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International Clinical Trials

Look Local

ICT: Which part of your current role do you most enjoy?

Takis Zervakakis: After years of executive management and leadership in a large, global pharma organisation, I am currently working at a contract research organisation (CRO), Zeincro, where I enjoy the satisfaction derived from the company’s successful growth in Central and South Eastern Europe. I have found the CRO industry very challenging, but rewarding as we are partners in helping to develop new products that address the unmet medical needs of patients.

Which part is the most challenging?

Building a homogeneous operational model in a rather heterogeneous region, where each country has its own regulatory differences, language and culture, requires a focused expertise. To start with, understanding the local rules and processes are as important as simply knowing them. Being open to change, developing new ideas and recognising continuous improvements are critical. Following 14 years of successful operation with continuous growth and profitability, Zeincro’s strategy is clear and focused, with a strong local expertise and physical presence in the countries we cover.

How would you describe your business philosophy?

Two main concepts come to mind. You really do have to believe in what you are doing: passion is one of the key elements to overcome possible obstacles in the job. No great success can be reached without challenges. I believe creativity and passion are a must for effective leadership.

It is equally important to give others the confidence to follow your lead. You won’t be able to realise your objectives without the help of invaluable staff, so make sure you help business partners and team members reach their vision as well. Ultimately, companies rely on people, not only on strategies, especially in such a competitive service sector.

Zeincro operates in Central and South Eastern Europe – what are the benefits of clinical research in this region?

There are many reasons why this region is increasingly desirable for clinical trials: a large and easily accessible pool of patients with excellent compliance rates; highly qualified and reliable researchers motivated to participate in trials; a cost-effective workforce with impressive professional qualifications; and well-established healthcare infrastructures.

According to a CenterWatch publication, studies in Central and Eastern Europe have tripled global trial participation. Between 2004 and 2007, the number of Food and Drug Administration regulated investigators increased by 15.9 per cent in this region; meanwhile, the number of North American and Western European investigators declined by 5.2 per cent and 6.1 per cent, respectively. Another PMR Publications report said the clinical trials market in Central Europe would grow by six to seven per cent per year between 2012 and 2014.

However, despite emerging as a preferred clinical research destination, the countries are still less saturated with trials. Zeincro’s current coverage in 14 countries allows us to reach a population of some 250 million people.

Are there many barriers to trials, such as cultural or regulatory problems?

Although the majority of the countries we operate in have adopted European Union guidelines – or, in some cases, regulating authorities have adapted in-country systems to the European one – local regulatory nuances and needs remain a challenge. Local expertise and effective clinical project management systems are vital.

Should a sponsor choose a global or local CRO?

Pharmaceutical and biotech companies are looking for service providers that can help them get as many promising drugs to market in the shortest amount of time, at reasonable costs, while adhering to increased safety concerns. Therefore, they must be sure to make the right partnering decisions in a highly fragmented CRO market. The fundamental question a sponsor has to ask itself is: “What do I need from the outsourcing partner?”

Global CROs can often have very rigid processes and be slow to adapt to local requirements. They do an excellent job in Central and South Eastern Europe, as everywhere, but may lack local expertise and could potentially have acceptance issues with the investigators.

The key success factors in this region are flexibility and adaptability to the specific local environment, and the ability to handle unpredictable difficulties in site contracting processes and logistics. A regional CRO using local staff could easily discuss requirements in the local language and provide an efficient feasibility with realistic timelines, ensuring a smooth regulatory process. It also arguably has a better understanding of, for example, local customs and how regulatory bodies work, as well as strong connections with investigators and sites. The biopharma industry needs CRO partners more today than ever; and in order to make outsourcing successful, sponsors need to start with an outsourcing strategy.

What does the global clinical trials sector need to focus on in 2014?

R&D spending per new molecular entity has grown significantly in recent years. With the increasing pressure on pharma and biotech companies to get their drugs successfully through trials, and considering the expense involved, it is not surprising that sponsors are looking to clinical research destinations that are most efficient and cost-effective to optimise their R&D productivity. Sponsors should not be intimidated by the perceived complexity of Central and South Eastern Europe.

What is the most important business lesson you have learnt?

Business is all about relationships. It is important to develop and maintain strong relationships, not only with employees but also with peers, customers and vendors, including competitors. I always try to create necessary time to keep in touch. Businesses come and go, but the one thing you should protect more than anything else is the trust and respect you have built. 

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Takis Zervakakis studied pharmacy before starting his career in the pharmaceutical industry as a medical representative and then taking on duties relating to regulatory issues. He has previously worked as a Product Manager, Marketing Manager, Managing Director and Regional Managing Director with responsibility for Greece, Cyprus, Turkey and the Balkan countries. Takis joined Zeincro in May 2011, where he holds the position of Vice President Marketing and Business Development, with the aim of expanding the company’s group activities to a greater environment. He has extensive experience in operations, marketing and sales, regulatory areas, as well as human resources.
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