Diagnostic Strategy and Drug Strategy – Alignment and Integration

Tessa Sandberg

In Part 2 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses integrating and aligning the diagnostic strategy with the drug strategy.

Do you know Bob, the guy who holds the budget for the project? At kick-off, he made it clear that failure was not an option and that the whole company would be dependent on this project being delivered. After that, he never turned up to a single team meeting. Suddenly, it’s six months later, there is a three week slippage against the timeline and milestone three has not been met. Enough reasons for Bob to go absolutely ballistic!

I am sure you all know Bob (apologies to all the Bobs among our readers who are, most certainly, not the one I’m talking about). His behaviour is quite often encouraged in a company as it is a managerial necessity going under the name of ‘delegation’. But let’s define that term: delegation means that tasks are assigned to and executed by others because they can carry out those tasks equally well or even better than the representative issuing the instruction. To achieve this goal successfully, the representative provides supervision, guidance and support to the team whenever and wherever it is needed. Supervision and guidance can constitute a rather trivial reminder but how often does this essentially crucial aspect get forgotten? How often should “I have delegated this task” in effect be read as “I have renounced all responsibility for this deliverable”? Delegation is very different from negligence.

This is unfortunately a feature that is common not only between individual members of a team but also between companies who partner on a diagnostic (Dx) strategy. Having worked with nearly all top twenty pharma companies over the last ten years, Diaceutics has come across too many examples of “We don’t know, our Dx partner will take care of that”.

When developing a drug, the majority of pharma companies partner with Dx companies to develop a diagnostic test which will support the drug. Pharma tends to delegate the diagnostic process completely, including the aspects of supervision or guidance. The main consequence of this essentially negligent behaviour, is that the drug and the diagnostic strategies are not properly aligned which results in the test not supporting the drug and, in a worst case scenario, has a negative impact on the drug.

Based on our expertise in the field we have identified the three best practices that pharma should consider to avoid such a scenario:

  1. Review the positioning of the diagnostic in the drug development process
    Assume that the asset will need a diagnostic test. Pharma and diagnostic companies come together to review and define how they want to position the diagnostic test to best support the drug.
  2. Develop a diagnostic strategy
    Once the question ‘How do we want to position the diagnostic test?’ has been answered, pharma and diagnostic companies will develop a Dx strategy with feasible milestones. To achieve this goal, a Dx strategy has to be developed early enough in the drug development process as discussed in article 1 of this series.
  3. Fully integrate the Dx strategy with the drug strategy
    While developing the Dx strategy, we highly recommend fully aligning the Dx and the drug strategy so the test and the drug can be launched simultaneously (Figure 1). Lack of coordination between drug and Dx test development can lead to the drug being launched without the diagnostic on the label. To facilitate this, pharma companies can integrate the Dx strategy into the Target Test Profile, a key strategic planning document.

Now, just think for one more moment about a new and improved Bob, and imagine him properly delegating tasks and supervising, supporting and giving guidance to his team. He knows what’s happening, he’s keeping a watchful eye but he trusts his team to do their job. Thinking of Bob using his best managerial talents will help us to see how pharma can only fully integrate the Dx strategy to the drug if they delegate the Dx development and commercialization to their Dx company, checking in from time to time rather than giving them total responsibility. Ensuring a good and strong partnership deal is essential and something that will be discussed in the next article.



Figure 1. The diagnostic and drug strategies are aligned to each other to ensure simultaneous launch which will contribute to drug adoption.


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