Diagnostic Development and Commercialization – Establishing a Strategy on Time

Tessa Sandberg

In Part 1 of the series, ‘Personalized Medicine: What Pharma Should Do to Get Ready’, Tessa Sandberg of Diaceutics discusses the importance of establishing a robust diagnostic development and commercialization strategy on time.

Christmas always comes as a surprise, right? All of a sudden it’s 22nd December and not only have you not bought a single Christmas present for your wife/husband/kids but what’s worse is you haven’t got the foggiest idea what to get them. Sounds familiar? You may not celebrate Christmas itself but you can all relate to a particularly important event that everyone is well aware of and some even wildly excited about. The people around you—and you, too—know this great event needs careful preparation but year in, year out, you somehow never manage to get everything ready in time.

Now, what could this silly and possibly unseasonable example have in common with the pharmaceutical industry, where whole project management departments watch deadlines with eagle eyes, hang giant progress charts on meeting room walls and where launch dates mean the culmination of not one year, but a decade of hard work and eager expectations? Nothing, you might say. But think again, and think of diagnostic planning. Have you ever heard someone say, “We’ll worry about the diagnostic when we have more robust clinical data, including the biomarker analysis read-out next spring?” Maybe you said it yourself?

Here at Diaceutics, we have delivered many projects to clients who came to us, in near panic mode, six months before an anticipated drug launch that they knew would require a companion diagnostic (CDx). Nevertheless, that CDx would not be anywhere near ready for launch and the clients would have no hint of a plan for bringing a CDx to market successfully. I must admit to hating these  ‘firefighting projects’, as we call them within Diaceutics. Not because we can’t cope with the immense yet unneccessary pressure caused by having to fast track every activity—of course we can—but mainly because there is simply no way that a last minute Dx launch could be as well-designed and organized as it could have been if prepared in advance.

When the strategy is well designed and planned a diagnostic can and often does play a crucial role in driving the uptake of a novel drug. If it is not the case, like with the last-minute Christmas shopping panic, you will have to go for a somewhat bland and uncreative solution just to have something to offer. The reaction of the person on the receiving end will often be polite but not particularly enthusiastic, whether that is your husband opening yet another tie, or the oncologist facing another CDx that he does not know how to use or get reimbursed for.

Based on our expertise in the field we have identified the three best practices we consider critical for developing an early and robust diagnostic development and commercialization strategy.

  1. Develop the diagnostic commercialization strategy at least 18 months before launch
    All pharma companies know that implementing a test is time consuming but they are not aware the same is true of Dx implementation. Diagnostic commercial strategy should start at least 18 months before launch to ensure a simultaneous release with the drug (Figure 1). During these 18 months, pharma can develop a robust strategy that aligns the Dx to the drug, determines the strategic and technical goals, prepares for engagement and management with stakeholders and plans the diagnostic lifecycle.
  2. Create a Target Test Profile
    A Target Test Profile (TTP) is a main component of the diagnostic strategy. Similar to an architectural drawing showing the essential components of a house, a TTP is a key strategic planning document that provides a summary of a test’s desired characteristics and expected technical, clinical and commercial features. To reach the required commercial development outcome, the TTP is continuously adapted along the drug development pathway. Diaceutics offers their clients a well-designed TTP to ensure they embark on a product development program that is effective and efficient, addressing all relevant clinical, technical and scientific requirements.
  3. Engage in early dialogue with third parties
    As launching a test may take significantly more time than expected, pharmaceutical companies are advised to engage in early dialogue with third parties such as the Food and Drug Administration (FDA). Pharma can also engage with payers about issues such as test reimbursement. A test requiring a new current procedure terminology (CPT) code may take 12 to 18 months to diffuse across the payer system. Late planning can lead to frustrating, unforeseen events. Furthermore, engaging early with third party stakeholders may bring positive and beneficial surprises. The FDA approval or clearance of a test, for instance, can be accelerated when the drug and CDx are being launched at the same time.

To avoid lagging behind with the Dx strategy, pharma should start developing the commercialization strategy 18 months before launch, invest time and effort to keep track of a TTP and engage in early dialogue with third parties, as you never know how long everything will take. In parallel, drug implementation can be leveraged by aligning the robust Dx strategy to the drug development process, and it’s this topic we will discuss next.

For now, we will let you start planning your diagnostic strategy


Figure 1. The importance of planning the diagnostic strategy early in time: shifting from A to B.


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