12.Mar.2013

OCT took part in the European Life Sciences CEO Forum in Zurich, Switzerland

OCT took part in the European Life Sciences CEO Forum in Zurich, Switzerland
Along with about 350 delegates and 80 presenting companies OCT participated in the 6th Annual European Life Sciences CEO Forum in Zurich, Switzerland.

Along with about 350 delegates and 80 presenting companies OCT participated in the 6th Annual European Life Sciences CEO Forum that took place on the 5-6 of March 2013 at the Hilton Zurich Airport Hotel, Switzerland.

This exclusive and transactional event complimented the Annual Biotech in Europe Investor 

Forum that is planned for later in the year, but with added focus on Partnering & the Pharmaceutical industry, feature presentations from Big Pharma representatives demonstrating their current and future partnering strategies through thought-provoking case studies.

The Forum’s program comprised series of panels and presentations from leading investment, pharmaceutical and biotech companies, highlighting the current issues surrounding the evolving 

Finance and M&A market, Partnering activity, Vaccines, Oncology and Biomedical Investment, and included special keynote speeches, providing an expert outlook on Europe’s Biotech industry. 

OCT is a Contract Research Organization performing clinical trials in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia, and Bulgaria and has been in business since 2005. 

With headquarters in St. Petersburg, Russia, OCT has an international and highly skilled multidisciplinary team providing solutions across the entire spectrum of clinical research as well as clinical support for phase I-IV clinical trials.

Until recently OCT has been working with US and European clients. 

Julia Sardaryan, Head of Business Development at OCT, who has been participating in the Pharma Partners and Investment Opportunities Panel of the Forum, covered the aspect of the reasons why sponsors choose Russia as a place for their clinical trials.

Today many companies target Russia as a place to perform clinical trials of phase II and phase III, so called late stage trials. FDA accepts “foreign” data – as long as it is relevant to the practice of Medicine in the USA. Therefore, there was adrift of industry sponsored phase II and III clinical trials from North America and Europe to the rest of the world. Russia is one of the countries in the “rest of the world”. 

The external context of the discussed issue can be specified by the following features:

  • Pharmaceutical  companies often suffer from marginpressure;
  • Developed marketsare characterized by a limited market growth and restricted patient access;
  • And as for developing nations, their opportunities include the highest market growth rates, access to drug naive patients and increasing clinical infrastructure growth;
  • Also, foreign companies experience increasing competitive intensity ascompetitors are also entering the developing nations.

Julia informed that offshoring was primarily driven by cost savings, lower investigators fees and speed of enrollment. Including Russia into a clinical program can help bringing new medicines to a global population in a timely and efficient manner. There are several benefits for a Sponsor of doing clinical trials in Russia.

First of all, the companies enjoy cost-savings (the costs of projects in developing countries can be half of the USA rate or even less)

Secondly, accelerated recruitment timelines can enable sooner global filing

Thirdly, regulatory access is easier if local patients are included in studies in Russia. Russian law requires local population to be included into clinical trials to get the drug registered.

All these factors made Russia a part of global drug development programs today. 

Besides, Julia stressed that the patient recruitment in Russia was very good in comparison with western countries because of the following factors:

  • Huge patient populationsof 143 mio people;
  • Patients see trials as an opportunityto receive proper treatment;
  • Large percent of patients are drug naive patients;
  • Russia has a centralized medical system;
  • Physicians are eager to participate in clinical trials;
  • Russia has less competition for investigators.

Julia outlined general situation of conducting clinical trials in Russia. The year of 2012 showed growth in clinical trials market in comparison with 2011. Up to 700 studies were approved in 2012.

growth in clinical trials market in comparison with 2011

There were 280 multinational studies initiated by foreign clients. 36 of those were initiated by foreign clients as “bridging local studies”. 74 studies were bioequivalence studies initiated by foreign clients. 169 studies were bioequivalence studies initiated by Russian clients. And 127 studies were non- bioequivalence studies initiated by Russian clients. 

However despite the fact that Russia has a very positive environment for clinical trials, the number of international projects initiated by foreign Sponsors and conducted in Russia decreased during the last years. The number of clinical trials conducted in Russia in 2012 could have been much higher if no changes in Regulatory took place.

The decrease of multinational studies initiated by foreign clients in Russia is the result of the regulatory changes which came into force in 2010. The new law FZ-61 “On circulation of medicinal products” introduced a lot of problems which hindered initiation of new clinical trials in Russia. The following changes were introduced by the new law:

  • The law required to perform local studies if the drug was not tested in Russian population during the clinical program.
  • The law required Principal Investigators to have at least 5 years of experience in clinical trials
  • It introduced a difficult mechanism of patients’ insurance
  • The law required Investigational site accreditation by the Ministry of Health
  • Ethical Expertise has become the state responsibility
  • The law abolished phase I studies of foreign drugs on healthy volunteers 

Thus, 2010 and 2011 were quite difficult years for clinical trials approval. Firstly because the regulating body was changed, secondly, because it was impossible to insure clinical trials subjects, thirdly because it was impossible to import registered medication into Russia, it was supposed that the medication for clinical trials had to be purchased locally, what is more, the number of sites which could be used in clinical trials decreased because the MoH made the sites to go through new accreditation for clinical trials.  

Although until recently OCT has been working with the European and USA based companies, since the initiation of the Strategy of pharmaceutical industry development up to 2020, OCT has been actively cooperating with Russian Innovative companies. One of the main objectives of the Strategy is the stimulation of development and production of analogues of foreign import generic and innovative medicines. Since then, OCT has seen their profits grow by more than 25% due to the cooperation with Russian innovation companies and indeed today Russia has created a fertile ground for research and development.

The main questions that OCT was addressed with during the panel discussion: 

What advantages do you bring to the table as a domestic CRO?

Julia expressed the following expert opinion. Although the six largest CROs now account for the 50% of total clinical CRO revenues and Global CROs have the advantages of being present in many projects, today more and more companies hire local CROs.The main reason for employing the services of a local CRO is obvious - cost reduction.

Domestic CROs can provide local expertise. CROs have adequate knowledge of the local regulatory and ethic requirements. They know requirements to documents, documents wording, pre-clinical and clinical data.  It is especially relevant in Russia when regulations are changing so quickly, and the local CROs can help mitigating some of the problems that could potentially impede the approval, patient recruitment or successful implementation of a study. 

Knowledge of the current legislation and relationships with regulatory experts is also important.Local service provides local staff employment to run their activities. Such staff speak local languages and are well conversant with local culture, thus relationships with the sites can be established with no problems.

It is critical to know the local medical practices and the standards of treatment not to start a clinical trial which is not feasible in Russia or which requires medications which are not used here. 

The local contractors are popular for work in the areas requiring local regulatory knowledge or expertise in areas such as regulatory, pharmacovigilance, and medical writing.

Do you see any differences in working with Russian vs. foreign biopharma clients?

Julia has replied with a detailed elucidation thatthere is a big difference in working with foreign and domestic companies. And, to tell the truth, it is more difficult to do business with Russian companies.

Usually when foreign companies perform trials in Russia as a part of a big global clinical trial the Sponsor follows international standards and guidelines. But when you perform a trial for a Russian company several instruments are missing.

Unlike the USA and EU, in Russia there is no guidance on pre-clinical and clinical programs for certain classes of drugs (such as biosimilar), for certain diseases and therapeutic areas. The best example of this is in the development of bio similar. Currently in Russia there are no manuals to develop such drugs.

The Russian legislation does not give a definition to biosimilar drugs. There are no regulatory requirements for preclinical and clinical trials which need to be conducted in order to be approved for marketing by the Russian Ministry of Health. Nevertheless, clinical trials of biosimilars and biobetters are being conducted in Russia. Several clinical trials of biosimilars produced by local and foreign pharmaceutical companies have been approved by the Russian ministry of Health.

Since there are no guidelines in Russia, OCT has been referring to EMEA’s general and product specific guidelines like “Guideline on similar biological medicinal products containing monoclonal antibodies” for the development of clinical and preclinical programs.

Another problem we face when developing clinical trials programs is the absence of a scientific advice procedure in Russia.

To obtain the views of regulatory experts in Russia often you have to resort to unofficial expert recommendations of the MOH. This method of expert opinion does not carry any guarantee; ideas are not supported by any written documents, so the bounce rate statements on clinical trials (CTA) can be quite high. To get the official confirmation in Russia you must apply for approval of a clinical trial. As we all know, this process takes time. In case of refusal to conduct clinical trials, experts issue a letter of recommendation. By following the recommendations have a chance to get approval. But this is not the fact that after all the requirements Health Ministry will not issue a second list of recommendations.

Unlike Russia, it is a routine practice to obtain scientific advice in the USA and Europe. In contrast to the Russian regulatory authorities, MHRA is quite active in helping companies. MHRA licensing division was conducted in 2011, 275 scientific advice MHRA clinical trials unit held 80 meetings in just the last 10 months. Email CTU comes to 250 requests a month.

Unlike Russia, in Europe and the USA t is possible to dispute about scientific matters with regulators.