should the focus be from the pharma company perspective? More importantly, are you asking the right questions to start with? Here are some example questions that should be considered early on:

1. Do you really comprehend the value that a diagnostic brings to your drug?

A companion diagnostic can help to select the patients that are most likely to give cleaner data and therefore reduce not only the sample sizes needed for trials but also the development costs incurred. In some instances, a diagnostic could even help save a patient from getting a drug that would otherwise fail. The market size may also be increased if the diagnostic identifies suitable patients that are getting an alternate drug.

2. Have you taken into account all the adoption hurdles that diagnostics face?

During the launch, confidence in a diagnostic may not be at the same desired level as a drug and therefore the relevance of chosen biomarkers to clinical outcomes may still not be considered direct or 100% predictive. Additionally, even if the test is ready, the physicians in the clinic may still be very reluctant to immediately accept the diagnostic without robust evidence and education.

3. Is it important to have a team for the product launch?

Having a team is very important when designing a commercial strategy as well as the associated tactical plans. The team should incorporate people who really know both the therapeutic and the diagnostic components. This should help to avoid potential miscommunication between the two siloed organizations that might otherwise be working independently on the diagnostic and the drug. This also ensures you have a shared direction and set of goals that work well for both parts of your product.

4. When do I need to start planning the launch?

Many companies have made the mistake of planning the launch too late and getting overwhelmed by the complexity of the process. Therefore, start your planning process early enough for a successful launch.

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