The Critical Benefit of Clinical Trials

SEP-OCT 2016|BY RAYMOND MATERA
Spyros Filiotis, Vice President & General Manager of Pharmaserve–Lilly; Vice President of  SFEE; Treasurer of the Pharmaceutical Innovation Forum and member of the Amcham Pharmaceutical Committee, discusses the importance of promoting clinical trials in Greece—a boost to healthcare, patients, and the national economy.

As Vice President of SFEE and a member of the Chamber’s Pharma Committee, you have a particular interest in promoting clinical research in Greece. Why are clinical trials important for Greece?

Clinical trials are important for Greece because they have multiple benefits on multiple levels to a wide range of stakeholders. Most important, of course, are patients. Through participation in clinical research patients have access to new therapies being researched by the best pharmaceutical companies in the world. Patients also receive state-of-the-art health care and increased attention from their physicians. We hear over and over again that patients appreciate the extra attention from the doctors and pharmaceutical companies conducting the research.

What other stakeholders and benefits are involved?

Medical professionals, mainly physicians, conduct the clinical trials, as investigators. The physicians, in addition to their research team (including nurses, pharmacists and other staff) all benefit from being part of cutting edge international research and learning firsthand the latest in science. This new knowledge is then shared with others in the healthcare community, advancing patient care for everyone, and advancing the research know-how of the medical staff.

The healthcare system also benefits through the knowledge shared and by some direct investments that take place, including in diagnostic tools, laboratory tests and medicinal products for all patients participating in clinical trials, as well as in equipment, machinery and administrative infrastructure that stays with the hospital after a trial has ended.

There is, of course, the direct and indirect financial impact. All researchers, staff, hospitals and regional healthcare authorities are paid for their services. The average clinical trial represents a direct investment of about 250,000 Euros and through the multiplier effect leads to local investment of about 1 million Euros.

Let me underline the rigorous attention to safety that clinical research involves. Safety of patients is always the first concern and there are very strict international (ICH-GCP) and European (EMA) clinical research guidelines that are followed in every clinical trial implemented in Greece.

What kind of impact would clinical trials have in areas such as employment?

Clinical trials are a boon not only to science but to employment, and for Greece the benefit of this cannot be stressed enough. Clinical trials are implemented by local offices of pharmaceutical companies or contract research organizations (CROs) who must hire professionals to support and execute each trial conducted. The more trials, the more professionals needed. Research sites in hospitals also need additional staff beyond the base physicians for some clinical trials.

And of course in all cases we are talking about high-level professionals who might otherwise seek employment outside Greece.

This area is a vital front against brain drain and a crucial step for brain drain reversal, especially of bio science graduates who can then go on to create new start ups, new companies, and new industries in Greece, as they do in other countries.

Clinical research is directly related to the development of new therapies. How might pharmaceutical development, and possibly manufacturing, be boosted in Greece?

Here we could see the benefits of a network effect. Once we succeed in putting Greece on the clinical research international map Greece becomes known internationally as a life science location. When this happens pharmaceutical companies know they can tap into this valuable resource for R&D, new partnerships, and manufacturing. This result is new activity from research agreements with university labs to international manufacturing deals.

To give a sense of the size of the opportunity here, Greece now receives about 100 million Euros investment annually from clinical trials. That is 0.3% of the 35 billion invested in Europe every year. Considering that Greece is 2% of the European population, a tenfold increase to 1 billion would just be our “fair share.” Today Belgium, which is similar in size to Greece, after decades of coordinated efforts, receives 2 billion investment annually. The opportunity is enormous and growing.

What are some examples of new therapies that are entering the market today?

At Pharmaserve – Lilly we are developing advanced therapies in, historically, some of our most important therapeutic areas, such as diabetes, cancer and neurodegeneration, with focus on Alzheimer’s as well as entering new areas such as auto immune diseases and pain management.

The industry has made huge strides over the past decades and has completely changed the way we deal with diabetes, cancer, HIV/AIDS and hepatitis C, and these are just some examples. We have therapies today, that we did not have even a few years ago, that literally change people’s lives.

Let me point out that for each new medicine available to patients there is a lengthy and expensive process that starts with 10,000 molecules in a lab, leads to 10 prospective medicines entering clinical research that finally results in one single medicine being approved. The development process involves distinct stages, usually extends over ten years, and has a cost of between 1 and 2 billion Euros. It is one of the most expensive and lengthy research processes in any industry in the global economy.

What are the key proposals you would make to advance clinical trials in Greece?

It is clear that clinical trials are important for Greece for a number of reasons. The most important of which is that patients get access to the best therapies and the best treatments possible.

For Greece to benefit from clinical research we must compete with other countries, just as we do in tourism, shipping or agriculture. For years we have known and recognized the high level of professionals in the Greek healthcare system. Today we can harness that valuable national asset to the benefit of all Greeks—as patients, as workers, as citizens who benefit from an improved economy.

There are three critical factors anyone running a clinical trial must optimize: quality, speed, and cost. Fortunately in Greece we have the most important, quality, well established. We must work on the other two. The first and easiest to improve is the cost component. Greece must copy best practices from other European country’s incentive frameworks. The overwhelming need today is to apply tax incentives that are competitive versus other European countries.

Second, and more important, is to tackle speed. The way we believe this could be achieved is for Greece to create a highly effective office within the Ministry of Health that will oversee clinical research. This office can act as a watchdog, liaise disparate bodies that must cooperate, support the clinical trial process from A to Z, ensure standards and timelines are followed, enforce regulations, and protect patient interests. It goes without saying that this office must be independent of political interests and be staffed with permanent professionals. Like many other parts of Greek life the problems do not stem from lack of laws and regulations but from lack of implementation. This office must have the authority to force implementation for it to be effective.

Final thoughts?

Clinical research offers a tremendous opportunity for Greece, which is, in so many respects, an ideal location for trials to be conducted. Without them, we are literally losing billions of Euros each year for no good reason. Patients would benefit, physicians, nurses, researchers, students and scientists would benefit. Local economies would benefit. Local pharmaceutical companies, the healthcare system and of course the Greek national economy would all benefit. And, since clinical trials are 100% private sector funded, all at no cost to the government!

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