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European Biopharmaceutical Review

How to Get a Pre-Competitive Edge

A recent survey by the Alzheimer’s Society revealed that one person every three minutes will be diagnosed with dementia this year. Perhaps it is for this reason that Alzheimer’s is the most feared health condition in the UK, with 62% of those who took part in the survey revealing that an official diagnosis would mean that their “life is over”.

With dementia being one of the biggest threats to our health, it is no wonder there are so many initiatives taking place around the world to delve deeper into the disease in the hope of finding answers.

One of these projects is the European Prevention of Alzheimer’s Dementia (EPAD) project. This project is a €64 million European collaboration between 36 organisations from the public and private sector. It could be this collaboration that gives us our most significant insight into the illness yet.

EPAD will use an adaptive trial design to test Alzheimer’s dementia prevention treatments while the disease is in its pre-symptomatic phase. The group has created its own register, identifying 24,000 people across Europe who already participate in national and regional research studies, long-term cohorts or clinical registers. From this register, people with varying likelihoods of developing Alzheimer’s dementia will undergo standardised tests, and will be considered for selection to take part in EPAD’s proof of concept trials. It is hoped that this trialling process will lead to significant discovery and subsequent understanding of the illness and how it can be managed.

Pre-Competitive Environment

This groundbreaking collaboration has adopted a pre-competitive approach to carry out its research. This means each organisation will bring its own knowledge and expertise together in a neutral environment with the aim of working towards the project’s common goals, which are to reduce the number of people developing dementia and delay the progression of symptoms.

Adopting this approach means that everyone involved contributes their resources, knowledge (intellectual property) and expertise in order to work collaboratively towards positive results in a non-competitive way. Pre-competitive environments offer an opportunity for everyone to pool their background research, previous findings and proprietary data in a controlled way to ultimately develop a more accurate result and individually benefit from it, whether it be commercially or in further research.

Benefits for EPAD


So what can be achieved via the EPAD project that cannot be done individually?

Collaboration and Flexibility
A pre-competitive environment provides significant flexibility in comparison to other, more traditional contractual frameworks. This is largely because it offers a collaborative approach that sees everyone working together in a neutral environment, enabling researchers to focus on their specific areas of expertise but collecting data from a broad source.

The natural history of Alzheimer’s dementia and its longterm nature means there have been many dedicated efforts over the years to try to understand the disease. While we have not yet found a cure, these studies have collected extensive data surrounding the illness. Given the broad scale of this information, it becomes difficult for any one pharmaceutical organisation to interrogate without the help of others. A pre-competitive environment helps to remove any issues of ‘boundary crossing’, as organisations can work and communicate with more people to examine, analyse and interpret this data, rather than working independently.

Thanks to the advancement of cloud technologies and data analysis platforms, pre-competitive collaborations offer flexibility when it comes to sharing data and facilitating fast, transparent communication between those involved in a research project. The cloud acts as a data safe haven, which can help to overcome barriers and enable faster, more efficient and, most importantly, safer sharing of data. By using the same data analysis platform, teams spanning a continent and even further afield can share all data collected and communicate with one another in a neutral workspace that has the ability to carry out advanced analytics during complex projects. Bringing together organisations in a pre-competitive way means that a project as a whole can benefit from the vast and extensive range of knowledge and expertise that each organisation can bring to the table.

Increased Accuracy
A pre-competitive environment offers a number of opportunities to increase a project’s chances of obtaining accurate results.

Any research project stands a greater chance of making a significant scientific discovery when the entire consortium neutrally brings knowledge together to work towards a common goal. The sharing of new strategies and expertise can give a fresh perspective and approach, which may lead to groundbreaking findings.

The increase of patients agreeing to participate in dementia research is critical to work towards identifying a way to both reduce the development of the disease and help treat people already displaying symptoms. Dementia costs the global economy £818 billion per year and healthcare systems are already under immense strain. A pre-competitive environment can increase chances of a smoother recruitment process for trial research, empowering participants by giving them more say over their personal data and the opportunity to share vital information with collaborative partners. Organisations, rather than individuals, can ‘grasp the nettle’ by implementing a shared system of dynamic consent and work with patient organisations to establish trust and reliable participation.

For every research project, there is a bar of quality that must be obtained before a product can be taken to market. Pre-competitive collaborations can make reaching this target much easier and more manageable due to the wide range of resources and knowledge available within a consortium.

Risk Reduction
Drug discovery and development is perhaps the riskiest and costliest business there is; high failure rates increase the risks and costs associated with R&D and any steps that can be taken to improve the success rates, and hence the return on pharma investment, are to be welcomed. Pre-competitive environments are, therefore, gradually becoming a preferred approach for research projects, as they can significantly reduce risk when it comes to issues like funding and regulations.

Pre-competitive collaborations require organisations to pool funding for a project. This is often a safer method for organisations than to work independently with less funding. By doing this, pre-competitive collaborations have more money available to spend on conducting research, which can lead to faster and more accurate results. Smaller initiatives in particular favour this approach, because they tend to have less funding and fewer resources to conduct research. Traditionally, larger companies often shy away from sharing information due to the competitive nature of business. However, current trends and changes in regulation are for organisations to be more transparent. Pre-competitive environments often appeal to larger companies seeking commercial results, because they help to reduce reputational risk. They offer a platform for businesses to share information with others in a way that ensures they are remaining within regulation guidelines. Given these recent calls for transparency, companies now have to share their information, so logically it makes sense for them to do this publicly and efficiently through a pre-competitive collaboration.

Good Use of Time
There are a number of ways that pre-competitive environments make better use of time than more traditional research projects.

Currently, EPAD is working on data analytics to develop the longitudinal cohort that the adaptive proof of concept trials will recruit from. Their platform’s advanced technologies mean that it is capable of interrogating any and all kinds of data quickly and efficiently. EPAD uses clinical, cognitive questionnaires, laboratory imaging and genetic data to understand the risk of onset of dementia. The adoption of traditional tools and technologies can be more limiting, as they are known for separating information into silos and taking longer to conclude results.

The sharing of resources and knowledge can also accelerate projects within pre-competitive collaborations, because this approach allows partnerships to experiment with different or previously ‘tried and tested’ systems to see what works and what does not. This means that if a method sees minimal results, it can be identified by partners sooner to reduce duplicates, thereby saving time and money.

Introducing a dynamic consent model is easier and more common for pre-competitive collaborations and can be a good way to save time when recruiting for trials. By implementing a dynamic consent model, collaborations can see which terms and conditions each subject has agreed to, such as whether they allow their data to be used for academic researchers studying dementia, or only for those studying genomics or nutrition. Not only does this help save time when recruiting, but it also gives patients a sense of trust as they have control over their own data. It also enables partners to use information from a different pool of participants than that which they would traditionally have access to.

Stronger Together


Dementia currently affects 46.8 million people worldwide and it is showing no signs of slowing down. However, dementia studies adopting a pre-competitive collaborative approach, like EPAD, are hoping to make a difference by bringing us closer to obtaining answers. With a proper understanding of dementia and an idea of how it can be managed, it could be possible for us to win the war against dementia.

Acknowledgements

The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no. 115736, resources of which are composed of fincancial contribution from the EU's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies in kind contribution.

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Aridhia Chief Technical Officer Rodrigo Barnes is an R&D software engineer with a mathematical background and has designed and developed analytical and data management applications in a number of healthcare, life sciences and knowledge management startups. Rodrigo is skilled at developing new approaches to healthcare information problems, and has been instrumental in designing Aridhia’s approach to big data within healthcare and to the development of AnalytiXagility, the company’s data analysis platform. He is now responsible for technical and product strategy and takes a lead in Aridhia’s approach to precision medicine.
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