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European Pharmaceutical Contractor

Supporting Role

The ‘promise’ of personalised medicine is quickly becoming a reality, as the biopharmaceutical industry increasingly focuses on discovering and delivering targeted, personalised therapeutics. Companion diagnostics are at the core of this personalised medicine shift, helping provide more effective and efficient treatments in smaller numbers of patients. In fact, indications are that a companion diagnostic will accompany up to half of all future drug launches, boosting the worldwide companion diagnostics market to an estimated $3.45 billion by 2015.

Contract research organisations (CROs), which are uniquely positioned to span the gap between pharmaceuticals and their companion diagnostic partner assays, have a critical role to play in the process of drug and companion diagnostic co-development.

Personalised Medicine
With the disappearance of the blockbuster, one-size-fits-all treatment model, the industry is moving from a drug discovery process focused on discovering the right drugs, to one that is focused on finding the right patients. The benefits of this personalised medicine approach are clear: it shifts the emphasis from reaction to prevention, through the tailoring of medical treatment to the individual characteristics of the patient; it enables the selection of the therapy most likely to be successful in a specific patient cohort; and it minimises or reduces the risk of adverse drug reactions.

Core Findings
So what is a companion diagnostic? The official definition is “an in vitro device that is essential for the safe and effective use of a drug.”

In its simplest definition, it is a test that improves the outcomes of drug therapy – one that, when used correctly, will determine whether a particular patient will show a positive response to therapy with a certain drug; whether there is an increased likelihood of an adverse drug reaction; or if the dosing needs to be adjusted to achieve optimal blood levels.

A decade ago, the industry considered tests such as therapeutic drug monitoring an encumbrance to the adoption of a drug – one that increased the cost of therapy and posed questions around the drug’s safety profile. Overall, these perceptions hindered the widespread adoption of such diagnostic techniques.

Fast-forward ten years and these perceptions have dramatically changed. A better understanding of the genetic causes of disease and the response of patients to therapy has resulted in some notable success stories, especially in the oncology field. Consequently, there has been an evolution in thinking around the entire companion diagnostics field. The industry now sees it as it truly is: a suite of effective techniques that can improve outcomes – of drug development, patient treatment and healthcare strategy.

FDA on Co-Development
Over the past few years, the US Food and Drug Administration (FDA) has become increasingly visible as it moves to tighten its oversight of the companion diagnostics development process. In a 2011 guidance document, it reaffirmed that “if use of an in vitro companion diagnostic device is essential for the safe and effective use of a therapeutic product, the IVD companion diagnostic device and therapeutic product should be approved or cleared contemporaneously by the FDA for the use indicated in the therapeutic product labelling.”

The FDA cites several benefits of co-development, including:

● Allowing the drug and device to be evaluated in the same trials, eliminating the need for additional trials for the companion diagnostic ● Producing real-time validation of the companion diagnostic’s performance and clinical utility
● Improving the safety/efficacy profile of the drug

So what we have now is a changing marketplace where more stakeholders are involved. This is not only limited to the biopharma and diagnostic companies, but also includes physicians, patients, regulatory authorities, and payers who are investing heavily in medical research to ensure patients only receive therapy from which they will benefit. Although developing a companion diagnostic is not without cost or risk, co-developing the drug and diagnostic has the potential to both reduce cost and shorten drug development timelines.

Voice of the Client
In an effort to gain a better understanding of the whole companion diagnostics arena, we surveyed experts from leading biopharma and in vitro diagnostic firms on how they were currently implementing their strategies. We enquired as to their general needs around the companion diagnostic space, their strategy for building internal capabilities versus engaging external collaborators, and ultimately asked them what role, if any, they felt CROs could play in their drug/companion diagnostic co-development strategy.

As expected, all of the companies involved had some form of companion diagnostic strategy and were looking to establish external partnerships to support their strategy. Their needs were clear – they wanted partners with wide-ranging, fully-integrated technical capabilities, who were flexible and agile, had a global footprint, and possessed a detailed knowledge and vision around development.

Although most had not yet considered CROs as companion diagnostic development partners, they quickly recognised that CROs were indeed highly experienced in the development and validation of diagnostic assays for use in clinical trials, and clearly appreciated the efficiency of retaining a CRO to develop this. They identified the benefits as:

● The drug and device may be developed in collaboration, removing problems with sample availability and/ or the need for additional device trials
● A reduced time to market for the drug by coordinating better communication between divisions of the FDA, providing clarity on optimal use of drug, and ensuring drug approval is not delayed by the lack of a companion diagnostic
● Providing clarity on optimal use of a drug, as well as the potential for differentiation in an increasingly crowded market

Commercial Considerations
One important aspect of the companion diagnostic development process that many biopharma companies overlook – particularly in the early stages of development – is the commercialisation of the companion diagnostic. By its very definition, for a companion diagnostic to be an essential part of safe and effective drug use it needs to be accessible. In other words, the physician needs to be able to obtain the test result in the timeframe required for the result to be meaningful.

When choosing both the optimal commercialisation partner and the optimal technology platform, the biopharma company should consider a number of factors that will influence not only the type of testing to be performed, but also the location of testing. For example, the nature of the marker – its concentration, its stability and the sample type – and the required turnaround time of the result – whether this is minutes, one to two weeks, or the same day.

In choosing the correct commercialisation partners, the biopharma company should review the partner’s channel to market: is it direct to end-user through a lab-developed test strategy, or through the global launch of a regulatory cleared kit? If the latter, does the partner have a global commercial reach, or will they need to engage a distribution network?

Finally, the importance of market economics cannot be overstated. A high-quality product will always be adopted, but in this emerging field the question of who pays for the companion diagnostic often arises. Many payers reject coverage for companion diagnostics because they do not understand their intended use, so engaging the payers upfront is critical for access to and commercial success of the companion diagnostic.

As the pace of companion diagnostic innovation accelerates, CROs are in a unique position to leverage the non-competitive nature of their business model, and help their biopharma and diagnostic partners to fill a void in the drug/companion diagnostic co-development process.

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Mark Roberts received his PhD in Pharmaceutical Sciences from the University of Nottingham (UK) and has worked in the clinical diagnostics arena for over 20 years, holding senior positions in both the in vitro diagnostic and reference laboratory industries. He joined Covance at the end of 2012 to spearhead the company’s companion diagnostics programme which is designed to assist pharmaceutical and diagnostic companies in drug/companion diagnostic co-development.
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