26 Sep 2018
26 Nov 2018 - 28 Nov 2018
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TAKING STOCK - Taking Stock
EAPM Director Dialogues - Roberto Salgado
Roberto Salgado is a molecular pathologist who received his medical training at the University Hospital of Antwerp, Belgium, and the University Hospital in Leiden in The Netherlands.
His PhD thesis was obtained through working with the Translational Cancer Research Group of the AZ Sint-Augustinus Hospital, Antwerp, as well as at the Department of Pathology at the University Hospital of Antwerp. Salgado studied the interactions of haemostasis and angiogenesis in breast cancer.
His training in anatomic pathology and molecular pathology also took place at the University Hospital of Antwerp, as well as at the University Hospital Leuven and at the Jules Bordet Institute in Brussels.
Nowadays, he works in close collaboration with the EORTC, as an active member of the Pathobiology Group and he is also an auditor on Molecular Pathology/Genetic laboratories for the Belgian government.
He says: “As part of my work as a molecular pathologist, I’m involved in several screening programmes at the regional level which will be initiated in Antwerp early next year. Also, at international level with the EORTC, where I’m part of the group that conducts an EORTC-led European-wide screening effort in different cancer types.”
As a pathologist he says he provides advice on anything that relates to tissue handling, tissue quality handling and quality metrics of the technologies being used, while interacting with clinicians, oncologists, fellow pathologists and mathematicians. This, he says, is in order “to provide added value to the development and integration of these types of technologies, not only in a clinical trial context but also in a clinical practice context”.
When asked how new advances in science and the growth of personalised medicine have affected his field, Salgado says: “In the past, personalised medical pathology was mostly centred on a single gene, single kit testing, with a single agent against the molecular aberration.
“European regulators, like EMA, are now adding molecular alterations to the indications to get reimbursement for specific agents. A typical example is the well-known NRAS addition to the approval of treatment of anti-EGFR colorectal cancer. This was the first hint in medical pathology that we needed to switch some strategy because the kits they developed initially did not contain this NRAS mutation. So they had to develop either a second kit, or adapt the methodology to include this mutation.”
Salgado admits that this development “complicated matters for most pathology labs - including mine” and “initiated the thinking of developing a multi-gene approach to cancer in which you have, again, two different options.
He explains: “Either you do a multi-gene approach and you limit it to those aberrations that are related to a treatment reimbursement, or you provide gene panels so you also have additional molecular alterations which are found in a patient.
“You can use the results to develop big, national and international molecular data bases on a pan-European-wide scale (and) that’s the added value of next-generation sequencing (NGS) compared to more-or-less simple, multiplex molecular testing.
“For the patient, the European citizen, it provides much more added value…because you may identify those patients to be included in clinical trials, for example, which is less frequent than it should be.”
On the subject of reimbursement and testing standards, Salgado is focused: “There is a clear need to have harmonisation at a Europe-wide level on how the reimbursement of clinical trial essays is being done. Also, you will have movements of patients across different countries, and it will be the case that patients with cancer will have their cancer types tested in different countries, in which you have different gene panels and different multi-metrics and different interpretations.”
“We need to have a uniform methodology on a European-wide scale in order that a patient – in Spain, for example – gets the same approach whether it be in Holland or in Germany. In addition, the reimbursement agencies might also have a different approach.
“One of the added values for having a reimbursement system across Europe is that patients get the most out of it when doing NGS.”
There have been many calls in the personalised medicine era for a new style of clinical trial in Europe. Salgado says: “Personally I think that the evolution of clinical trials should have an integrated approach, not only integrating pharma-sponsored trials but also having - at the very early stage - health authorities and reimbursement agencies involved.
“This is because,” he says, “one of the problems today is that we have tremendous, very interesting and highly important clinical trials which do not translate into a change in daily practice in patients. The reason is that these are mostly done outside the realm of the health authorities, so you may have phase 3 clinical trials with level-one evidence and health authorities will ask for information that is not part of that trial. This will impede translation of the findings of the trial into real life.
“One way to overcome this is to involve health authorities early on in clinical trial management, so the translation from the trial into real practice might be quicker,” he adds.
Salgado continues: “Additionally, there is now more and more discussion about having state-funded clinical trials, which are not industry sponsored. And there we may have plenty of opportunities. Why? Because you have cancer registries, for example, which may be exploited to collect as much molecular data as possible on a Europe-wide level. You may have government-sponsored clinical trials using these enormous data bases that may exist in the future in Europe.”
He says: “This paradigm shift in conducting clinical trials will not initially be publicly funded clinical trials, but will be a joint collaboration between health authorities and pharmaceutical companies developing clinical trials on a cross-continental basis. That should be one of the first steps; to try to develop confidence between two stakeholders which, at first glance, may have completely different views on this process.”
But, at the end, Salgado insists: “They all have converging interests and that’s why I think that, as well as the easily made diagnosis that we should redesign and try to adapt clinical trials – which is correct – we need to go a step further. Because even with these newly designed clinical trials, practice in real life does not change as drastically as we tend to think.”
Asked about the next five years in his field and others, Salgado points to the European Commission-initiated discussions on an action plan for public health genomics. This aims to evaluate to what extent NGS technologies can be brought into the different health systems across Europe.
He says: “Here I think that we should not do this without the involvement of industry and patient organisations. Let’s call it a ‘bottom up approach' on integrating NGS into healthcare. Otherwise, despite all this progress in molecular technology that is being made in the academic setting, patients in the real-life setting may not benefit as much as they should.
In the end, he says, many issues surrounding the advances in medicine are “all a matter of trans-continental communication between different stakeholders at a very early stage of incorporating these technologies into daily practice in the different healthcare systems. That’s the key message.”