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#EAPM - Climate change is one thing, Mr President - changes in cancer treatments are another…

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Love them or loath them, politicians from left, right and centre are an essential part of the landscape in every important arena affecting citizens, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Whatever one may make of the recent news that US President Donald Trump no longer believes that climate change is a ‘hoax’, in the wake of scientists issuing a final call to halt rising temperatures, he still says the experts have a ‘political agenda’.

Well, doesn’t everyone? And that includes in the vast arena of healthcare, although all parties are pushing for ways to imbed innovation and personalised medicine into healthcare systems as they all have a stake in making it work.

Each aspect of related regulation may not always suit everyone, but all are agreed that it is necessary, alongside cooperation, if we are to make the best of the fast-moving science for the benefit of patients.

Against this backdrop, many stakeholders in the field of cancer will come together at the ESMO Congress, which this year takes place in Munich (19-23 October). The European Alliance for Personalised Medicine (EAPM) will once again be on board, and the keynote annual oncology conference comes just a few weeks ahead of EAPM’s own event in Milan in late November. (Please see link to programme.)

The two gatherings will happen at a time when health technology assessment (HTA) is filling everyone’s minds. Indeed, last week, EAPM and its associate the Bulgarian Alliance for Precision and Personalised Medicine (BAPPM), held a key event on the future of HTA.

The conference presented and discussed the specifics of HTA in respect of personalised medicine products as well as target therapies, companion diagnostics, and innovative pharmaceutical products for personalised treatment.

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Real-world data and date sharing 

One of the many important topics set to be discussed by ESMO in Munich will be the use of real-world data to complement the traditional evidence from randomised clinical trials, and EAPM has already moved forward in this regard when scoring an important victory with its MEGA initiative.     MEGA stands for Million European Genomes Alliance, and was adopted by 16 countries in a joint declaration in April 2018. It zooms in on the key goal of engaging EU and national policy makers now, in order that they understand and shape the landscape for the successful implementation of genomics and related technologies throughout healthcare.

MEGA constituted a major commitment on behalf of a coalition of willing Member States, alongside the European Commission, to join genomic databanks at an EU level for medical research.

The signatories agreed to work together “towards building a research cohort of at least one million genomes accessible in the EU by 2022”.

But although genome sequencing is starting to be introduced to clinical care, improving diagnosis and care of patients with rare genetic diseases and starting to impact on cancer diagnosis and stratification of therapies, there remain a number of key challenges to ensure genomics and related technologies are applied such that over the next few years we can fully realise the potential of personalised medicine. These will be discussed at ESMO as well as at the EAPM event a few weeks later.

Real-world data promises to substantially increase the effectiveness and efficiency of all processes in the development and utilization of medicines, from research and development, to regulatory decision-making, pricing and reimbursement decisions to use in medical practice.

However, to realize the full potential of real-world data requires a ‘learning healthcare system’, based on electronic health records and other collected healthcare data.  This would allow real-world data to be continuously fed into the system,and would complement the traditional evidence from randomised clinical trials.

However, health-care systems must be ready in terms of technology to collect data, using a methodology that analyses information taking into account aspects such as protection of personal data, consent, ethics and data access.

On immunotherapy… 

The Nobel Assembly at Karolinska Institutet this month awarded the 2018 Nobel Prize in Physiology or Medicine jointly to James P. Allison and Tasuku Honjo. The award was given “for their discovery of cancer therapy by inhibition of negative immune regulation”.

By stimulating the inherent ability of immune system to attack tumour cells the pair have established a new principle for cancer therapy.

For more than 100 years scientists attempted to engage the immune system in the fight against cancer, but progress into clinical development was modest.

Immune checkpoint therapy has now revolutionized cancer treatment and fundamentally changed the way cancer can be managed. Allison and Honjo have inspired efforts to combine different strategies to release the brakes on the immune system with the aim of eliminating tumour cells even more efficiently.

A large number of checkpoint therapy trials are currently under way against most types of cancer, and new checkpoint proteins are being tested as targets.

Targeted drugs moving house 

Targeted drugs for advanced cancer are moving from specialist units to a more-community setting these days. Almost 25% of patients with advanced cancer, treated at Comprehensive Cancer Care Network centres in the United States, are receiving innovative drugs matched to DNA mutations in their tumours.

This achievement will be reported at the ESMO Congress and will show that “cutting-edge precision medicine is spreading from highly specialist cancer units to other healthcare facilities so more patients can benefit, wherever they are treated”, say the event’s organizers.

EAPM is watching matters closely, and will follow up at its own Congress on the many important developments emerging from ESMO 2018 in Germany.  One thing is already clear, the climate is certainly changing in cancer treatment.

To register for the EAPM Congress, please click here and to see the programme click here.

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