The main factor in the development of the Russian economy at present is human
capital. The capitalization of the human factor, i.e. the transformation of knowledge
into value added, is impossible without increasing innovation activity. In Russia,
despite the rather high educational level of the population, there is low innovation
activity in comparison with the leading countries. There is a clear contradiction. One
problem is the assessment of human capital. The article presents the author's method
of assessing the human capital of an innovative organization. To determine the
scenario of human capital development, a theoretical matrix is used, which
characterizes the interdependence of the level of human capital assessment and the
effectiveness of innovative activity of the organization.
Идеальный завтрак: КИ в России. Итоги 2015. Игорь СтефановIgor Stefanov
Предварительные итоги (Оранжевая книжка) рынка клинических исследований в России. Презентация И.Стефанова на Первом "Идеальном завтраке" 28 января 2016г.
The Biosimilars Twittersphere study analyzes the latest discussions on biosimilars, identifying critical topics and areas of interest from relevant stakeholder groups, subject matter experts, and their audiences.
The research includes an assessment of pharma companies’ and emerging biosimilar specialists’ contributions to Twitter biosimilar conversations and recommendations for how pharma can engage with biosimilar stakeholders.
The main factor in the development of the Russian economy at present is human
capital. The capitalization of the human factor, i.e. the transformation of knowledge
into value added, is impossible without increasing innovation activity. In Russia,
despite the rather high educational level of the population, there is low innovation
activity in comparison with the leading countries. There is a clear contradiction. One
problem is the assessment of human capital. The article presents the author's method
of assessing the human capital of an innovative organization. To determine the
scenario of human capital development, a theoretical matrix is used, which
characterizes the interdependence of the level of human capital assessment and the
effectiveness of innovative activity of the organization.
Идеальный завтрак: КИ в России. Итоги 2015. Игорь СтефановIgor Stefanov
Предварительные итоги (Оранжевая книжка) рынка клинических исследований в России. Презентация И.Стефанова на Первом "Идеальном завтраке" 28 января 2016г.
The Biosimilars Twittersphere study analyzes the latest discussions on biosimilars, identifying critical topics and areas of interest from relevant stakeholder groups, subject matter experts, and their audiences.
The research includes an assessment of pharma companies’ and emerging biosimilar specialists’ contributions to Twitter biosimilar conversations and recommendations for how pharma can engage with biosimilar stakeholders.
Presentation: Transparency initiatives and the TGATGA Australia
This presentation provides an overview of the web publication of Australian Public Assessment Reports (AusPARs), including findings of the recent survey.
Drug of abuse testing market global trends, market share, industry size, grow...Shubham Bhosale
Drug of abuse testing is a process of identification of illegal drugs in blood, urine, saliva and others. The drugs include cocaine, opiates, marijuana, methamphetamine, benzodiazepine, methadone, ecstasy, amphetamine, barbiturates, PCP and others. Drug of abuse testing is a qualitative process and mostly performed in clinical settings.
In this report, we cover catalysts from 21 drugs, devices and diagnostics expected to occur in Q2 2016. We have also included a list of large Impact catalysts in the drug and device/diagnostic areas through Q2 2016 from our sister product, CatalystTracker. In addition, each drug’s likelihood of Phase/PDUFA review success and overall Likelihood of Approval (LOA) given their particular phase, drug class, and disease group are provided.
Our Early 2016 Outlook Report highlighted several high- impact catalysts. The results of these catalysts can be found on Page 5 of this report. Biomedtracker Likelihood of Approval (LOA) opinions successfully predicted 78% of catalyst outcomes that occurred in Early 2016.
We have provided a sample of this 52 page report - to download
your complimentary copy of Biomedtrackers & Meddevicetrackers Q2 2016 Outlook report, please use the following link http://ow.ly/BG9g3004er4
A presentation by Dr. Natalia Nayanova, Director of Clinical Operations at Accell Clinical Research, at Clinical Operations in Oncology Trials Europe 2015 (December 1-2, 2015) in Amsterdam.
SVMPharma Real World Evidence – Real World Evidence as a driver of HTA approv...SVMPharma Limited
SVMPharma Real World Evidence (RWE) – In this article we examine the benefits of RWE in support of HTA submissions and re-submissions, and ask whether RWE is something you can afford to pass up. For more resources RWE visit us at svmpharma.com
"Pharmaceutical sciences
and the challenge for a healthcare focused agenda for pharmacists training"
(A interface ensino-profissão no desenvolvimento das Ciências Farmacêuticas)
Rogério Gaspar
(Presidente da SPCF)
21.SET.2016
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
Nursing research is research that provides evidence used to support nursing practices. Nursing, as an evidence-based area of practice, has been developing since the time of Florence Nightingale to the present day, where many nurses now work as researchers based in universities as well as in the health care setting.
This report provides comprehensive information on the therapeutic development for Food Allergy, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Food Allergy and special features on late-stage and discontinued projects.
http://www.researchmoz.us/food-allergy-pipeline-review-h1-2015-report.html
Arrhythmias - Pipeline Review, H1 2015 Summary Global Markets Directs, Arrhythmias - Pipeline Review, H1 2015, provides an overview of the Arrhythmiass therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Arrhythmias, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Arrhythmias and special features on late-stage and discontinued projects.
http://www.researchmoz.us/arrhythmias-pipeline-review-h1-2015-report.html
Outsourcing in Drug Development: The Contract Research (Clinical Trial) MarketMarketResearch.com
The cost and time of developing and bringing a drug to market is over $1.3 billion and often takes as long as 15 years, if not longer. Because of this, major pharmaceutical marketers continue to outsource stages of development, and over the years Kalorama Information has observed this process. In past editions of our outsourcing market studies, we found that outsourcing moved from "should" to "must." for manufacturers. This trend has only continued in the past two years. Contract Research Organizations (CROs) and other entities can expect growing demand for their services.
The demand for new drugs remains unabated, but the cost and need to bring those drugs to market is ever-increasing and intensifying. A key cost driver is the large number of failures during the expensive clinical trial phases. Driven by pressures to reduce costs, companies are increasingly implementing outsourcing strategies to increase revenues through faster drug development. By decreasing their in-house facilities and staff, and outsourcing more of their R&D functions, pharmaceutical and biotechnology companies are reshaping the drug development services industry.
Kalorama Information's Outsourcing in Drug Development: The Contract Research (Clinical Trial) Market is the third edition of this study of the drivers for outsourcing drug development, the companies involved in this market and the opportunity for revenues.
This report provides comprehensive information on the therapeutic development for Traveler's Diarrhea, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Traveler's Diarrhea and special features on late-stage and discontinued projects.
http://www.researchmoz.us/travelers-diarrhea-pipeline-review-h1-2015-report.html
Petr Lyalin, Synergy's CLO and a leading Russian expert in blockchain healthcare applications explains the current status and provides an outlook on the Tokenization regulations in Russia and CIS countries
Presentation: Transparency initiatives and the TGATGA Australia
This presentation provides an overview of the web publication of Australian Public Assessment Reports (AusPARs), including findings of the recent survey.
Drug of abuse testing market global trends, market share, industry size, grow...Shubham Bhosale
Drug of abuse testing is a process of identification of illegal drugs in blood, urine, saliva and others. The drugs include cocaine, opiates, marijuana, methamphetamine, benzodiazepine, methadone, ecstasy, amphetamine, barbiturates, PCP and others. Drug of abuse testing is a qualitative process and mostly performed in clinical settings.
In this report, we cover catalysts from 21 drugs, devices and diagnostics expected to occur in Q2 2016. We have also included a list of large Impact catalysts in the drug and device/diagnostic areas through Q2 2016 from our sister product, CatalystTracker. In addition, each drug’s likelihood of Phase/PDUFA review success and overall Likelihood of Approval (LOA) given their particular phase, drug class, and disease group are provided.
Our Early 2016 Outlook Report highlighted several high- impact catalysts. The results of these catalysts can be found on Page 5 of this report. Biomedtracker Likelihood of Approval (LOA) opinions successfully predicted 78% of catalyst outcomes that occurred in Early 2016.
We have provided a sample of this 52 page report - to download
your complimentary copy of Biomedtrackers & Meddevicetrackers Q2 2016 Outlook report, please use the following link http://ow.ly/BG9g3004er4
A presentation by Dr. Natalia Nayanova, Director of Clinical Operations at Accell Clinical Research, at Clinical Operations in Oncology Trials Europe 2015 (December 1-2, 2015) in Amsterdam.
SVMPharma Real World Evidence – Real World Evidence as a driver of HTA approv...SVMPharma Limited
SVMPharma Real World Evidence (RWE) – In this article we examine the benefits of RWE in support of HTA submissions and re-submissions, and ask whether RWE is something you can afford to pass up. For more resources RWE visit us at svmpharma.com
"Pharmaceutical sciences
and the challenge for a healthcare focused agenda for pharmacists training"
(A interface ensino-profissão no desenvolvimento das Ciências Farmacêuticas)
Rogério Gaspar
(Presidente da SPCF)
21.SET.2016
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
Nursing research is research that provides evidence used to support nursing practices. Nursing, as an evidence-based area of practice, has been developing since the time of Florence Nightingale to the present day, where many nurses now work as researchers based in universities as well as in the health care setting.
This report provides comprehensive information on the therapeutic development for Food Allergy, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Food Allergy and special features on late-stage and discontinued projects.
http://www.researchmoz.us/food-allergy-pipeline-review-h1-2015-report.html
Arrhythmias - Pipeline Review, H1 2015 Summary Global Markets Directs, Arrhythmias - Pipeline Review, H1 2015, provides an overview of the Arrhythmiass therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Arrhythmias, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Arrhythmias and special features on late-stage and discontinued projects.
http://www.researchmoz.us/arrhythmias-pipeline-review-h1-2015-report.html
Outsourcing in Drug Development: The Contract Research (Clinical Trial) MarketMarketResearch.com
The cost and time of developing and bringing a drug to market is over $1.3 billion and often takes as long as 15 years, if not longer. Because of this, major pharmaceutical marketers continue to outsource stages of development, and over the years Kalorama Information has observed this process. In past editions of our outsourcing market studies, we found that outsourcing moved from "should" to "must." for manufacturers. This trend has only continued in the past two years. Contract Research Organizations (CROs) and other entities can expect growing demand for their services.
The demand for new drugs remains unabated, but the cost and need to bring those drugs to market is ever-increasing and intensifying. A key cost driver is the large number of failures during the expensive clinical trial phases. Driven by pressures to reduce costs, companies are increasingly implementing outsourcing strategies to increase revenues through faster drug development. By decreasing their in-house facilities and staff, and outsourcing more of their R&D functions, pharmaceutical and biotechnology companies are reshaping the drug development services industry.
Kalorama Information's Outsourcing in Drug Development: The Contract Research (Clinical Trial) Market is the third edition of this study of the drivers for outsourcing drug development, the companies involved in this market and the opportunity for revenues.
This report provides comprehensive information on the therapeutic development for Traveler's Diarrhea, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Traveler's Diarrhea and special features on late-stage and discontinued projects.
http://www.researchmoz.us/travelers-diarrhea-pipeline-review-h1-2015-report.html
Similar to Clinical Trials in Russia: Q3 2016 (20)
Petr Lyalin, Synergy's CLO and a leading Russian expert in blockchain healthcare applications explains the current status and provides an outlook on the Tokenization regulations in Russia and CIS countries
Статья во втором номере журнала "Качественная клиническая практика" за 2016 год. Описаны вопросы стоимости проведения клинических исследований, применения риск-ориентированного мониторинга (РОМ). Проблема состоит в том, что новая модель мониторинга требует также и новой модели бюджетирования, основанного на оценке стоимости рисков, тогда как на сегодняшний день в исследованиях с РОМ применяется
традиционная модель фиксированного бюджета.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
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TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
3. Clinical Trials in Russia
Orange Paper. 3
rd
Quarter 2016________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
3
Executive Summary – English
The Ministry of Health of the Russian Federation approved 241 new clinical trials of all types,
including local and bioequivalence studies, during Q3 2016. This represents a 18% increase over
Q3 2015.
The main contribution into the total number of studies in Q3 2016 was made by multinational
multi-center clinical trials (MMCT), the number of these studies is 89 and it is 3.5% more than in
Q3 2015. The number of bioequivalence studies (BE) decreased from 77 studies in Q3 2015 to 72
in Q3 2016, a 6.5% decrease from last year’s figure. The number of local clinical trials (LCT)
significantly increased from 40 in Q3 2015 to 80 in Q3 2016.
Clinical trials in Russia in Q3 2016 were sponsored by companies from 28 countries. The
maximum number of trials (93) were initiated by Russian sponsors. American sponsors with 33
new studies took the runner-up place; they are followed by Indian sponsors (22 trials), and Swiss
sponsors (15 trials).
The number of Phase I clinical trials has increased from 12 studies to 23 new studies in Q3 2016
(92% increase). The number of Phase II trials (23 new studies) was similar to that in Q3 2015 (21
studies). The number of Phase III trials increased from 90 to 115 studies, 28% more than in Q3
2015. The number of Phase IV trials increased in comparison with Q3 2015 from three to eight
studies.
The number of subjects planned to be enrolled in Phase I-IV trials launched in Q3 2016 is 22,226,
two-fold more than Q3 2015 figure, when 10,689 subjects were planned to be enrolled.
Novartis is on the top of the heap of foreign pharmaceutical manufacturers in Q3 2016 by
sponsoring seven new studies. They are followed by Merck & Co., having six new trials,
H. Lundbeck A/S and Bristol-Myers Squibb, each with five new studies in Q3 2016, differentiating
in number of patients, and Teva Pharmaceutical Industries Ltd, having four new trials.
Top five domestic pharmaceutical manufacturers by the number of new studies in Q3 2016 is
headed by Biocad, having six new trials. They are followed by Sotex and Atoll with five and four
new trials, respectively. Top five is concluded by companies R-Pharm and Materia Medica
Holding, each having three new studies and differentiating in the number of patients.
In this issue we decided to make two research centers ratings according to phases of their clinical
trials to get a more objective overview.
The top five Russian research sites (BE and Phase I studies) include: Ecosafety Ltd. (16 new
studies), Bioeq Ltd. (12 studies), Clinical Hospital N2 of the Yaroslav Region (8 studies).
The top Russian research sites (Phase II-IV studies) include: Russian Oncological Scientific
Center named after N.N. Blokhin (26 new studies), Kazan State Medical University (23 studies),
Ryazan State Medical University named after I.P. Pavlov (19 studies).
The top five CROs in Russia are: Quintiles (10 new studies), MSD Pharmaceuticals,
Covance Clinical and Trokas Pharma Ltd. (six studies each), and Parexel (four studies).
The top therapeutic areas were: Oncology (44 new studies); Neurology (30 new studies), Therapy
(25 studies), Cardiology and Infectious diseases (23 studies each), Rheumatology and Psychiatry
(16 studies each).
The Center for Drug Evaluation and Research (CDER) of the FDA approved 22 new drugs during
Q3 2016, and four of them were (or are being) studied in clinical trials conducted in Russia.
During Q3 2016, the Committee for Medicinal Products for Human Use (CHMP) of the European
Medicine Agency (EMA) gave positive recommendations on 18 new drug applications1
. Twelve of
the drugs which received positive opinions were (or are being) tested in clinical trials in Russia.
1
Positive opinions on new generic, hybrid and biosimilar medicines are not included.
4. Clinical Trials in Russia
Orange Paper. 3
rd
Quarter 2016________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
4
Executive Summary – Russian
В третьем квартале 2016 года Министерством здравоохранения Российской Федерации
было выдано 241 разрешение на все виды клинических исследований (КИ), что на 18%
больше, чем за аналогичный период 2015 года.
При этом количество новых международных многоцентровых КИ, инициированных в
третьем квартале 2016 года, составило 89, что на 3,5% больше по сравнению с
аналогичным периодом прошлого года. Количество исследований биоэквивалентности
уменьшилось на 6,5% по сравнению с 2015 годом и составило 72 против 77. Количество
локальных КИ, проводимых на территории России, значительно увеличилось по сравнению
с третьим кварталом 2015 года и составило 80 исследований против 40.
Спонсорами КИ, разрешенных к проведению в России в третьем квартале 2016 года,
выступили компании из 28 стран. На первое место вышли российские производители с 93
КИ, за ними идут американские спонсоры с 33 КИ, Индия (21 КИ) и Швейцария (15 КИ).
В третьем квартале 2016 года было инициировано 23 новых КИ I фазы, что на 92% больше,
чем за тот же период 2015 года (12 КИ). Количество исследований II фазы (23 новых
исследования) было примерно таким же, как в третьем квартале 2015 года (21 КИ).
Количество КИ III фазы увеличилось с 90 до 115, что на 28% больше по сравнению с
аналогичным периодом прошлого года. Количество исследований IV фазы увеличилось по
сравнению с третьим кварталом 2015 года с трех до восьми исследований.
Количество субъектов для участия в исследованиях I-IV фаз в третьем квартале 2016 года
составило 22 226, что в два раза больше, чем в третьем квартале 2015 года, когда
планировалось участие 10 689 субъектов.
В третьем квартале 2016 года лидирующие позиции среди иностранных производителей по
количеству новых исследований заняла компания Novartis с семью новыми
исследованиями. Далее следуют компании Merck & Co. с шестью новыми КИ,
H. Lundbeck A/S и Bristol-Myers Squibb, каждая с пятью новыми КИ, но с разным
количеством пациентов, и Teva Pharmaceutical Industries Ltd с четырьмя исследованиями.
Список пяти лидирующих отечественных производителей по количеству новых
исследований в третьем квартале 2016 года возглавила компания Биокад с шестью
исследованиями. Далее следуют компании Сотекс и Атолл (пять и четыре новых КИ
соответственно), Р-Фарм и Материа Медика Холдинг (три исследования каждая).
В этом выпуске мы решили составить два рейтинга исследовательских центров по фазам
проводимых в них исследований, чтобы получить более объективную оценку.
В пятерку передовиков по исследованиям биоэквивалентности и I фазы в третьем квартале
2016 года вошли следующие центры: ООО «НИЦ Эко-безопасность» (16 новых КИ), ООО
«БиоЭк» (12 КИ), Клиническая больница №2 Ярославской области (8 КИ).
Лидирующие центры по исследованиям II-IV фаз: Российский онкологический научный
центр имени Н.Н. Блохина (26 новых исследований), Казанский государственный
медицинский университет (23 исследования), Рязанский государственный медицинский
университет имени академика И.П. Павлова (19 исследований).
Пятерка лидеров среди КИО в России: Quintiles (10 новых КИ), MSD Pharmaceuticals,
Covance Clinical и Trokas Pharma Ltd. (по шесть КИ), Parexel (четыре КИ).
Наибольшее количество исследований проведено в следующих областях: онкология – 44,
неврология – 30, терапия – 25, кардиология и инфекционные болезни – по 23 новых КИ,
ревматология и психиатрия – по 16 новых КИ.
FDA одобрено в третьем квартале 2016 года 22 новых лекарственных препарата, по
четырем из которых в России проводились (или проводятся) КИ. EMA одобрено в третьем
квартале 2016 года 18 новых лекарственных препаратов, по 12 из которых в России
проводились (или проводятся) КИ.
5. Clinical Trials in Russia
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Clinical Trials by Type and Manufacturing Country
The Russian MoH approved 241 new clinical trials of all types including local and bioequivalence
studies during Q3 2016, demonstrating a 18% increase in comparison with the same point of the
last year.
As shown in Figure 1, the main contribution into the total number of studies was made by
multinational multi-center clinical trials (MMCT); the number of these studies has increased from
86 studies in Q3 2015 to 89 in Q3 2016, a 3.5% increase from last year’s figure.
The number of bioequivalence studies (BE) decreased from 77 studies in Q3 2015 to 72 in Q3
2016, a 6.5% decrease from last year’s figure.
The number of local clinical trials (LCT) has significantly increased from 40 in Q3 2015 to 80 in Q3
2016, a 100% increase from last year’s figure.
Figure 1. Clinical Trials in Russia in Q3 2016
The proportions between different study types (multinational multi-center clinical trials, local
clinical trials and bioequivalence studies) changed since last year (see Figure 2).
The share of bioequivalence studies decreased from 38% to 30% of the total number of clinical
trials approved in Q3 2016.
The share of the local clinical trials increased from 20% in Q3 2015 to 33% in Q3 2016, and the
share of multinational multi-center clinical trials was 37% of the total number of trials approved
during Q3 2016 (42% in Q3 2015).
203
86
40
77
241
89
80 72
Total MMCT LCT BE
Q3 2015 Q3 2016
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Figure 2. Clinical Trials by Type in Q3 2016
The geographic origins of sponsors changed slightly in comparison with last year. 61% of the total
number of new studies in Q3 2016 were sponsored by foreign companies which received 148
study approvals (60% in Q3 2015). The share of studies of local manufacturers decreased from
40% in Q3 2015 to 39% in Q3 2016, and amounted to 93 studies (Figure 3).
Figure 3. Russian vs International Sponsors in Q3 2016
Clinical trials in Russia in Q3 2016 were sponsored by companies from 28 countries. Figure 4
indicates the geographic breakdown in sponsors’ country of origin.
The maximum number of trials (93) were initiated by Russian sponsors. American sponsors with
33 new studies took the runner-up place; they are followed by Indian sponsors with 21 trials, then
by Swiss sponsors with 15 new studies. The group of leaders is concluded by Turkish and Danish
Sponsors, each having nine studies, United Kingdom and France (each having seven studies).
42% 37%
20% 33%
38%
30%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Q3 2015 Q3 2016
MMCT LCT BE
60% 61%
40% 39%
Q3 2015 Q3 2016
International Sponsors Russian Sponsors
7. Clinical Trials in Russia
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Figure 4. Sponsors’ Country of Origin for Q3 2016 Clinical Trials in Russia
Other sponsors include: Poland (five studies), Belgium, Croatia, Germany, Israel (four studies
each), Czech Republic, Iceland and Sweden (three studies each), Austria, Hungary, Italy,
Netherlands and Slovenia (two studies each), and Brazil, Latvia, Luxembourg, Republic of
Belarus, Republic of Korea, Romania, Ukraine, each started one new study in Q3 2016.
Clinical trials by Phase
The number of Phase I clinical trials increased to 92% compared to Q3 2015: from 12 studies to
23 new studies in Q3 2016. The number of Phase II trials increased to 9% compared to Q3 2015
from 21 studies to 23 new studies (Figure 5).
The number of Phase III trials increased from 90 to 115 studies, 28% more than in Q3 2015. The
number of Phase IV trials increased in comparison with Q3 2015 from three to eight studies in
Q3 2016.
Figure 5. Clinical Trials in Russia in Q3 2016 by Phase1
1
Studies indicated by sponsors as Phase I-II in the applications submitted to MoH, are shown in Phase II
studies group; Phase II-III – in Phase III group; Phase III-IV – in Phase IV group. BE studies were not
included in any phase group.
Russia 39%
USA 14%
India 9%Switzerland 6%
Turkey 4%
Denmark 4%
UK 3%
France 3%
Other Countries
20%
12
21
90
3
23 23
115
8
Phase I Phase II Phase III Phase IV
Q3 2015 Q3 2016
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As shown in Figure 6, the share of Phase III trials in Q3 2016 is 68% of the total number of
studies, the share of Phase I trials is 14%, Phase II trials is 14% and the share of Phase IV
studies accounted to 4%.
Figure 6. Percentage Breakdown of Russian Clinical Trials by Phase
The number of subjects planned to be enrolled in Phase I-IV trials launched in Q3 2016 is 22,226,
two-fold more than in Q3 2015, when 10,689 subjects were planned to be enrolled.
1,277 subjects will be recruited in Phase I trials; 2,235 – in Phase II trials; 17,721 – in Phase III
studies and 993 subjects will be enrolled in Phase IV studies.
The minimal number of subjects in a single study is two, the maximum number is 1,910.
Figure 7 indicates the distribution of subjects by study phase (only studies in which phase is
specified were included), with Phase III clearly enrolling the majority of patients, as is to be
expected.
Figure 7. Number of Study Subjects in Q3 2016 by Study Phase
Phase I
14%
Phase II
14%
Phase III
68%
Phase IV
4%
Phase I
6% Phase II
10%
Phase III
80%
Phase IV
4%
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The Top Five: Sponsors, Sites and CROs
Table 1. Top-5 International Study Sponsors in Q3 2016
№ Company Name No. studies1
No. patients
1 Novartis 7 792
2 Merck & Co. 6 1360
3 H. Lundbeck A/S 5 560
4 Bristol-Myers Squibb 5 235
5 Teva Pharmaceutical Industries Ltd 4 730
Table 2. Top-5 Russian Study Sponsors in Q3 2016
№ Company Name No. studies No. patients
1 Biocad 6 411
2 Sotex 5 538
3 Atoll 4 210
4 R-Pharm 3 621
5 Materia Medica Holding 3 615
Table 3. Top-5 Russian Research Sites (BE and Phase I studies) in Q3 2016
№ Site Name City
No.
studies
1 Ecosafety Ltd. Saint-Petersburg 16
2 Bioeq Ltd. Saint-Petersburg 12
3 Clinical Hospital N2, Yaroslavl Yaroslavl 8
4 Clinical Hospital N3, Yaroslavl Yaroslavl 6
5
Road Clinical Hospital at the station Yaroslavl of Russian
Railways
Yaroslavl 6
1
Excluding BE studies.
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Table 4. Top-5 Russian Research Sites (Phase II-IV studies) in Q3 2016
№ Site Name City
No.
studies
1 N.N. Blokhin Russian Oncological Scientific Center Moscow 26
2 Kazan State Medical University Kazan 23
3 Ryazan State Medical University named after I.P.Pavlov Ryazan 19
4 I.P. Pavlov First St.Petersburg State Medical University Saint-Petersburg 18
5 I.M. Sechenov First Moscow State Medical University Moscow 17
Table 5. Top-5 Russian Research Sites (all studies) in Q3 2016
№ Site Name City
No.
studies
1 N.N. Blokhin Russian Oncological Scientific Center Moscow 31
2 Kazan State Medical University Kazan 24
3 Ecosafety Ltd. Saint-Petersburg 21
4 I.P. Pavlov First St.Petersburg State Medical University Saint-Petersburg 20
5 I.M. Sechenov First Moscow State Medical University Moscow 20
Table 6. Top-CROs in Russia in Q3 2016
№ CRO Name No. studies
No.
patients
1 Quintiles 10 839
2 MSD Pharmaceuticals 6 1,360
3 Trokas Pharma Ltd. 6 574
4 Covance Clinical and Periapproval Services Ltd 6 550
5 Parexel 4 413
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Therapeutic Areas of Russian Clinical Trials in Q3 2016
The largest number of studies were initiated in Oncology (44 studies); and is followed by
Neurology (30 new studies), Therapy (25 studies), Cardiology and Infectious diseases (23 studies
each), Rheumatology and Psychiatry (16 studies each).
The breakdown of therapeutic areas is shown in Figure 8.
Figure 8. Clinical Trials in Russia in Q3 2016 by Therapeutic Area
Clinical Trials Results
The Center for Drug Evaluation and Research (CDER) of the FDA approved 22 new drugs during
Q3 2016; three of them are new molecular entities (NME); other approvals concern new dosages,
combinations or manufacturers. Four of 22 drugs were (or are being) studied in clinical trials
involving Russian sites.
The Table 7 shows the drugs which were approved by FDA in Q3 2016 that were (or are being)
tested in clinical trials in Russia.
Table 7. New Drugs Approved by FDA in Q3 2016 and Tested in Russian Sites
Appr.date Drug (active ingredient) Company
07/27/2016 Adlyxin (lixisenatide) Sanofi-Aventis US
09/16/2016 Kyleena (levonorgestrel) Bayer Healthcare Pharms
09/20/2016 Invokamet XR (canagliflozin /
metformin hydrochloride)
Janssen Pharms
09/23/2016 Stelara (ustekinumab) Janssen Biotech
Source: FDA
Oncology
18%
Neurology
12%
Therapy
10%
Cardiology
10%
Infectious
diseases
10%
Rheumatology
7%
Psychiatry
7%
Other
52%
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During Q3 2016, the Committee for Medicinal Products for Human Use (CHMP) of the European
Medicine Agency (EMA) gave positive recommendations on 18 new drug applications1
, five
positive recommendations on new generic medicines, one for new hybrid medicines and two for
new biosimilar medicines. 12 of the drugs which received positive opinions were (or are being)
tested in clinical trials in Russia.
The Table 8 represents those of them which were, or are being tested in clinical trials in Russia in
Q3 2016.
Table 8. New Drugs Approved by EMA in Q3 2016 and Tested in Russian Sites
Appr. date Drug (active ingredient) Manufacturer
07/21/2016 Imbruvica (ibrutinib) Janssen-Cilag International NV
07/21/2016 Orencia (abatacept) Bristol-Myers Squibb Pharma EEIG
07/21/2016
Truvada (emtricitabine / tenofovir
disoproxil)
Gilead Sciences International Ltd
07/21/2016 Xalkori (crizotinib) Pfizer Limited
07/21/2016 Kisplyx (lenvatinib) Eisai Europe Ltd
09/15/2016 NovoRapid (insulin aspart) Novo Nordisk A/S
09/15/2016 Stelara (ustekinumab) Janssen-Cilag International NV
09/15/2016 Glyxambi (empagliflozin / linagliptin)
Boehringer Ingelheim International
GmbH
09/15/2016 Ibrance (palbociclib) Pfizer Limited
09/15/2016 Lartruvo (olaratumab) Eli Lilly Nederland B.V.
09/15/2016 Ninlaro (ixazomib) Takeda Pharma A/S
09/15/2016 Parsabiv (etelcalcetide) Amgen Europe B.V.
Source: EMA
About Synergy Research Group
Synergy Research Group is a Russian contract research organization successfully operating in
Russia since 2002. Synergy provides a full range of CRO services to help Russian and foreign
pharmaceutical and biotechnological companies conduct cost-effective clinical trials. Today,
Synergy is represented in Moscow, Saint-Petersburg, Novosibirsk, Yekaterinburg, Perm,
Krasnodar, and also in Almaty and Astana (Kazakhstan) and Kyiv (Ukraine). The company’s
headquarters are in Moscow.
1
Positive opinions on new generic, hybrid and biosimilar medicines are not included.