The Overactive Bladder Disease and Therapy Review provides an overview of the condition, withprevalence numbers for major countries worldwide, information on diagnosis, and an overview of treatment. Dosing and treatment cost information is provided for various treatment types and for medication. General information on the OAB market, as well as sales of leading drugs and therapies are provided.
Disease and Therapy Reviews were developed to provide a basic understanding of the key facts about a disease and market in a quick, easy-to-read format. These reports are prepared by the senior market research team of Timely Data Resources. Each Disease and Therapy Review provides a concise analysis of the most important information about a particular disease, its treatment, and the market opportunities. Reports begin with an overview of the condition, and also contain tables that summarize the available worldwide incidence and prevalence data for the condition, a review of current diagnosis strategies and treatment options, general information about the market size, and information about important market trends. The data contained in these reports comes from key industry secondary data sources, such as the Timely Data Resources Incidence and Prevalence Database, and Lange's Current Medical Diagnosis and Treatment. This information is supplemented by reviews of analyst reports, company reports, and medical websites. Sources and references are provided.
Table of Contents:
I. OVERVIEW
General overview of the condition
Types of overactive bladder
II. PREVALENCE
Prevalence Table (US, UK, France, Germany, Italy, Spain, Japan, Worldwide)
III. DIAGNOSIS
Diagnostic tools and procedure
IV. TREAMENT
Behavioral
Medications
Surgery
V. DOSING AND TREATMENT COSTS
VI. MARKET SIZE
VII. COMMENTS
VIII. REFERENCES/RESOURCES
For more please visit
http://www.bharatbook.com/detail.asp?id=167609&rt=Disease-and-Therapy-Review-Overactive-Bladder.html
OR Contact us at
Bharat Book Bureau
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai - 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Showing posts with label Diseases. Show all posts
Showing posts with label Diseases. Show all posts
Friday, January 7, 2011
Disease and Therapy Review: Irritable Bowel Syndrome
The Irritable Bowel Syndrome Disease and Therapy Review provides an overview of the condition, with prevalence numbers for major countries worldwide, information on diagnosis, and an overview of treatment. Dosing and treatment cost information is provided for various treatment types and for medication. General information on the IBS market, as well as sales of leading drugs and therapies are provided.
Disease and Therapy Reviews were developed to provide a basic understanding of the key facts about a disease and market in a quick, easy-to-read format. These reports are prepared by the senior market research team of Timely Data Resources. Each Disease and Therapy Review provides a concise analysis of the most important information about a particular disease, its treatment, and the market opportunities. Reports begin with an overview of the condition, and also contain tables that summarize the available worldwide incidence and prevalence data for the condition, a review of current diagnosis strategies and treatment options, general information about the market size, and information about important market trends. The data contained in these reports comes from key industry secondary data sources, such as the Timely Data Resources Incidence and Prevalence Database, and Lange's Current Medical Diagnosis and Treatment. This information is supplemented by reviews of analyst reports, company reports, and medical websites. Sources and references are provided.
Table of Contents:
I. OVERVIEW
General overview of the condition
Causation theories
II. INCIDENCE AND PREVALENCE
Prevalence Table (US, Canada, France, Germany, Greece, Italy, Spain, UK, China, Hong Kong, Japan, North America, Worldwide)
III. DIAGNOSIS
Rome criteria
Symptoms
Laboratory findings and special exams
Differential diagnosis
IV. TREAMENT
Dietary treatment
Pharmacologic measures
Probiotics
Psychological treatment
V. DOSING AND TREATMENT COSTS
VI. MARKET SIZE
Future therapies
VII. COMMENTS
VIII. REFERENCES/RESOURCES
For more please visit
http://www.bharatbook.com/detail.asp?id=167606&rt=Disease-and-Therapy-Review-Irritable-Bowel-Syndrome.html
OR Contact us at
Bharat Book Bureau
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai - 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Disease and Therapy Reviews were developed to provide a basic understanding of the key facts about a disease and market in a quick, easy-to-read format. These reports are prepared by the senior market research team of Timely Data Resources. Each Disease and Therapy Review provides a concise analysis of the most important information about a particular disease, its treatment, and the market opportunities. Reports begin with an overview of the condition, and also contain tables that summarize the available worldwide incidence and prevalence data for the condition, a review of current diagnosis strategies and treatment options, general information about the market size, and information about important market trends. The data contained in these reports comes from key industry secondary data sources, such as the Timely Data Resources Incidence and Prevalence Database, and Lange's Current Medical Diagnosis and Treatment. This information is supplemented by reviews of analyst reports, company reports, and medical websites. Sources and references are provided.
Table of Contents:
I. OVERVIEW
General overview of the condition
Causation theories
II. INCIDENCE AND PREVALENCE
Prevalence Table (US, Canada, France, Germany, Greece, Italy, Spain, UK, China, Hong Kong, Japan, North America, Worldwide)
III. DIAGNOSIS
Rome criteria
Symptoms
Laboratory findings and special exams
Differential diagnosis
IV. TREAMENT
Dietary treatment
Pharmacologic measures
Probiotics
Psychological treatment
V. DOSING AND TREATMENT COSTS
VI. MARKET SIZE
Future therapies
VII. COMMENTS
VIII. REFERENCES/RESOURCES
For more please visit
http://www.bharatbook.com/detail.asp?id=167606&rt=Disease-and-Therapy-Review-Irritable-Bowel-Syndrome.html
OR Contact us at
Bharat Book Bureau
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai - 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Disease and Therapy Review: Stroke
The Stroke Disease and Therapy Review provides an overview of the condition, with incidence, prevalence, and mortality numbers for major countries worldwide, information on diagnosis, and an overview of treatment for different types of strokes. Dosing and treatment cost information is provided for various treatment types and for medication. General information on the stroke market, as well as sales of leading drugs and therapies are provided.
Disease and Therapy Reviews were developed to provide a basic understanding of the key facts about a disease and market in a quick, easy-to-read format. These reports are prepared by the senior market research team of Timely Data Resources. Each Disease and Therapy Review provides a concise analysis of the most important information about a particular disease, its treatment, and the market opportunities. Reports begin with an overview of the condition, and also contain tables that summarize the available worldwide incidence and prevalence data for the condition, a review of current diagnosis strategies and treatment options, general information about the market size, and information about important market trends. The data contained in these reports comes from key industry secondary data sources, such as the Timely Data Resources Incidence and Prevalence Database, and Lange's Current Medical Diagnosis and Treatment. This information is supplemented by reviews of analyst reports, company reports, and medical websites. Sources and references are provided.
Table of Contents:
I. OVERVIEW
General description of the condition
Types of strokes
II. INCIDENCE, PREVALENCE AND MORTALITY
Incidence Table (US, Canada, Brazil, UK, France, Germany, Italy, Spain, Japan, China, India, Worldwide)
Prevalence Table (US, Canada, UK, England, France, Germany, Italy, Spain, Japan, China, India, Thailand, Australia, Worldwide)
Mortality Table (US, Canada, Brazil, UK, Japan, China, India, Worldwide)
III. TREATMENT
Ischemic strokes: acute and preventative
Hemorrhagic strokes
IV. DOSING AND TREATMENT COSTS
V. MARKET SIZE
VI. FUTURE THERAPIES
VII. COMMENTS
VIII. REFERENCES/RESOURCES
For more please visit
http://www.bharatbook.com/detail.asp?id=167604&rt=Disease-and-Therapy-Review-Stroke.html
OR Contact us at
Bharat Book Bureau
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai - 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Disease and Therapy Reviews were developed to provide a basic understanding of the key facts about a disease and market in a quick, easy-to-read format. These reports are prepared by the senior market research team of Timely Data Resources. Each Disease and Therapy Review provides a concise analysis of the most important information about a particular disease, its treatment, and the market opportunities. Reports begin with an overview of the condition, and also contain tables that summarize the available worldwide incidence and prevalence data for the condition, a review of current diagnosis strategies and treatment options, general information about the market size, and information about important market trends. The data contained in these reports comes from key industry secondary data sources, such as the Timely Data Resources Incidence and Prevalence Database, and Lange's Current Medical Diagnosis and Treatment. This information is supplemented by reviews of analyst reports, company reports, and medical websites. Sources and references are provided.
Table of Contents:
I. OVERVIEW
General description of the condition
Types of strokes
II. INCIDENCE, PREVALENCE AND MORTALITY
Incidence Table (US, Canada, Brazil, UK, France, Germany, Italy, Spain, Japan, China, India, Worldwide)
Prevalence Table (US, Canada, UK, England, France, Germany, Italy, Spain, Japan, China, India, Thailand, Australia, Worldwide)
Mortality Table (US, Canada, Brazil, UK, Japan, China, India, Worldwide)
III. TREATMENT
Ischemic strokes: acute and preventative
Hemorrhagic strokes
IV. DOSING AND TREATMENT COSTS
V. MARKET SIZE
VI. FUTURE THERAPIES
VII. COMMENTS
VIII. REFERENCES/RESOURCES
For more please visit
http://www.bharatbook.com/detail.asp?id=167604&rt=Disease-and-Therapy-Review-Stroke.html
OR Contact us at
Bharat Book Bureau
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai - 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Disease and Therapy Review: Non Small Cell Lung Cancer
The Non Small Cell Lung Cancer Disease and Therapy Review provides an overview of the disease and related conditions, with incidence, prevalence, and mortality numbers for major countries worldwide, information on diagnosis, and an overview of treatment. General information on the lung cancer market, as well as sales of leading drugs and therapies are provided.
Disease and Therapy Reviews were developed to provide a basic understanding of the key facts about a disease and market in a quick, easy-to-read format. These reports are prepared by the senior market research team of Timely Data Resources. Each Disease and Therapy Review provides a concise analysis of the most important information about a particular disease, its treatment, and the market opportunities. Reports begin with an overview of the condition, and also contain tables that summarize the available worldwide incidence and prevalence data for the condition, a review of current diagnosis strategies and treatment options, general information about the market size, and information about important market trends. The data contained in these reports comes from key industry secondary data sources, such as the Timely Data Resources Incidence and Prevalence Database, and Lange's Current Medical Diagnosis and Treatment. This information is supplemented by reviews of analyst reports, company reports, and medical websites. Sources and references are provided.
Table of Contents:
I. OVERVIEW
General overview of the condition
Types
Staging
Survival rates
II. INCIDENCE, PREVALENCE AND MORTALITY
Incidence Table (US, Canada, Argentina, Brazil, Mexico, France, Germany, Greece, Italy, Russian Federation, Poland, Spain, Sweden, Turkey, UK, China, India, Japan, Philippines, Thailand, Egypt, South Africa, Africa, Americas, Eastern Mediterranean, Europe, Southeast Asia, Western Pacific, Worldwide)
Prevalence Table (US, Canada, Mexico, UK, France, Germany, Italy, Spain, Japan, China, India, Worldwide)
Mortality Table (US, Canada, Argentina, Brazil, Mexico, France, Germany, Greece, Italy, Russian Federation, Poland, Spain, Sweden, Turkey, UK, China, India, Japan, Philippines, Thailand, Egypt, South Africa, Africa, Americas, Eastern Mediterranean, Europe, Southeast Asia, Western Pacific, Worldwide)
III. DIAGNOSIS
Symptoms and signs
Diagnostic tools and procedure
IV. TREAMENT
Recommended treatment by stage
Chemotherapy
V. MARKET SIZE
VI. COMMENTS
VII. REFERENCES/RESOURCES
For more please visit
http://www.bharatbook.com/detail.asp?id=167603&rt=Disease-and-Therapy-Review-Non-Small-Cell-Lung-Cancer.html
OR Contact us at
Bharat Book Bureau
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai - 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Disease and Therapy Reviews were developed to provide a basic understanding of the key facts about a disease and market in a quick, easy-to-read format. These reports are prepared by the senior market research team of Timely Data Resources. Each Disease and Therapy Review provides a concise analysis of the most important information about a particular disease, its treatment, and the market opportunities. Reports begin with an overview of the condition, and also contain tables that summarize the available worldwide incidence and prevalence data for the condition, a review of current diagnosis strategies and treatment options, general information about the market size, and information about important market trends. The data contained in these reports comes from key industry secondary data sources, such as the Timely Data Resources Incidence and Prevalence Database, and Lange's Current Medical Diagnosis and Treatment. This information is supplemented by reviews of analyst reports, company reports, and medical websites. Sources and references are provided.
Table of Contents:
I. OVERVIEW
General overview of the condition
Types
Staging
Survival rates
II. INCIDENCE, PREVALENCE AND MORTALITY
Incidence Table (US, Canada, Argentina, Brazil, Mexico, France, Germany, Greece, Italy, Russian Federation, Poland, Spain, Sweden, Turkey, UK, China, India, Japan, Philippines, Thailand, Egypt, South Africa, Africa, Americas, Eastern Mediterranean, Europe, Southeast Asia, Western Pacific, Worldwide)
Prevalence Table (US, Canada, Mexico, UK, France, Germany, Italy, Spain, Japan, China, India, Worldwide)
Mortality Table (US, Canada, Argentina, Brazil, Mexico, France, Germany, Greece, Italy, Russian Federation, Poland, Spain, Sweden, Turkey, UK, China, India, Japan, Philippines, Thailand, Egypt, South Africa, Africa, Americas, Eastern Mediterranean, Europe, Southeast Asia, Western Pacific, Worldwide)
III. DIAGNOSIS
Symptoms and signs
Diagnostic tools and procedure
IV. TREAMENT
Recommended treatment by stage
Chemotherapy
V. MARKET SIZE
VI. COMMENTS
VII. REFERENCES/RESOURCES
For more please visit
http://www.bharatbook.com/detail.asp?id=167603&rt=Disease-and-Therapy-Review-Non-Small-Cell-Lung-Cancer.html
OR Contact us at
Bharat Book Bureau
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai - 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Tuesday, December 28, 2010
Emerging Pharmaceutical Markets Globally
The growth in pharma markets in emerging countries has outpaced the overall growth of the global pharma market. The growth in these markets is being driven by rapidly growing economies of these countries, increasing per capita income, increasing prevalence of lifestyle diseases, and low-cost factors. In 2008, pharma market in E7 countries (Brazil, Russia, China, India, Turkey, Mexico and Indonesia) was estimated at around US$ 96 Billion, and it is expected that high growth in these markets will help these countries increase their share in global pharma market.
According to our new research study on the sector titled “Emerging Pharmaceutical Markets Globally”, the pharmaceutical market in the abovementioned emerging countries is projected to grow at a CAGR of around 14.7% during 2009-2012. Currently, these markets are characterized by rapid urbanization, which has led to the growth in prevalence of lifestyle diseases.
Our report has found that China has the largest pharma market out of these seven countries, followed by Brazil, Mexico and India. However, the maximum growth in future is expected to be in Russia and China due to strong government support. Besides, we have identified that most of the E7 pharmaceutical markets are still dominated by acute therapies, but the growth rate of chronic therapies far exceeds that of acute therapies. Thus, the therapy mix of the market in the next few years will be much different from what it is today.
The research study provides extensive and coherent information about pharma markets in emerging countries. It highlights several emerging opportunities growing in line with development of pharma markets in E7 countries. The research study gives detailed statistical and analytical review on demographics, macroeconomic indicators, disease profile, key drivers and restraints. It contains all the key details that will help clients to draw up market strategies and assess opportunity areas for their success in these emerging pharma markets.
For more please visit
http://www.bharatbook.com/detail.asp?id=73228&rt=Emerging-Pharmaceutical-Markets-Globally.html
OR Contact us at
Bharat Book Bureau
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai - 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
According to our new research study on the sector titled “Emerging Pharmaceutical Markets Globally”, the pharmaceutical market in the abovementioned emerging countries is projected to grow at a CAGR of around 14.7% during 2009-2012. Currently, these markets are characterized by rapid urbanization, which has led to the growth in prevalence of lifestyle diseases.
Our report has found that China has the largest pharma market out of these seven countries, followed by Brazil, Mexico and India. However, the maximum growth in future is expected to be in Russia and China due to strong government support. Besides, we have identified that most of the E7 pharmaceutical markets are still dominated by acute therapies, but the growth rate of chronic therapies far exceeds that of acute therapies. Thus, the therapy mix of the market in the next few years will be much different from what it is today.
The research study provides extensive and coherent information about pharma markets in emerging countries. It highlights several emerging opportunities growing in line with development of pharma markets in E7 countries. The research study gives detailed statistical and analytical review on demographics, macroeconomic indicators, disease profile, key drivers and restraints. It contains all the key details that will help clients to draw up market strategies and assess opportunity areas for their success in these emerging pharma markets.
For more please visit
http://www.bharatbook.com/detail.asp?id=73228&rt=Emerging-Pharmaceutical-Markets-Globally.html
OR Contact us at
Bharat Book Bureau
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai - 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Sunday, July 25, 2010
Conference on Phase I Clinical Trials Summit
Conference on Phase I Clinical Trials Summit
Strategies for improving Phase I trial design, management and execution
To be held at 28th – 29th October 2010, BSG Conference Centre, London, UK
Key Speakers
Dr. Eckhard von Keutz, Senior Vice President Head Global Early Development, Bayer Schering Pharma
Dr. Walter Janssens Coordinator Early Phase Development, FAGG/AFMPS
Corina Dota ECG Centre Manager, Medical Science Sweden, AstraZeneca
Dr. Fatiha Sadallah, Principal Scientifi c Manager, Innovative Medicines Initiative (IMI)
Dr. Andrea Laslop, Head of Institute Science and Information, AGES PharmMed
Rob Nichols, Director of Commercial Development, Phase Forward Europe
Dr. Finbarr Cotter Prof of Haematology, Medical Oncology, Barts and the London School of Medicine
Robert Blakie, Director, ERA Consulting
Dr. Assem S. el Baghdady, Director, Alpha Beta Pharma
Dr. Jennifer J. Wheler, Assistant Professor, Department of Investigational Cancer Therapeutics, Division of Cancer
Medicine, The University of Texas M. D. Anderson Cancer Center
Professor Atholl Johnston, Professor of Clinical Pharmacology, Barts and the London School of Medicine and
Dentistry, Queen Mary University of London
Dr. Dominic Williams, MRC Centre for Drug Safety Science, The University of Liverpool
Who should attend?
Vice/Presidents, Directors, Heads of:
• Clinical Operations • Clinical Research
• Clinical Development
• Exploratory Development
• Strategic Drug Development
• Clinical Trial Design
• Clinical Pharmacology / Pharmacometrics
• Quality Assurance / Quality Control • Pharmacokinetics/ Pharmacodynamics
• Project Management
• Regulatory Affairs
• Scientifi c Relations
• Statistical Methodology
Day 1
Phase I Clinical Trials Summit
Thursday 28th October 2010
09:00 Registration and refreshments
09:30 Opening address from the chair
09:40 The use of biomarkers early in clinical development
• Biomarkers as go/no-go in early clinical development
• Do biomarkers worth the cost or the time?
• Can we use biomarkers in late clinical development too?
• What role do biomarkers play in the clinic?
Dr. Assem S. el Baghdady
Director, Alpha Beta Pharma
Formerly Medical Director R&D, Norgine
10:20 Exploring translatability from phase I to phase IIb
• Clarify different concepts of biomarkers
• Speed up the transition from Phase I to Phase IIb
• Integrative assessment of available data
• Designing biomarker studies efficiently for informative decision making in clinical development
• Illustrative example in diabetes
Dr. Arne Ring
Team Leader Biostatistics Phase I/IIa
Boehringer Ingelheim Pharma
11:00 Morning refreshments
11:20 Regulatory experience with exploratory clinical trials
• Critical issues in the trial application
- preclinical
- quality issues
- protocol related
• Experience in Belgium with exploratory clinical trials
Dr. Walter Janssens
Coordinator Early Phase Development
FAGG/AFMPS
12:00 Phase I clinical trials: beside to bench
Dr. Jennifer J. Wheler
Assistant Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine
The University of Texas M. D. Anderson Cancer Center
12:40 Networking lunch
13:40 Reducing the cost of clinical QT studies
• Relationship between the electrocardiographic precision and the study size
• Electrocardiographic methods to increase measurement precision
• Design implications for crossover and parallel studies
• Advantages of continuous ECG acquisition
• Optimum combinations of computerised and manual readings to reduce the cost of ECG analysis
Marek Malik
Professor of Cardiac Electrophysiology, Head, Noninvasive Electrocardiology
St. George’s, University of London
14:20 Evaluating the efficiency of design methods and implementing early clinical trials with novel therapeutics
• Determine dose and schedule
• Discuss continual reassessment methods
• Study specific target patient populations
15:00 Afternoon refreshments
15:20 Study design for Leukaemia therapy
• What does we mean by Phase I studies in the context of Leukaemia
• What are the goals
• How do we design the study
• How to we record and evaluate the trial
• What are added value studies
Dr. Finbarr Cotter
Prof of Haematology, Medical Oncology
Barts and the London School of Medicine
16:00 Update on ICH guidelines
• Review the guidelines
• Discuss the risk benefit
• Examine the regulatory requirements
16:40 Closing remarks from the chair
16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting.
Day 2
Phase I Clinical Trials Summit
Friday 29th October 2010
09:00 Registration and refreshments
09:30 Opening address from the chair
09:40 Preparing phase I clinical trials
• Early clinical trials methodology
• Principles of laboratory methodologies
• Reviewing preclinical data
Professor Atholl Johnston
Professor of Clinical Pharmacology, Barts and the London
School of Medicine and Dentistry
Queen Mary University of London
10:20 Understanding the importance of preclinical
studies for clinical success
• What has changed?
• What is necessary?
• Opportunities for better investigations
• Opportunities for cross-functional cooperation
Dr. Eckhard von Keutz
Senior Vice President, Head, Global Early Development
Bayer Schering Pharma
11:00 Morning refreshments
11:20 Clinical trials data management in phase I
12:00 The case for automating phase I clinical trials
• Understand the unique challenges for phase I clinical units and how these can be addressed by improved use of automated
solutions
• Appreciate the breadth of available solutions suitable for phase I
• Understand the key issue areas to consider when planning a
smooth implementation
Rob Nichols
Director, Commercial Development
Phase Forward Europe
12:40 Networking lunch
13:40 Translational medicine in Europe: Role of the innovative medicines initiative :IMI
• Public-private partnership in the health sector
• Building on strengths and tackling weaknesses in the EU
• IMI first two calls for proposals
Dr. Fatiha Sadallah
Principal Scientific Manager
Innovative Medicines Initiative (IMI)
14:20 Presentation to be announced
Dr. Andrea Laslop
Head of Institute Science and Information
AGES PharmMed
15:00 Afternoon refreshments
15:20 Cardiovascular risk profiling in early clinical development
• Role of preclinical testing for cardiovascular safety profiling
• What can be achieved in the early phase 1 studies?
• What are the technologies at hand to ensure quality and cost efficiencies in early clinical development
Corina Dota
ECG Centre Manager, Medical Science Sweden
AstraZeneca
16.00 Mechanism-based markers of murine drug-induced liver injury
• Paracetamol as a tool for translational hepatotoxicity
• Use of keratin-18 as a serum marker of apoptosis
• Use of High Mobility Group box-1 as a serum marker of necrosis
• Fed and fasted animal models in pre-clinical development
Dr. Dominic Williams
MRC Centre for Drug Safety Science, Dept.
Pharmacology & Therapeutics
The University of Liverpool
16:40 Chair’s closing remarks
16:50 End of conference
For more information visit
http://www.bharatbook.com/detail.asp?id=136318&rt=Conference-on-Phase-I-Clinical-Trials-Summit.html
OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Follow us on twitter: http://twitter.com/3bbharatbook
Please visit our blog at http://bharatbookseo.blogsome.com
Strategies for improving Phase I trial design, management and execution
To be held at 28th – 29th October 2010, BSG Conference Centre, London, UK
Key Speakers
Dr. Eckhard von Keutz, Senior Vice President Head Global Early Development, Bayer Schering Pharma
Dr. Walter Janssens Coordinator Early Phase Development, FAGG/AFMPS
Corina Dota ECG Centre Manager, Medical Science Sweden, AstraZeneca
Dr. Fatiha Sadallah, Principal Scientifi c Manager, Innovative Medicines Initiative (IMI)
Dr. Andrea Laslop, Head of Institute Science and Information, AGES PharmMed
Rob Nichols, Director of Commercial Development, Phase Forward Europe
Dr. Finbarr Cotter Prof of Haematology, Medical Oncology, Barts and the London School of Medicine
Robert Blakie, Director, ERA Consulting
Dr. Assem S. el Baghdady, Director, Alpha Beta Pharma
Dr. Jennifer J. Wheler, Assistant Professor, Department of Investigational Cancer Therapeutics, Division of Cancer
Medicine, The University of Texas M. D. Anderson Cancer Center
Professor Atholl Johnston, Professor of Clinical Pharmacology, Barts and the London School of Medicine and
Dentistry, Queen Mary University of London
Dr. Dominic Williams, MRC Centre for Drug Safety Science, The University of Liverpool
Who should attend?
Vice/Presidents, Directors, Heads of:
• Clinical Operations • Clinical Research
• Clinical Development
• Exploratory Development
• Strategic Drug Development
• Clinical Trial Design
• Clinical Pharmacology / Pharmacometrics
• Quality Assurance / Quality Control • Pharmacokinetics/ Pharmacodynamics
• Project Management
• Regulatory Affairs
• Scientifi c Relations
• Statistical Methodology
Day 1
Phase I Clinical Trials Summit
Thursday 28th October 2010
09:00 Registration and refreshments
09:30 Opening address from the chair
09:40 The use of biomarkers early in clinical development
• Biomarkers as go/no-go in early clinical development
• Do biomarkers worth the cost or the time?
• Can we use biomarkers in late clinical development too?
• What role do biomarkers play in the clinic?
Dr. Assem S. el Baghdady
Director, Alpha Beta Pharma
Formerly Medical Director R&D, Norgine
10:20 Exploring translatability from phase I to phase IIb
• Clarify different concepts of biomarkers
• Speed up the transition from Phase I to Phase IIb
• Integrative assessment of available data
• Designing biomarker studies efficiently for informative decision making in clinical development
• Illustrative example in diabetes
Dr. Arne Ring
Team Leader Biostatistics Phase I/IIa
Boehringer Ingelheim Pharma
11:00 Morning refreshments
11:20 Regulatory experience with exploratory clinical trials
• Critical issues in the trial application
- preclinical
- quality issues
- protocol related
• Experience in Belgium with exploratory clinical trials
Dr. Walter Janssens
Coordinator Early Phase Development
FAGG/AFMPS
12:00 Phase I clinical trials: beside to bench
Dr. Jennifer J. Wheler
Assistant Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine
The University of Texas M. D. Anderson Cancer Center
12:40 Networking lunch
13:40 Reducing the cost of clinical QT studies
• Relationship between the electrocardiographic precision and the study size
• Electrocardiographic methods to increase measurement precision
• Design implications for crossover and parallel studies
• Advantages of continuous ECG acquisition
• Optimum combinations of computerised and manual readings to reduce the cost of ECG analysis
Marek Malik
Professor of Cardiac Electrophysiology, Head, Noninvasive Electrocardiology
St. George’s, University of London
14:20 Evaluating the efficiency of design methods and implementing early clinical trials with novel therapeutics
• Determine dose and schedule
• Discuss continual reassessment methods
• Study specific target patient populations
15:00 Afternoon refreshments
15:20 Study design for Leukaemia therapy
• What does we mean by Phase I studies in the context of Leukaemia
• What are the goals
• How do we design the study
• How to we record and evaluate the trial
• What are added value studies
Dr. Finbarr Cotter
Prof of Haematology, Medical Oncology
Barts and the London School of Medicine
16:00 Update on ICH guidelines
• Review the guidelines
• Discuss the risk benefit
• Examine the regulatory requirements
16:40 Closing remarks from the chair
16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting.
Day 2
Phase I Clinical Trials Summit
Friday 29th October 2010
09:00 Registration and refreshments
09:30 Opening address from the chair
09:40 Preparing phase I clinical trials
• Early clinical trials methodology
• Principles of laboratory methodologies
• Reviewing preclinical data
Professor Atholl Johnston
Professor of Clinical Pharmacology, Barts and the London
School of Medicine and Dentistry
Queen Mary University of London
10:20 Understanding the importance of preclinical
studies for clinical success
• What has changed?
• What is necessary?
• Opportunities for better investigations
• Opportunities for cross-functional cooperation
Dr. Eckhard von Keutz
Senior Vice President, Head, Global Early Development
Bayer Schering Pharma
11:00 Morning refreshments
11:20 Clinical trials data management in phase I
12:00 The case for automating phase I clinical trials
• Understand the unique challenges for phase I clinical units and how these can be addressed by improved use of automated
solutions
• Appreciate the breadth of available solutions suitable for phase I
• Understand the key issue areas to consider when planning a
smooth implementation
Rob Nichols
Director, Commercial Development
Phase Forward Europe
12:40 Networking lunch
13:40 Translational medicine in Europe: Role of the innovative medicines initiative :IMI
• Public-private partnership in the health sector
• Building on strengths and tackling weaknesses in the EU
• IMI first two calls for proposals
Dr. Fatiha Sadallah
Principal Scientific Manager
Innovative Medicines Initiative (IMI)
14:20 Presentation to be announced
Dr. Andrea Laslop
Head of Institute Science and Information
AGES PharmMed
15:00 Afternoon refreshments
15:20 Cardiovascular risk profiling in early clinical development
• Role of preclinical testing for cardiovascular safety profiling
• What can be achieved in the early phase 1 studies?
• What are the technologies at hand to ensure quality and cost efficiencies in early clinical development
Corina Dota
ECG Centre Manager, Medical Science Sweden
AstraZeneca
16.00 Mechanism-based markers of murine drug-induced liver injury
• Paracetamol as a tool for translational hepatotoxicity
• Use of keratin-18 as a serum marker of apoptosis
• Use of High Mobility Group box-1 as a serum marker of necrosis
• Fed and fasted animal models in pre-clinical development
Dr. Dominic Williams
MRC Centre for Drug Safety Science, Dept.
Pharmacology & Therapeutics
The University of Liverpool
16:40 Chair’s closing remarks
16:50 End of conference
For more information visit
http://www.bharatbook.com/detail.asp?id=136318&rt=Conference-on-Phase-I-Clinical-Trials-Summit.html
OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Follow us on twitter: http://twitter.com/3bbharatbook
Please visit our blog at http://bharatbookseo.blogsome.com
Conference on CNS Clinical Trials
Conference on CNS Clinical Trials
Optimising development, management and recruitment for clinical trials in CNS
16th - 17th September 2010, BSG Conference Centre, London, UK
Background Info
Key Speakers
Dr Erik Buntinx, Managing Director and Chief Scientifi c Offi cer, PharmaNeuroBoost
Dr Samuel Agus, Global Medical Affairs Director, Neurology, Solvay Pharmaceuticals Marketing and Licensing
Dr Stig Johan Wiklund, Statistical Science Director, AstraZeneca R&D
Dr Fabrizio Gasparini, Sr Research Investigator, Novartis Institutes for BioMedical Research
Dr Mark Tricklebank Director, Senior Research Fellow - Psychiatric Disorders Drug Hunting Team, Lilly
Dr Simone Braggio, Director Neurosciences CEDD DMPK, GlaxoSmithKline
Dr Karl Herholz Director, Wolfson Molecular Imaging Centre/ Professor of Clinical Neuroscience, University of Manchester
Professor Elaine Rankin, Medical Oncology, University of Dundee
Professor Alan M Palmer, Chief Scientifi c Offi cer, MS Therapeutics
Nancy Mulligan, VP, CNS / Mental Health, MMG
Professor Mehdi Adineh, Scientifi c Director Diagnostic Imaging Core Laboratory, American College of
Radiology Imaging Network (ACRIN)
CNS is one of the largest and fastest growing therapeutic areas of the
pharmaceutical market. The ageing of the baby-boom generation combined
with new and emerging treatments for neurodegenerative disorders, including multiple sclerosis, Alzheimer’s disease and Parkinson’s disease, will lead to further expansion of the neurodegenerative therapies market.
CNS Clinical Trials conference you will examine the strategies offering
the greatest potential for success in CNS drug development, and understand the specifi c
challenges currently faced by developers in this market. In order to enhance productivity
in this fi eld, there has been an increased awareness of the need to align clinical and
preclinical research to facilitate rapid development of new CNS drug therapies. Medical
imaging is increasingly being used as a surrogate endpoint or biomarker of drug effi cacy
in all phases of CNS trials, enabling CNS developers to make more timely decisions.
By attending this conference you will:
• Examine novel approaches for assessing cognitive function
• Explore the latest advances in neuroimaging
• Develop effective methods for improved patient recruitment and retention
• Understand statistical thinking for designing adaptive trials
• Review Good Clinical Practice GCP guidelines
• Address the regulatory challenges for CNS drug approval
• Utilise biomarkers for Proof of Concept in CNS clinical trials
• Improve trial outcomes through increased communication, ethical consent and
patient care
• Implement translational methods to bridge the gap between pre-clinical and clinical
CNS trials
• Be part of a major networking opportunity
Target Audience:
• Pharmaceutical and biotech companies
• Clinical research organisations
• Regulatory agencies/ associations
Who will be there?
Senior VPs, VPs, Chief Scientifi c Offi cers, Directors, Heads and
Managers of:
• CNS Trials
• Clinical Trials
• Clinical Research & Development
• Clinical Operations
• CNS
• CNS Clinical Biomarker Group
• Clinical Pharmacology
• Neurobiology
• Neuromedical Oncology
• Neurology/ Neuroscience Research
• Psychiatry
• Psychology
• CNS Ageing Research
• Dementia
• Imaging/ Neuroimaging
• Movement Disorders
• CNS Global Marketing & Medicine
• Preclinical R&D
• Translational Medicine
• Biostatistics
• Experimental Therapeutics
• Clinical Technology
• Outcomes Research
• Regulatory Affairs
• Product Development
Day 1,Monday 16th March 2010, London, UK
09:30 Registration and refreshments
10:00 Opening address from the chair
10:10 The discovery and development of CNS medicines
• Progress in CNS medicines research
• Market landscape
• The challenges for CNS R&D
• Future prospects
Professor Alan M Palmer
Chief Scientific Officert
MS Therapeutics
10:50 Addressing specific challenges arising in the clinical trials of neuroprotective agents
11:30 Morning refreshments
11:50 Clinical value of accelerated anti-depressant effect
• Lag time of antidepressants: an unmet medical need
• Early and Sustained Full Response: A new FDA approved
efficacy paradigm
• Pharmacological considerations to induce accelerated
antidepressant effect
• Treatment adherence in relation to an antidepressant with an
accelerated effect
Dr Erik Buntinx
Managing Director and Chief Scientific Officer
PharmaNeuroBoost
12:30 Considerations for design and statistical analysis
of CNS trials
• Analysis and design for disease modification
• Missing data issues
• Adaptive design issues when applied in CNS trials
Dr Stig Johan Wiklund
Statistical Science Director
AstraZeneca R&D
13:10 Networking Lunch
14:30 mGluR5 Allosteric Antagonists: Preclinical profile and choice of therapeutic indication
• Characterization of mGluR5 antagonist in preclinical paradigm
• Validation of objective markers for monitoring drug action
• Use of preclinical profiling and proof-of-concept clinical trials to
select therapeutic indications for full development
Dr Fabrizio Gasparini
Sr Research Investigator Novartis Institutes for BioMedical Research
15:10 Suicidality: Ensuring quality in mandated prospective monitoring
• Overview of the Columbia-Suicide Severity Rating Scale (C-SSRS)
• Potential pitfalls with collection of suicidality monitoring data
• eC-SSRS - electronically modeling and reproducing the optimal
human interview
• eC-SSRS – meeting the goals of excellent science and clinical care
• eC-SSRS – a clinical trial case study
Dr John Greist
Distinguished Senior Scientist, Madison Institute of Medicine
Clinical Professor of Psychiatry, University of Wisconsin School of Medicine and Public Health
15:50 Afternoon refreshments
16:10 CNS clinical trials beyond registration
• Trials beyond registration a tool for assessing a drug in real-life setting
• Types of post-registration studies, goals, deliverables and methods
• When should trials beyond registration begin?
• Life cycle management and drug safety- 2 sides for the same coin
• Who initiates investigator-initiated-trials and what is their purpose
Dr Samuel Agus
Global Medical Affairs Director, Neurology
Solvay Pharmaceuticals Marketing and Licensing
16:50 Closing remarks from the chair
Day2,Thursday 17th March 2010, London, UK
09:30 Registration and refreshments
10:00 Opening address from the chair
10:10 Bridging the gap between pre-clinical and
clinical CNS trials
• Translational assays of cognition
• Animal models of cognitive impairment
• Use of preclinical biomarkers to enhance assay translation
• Clinical testing of preclinical hypotheses
Dr Mark Tricklebank
Director, Lilly Centre for Cognitive Neuroscience
Eli Lilly and Co
10:50 Reducing the gap between preclinical PK/PD and CNS clinical trials
• Adding value to the discovery of CNS active drugs through the application of mechanistic PK/PD principles
• Understanding the key drivers of in-vivo pharmacological effects and ensuring they are prominent in the lead optimisation paradigm
• Establishing the link between blood concentration, receptor occupancy and drug efficacy
11:30 Morning refreshments
11:50 Novel imaging approaches in clinical trials and the role of an imaging CRO
• Novel Imaging Approaches including Structural, Functional and Molecular in CNS Drug Discovery including PET, DTI, fMRI and vCT.
• Imaging Drug Actions Including Neuroreceptor Mapping
• The role of an Imaging CRO in Managing an Imaging Clinical Trial
Professor Mehdi Adineh
Scientific Director Diagnostic Imaging Core Laboratory
American College of Radiology
12:30 Utilising PET imaging biomarkers
• Dementia: glucose metabolism, amyloid tracers, acetylcholine analogues
• Parkinson’s disease: dopamine synthesis & storage capacity
• Psychiatric disorders: dopamine & serotonin receptor occupancy
• Brain tumours: progression and infiltration
• Tracers and techniques for quantitative standardised analysis will be presented
Dr Karl Herholz
Director, Wolfson Molecular Imaging Centre/ Professor of
Clinical Neuroscience
University of Manchester
13:10 Networking Lunch
14.10 Use of biomarkers for demonstrating CNS effects of drugs early in clinical development
• Using animal PK/PD data to set dose range finding in Phase 1
• Use of QEEG to demonstrate CNS activity
• Computer measures of cognition
• Evoked potentials to demonstrate clinical potential
Dr. Michael G. Palfreyman
Head, Translational R&D, ChemDiv
Executive Program Director, Senior Scientific Advisor, EnVivo Pharmaceuticals
14:50 Recruiting strategies for Huntington’s Disease
clinical trials
• The importance of identifying unique barriers to participation in HD clinical trials
• Grass-roots social marketing for HD trials can speed enrollment:
a pilot study
• Treating the HD trial participant as VIP is a cost-effective approach.
Dr LaVonne Veatch Goodman
Co-founder
Huntington’s Disease Drug Works (HDDW)
15:30 Afternoon refreshments
15:50 Patient recruitment and retention strategies for
CNS clinical trials
• Patient population insights that need to be considered in designing recruitment and retention programs for CNS trials
• Strategies for overcoming global CNS patient recruitment challenges
• Updates on evolving trends in patient recruitment and retention methodologies
• Illustrative case studies of effective tactics
Gaynor Anders
Vice President Global Operations
MMG
16.30 Successful strategies for accelerating
patient recruitment
• Preparing for successful enrolment
• The ideal set-up
• Avoiding the pitfalls for a pharma-driven trial
• Enlisting support from patients
Professor Elaine Rankin
Medical Oncology
University of Dundee
17:10 Chair’s closing remarks
17:20 End of conference
Related Reports:
Clinical Trials Market India
Clinical Trials: World Market 2009-2024
Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment
Trends in Clinical Trials Strategies to enhance clinical trial design
Medical Device Clinical Trials Destination India
For more information visit
http://www.bharatbook.com/detail.asp?id=128073&rt=Conference-on-CNS-Clinical-Trials.html
OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Follow us on twitter: http://twitter.com/3bbharatbook
Please visit our blog at http://bharatbookseo.blogsome.com
Optimising development, management and recruitment for clinical trials in CNS
16th - 17th September 2010, BSG Conference Centre, London, UK
Background Info
Key Speakers
Dr Erik Buntinx, Managing Director and Chief Scientifi c Offi cer, PharmaNeuroBoost
Dr Samuel Agus, Global Medical Affairs Director, Neurology, Solvay Pharmaceuticals Marketing and Licensing
Dr Stig Johan Wiklund, Statistical Science Director, AstraZeneca R&D
Dr Fabrizio Gasparini, Sr Research Investigator, Novartis Institutes for BioMedical Research
Dr Mark Tricklebank Director, Senior Research Fellow - Psychiatric Disorders Drug Hunting Team, Lilly
Dr Simone Braggio, Director Neurosciences CEDD DMPK, GlaxoSmithKline
Dr Karl Herholz Director, Wolfson Molecular Imaging Centre/ Professor of Clinical Neuroscience, University of Manchester
Professor Elaine Rankin, Medical Oncology, University of Dundee
Professor Alan M Palmer, Chief Scientifi c Offi cer, MS Therapeutics
Nancy Mulligan, VP, CNS / Mental Health, MMG
Professor Mehdi Adineh, Scientifi c Director Diagnostic Imaging Core Laboratory, American College of
Radiology Imaging Network (ACRIN)
CNS is one of the largest and fastest growing therapeutic areas of the
pharmaceutical market. The ageing of the baby-boom generation combined
with new and emerging treatments for neurodegenerative disorders, including multiple sclerosis, Alzheimer’s disease and Parkinson’s disease, will lead to further expansion of the neurodegenerative therapies market.
CNS Clinical Trials conference you will examine the strategies offering
the greatest potential for success in CNS drug development, and understand the specifi c
challenges currently faced by developers in this market. In order to enhance productivity
in this fi eld, there has been an increased awareness of the need to align clinical and
preclinical research to facilitate rapid development of new CNS drug therapies. Medical
imaging is increasingly being used as a surrogate endpoint or biomarker of drug effi cacy
in all phases of CNS trials, enabling CNS developers to make more timely decisions.
By attending this conference you will:
• Examine novel approaches for assessing cognitive function
• Explore the latest advances in neuroimaging
• Develop effective methods for improved patient recruitment and retention
• Understand statistical thinking for designing adaptive trials
• Review Good Clinical Practice GCP guidelines
• Address the regulatory challenges for CNS drug approval
• Utilise biomarkers for Proof of Concept in CNS clinical trials
• Improve trial outcomes through increased communication, ethical consent and
patient care
• Implement translational methods to bridge the gap between pre-clinical and clinical
CNS trials
• Be part of a major networking opportunity
Target Audience:
• Pharmaceutical and biotech companies
• Clinical research organisations
• Regulatory agencies/ associations
Who will be there?
Senior VPs, VPs, Chief Scientifi c Offi cers, Directors, Heads and
Managers of:
• CNS Trials
• Clinical Trials
• Clinical Research & Development
• Clinical Operations
• CNS
• CNS Clinical Biomarker Group
• Clinical Pharmacology
• Neurobiology
• Neuromedical Oncology
• Neurology/ Neuroscience Research
• Psychiatry
• Psychology
• CNS Ageing Research
• Dementia
• Imaging/ Neuroimaging
• Movement Disorders
• CNS Global Marketing & Medicine
• Preclinical R&D
• Translational Medicine
• Biostatistics
• Experimental Therapeutics
• Clinical Technology
• Outcomes Research
• Regulatory Affairs
• Product Development
Day 1,Monday 16th March 2010, London, UK
09:30 Registration and refreshments
10:00 Opening address from the chair
10:10 The discovery and development of CNS medicines
• Progress in CNS medicines research
• Market landscape
• The challenges for CNS R&D
• Future prospects
Professor Alan M Palmer
Chief Scientific Officert
MS Therapeutics
10:50 Addressing specific challenges arising in the clinical trials of neuroprotective agents
11:30 Morning refreshments
11:50 Clinical value of accelerated anti-depressant effect
• Lag time of antidepressants: an unmet medical need
• Early and Sustained Full Response: A new FDA approved
efficacy paradigm
• Pharmacological considerations to induce accelerated
antidepressant effect
• Treatment adherence in relation to an antidepressant with an
accelerated effect
Dr Erik Buntinx
Managing Director and Chief Scientific Officer
PharmaNeuroBoost
12:30 Considerations for design and statistical analysis
of CNS trials
• Analysis and design for disease modification
• Missing data issues
• Adaptive design issues when applied in CNS trials
Dr Stig Johan Wiklund
Statistical Science Director
AstraZeneca R&D
13:10 Networking Lunch
14:30 mGluR5 Allosteric Antagonists: Preclinical profile and choice of therapeutic indication
• Characterization of mGluR5 antagonist in preclinical paradigm
• Validation of objective markers for monitoring drug action
• Use of preclinical profiling and proof-of-concept clinical trials to
select therapeutic indications for full development
Dr Fabrizio Gasparini
Sr Research Investigator Novartis Institutes for BioMedical Research
15:10 Suicidality: Ensuring quality in mandated prospective monitoring
• Overview of the Columbia-Suicide Severity Rating Scale (C-SSRS)
• Potential pitfalls with collection of suicidality monitoring data
• eC-SSRS - electronically modeling and reproducing the optimal
human interview
• eC-SSRS – meeting the goals of excellent science and clinical care
• eC-SSRS – a clinical trial case study
Dr John Greist
Distinguished Senior Scientist, Madison Institute of Medicine
Clinical Professor of Psychiatry, University of Wisconsin School of Medicine and Public Health
15:50 Afternoon refreshments
16:10 CNS clinical trials beyond registration
• Trials beyond registration a tool for assessing a drug in real-life setting
• Types of post-registration studies, goals, deliverables and methods
• When should trials beyond registration begin?
• Life cycle management and drug safety- 2 sides for the same coin
• Who initiates investigator-initiated-trials and what is their purpose
Dr Samuel Agus
Global Medical Affairs Director, Neurology
Solvay Pharmaceuticals Marketing and Licensing
16:50 Closing remarks from the chair
Day2,Thursday 17th March 2010, London, UK
09:30 Registration and refreshments
10:00 Opening address from the chair
10:10 Bridging the gap between pre-clinical and
clinical CNS trials
• Translational assays of cognition
• Animal models of cognitive impairment
• Use of preclinical biomarkers to enhance assay translation
• Clinical testing of preclinical hypotheses
Dr Mark Tricklebank
Director, Lilly Centre for Cognitive Neuroscience
Eli Lilly and Co
10:50 Reducing the gap between preclinical PK/PD and CNS clinical trials
• Adding value to the discovery of CNS active drugs through the application of mechanistic PK/PD principles
• Understanding the key drivers of in-vivo pharmacological effects and ensuring they are prominent in the lead optimisation paradigm
• Establishing the link between blood concentration, receptor occupancy and drug efficacy
11:30 Morning refreshments
11:50 Novel imaging approaches in clinical trials and the role of an imaging CRO
• Novel Imaging Approaches including Structural, Functional and Molecular in CNS Drug Discovery including PET, DTI, fMRI and vCT.
• Imaging Drug Actions Including Neuroreceptor Mapping
• The role of an Imaging CRO in Managing an Imaging Clinical Trial
Professor Mehdi Adineh
Scientific Director Diagnostic Imaging Core Laboratory
American College of Radiology
12:30 Utilising PET imaging biomarkers
• Dementia: glucose metabolism, amyloid tracers, acetylcholine analogues
• Parkinson’s disease: dopamine synthesis & storage capacity
• Psychiatric disorders: dopamine & serotonin receptor occupancy
• Brain tumours: progression and infiltration
• Tracers and techniques for quantitative standardised analysis will be presented
Dr Karl Herholz
Director, Wolfson Molecular Imaging Centre/ Professor of
Clinical Neuroscience
University of Manchester
13:10 Networking Lunch
14.10 Use of biomarkers for demonstrating CNS effects of drugs early in clinical development
• Using animal PK/PD data to set dose range finding in Phase 1
• Use of QEEG to demonstrate CNS activity
• Computer measures of cognition
• Evoked potentials to demonstrate clinical potential
Dr. Michael G. Palfreyman
Head, Translational R&D, ChemDiv
Executive Program Director, Senior Scientific Advisor, EnVivo Pharmaceuticals
14:50 Recruiting strategies for Huntington’s Disease
clinical trials
• The importance of identifying unique barriers to participation in HD clinical trials
• Grass-roots social marketing for HD trials can speed enrollment:
a pilot study
• Treating the HD trial participant as VIP is a cost-effective approach.
Dr LaVonne Veatch Goodman
Co-founder
Huntington’s Disease Drug Works (HDDW)
15:30 Afternoon refreshments
15:50 Patient recruitment and retention strategies for
CNS clinical trials
• Patient population insights that need to be considered in designing recruitment and retention programs for CNS trials
• Strategies for overcoming global CNS patient recruitment challenges
• Updates on evolving trends in patient recruitment and retention methodologies
• Illustrative case studies of effective tactics
Gaynor Anders
Vice President Global Operations
MMG
16.30 Successful strategies for accelerating
patient recruitment
• Preparing for successful enrolment
• The ideal set-up
• Avoiding the pitfalls for a pharma-driven trial
• Enlisting support from patients
Professor Elaine Rankin
Medical Oncology
University of Dundee
17:10 Chair’s closing remarks
17:20 End of conference
Related Reports:
Clinical Trials Market India
Clinical Trials: World Market 2009-2024
Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment
Trends in Clinical Trials Strategies to enhance clinical trial design
Medical Device Clinical Trials Destination India
For more information visit
http://www.bharatbook.com/detail.asp?id=128073&rt=Conference-on-CNS-Clinical-Trials.html
OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Follow us on twitter: http://twitter.com/3bbharatbook
Please visit our blog at http://bharatbookseo.blogsome.com
Conference on Clinical Trials Asia Summit 2010
Clinical trials in India are finally becoming transparent. There has been a dramatic increase in the number of trials that have got officially registered in Clinical Trials Registry-India (CTRI). According to records collected by the Indian Council of Medical Research and the Drug Controller General's office, between July-December 2007, only 11 trials were registered. The number increased to 137 between Jan-Dec 2008 and then to an all-time high of 546 between Jan-Dec 2009. This year, while January saw 58 trials registered, February recorded 60. India has all the competitive advantages for conducting clinical trials. As the country is increasingly becoming a favoured destination for clinical trials, a gap analysis needs to be done to scale up all resources for clinical trials. This scale up is essential for India to cope with the large global clinical trial projects. It is no coincidence over the last decade or more of economic liberalization, and years of unprecedented growth, that India and parts of South Asia are becoming a preferred clinical research destination for multinational pharmaceutical and biotechnology corporations.
CTAS 2010 will examine the current issues faced in clinical trials operations, addressing the risks, timeline and budget stipulations, while effectively tackling key challenges in overcoming trials agreement and site contract arbitration problems. This summit will discuss the operational element of trial site management, strategic partnership with CROs and SMOs, patient, talent & investigators management in order to improve & optimise the overall drug development effectiveness and ROI. Discover on how to implement and benefit from electronic data management & monitoring cost effectively. This conference will be shared by leading industrial practitioners across the region to promote practical discussions; especially on the know-how to manage needs, variability of different countries and institutions to enhance clinical operational excellence and vigilance. Attendees will have the chance to learn, network and benchmark against the global top pharmas and local industry leaders on the best practices in talent, site, budget and performance management in clinical trials. The conference aims to provide a detailed analysis of what it takes to conduct clinical trials from a biopharmaceuticals and vaccines perspective in India and China and also addressing risk/benefit balance, anecdotal experiences of the multinational pharmaceutical industry in India and China, selection and role of CROs, logistics of operations, clinical trials management, government policies and pharmacovigilance.
CTAS 2010 will provide you with the data that you need to recognize this complex and rapidly-expanding sector. Knowing the future market, and what impact will that have on future business opportunities? This is your opportunity to stay ahead by learning the latest trends and networking with the trend setters. It gives us immense pleasure in welcoming you to the Clinical Trials Asia Summit '2010.
Key Speakers Include:
Akhilesh Sharma, Vice President & Global head Clinical management & Global Pharmacovigilance, Dr. Reddy’s,
Bakulesh Khamar, Executive Director – Research Cadila,
Deven Parmar Vice President - Clinical Research & Pharmacovigilance, Wockhardt,
Shashidhar Rao, India Operations Head (IID and IA&R), Novartis,
Mohan Bangalore, Senior Director & Site Head, Pfizer,
Parminder Kaur, Managing Director, RegPak BioPharma, Consulting, (Netherlands),
Ramesh Jagannathan, Director-Clinical Research, AstraZeneca,
Deepti Sanghavi, Medical Advisor- Clinical Research, Wockhardt Limited,
Arun Bhatt, President, Clininvent Research,
Milind Antani, Head-Pharma LifeSciences group, Nishith Desai, Associates,
Sanjay Zodpey, Director, Indian Institute of Public Health,
S.K.Bhattacharya, Medical Officer, Depart of Communicable Diseases, WHO (World Health Organisation),
Shailesh Mehta, Director Clinical R&D and Med Affairs, South Asia, Glaxosmithkline,
Roopa Basrur, Associate Director - Clinical Writing and Document, Quality, Pfizer,
Yamin ’Mo’ Khan, Executive Vice President, Clinical Development Pharma-Olam (U.K),
Marcus Hompesch, President – CEO, Clinical Research, (USA),
Larisa Nagra Singh, General Manager and Project Director, Voisin Consulting Life Science,
Darshan Bhatt, Consultant, Patient Safety and Pharmacovigilance,
Mala Srivastava, Partner, Nextvel Consulting,
R Ezhil Arasan, Managing Director, VRE Research Laboratories,
(Former Head of Medical Affairs & Differentiated Products, Development at Dr.Reddy's)
Key Themes Discussed at this conference:
*
Current trends of clinical trials environment.
*
How can you take advantage of the global market for clinical trials?
*
Discovering technologies and strategies for successful clinical trial management.
*
Analyzing the successes and challenges of Phase I and Phase II clinical trials.
*
Setting up clinical trial research hub & techniques for applying risk management principles.
*
Discover how to improve your supplier-client relationships.
*
Complete trials on schedule & budget by overcoming hurdles in investigator/patient recruitment.
*
Avoiding potential pitfalls of trials agreement.
*
Gather the latest regulatory updates impacting global and Indian clinical development.
*
Explore innovative strategies for outsourcing, what should you be looking for in a CRO?
*
Improving and optimizing site management and overall productivity of clinical operations.
*
Data management, CMC SCM, operational requirements & CRO infrastructure in India & South Asia.
*
Optimising clinical trials operation effectiveness and ROI through strategic site, patient, data and risk management in the regulated markets.
*
What are the issues with off-shoring trials to countries such as India & South Asia? – Solutions?
*
Working with limited budget to ensure on time study completion.
*
Motivating and managing clinical project teams to improve timeline and progress.
*
Exploring the efficacy and safety of new interventions in clinical trials.
*
Drawing and retaining clinical talent pool to minimise turnover in clinical studies.
*
Next generation of clinical trials – How big will the market be?
Who Should Attend:
*
Vice Presidents,
*
Directors Heads & Managers of: Clinical Research & Development,
*
Clinical Research Services,
*
Clinical Operations,
*
Clinical Data Management,
*
Clinical IT,
*
Clinical Trials,
*
Medical Affairs, Regulatory Affairs,
*
Compliance,
*
Quality Control/Assurance/GCP,
*
Clinical Study Design,
*
Safety Surveillance,
*
Subject Recruitment,
*
E-Clinical Systems.
Target Audience - Industry:
*
Pharmaceutical Organisations,
*
Generic pharmaceutical companies,
*
Contract Research Organisations ,
*
Patient Recruitment Companies,
*
Government- Department of Health,
*
Non-profit Organisations/Association,
*
Academics, Consultants.
Why should you attend:
Clinical Trials Asia Summit 2010 - "Improving clinical practice & trial success rates with improved technologies, strategies & alliance management"
Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking drinks time meet the leading international vendors. showcasing the technology of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and technologies in the high-level conference.
DAY 1
19th August 2010,
08:30 – Coffee and registration.
09:30 – Chair's opening remarks.
09:40 – Examining the evolution of clinical trials.
*
Where does India stand in the current global clinical trials market?
*
How can you take advantage of the global market for clinical trials?
*
Identify the significance of the clinical trial in India and South Asia market
*
Emerging technologies that can be deployed to generate revenue.
*
Allied services - Data Management & IT services – Can they play significant role in outsourcing clinical trials?
10:20 Changing concept of conducting clinical trials.
*
Challenges in conduct of investigator initiated research.
*
Biomarkers and newer endpoints in oncology.
*
Structure of existing system for training and monitoring staff performance.
*
What are the common problems of staff monitoring and effective solutions to minimise cost for your trials.
*
Challenges in conducting medical device trials.
11:00 – Morning coffee & Discussion.
11:20 – “Factors limiting acceptability of foreign clinical data: EMEA perspective”
Parminder Kaur, Managing Director, RegPak BioPharma Consulting, (Netherlands).
12:00 – Panel Discussion: Evaluating key emerging markets for improved strategy.
*
Which emerging markets are hottest today?
*
Offshoring - Balancing the right opportunities and risks.
*
What makes each market unique and how do markets compare?
*
Successful budget development & analysis - How do sponsors develop study budgets? How do sites price their services?
*
How to go about tracking & collecting payments properly?
Moderator –
Shashidhar Rao, India Operations Head (IID and IA&R), Novartis.
Panelists –
*
Arun Bhatt, President, Clininvent Research,
*
Parminder Kaur, Managing Director, RegPak BioPharma Consulting, (Netherlands),
*
Deepti Sanghavi, Medical Advisor- Clinical Research, Wockhardt Limited,
*
Ramesh Jagannathan, Director-Clinical Research, AstraZeneca,
12:40 – Networking lunch.
14:00 – Impact of advanced technology in today's clinical trials.
*
Enable more reliable, smaller, faster, safer trials.
*
Benefits of Information Technology in clinical trials - (EDC), (CTMS), (CDMS), (DBMS).
*
Overcoming issues related with managing security, confidentiality and ethical concerns.
14:40 – Relationships: Sponsor – Site - CRO.
*
Three-way relationship between sponsors, sites and CROs realistic expectations, clear communications, shared understandings,
practical policies, and efficient problem resolution.
*
Identifying the anticipated advantages of a collaborative clinical trial alliance for greater efficiency and cost reduction.
*
Developing programs for successful partnership.
*
Quantitative analysis reveals rapid changes in the industry and trends for the future. How can sponsors, sites and CROs meet the challenges?
Arun Bhatt, President, Clininvent Research.
15:20 – Afternoon tea.
15:40 – Panel Discussion: Overcoming regulatory challenges in Asian clinical trials.
*
Introducing recent developments in regulatory affairs and legal challenges for clinical trials.
*
Understanding how Indian companies can work in harmony with the European legal framework.
*
Analysing the current scope and strategies of pharmaceutical / biopharmaceutical regulatory harmonization
*
Government incentives for Clinical Research in India.
*
Quality standards in clinical trials.
Moderator –
Milind Antani, Head-Pharma LifeSciences group, Nishith Desai Associates.
Panelists –
Sanjay Zodpey, Director, Indian Institute of Public Health,
16:20 – Safety data Management.
Darshan Bhatt, Consultant, Patient Safety and Pharmacovigilance,
17:00 - Start-up teams to manage clinical trials: Advantages and Limitations.
*
Structure and set-up of an effective start-up team.
*
Communication channels between start-up team, operations and Investigator sites.
*
Advantages and Limitations of managing projects under above structure.
Larisa Nagra Singh, General Manager and Project Director, Voisin Consulting Life Science,
17:30 - Logistics as a facilitator of growth in the pharma industry.
*
What are the current logistics challenges in pharma industry?
*
What are the recent applications of technology to aid the Clinical SCM?
*
Secure strategies – for maintaining your materials during transits.
*
Efficiency of a potential logistics – transforming the pharma sector.
18:00 - Chairperson's closing remarks and end of conference.
18:10 - Networking Drinks - Take your discussions further & build new relationships in a relaxed & informal setting...
DAY 2
20 th August 2010
08:30 – Coffee and registration.
09:30 – Chair's opening remarks.
R Ezhil Arasan, Managing Director, VRE Research Laboratories.
(Former Head of Medical Affairs & Differentiated Products Development at Dr.Reddy's)
09:40 – Opportunity trials of Clinical Research in India: Focusing on Phase I and Phase II
*
Reviewing the phase I and II clinical research environment in India.
*
Focus on related business models in conducting clinical trials in India.
*
Evaluating the opportunities of potential collaborations.
Deven Parmar Vice President - Clinical Research & Pharmacovigilance, Wockhardt,
10:20: Clinical Data Management (CDM) – Guidelines for a successful future.
Safety data management.
*
Good data review and validation practices.
*
Challenges! In medical coding.
*
Consideration in database designing & edit check programming.
*
Good programming practices and where can one go wrong in query management?
*
Developing protocols that generate useful data, practical for sites to implement, acceptable to subjects, and work internationally.
11:00 – Morning coffee & discussion.
11:20 – Innovative designing of clinical trials.
Akhilesh Sharma, Vice President & Global head Clinical management & Global Pharmacovigilance, Dr. Reddy's,
12:00 – Panel Discussion: Sourcing the right partners, Sponsor – Vendor partnerships.
*
How to work with your sponsor for a profitable study.
*
What do CRO look for in a good sponsor?
*
Analysing India's offering in large scale global trials: cost, resources, patient pool.
*
Avoiding mistakes in selecting an outsourcing partner to conduct clinical trials.
*
Quantitative analysis reveals rapid changes in the industry and trends for the future. How can sponsors, sites and CROs meet the challenges?
Moderator –
Shashidhar Rao, India Operations Head (IID and IA&R), Novartis.
Panelists –
Mohan Banglore, Senior Director & Site Head, Pfizer,
Marcus Hompesch, President – CEO, Profile Institute - Clinical Research, (USA),
Yamin 'Mo' Khan, Executive Vice President, Clinical Development, Pharm-Olam (UK),
Mala Srivastava, Partner, Nextvel Consulting,
12:40 – Networking lunch.
14:00 – Challenges of conducting Phase III cancer trails in India.
Bakulesh Khamar, Executive Director – Research, Cadila,
14:40 – Conducting large-scale community trials.
S.K.Bhattacharya, Medical Officer, Depart of Communicable Diseases, WHO (World Health Organisation).
15:20 – Afternoon tea.
15:40 – Exploring the efficacy and safety of new interventions in clinical trials.
Shailesh Mehta, Director Clinical R&D and Med Affairs, South Asia, Glaxosmithkline.
16:20 - Setting up a medical writing unit in India.
*
Outsourcing medical writing to India – a novel business model.
*
What factors are important at start-up and later on?
*
Measuring success in a subjective domain – metrics.
*
Challenges and solutions.
Roopa Basrur, Associate Director - Clinical Writing and Document Quality, Pfizer.
17:00 – Panel Discussion – SWOT analysis - Strength, Weakness, Opportunities & Threats of Clinical Trials in India (Overall review of this Clinical Trials Asia Summit 2010 conference).
*
Identifying market potential strengths and weakness.
*
Benefits of India - reducing costs, accelerating time to market?
*
Analysing India's offering in large scale global trials: cost, resources, patient pool.
*
Avoiding mistakes in selecting an outsourcing partner to conduct clinical trials.
Moderator:
Panellists:
Thuppil Venkatesh, Prof. St.John's Medical College & Principal Advisor, Quality Council of India,
17:30 Chairperson's closing remarks and end of conference.
Book Now:
1 Day Conference............Fee INR. 8824.00
2 Day Conference............Fee INR. 11030.00
For more information visit
http://www.bharatbook.com/detail.asp?id=104776&rt=Conference-on-Clinical-Trials-Asia-Summit-2010.html
OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Follow us on twitter: http://twitter.com/3bbharatbook
Please visit our blog at http://bharatbookseo.blogsome.com
CTAS 2010 will examine the current issues faced in clinical trials operations, addressing the risks, timeline and budget stipulations, while effectively tackling key challenges in overcoming trials agreement and site contract arbitration problems. This summit will discuss the operational element of trial site management, strategic partnership with CROs and SMOs, patient, talent & investigators management in order to improve & optimise the overall drug development effectiveness and ROI. Discover on how to implement and benefit from electronic data management & monitoring cost effectively. This conference will be shared by leading industrial practitioners across the region to promote practical discussions; especially on the know-how to manage needs, variability of different countries and institutions to enhance clinical operational excellence and vigilance. Attendees will have the chance to learn, network and benchmark against the global top pharmas and local industry leaders on the best practices in talent, site, budget and performance management in clinical trials. The conference aims to provide a detailed analysis of what it takes to conduct clinical trials from a biopharmaceuticals and vaccines perspective in India and China and also addressing risk/benefit balance, anecdotal experiences of the multinational pharmaceutical industry in India and China, selection and role of CROs, logistics of operations, clinical trials management, government policies and pharmacovigilance.
CTAS 2010 will provide you with the data that you need to recognize this complex and rapidly-expanding sector. Knowing the future market, and what impact will that have on future business opportunities? This is your opportunity to stay ahead by learning the latest trends and networking with the trend setters. It gives us immense pleasure in welcoming you to the Clinical Trials Asia Summit '2010.
Key Speakers Include:
Akhilesh Sharma, Vice President & Global head Clinical management & Global Pharmacovigilance, Dr. Reddy’s,
Bakulesh Khamar, Executive Director – Research Cadila,
Deven Parmar Vice President - Clinical Research & Pharmacovigilance, Wockhardt,
Shashidhar Rao, India Operations Head (IID and IA&R), Novartis,
Mohan Bangalore, Senior Director & Site Head, Pfizer,
Parminder Kaur, Managing Director, RegPak BioPharma, Consulting, (Netherlands),
Ramesh Jagannathan, Director-Clinical Research, AstraZeneca,
Deepti Sanghavi, Medical Advisor- Clinical Research, Wockhardt Limited,
Arun Bhatt, President, Clininvent Research,
Milind Antani, Head-Pharma LifeSciences group, Nishith Desai, Associates,
Sanjay Zodpey, Director, Indian Institute of Public Health,
S.K.Bhattacharya, Medical Officer, Depart of Communicable Diseases, WHO (World Health Organisation),
Shailesh Mehta, Director Clinical R&D and Med Affairs, South Asia, Glaxosmithkline,
Roopa Basrur, Associate Director - Clinical Writing and Document, Quality, Pfizer,
Yamin ’Mo’ Khan, Executive Vice President, Clinical Development Pharma-Olam (U.K),
Marcus Hompesch, President – CEO, Clinical Research, (USA),
Larisa Nagra Singh, General Manager and Project Director, Voisin Consulting Life Science,
Darshan Bhatt, Consultant, Patient Safety and Pharmacovigilance,
Mala Srivastava, Partner, Nextvel Consulting,
R Ezhil Arasan, Managing Director, VRE Research Laboratories,
(Former Head of Medical Affairs & Differentiated Products, Development at Dr.Reddy's)
Key Themes Discussed at this conference:
*
Current trends of clinical trials environment.
*
How can you take advantage of the global market for clinical trials?
*
Discovering technologies and strategies for successful clinical trial management.
*
Analyzing the successes and challenges of Phase I and Phase II clinical trials.
*
Setting up clinical trial research hub & techniques for applying risk management principles.
*
Discover how to improve your supplier-client relationships.
*
Complete trials on schedule & budget by overcoming hurdles in investigator/patient recruitment.
*
Avoiding potential pitfalls of trials agreement.
*
Gather the latest regulatory updates impacting global and Indian clinical development.
*
Explore innovative strategies for outsourcing, what should you be looking for in a CRO?
*
Improving and optimizing site management and overall productivity of clinical operations.
*
Data management, CMC SCM, operational requirements & CRO infrastructure in India & South Asia.
*
Optimising clinical trials operation effectiveness and ROI through strategic site, patient, data and risk management in the regulated markets.
*
What are the issues with off-shoring trials to countries such as India & South Asia? – Solutions?
*
Working with limited budget to ensure on time study completion.
*
Motivating and managing clinical project teams to improve timeline and progress.
*
Exploring the efficacy and safety of new interventions in clinical trials.
*
Drawing and retaining clinical talent pool to minimise turnover in clinical studies.
*
Next generation of clinical trials – How big will the market be?
Who Should Attend:
*
Vice Presidents,
*
Directors Heads & Managers of: Clinical Research & Development,
*
Clinical Research Services,
*
Clinical Operations,
*
Clinical Data Management,
*
Clinical IT,
*
Clinical Trials,
*
Medical Affairs, Regulatory Affairs,
*
Compliance,
*
Quality Control/Assurance/GCP,
*
Clinical Study Design,
*
Safety Surveillance,
*
Subject Recruitment,
*
E-Clinical Systems.
Target Audience - Industry:
*
Pharmaceutical Organisations,
*
Generic pharmaceutical companies,
*
Contract Research Organisations ,
*
Patient Recruitment Companies,
*
Government- Department of Health,
*
Non-profit Organisations/Association,
*
Academics, Consultants.
Why should you attend:
Clinical Trials Asia Summit 2010 - "Improving clinical practice & trial success rates with improved technologies, strategies & alliance management"
Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking drinks time meet the leading international vendors. showcasing the technology of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and technologies in the high-level conference.
DAY 1
19th August 2010,
08:30 – Coffee and registration.
09:30 – Chair's opening remarks.
09:40 – Examining the evolution of clinical trials.
*
Where does India stand in the current global clinical trials market?
*
How can you take advantage of the global market for clinical trials?
*
Identify the significance of the clinical trial in India and South Asia market
*
Emerging technologies that can be deployed to generate revenue.
*
Allied services - Data Management & IT services – Can they play significant role in outsourcing clinical trials?
10:20 Changing concept of conducting clinical trials.
*
Challenges in conduct of investigator initiated research.
*
Biomarkers and newer endpoints in oncology.
*
Structure of existing system for training and monitoring staff performance.
*
What are the common problems of staff monitoring and effective solutions to minimise cost for your trials.
*
Challenges in conducting medical device trials.
11:00 – Morning coffee & Discussion.
11:20 – “Factors limiting acceptability of foreign clinical data: EMEA perspective”
Parminder Kaur, Managing Director, RegPak BioPharma Consulting, (Netherlands).
12:00 – Panel Discussion: Evaluating key emerging markets for improved strategy.
*
Which emerging markets are hottest today?
*
Offshoring - Balancing the right opportunities and risks.
*
What makes each market unique and how do markets compare?
*
Successful budget development & analysis - How do sponsors develop study budgets? How do sites price their services?
*
How to go about tracking & collecting payments properly?
Moderator –
Shashidhar Rao, India Operations Head (IID and IA&R), Novartis.
Panelists –
*
Arun Bhatt, President, Clininvent Research,
*
Parminder Kaur, Managing Director, RegPak BioPharma Consulting, (Netherlands),
*
Deepti Sanghavi, Medical Advisor- Clinical Research, Wockhardt Limited,
*
Ramesh Jagannathan, Director-Clinical Research, AstraZeneca,
12:40 – Networking lunch.
14:00 – Impact of advanced technology in today's clinical trials.
*
Enable more reliable, smaller, faster, safer trials.
*
Benefits of Information Technology in clinical trials - (EDC), (CTMS), (CDMS), (DBMS).
*
Overcoming issues related with managing security, confidentiality and ethical concerns.
14:40 – Relationships: Sponsor – Site - CRO.
*
Three-way relationship between sponsors, sites and CROs realistic expectations, clear communications, shared understandings,
practical policies, and efficient problem resolution.
*
Identifying the anticipated advantages of a collaborative clinical trial alliance for greater efficiency and cost reduction.
*
Developing programs for successful partnership.
*
Quantitative analysis reveals rapid changes in the industry and trends for the future. How can sponsors, sites and CROs meet the challenges?
Arun Bhatt, President, Clininvent Research.
15:20 – Afternoon tea.
15:40 – Panel Discussion: Overcoming regulatory challenges in Asian clinical trials.
*
Introducing recent developments in regulatory affairs and legal challenges for clinical trials.
*
Understanding how Indian companies can work in harmony with the European legal framework.
*
Analysing the current scope and strategies of pharmaceutical / biopharmaceutical regulatory harmonization
*
Government incentives for Clinical Research in India.
*
Quality standards in clinical trials.
Moderator –
Milind Antani, Head-Pharma LifeSciences group, Nishith Desai Associates.
Panelists –
Sanjay Zodpey, Director, Indian Institute of Public Health,
16:20 – Safety data Management.
Darshan Bhatt, Consultant, Patient Safety and Pharmacovigilance,
17:00 - Start-up teams to manage clinical trials: Advantages and Limitations.
*
Structure and set-up of an effective start-up team.
*
Communication channels between start-up team, operations and Investigator sites.
*
Advantages and Limitations of managing projects under above structure.
Larisa Nagra Singh, General Manager and Project Director, Voisin Consulting Life Science,
17:30 - Logistics as a facilitator of growth in the pharma industry.
*
What are the current logistics challenges in pharma industry?
*
What are the recent applications of technology to aid the Clinical SCM?
*
Secure strategies – for maintaining your materials during transits.
*
Efficiency of a potential logistics – transforming the pharma sector.
18:00 - Chairperson's closing remarks and end of conference.
18:10 - Networking Drinks - Take your discussions further & build new relationships in a relaxed & informal setting...
DAY 2
20 th August 2010
08:30 – Coffee and registration.
09:30 – Chair's opening remarks.
R Ezhil Arasan, Managing Director, VRE Research Laboratories.
(Former Head of Medical Affairs & Differentiated Products Development at Dr.Reddy's)
09:40 – Opportunity trials of Clinical Research in India: Focusing on Phase I and Phase II
*
Reviewing the phase I and II clinical research environment in India.
*
Focus on related business models in conducting clinical trials in India.
*
Evaluating the opportunities of potential collaborations.
Deven Parmar Vice President - Clinical Research & Pharmacovigilance, Wockhardt,
10:20: Clinical Data Management (CDM) – Guidelines for a successful future.
Safety data management.
*
Good data review and validation practices.
*
Challenges! In medical coding.
*
Consideration in database designing & edit check programming.
*
Good programming practices and where can one go wrong in query management?
*
Developing protocols that generate useful data, practical for sites to implement, acceptable to subjects, and work internationally.
11:00 – Morning coffee & discussion.
11:20 – Innovative designing of clinical trials.
Akhilesh Sharma, Vice President & Global head Clinical management & Global Pharmacovigilance, Dr. Reddy's,
12:00 – Panel Discussion: Sourcing the right partners, Sponsor – Vendor partnerships.
*
How to work with your sponsor for a profitable study.
*
What do CRO look for in a good sponsor?
*
Analysing India's offering in large scale global trials: cost, resources, patient pool.
*
Avoiding mistakes in selecting an outsourcing partner to conduct clinical trials.
*
Quantitative analysis reveals rapid changes in the industry and trends for the future. How can sponsors, sites and CROs meet the challenges?
Moderator –
Shashidhar Rao, India Operations Head (IID and IA&R), Novartis.
Panelists –
Mohan Banglore, Senior Director & Site Head, Pfizer,
Marcus Hompesch, President – CEO, Profile Institute - Clinical Research, (USA),
Yamin 'Mo' Khan, Executive Vice President, Clinical Development, Pharm-Olam (UK),
Mala Srivastava, Partner, Nextvel Consulting,
12:40 – Networking lunch.
14:00 – Challenges of conducting Phase III cancer trails in India.
Bakulesh Khamar, Executive Director – Research, Cadila,
14:40 – Conducting large-scale community trials.
S.K.Bhattacharya, Medical Officer, Depart of Communicable Diseases, WHO (World Health Organisation).
15:20 – Afternoon tea.
15:40 – Exploring the efficacy and safety of new interventions in clinical trials.
Shailesh Mehta, Director Clinical R&D and Med Affairs, South Asia, Glaxosmithkline.
16:20 - Setting up a medical writing unit in India.
*
Outsourcing medical writing to India – a novel business model.
*
What factors are important at start-up and later on?
*
Measuring success in a subjective domain – metrics.
*
Challenges and solutions.
Roopa Basrur, Associate Director - Clinical Writing and Document Quality, Pfizer.
17:00 – Panel Discussion – SWOT analysis - Strength, Weakness, Opportunities & Threats of Clinical Trials in India (Overall review of this Clinical Trials Asia Summit 2010 conference).
*
Identifying market potential strengths and weakness.
*
Benefits of India - reducing costs, accelerating time to market?
*
Analysing India's offering in large scale global trials: cost, resources, patient pool.
*
Avoiding mistakes in selecting an outsourcing partner to conduct clinical trials.
Moderator:
Panellists:
Thuppil Venkatesh, Prof. St.John's Medical College & Principal Advisor, Quality Council of India,
17:30 Chairperson's closing remarks and end of conference.
Book Now:
1 Day Conference............Fee INR. 8824.00
2 Day Conference............Fee INR. 11030.00
For more information visit
http://www.bharatbook.com/detail.asp?id=104776&rt=Conference-on-Clinical-Trials-Asia-Summit-2010.html
OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Follow us on twitter: http://twitter.com/3bbharatbook
Please visit our blog at http://bharatbookseo.blogsome.com
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