Russia: Clinical Development Country Profile
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Russia: Clinical Development Country Profile

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

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 Russia: Clinical Development Country Profile Document Transcript

  • EW PR EV I Russia: Clinical Development Country Profile Info@ISRreports.com ©2013 Industry Standard Research www.ISRreports.com
  • act with confidence 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. www.ISRreports.com ©2013 | Preview of: Russia: Clinical Development Country Profile 2
  • act with confidence 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 www.ISRreports.com ©2013 | Preview of: Russia: Clinical Development Country Profile 3
  • act with confidence 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/ www.ISRreports.com ©2013 | Preview of: Russia: Clinical Development Country Profile 4
  • act with confidence Sample Page: Report Introduction Introduction act with confidence 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 5 www.ISRreports.com ©2013 | Preview of: Russia: Clinical Development Country Profile 5
  • act with confidence Sample Page Russia Health Statistics act with confidence 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   © 2013|   R eport   T itle   g oes   h ere.   U se   t he   r uler   h andles   t o   a lign28     www.ISRreports.com ©2013 | Russia: Clinical Development Country Profile 28 www.ISRreports.com ©2013 | Preview of: Russia: Clinical Development Country Profile 6
  • act with confidence 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/ www.ISRreports.com ©2013 | Preview of: Russia: Clinical Development Country Profile 7
  • act with confidence Ordering Information For pricing and ordering information, please visit our website: http://www.isrreports.com/product/russia-clinical-development-country-profile/ Save on this, or any ISR report, by registering a free account Register now • Receive a $250 instant credit towards any ISR report • Earn 10% credit towards all future purchases • Receive advanced notifications on ISR’s latest reports and free resources About Industry Standard Research Industry Standard Research (ISR) is the premier, full service market research provider to the pharma and pharma services industries.  With over a decade of experience in the industry, ISR delivers an unmatched level of domain expertise.    For more information about our off-the-shelf intelligence and custom research offerings, please visit our Web site at www. ISRreports.com, email info@ISRreports.com, or follow us on twitter @ISRreports. www.ISRreports.com ©2013 | Preview of: Russia: Clinical Development Country Profile 8
  • The ISR Difference act with confidence Custom-quality syndicated market research www.ISRreports.com ISR's Reports vs. The Common Syndicated Report How confident are you? Research methods Mostly primary research; always appropriate for the topic vs. vs. One size fits all; usually publically available data Data Collection ISR's proprietary data collection tools and channels support fast, high quality data collection vs. Struggle to recruit the right targets and enough of them Respondents Sophisticated screening ensures genuine decision-makers vs. Undisclosed methodologies and respondent demographics Sample Sizes Robust sample sizes that instill confidence vs. Often insufficient industry representation that leaves you defending results Analysts Decades of experience means more insights that are immediately usable vs. vs. Junior analysts capable of reporting numbers www.ISRreports.com ©2013 | Preview|of: Benchmarking the Pharma Industry’s HEOR Functions www.ISRreports.com ©2013 Preview of: Russia: Clinical Development Country Profile 9