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European Pharmaceutical Contractor

Comply and Demand

EPC: In your current roles, what is involved in a typical day?

Yuri Afonchikov: After 10 years working in the Clinical Trials Department of the Russian Ministry of Health – and its control agency, Roszdravnadzor – as well as two years at Synergy Research Group in charge of regulatory affairs, my job responsibilities have stayed relatively similar. In both cases, my duties have included the constant interpretation and clarification of legislation and regulatory provisions that affect clinical research. The main difference is that I am now responsible not just for knowing the regulatory landscape of Russia, but also the rest of the world.

Igor Stefanov: Most of my day is spent in discussion with colleagues. I believe the reason behind under-achieving is usually not setting goals and, therefore, having no plans – resulting in no action. We ensure that our goals and plans are firmly in place, and my paramount objective as Synergy’s Chief Executive Officer (CEO) is to close the gap between plans and actions, to make sure everyone’s efforts are aligned in the same strategic direction.

What motivates you?

IS: I am motivated by a goal to build the ideal 21st century company: an organism rather than a mechanism, which can adapt to a rapidly-changing environment, is self-regulated and not over-organised; a living, organic structure where every employee shares common goals and objectives, and makes fast, independent decisions.

YA: Aside from delivering the best possible service for our sponsors, I am driven by my dream, which is to someday buy an apartment and own a boat on the bank of the Baltic Sea. I work hard to ensure this lifelong dream will one day come true.

What are the biggest challenges currently facing your sector?

YA: Most local companies will face certain difficulties in implementing upcoming legislative changes – for example, the Common Technical Document format of registration dossiers. In addition, with the Customs Union introduction, all revisions must be consolidated before 2016. This will affect regulatory procedures for businesses operating in Russia, Kazakhstan and Belarus.

IS: We are also seeing an increasing friction among players: between industry and regulators, sponsors and CROs, CROs and investigators, investigators and patients, and so on. Companies are being pushed by a demand for higher R&D effectiveness, which increases pressure and can have the opposite of the desired effect. It looks like a vicious circle, but there is a solution. Streamlining operations by taking business development out of the equation, and having the people who will run a trial work directly with sponsors during the request for proposals stage, eliminates ramp-up time, miscommunications and, thus, friction.

How have recent regulatory developments led to further complications with compliance?

Compliance has always been a challenge. Interestingly enough, your question uncovers the root of the issue – it is believed by many that each and every new regulatory initiative is supposed to further complicate processes. With this view, compliance becomes a goal rather than a means, and causes overhead costs to grow. In this respect, pharma needs to get back to commonsense and fi nd the right balance.

YA: Russia, in particular, has worked very hard to catch up with the rest of the world in terms of regulatory oversight. In some cases, changes to legislation happen a little too frequently and are tricky to keep up with – but this seems to be stabilising and slowing down.

You have both participated in Good Clinical Practice (GCP) inspections – what are the most common errors you see in trials?

We recently analysed results of GCP inspections by Roszdravnadzor and found that 75% of the negative findings were the result of poor management at a study site. I believe that the root of this problem lies in the alignment gap between sponsor plans and investigators’ actions. This should be addressed from the very beginning, at the feasibility stage.

YA: Another major concern is insufficient paperwork. This is true for both investigators and international review board/independent ethics committee (IRB/IEC) members. With investigators, some 30% of findings were related to inappropriate study document maintenance – source medical documents, case report forms and logs, for instance. With IRB/IEC members, around 33% of results were related to inadequate standard operating procedures. Even if internal regulations were in place, IRB/IEC members’ activities did not correspond with compliance provisions in about 18% of findings.

How can study quality protect vulnerable populations?

The answer is short and simple: the better the study, the safer the patient. Russian regulations have become very exacting in this area in order to protect vulnerable participants, and the definition of such groups is wider than in other regions. For example, clinical trials cannot be performed on orphans, military servicemen, law enforcement employees or prisoners.

YA: Studies in paediatric populations, or in pregnant or breast-feeding women are not prohibited, but not encouraged, and it is always a real challenge to obtain regulatory approval. So, at present, vulnerable populations are protected – not just by study quality, but also by an effort to place controls on their behalf.

As the competition ramps up, how can CROs differentiate themselves in the years to come?

By concentrating on key advantages. And this choice is quite limited as every client looks at just three factors: speed, quality and cost. All that CROs need do is select one and concentrate on it. Focus and persistence are the true secrets of differentiation.

YA: Differentiation lies in focusing on certain services too, as the CRO – by nature of a contractual business – accumulates experience gained with different sponsors and, in medical terms, acts like a general practitioner. However, this can substantially narrow the flow of revenue.

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As Chief Regulatory Officer at Synergy Research Group, Yuri Afonchikov MD, PhD works with sponsors and clinical trial researchers on compliance issues. A well-known expert in regulatory affairs, he has also worked with the Ministry of Health of the Russian Federation, with involvement in state quality control of medicines, and medical devices and equipment. Yuri has held a number of positions in the state regulatory agency, Roszdravnadzor.

Igor Stefanov is CEO of Synergy Research Group. After he received an MBA from Moscow International University, he provided consulting services for Fortune 500 companies – including leading pharma businesses. As CEO, Igor has brought innovative strategies to Synergy, increasing its ability to deliver on the company’s promise of speed, quality and cost.
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