In this report, ISR provides insight into the clinical development environment, sponsor and service provider activities, and population “health status” for Russia.

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Russia:
Clinical Development
Country Profile
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©2013 Industry Standard Research
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Report Overview
In this report, ISR provides insight into the clinical development environment, sponsor and service provider
activities, and population “health status” for Russia.
Methodology:
The contents of ISR’s report have been gathered via an exhaustive secondary research effort and several
KOL interviews.
58
Q3, 2013
Charts and Graphs
Publication Date
84
Pages
Major Sections:
1. Industry Interviews
ISR performed several interviews with respondents from the pharma industry. The goal of these interviews is
to capture sponsor and CRO experiences with Russia as a site for clinical trials, understand logistical details for
conducting Russian trials, and to illustrate the benefits and drawbacks of conducting trials in Russia.
2. Russia Health Statistics
ISR has gathered substantial information regarding health statistics in Russia. The goal is to provide a view into
how Russia compares to other countries on a variety of indices to aid in trial recruitment.
3. Clinical Trial Overview
ISR analyzes clinical trial metrics from multiple sources to provide readers with data they can use to set realistic
expectations for Russian clinical trials. This section also provides detailed regulatory information necessary for
faster study start-up for trials in Russia.
4. Clinical Service Provider Capabilities
ISR outlines the capabilities of domestic clinical service providers, provides a list of domestic pharma/CRO
association members, and provides a list of domestic and international pharmaceutical companies.
Valuable for:
•
Clinical operations and trial planning
•
Patient and site recruitment
•
R&D management
•
Regulatory
•
Project managers
Learn how you can use this report.
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What you will learn in this report:
•
On-the-ground insights from several industry KOLs from top pharma companies and
country heads from multinational CROs
•
How its economy and national policies make Russia an attractive country for clinical trial
activity, and why regulatory uncertainty and process challenges remain
•
Health statistics for Russia, including life expectancy, cancer and AIDS incidence rates,
alcohol and tobacco consumption, and more (see table of contents)
•
Capabilities of domestic service providers and contact details for domestic
pharmaceutical companies
•
Regulatory environment/ considerations and how they compare to EU standards
How you can use this report:
•
Understand how sponsors and CROs view Russia as a site for clinical trials and where the
country fits within their clinical development strategy
•
Uncover logistical details for conducting Russian trials
•
Illustrate the benefits and drawbacks of conducting trials in Russia
•
Target specific indications by learning how Russia compares to other countries on a
variety health statistics
•
Set realistic expectations for trial operations and timing by reviewing historic, country
specific trial metrics
List of Domestic Clinical Service Providers Included:
•
ACCELL Clinical
•
Eastern Clinical Trials
•
Accovion
•
Global Clinical Trials
•
Almedis
•
MatrixPharm
•
Congenix
•
Outsourcing Clinical Trials
•
Cromos Pharma
•
Synergy Research Group
Up next: Full table of contents and sample pages
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Table of Contents
Full table of contents and additional sample pages available in the full preview,
free on our website:
http://www.isrreports.com/product/russia-clinical-development-country-profile/
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Sample Page: Report Introduction
Introduction
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Introduction
One way to think about the Russian clinical trial and pharmaceutical
Facts:
environment is to think of the country as a publicly traded pharmaceutical
• Biologic medications are very expensive
company. If you were leafing through a prospectus or an investor presentation,
you • Blockbuster biologic drugs are coming off-patent over the next few years
would find a company with strong macro fundamentals, historic growth,
inconsistent performance,offered in the United States for generic-like $4 per
• Biosimilars will not be and some regulatory uncertainty. In short, Russia has
many prescription characteristics as a mid-stage pharmaceutical company. And,
of the same
if you take a portfolio theory approach to investing, you would likely want to
• The consumer decision-making process regarding biosimilars will be vastly
invest some portion of your assets in Russia.
more complicated than it is for chemical generics
Hypothesis:
Why? Here are just a few reasons
US patients are relatively naive regarding the medications they take and their
↑↑ understanding of biologic drugs is minimal� Knowledge can impact prescription
Positive balance sheet: Russia has ~$240B trade surplus from fossil fuel
decision-making�
reserves
↑↑ Impact: Putin announced $3.9B plan aimed at having 90% of medicines to
Focus:
If the locally produced by both affords an opportunity and presents a challenge
be hypothesis holds, this 2020
to setting strategies for pharmaceutical sales, marketing, and advertising�
↑↑ The oncoming wave of biosimilar products in the United States will cause a
Untapped potential: Many patients are treatment naïve, offering
fundamental shift forthe way US patients purchase medications� Successful
opportunities in clinical trial patient recruitment
pharmaceutical sales, marketing, and brand management personnel need to
↑↑ understand why consumers make the choices they do when it on their list of
Difficult: In 2012 the World Bank ranked Russia 122nd comes to these
economies by ease of doing business, 21 spots below China
“generic” medicines�
↑↑
Protection: IP protection is concerning
•
Takeda announced the completion of a manufacturing plant in Yaroslavl in
Why do some people take generic medications and others do not? Most people
in the United States can get their generic medications at a local Wal-Mart for
$4 per prescription, so it seems and the easy economic decision� But there is
Given the current environmentlike a fairlypotential future returns, many large
more to this decision than just economics� Maybe the pharmaceutical company
pharmaceutical companies are using portfolio theory and entering the Russian
that made their original medication has a well-publicized co-pay card or they
market.a fairly inexpensive branded generic option or the consumer doesn’t trust
offer
the generic manufacturer or their physician or family member has recommended
• they stay onis tooriginal medication�
Novartis the complete a manufacturing facility in St. Petersburg in 2014
So while currently it might make economic sense for a consumer to switch
September, 2012 and it will be operational by 2014
to a generic medication, what happens when the economic gap is not as
• pronounced? ISR has learned a manufacturing facilityprojects that the coming
AZ is scheduled to open through various research in Kaluga in mid-2013
biosimilars will not be offered for $4 per prescription� This research was designed
• toRussian pharmaceutical sales, marketing, and brand receiving take-over interest
provide biosimilar producer Biocad is currently management with data to
(~$1B valuation) from both Pfizer will Amgen
help them understand how US patients andmake what ISR believes to be a real
decision regarding their purchase and use of biosimilar medications�
www.ISRreports.com ©2013 | Public Knowledge, Perceptions, and Intentions for Biologic and Biosimilar Medicines
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Sample Page
Russia Health Statistics
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Male prostate cancer incidence
Male prostate cancer incidence
The following chart, from the age-standardizedOECD 2011 report, shows ageThe following chart shows Health at a Glance male prostate cancer
The following chart, from the Health at a Russia
incidence rates, 2009 (or cancer incidence rates, OECD(oranearest year)� Russia
standardized male prostate nearest year). Glance reports rate of 26.1 per
2009 2011 report, shows agestandardized male prostate cancer incidence rates, of 70.5. nearest year). Russia
100,000 rate of 26�1 per is lower males� This number2009 (or than the OECD average
reports a males, which 100,000 than the average is lower
of reports a rate of 26.1 per 100,000 males. This number is lower than the OECD average
70�5�
of 70.5.
126.3
118.3
115.6
114.2
Ireland
France
Norway
Sweden
Australia
Belgium
Iceland
Canada
New Zealand
Finland
Switzerland
United States
Austria
Germany
United Kingdom
Luxembourg
Netherlands
Denmark
OECD
Average
Czech Republic
Slovenia
South Africa
Italy
Chile
Spain
Israel
Brazil
Portugal
Poland
Estonia
Slovak Republic
Mexico
Hungary
Russian Federation
Japan
Korea
Greece
Turkey
Indonesia
China
India
105
102.3
102.2
101.5
99.7
96.6
91.3
83.8
83.1
82.7
79.7
74.8
73.4
72.5
70.5
63
61.6
59.7
58.4
57.4
57.2
55.1
50.3
50.1
44.3
42.8
39.8
33.4
32.9
26.1
22.7
22.4
17.7
14.8
10.6
4.3
3.7
0
© Industry Standard Research
20
40
60
80
100
120
140
Age-standardised rates per 100,000 population
www.isrreports.com
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Sample Page
Full table of contents and additional sample pages available in the full preview,
free on our website:
http://www.isrreports.com/product/russia-clinical-development-country-profile/
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