In this webinar, Pooja Jain, our solution expert, showed us how you may first use Embase to track and identify adverse events and move into PharmaPendium to drill down to important information such as looking for evidence of this adverse event in approval stage to mitigate risk moving forward.
Industry Cloud Rising - 2014 Industry Cloud Forum KeynoteEmergence Capital
This document discusses the rise of industry cloud solutions. It notes that enterprise software is moving to the cloud, and that vertical, industry-specific cloud solutions (industry cloud) represent the next major opportunity. Industry cloud solutions offer integrated, true insights because they allow for true, multi-tenant software across multiple platforms with little customization required. The document outlines five hallmarks of successful industry cloud companies and provides examples of Emergence Capital's industry cloud investments to date across various sectors such as healthcare, education, and energy.
Integrating Siebel CTMS with Medidata Rave and Veeva VaultPerficient, Inc.
Alliance Foundation Trials (AFT), a research organization that develops and conducts cancer clinical trials, selected Perficient’s Siebel Clinical accelerator, ASCEND, as its clinical trial management system (CTMS). Since the initial implementation they have added integrations with Medidata Rave, a unified electronic data capture (EDC) and clinical data management system (CDMS), and Veeva Vault eTMF, an electronic trial master file system.
Why did AFT choose ASCEND? Why did they prioritize the integration with Rave? What challenges led them to integrate with Veeva? How useful are the integrations proving to be? What are their future plans for their CTMS?
Param Singh, director of clinical operations solutions at Perficient, hosted a one-hour “fireside chat” with Jennifer Gaskin, operations director at AFT, in which Param asked all of these questions, and more.
DigiPharm Europe 2010: Reportable Adverse Events on the World Wide WebCREATION
At DigiPharm Europe 2010 Conference in London on 29 September, Paul Grant and Daniel Ghinn presented the highlights of a global study into reportable adverse events found online by therapeutic area, brand and territory.
The research was one of the most extensive studies of its kind ever conducted, and was carried out by nine of Creation Healthcare's international team of consultants based in seven countries.
The DigiPharm session included some interesting dialogue with conference participants, who shared their own experiences of adverse events monitoring.
The session concluded with a challenge to pharmaceutical professionals in marketing, communications and pharmacovigilence to collaborate, using these insights to develop appropriate strategies in their own companies.
Reporting and monitoring adverse events with cancer treatment [final]Rosalynn Pangan
This document discusses reporting and monitoring of adverse events from cancer treatment. It begins with objectives of understanding adverse drug events, their importance, common events from cancer treatment, and FDA reporting processes. It then presents a case study of a patient who developed erythema and burning sensations on her hands and heels after her fifth chemotherapy session. Various topics are covered like defining adverse events, reactions, and serious reactions. Common adverse effects of chemotherapy like alopecia, nausea, and peripheral neuropathy are discussed. The importance of monitoring and reporting adverse events is emphasized to improve patient safety.
Industry Cloud Forum 2015 - Emergence Capital KeynoteEmergence Capital
Gordon Ritter, co-founder and General Partner at Emergence Capital shares insights about how vertically-focused enterprise cloud companies are gaining ground. He highlights the two types of industry cloud companies: Enablers & Disruptors, and shares 10 questions to determine if you are an industry cloud leader.
Chemotherapy can cause mucositis, inflammation of the mucous membranes throughout the body. Oral mucositis specifically causes sores and ulcers in the mouth. It is a common side effect, affecting 40% of patients on standard chemotherapy and up to 80% of patients receiving radiation or stem cell transplants. Mucositis causes pain and difficulty eating or drinking, and can lead to hospitalization or dose reductions. Nurses monitor for mucositis and teach oral care techniques to prevent infections and promote healing. Physicians assess mucositis severity and may adjust chemotherapy doses accordingly.
(MBL311) Workshop: Build an Android App Using AWS Mobile Services | AWS re:In...Amazon Web Services
Learn how to build a powerful Android app that leverages a variety of AWS services. In this three-hour, demo-heavy workshop, we show how you can build a modern native client app using the AWS Mobile SDK that uses a number of cross-platform mobile cloud services directly with minimal code on the client. We share best practices for building a highly scalable backend so you can add your own functionality. This is a step-by-step journey where you configure and add components to your architecture, then modify and test your components inside a mobile location-based messaging application. In the end, you will have a mobile application with your own backend consisting of different AWS services including: Amazon Cognito, Amazon Mobile Analytics, Amazon SNS Push Notification, Amazon S3, Amazon CloudFront, Amazon CloudSearch, Amazon DynamoDB, Amazon SQS, and AWS Elastic Beanstalk.
Industry Cloud Rising - 2014 Industry Cloud Forum KeynoteEmergence Capital
This document discusses the rise of industry cloud solutions. It notes that enterprise software is moving to the cloud, and that vertical, industry-specific cloud solutions (industry cloud) represent the next major opportunity. Industry cloud solutions offer integrated, true insights because they allow for true, multi-tenant software across multiple platforms with little customization required. The document outlines five hallmarks of successful industry cloud companies and provides examples of Emergence Capital's industry cloud investments to date across various sectors such as healthcare, education, and energy.
Integrating Siebel CTMS with Medidata Rave and Veeva VaultPerficient, Inc.
Alliance Foundation Trials (AFT), a research organization that develops and conducts cancer clinical trials, selected Perficient’s Siebel Clinical accelerator, ASCEND, as its clinical trial management system (CTMS). Since the initial implementation they have added integrations with Medidata Rave, a unified electronic data capture (EDC) and clinical data management system (CDMS), and Veeva Vault eTMF, an electronic trial master file system.
Why did AFT choose ASCEND? Why did they prioritize the integration with Rave? What challenges led them to integrate with Veeva? How useful are the integrations proving to be? What are their future plans for their CTMS?
Param Singh, director of clinical operations solutions at Perficient, hosted a one-hour “fireside chat” with Jennifer Gaskin, operations director at AFT, in which Param asked all of these questions, and more.
DigiPharm Europe 2010: Reportable Adverse Events on the World Wide WebCREATION
At DigiPharm Europe 2010 Conference in London on 29 September, Paul Grant and Daniel Ghinn presented the highlights of a global study into reportable adverse events found online by therapeutic area, brand and territory.
The research was one of the most extensive studies of its kind ever conducted, and was carried out by nine of Creation Healthcare's international team of consultants based in seven countries.
The DigiPharm session included some interesting dialogue with conference participants, who shared their own experiences of adverse events monitoring.
The session concluded with a challenge to pharmaceutical professionals in marketing, communications and pharmacovigilence to collaborate, using these insights to develop appropriate strategies in their own companies.
Reporting and monitoring adverse events with cancer treatment [final]Rosalynn Pangan
This document discusses reporting and monitoring of adverse events from cancer treatment. It begins with objectives of understanding adverse drug events, their importance, common events from cancer treatment, and FDA reporting processes. It then presents a case study of a patient who developed erythema and burning sensations on her hands and heels after her fifth chemotherapy session. Various topics are covered like defining adverse events, reactions, and serious reactions. Common adverse effects of chemotherapy like alopecia, nausea, and peripheral neuropathy are discussed. The importance of monitoring and reporting adverse events is emphasized to improve patient safety.
Industry Cloud Forum 2015 - Emergence Capital KeynoteEmergence Capital
Gordon Ritter, co-founder and General Partner at Emergence Capital shares insights about how vertically-focused enterprise cloud companies are gaining ground. He highlights the two types of industry cloud companies: Enablers & Disruptors, and shares 10 questions to determine if you are an industry cloud leader.
Chemotherapy can cause mucositis, inflammation of the mucous membranes throughout the body. Oral mucositis specifically causes sores and ulcers in the mouth. It is a common side effect, affecting 40% of patients on standard chemotherapy and up to 80% of patients receiving radiation or stem cell transplants. Mucositis causes pain and difficulty eating or drinking, and can lead to hospitalization or dose reductions. Nurses monitor for mucositis and teach oral care techniques to prevent infections and promote healing. Physicians assess mucositis severity and may adjust chemotherapy doses accordingly.
(MBL311) Workshop: Build an Android App Using AWS Mobile Services | AWS re:In...Amazon Web Services
Learn how to build a powerful Android app that leverages a variety of AWS services. In this three-hour, demo-heavy workshop, we show how you can build a modern native client app using the AWS Mobile SDK that uses a number of cross-platform mobile cloud services directly with minimal code on the client. We share best practices for building a highly scalable backend so you can add your own functionality. This is a step-by-step journey where you configure and add components to your architecture, then modify and test your components inside a mobile location-based messaging application. In the end, you will have a mobile application with your own backend consisting of different AWS services including: Amazon Cognito, Amazon Mobile Analytics, Amazon SNS Push Notification, Amazon S3, Amazon CloudFront, Amazon CloudSearch, Amazon DynamoDB, Amazon SQS, and AWS Elastic Beanstalk.
Challenges In Pharmacovigilance Dr Vishwas, by Dr. Vishwas Sovani MD ,VP P...Until ROI
The document discusses several challenges related to pharmacovigilance when the same drug is marketed by different sponsors, such as generic manufacturers. It notes issues around aggregate safety reporting, signal detection, and obtaining safety data from other companies. The document also proposes "Safety in a Capsule" as a software solution that could help address these challenges by providing a unified platform for adverse event reporting, signal detection, and analytics across multiple drug manufacturers.
Earlier when you required a custom feature in your Salesforce installation to support your business process, the only available options were to create a brand new app and integrate it in your Salesforce or to use existing features in a creative way to achieve the same objective. However Salesforce evolved and we now have got Salesforce Visual Flow, also known as Salesforce Visual Workflow or simply Salesforce Flow.
Visual flow can be summed up as an app inside the Salesforce app. Analogically, what methods are to object oriented programming, visual flow is to Salesforce. To be more precise, a Flow is a wizard or a set of screens in sequential order which can be used to complete a business process. This business process can be anything like filling out a form, or working on a script, or even filling out a survey. The Flow has the ability to fetch, edit, and create all Salesforce information in an appealing, quick and smart manner.
Difference between Salesforce.com Flow and Workflow
Salesforce Flow or Visual Workflow is often confused with a feature named Workflow in Salesforce and that’s forgivable! They may be similar in certain fashion such as assisting in automating a business process, but in essence they both are different. Here is how:
- Visual Workflow is more of a front-end based tool. It is mainly used when you have to display or collect information through screens making it more visible to the users. Workflow on the other hand execute pre-defined rules behind the scenes. They are used to process information rather than collecting it.
- While Workflows are mainly triggered by events, Visual Workflows are triggered by user actions. However in Visual Workflows, you can also Autolaunch Flows i.e. start a Flow without user interaction. Since they are triggered without user interactions you cannot include steps, choices, screens or dynamic choices in your Autolaunch Flow.
- Flows can fetch, delete, update or even create records on multiple objects but Workflows are defined to affect only a single specified object. The exception to this is the case of Workflows having to update fields on specified object’s related master records.
How to create and trigger Flow?
Flows can be used to execute a business logic, interact with Salesforce Databases, call defined Apex classes and guide user through screens. There are three main aspects of a Flow creation process:
- Designing
- Management
- Flow Runtime
You can create Flows and open Cloud Flow Designer by going through the following steps
Name-> Setup-> App Setup-> Create-> Workflow & Approvals-> Flows-> New Flow.
Once you have defined your Flow you can easily add it to any Visualforce page or you can add your Flow’s URL link to your Salesforce installation’s homepage.
You can create your Flow triggers by going through the same above process and instead of clicking Flow, click Flow Trigger.
The law of diminishing marginal utility states that as consumption of a good increases, the marginal utility from each additional unit decreases. Marginal utility refers to the additional satisfaction gained from consuming one more unit of a good. An example is provided of a thirsty man drinking glasses of water, where the utility declines with each additional glass. A table shows total utility and marginal utility decreasing as consumption increases from 1 to 6 glasses. The marginal utility curve slopes downward to illustrate this pattern of diminishing returns to scale. There are assumptions and exceptions to the law, and it has practical implications such as diversification of production and progressive taxation.
The document provides an overview of a seminar presentation on ordinal utility analysis and indifference curve approach. It includes 13 sections covering topics like the introduction to utility analysis, cardinal vs ordinal utility approaches, assumptions of ordinal utility analysis, meaning and properties of indifference curves, marginal rate of substitution, and principles of diminishing marginal rate of substitution. The presentation aims to explain key concepts of ordinal utility theory using indifference curve analysis.
This document discusses adverse drug reactions, including definitions, classifications, monitoring, documentation, and reporting. It defines an adverse drug reaction as an unintended response to a drug that occurs at normal doses. Adverse events are classified as serious if they result in death, hospitalization, disability, or required intervention. Adverse reactions are categorized as Type A or Type B. Monitoring involves identifying reactions, assessing causality using methods like the Naranjo algorithm, documenting in forms, and reporting serious reactions to authorities.
The document discusses Journey Builder for Apps, a Salesforce Marketing Cloud product. It provides an overview of the webinar on Journey Builder, including information about the presenters and a safe harbor statement. It then discusses how Journey Builder allows companies to bring the customer journey to life across different channels like email, mobile, and apps to engage customers and improve retention. A live demo of Journey Builder's capabilities is included on the webinar.
The document discusses trends in the mobile enterprise market in 2015. It finds that the number of mobile enterprise application companies has grown 20% in the last year to 313 companies. While this growth rate is modest, it is similar to the early days of software as a service. Industry-focused mobile apps now make up about a third of companies. Early mergers and acquisitions have centered on productivity apps. The number of mobile enterprise enabler companies has also grown, now totaling 220 companies focused on problems like user engagement and development efficiency. Funding of both mobile apps and enablers is accelerating, with several categories like productivity, payments, and analytics receiving significant investments.
The document discusses cardinal and ordinal utility analysis, the law of diminishing marginal utility, consumer surplus, and the Engel curve. It explains that cardinal utility can be measured while ordinal utility focuses on preference ranking. The law of diminishing marginal utility states that the satisfaction from additional units of a good declines as consumption increases. Consumer surplus is the difference between the most one would pay and the actual price paid, representing surplus satisfaction. The Engel curve shows how spending patterns change with different income levels.
You’ve heard the word “Salesforce” being thrown around by small and big enterprises, but you have no idea if your business needs it? If you’re running a business that’s growing just the way you want it to, you will probably need Salesforce CRM sooner than later. But first things first—learn what Salesforce CRM is, how it works and how you should use it to support your day to day operations.
Read the blog in detail
http://suyati.com/how-salesforce-crm-works-and-uses/
For any information on our Salesforce capabilities, email services@suyati.com.
http://suyati.com/
This document provides an introduction to Six Sigma, including an overview of what it is, why it's used, key concepts like defects per million opportunities (DPMO) at different sigma levels, and the DMAIC methodology involving define, measure, analyze, improve, and control phases. It also outlines some common Six Sigma tools and roles like Green Belts, Black Belts, Master Black Belts, Champions, and executive leadership. The goal of Six Sigma is to improve quality, reduce defects and variation in processes, and increase customer satisfaction.
(MBL305) You Have Data from the Devices, Now What?: Getting the Value of the IoTAmazon Web Services
We are collecting tons of sensor data from billions of devices. How do you get the value from your IoT data sources? In this session, we will explore different strategies for collecting and ingesting data, understanding its frequency, and leveraging the potential of the cloud to analyze and predict trends and behavior to get most out of your deployed devices.
Six sigma is a statistical approach to process improvement that aims to reduce defects. It was developed by Motorola in the 1970s to improve quality. The six sigma method includes phases such as Define, Measure, Analyze, Improve, and Control to identify and remove defects in processes. It uses statistical tools and follows a DMAIC or DMADV model. While six sigma aims to improve processes and reduce defects, some critics argue it is more focused on appraisal than prevention and does not always yield quality improvements.
The document provides an overview of Six Sigma, including:
1) It defines Six Sigma as a methodology for continuous improvement and creating high quality products and processes using statistical tools.
2) It discusses the origins and growth of Six Sigma at Motorola and GE in the 1980s-1990s.
3) It describes the DMAIC methodology used for process improvement projects and the roles of Master Black Belts, Black Belts, and Green Belts in a Six Sigma organization.
A Planner's Playbook - Everything I learned about planning at Miami Ad School...Sytse Kooistra
After being in advertising for 4 years, I needed some new guidance and inspiration as a strategist. And that is exactly what I found: I spent the summer of 2013 with 17 other (soon to be) planners from all over the world attending the Account Planning Bootcamp at Miami Ad School New York.
Thanks to the 38 industry heroes and instructors that shared their knowledge and coached us in those 3 months, I learned more than I ever could imagine about planning.
'A Planner's Playbook' is my attempt to summarize all that wisdom in 30 short nuggets (or plays, to stick with the metaphor of a playbook) and share it with you. I left out all the difficult frameworks and models and kept in simple by just stating, in my opinion (and in that of my instructors), what a planner should be and do.
Enjoy reading.
This module is intended to introduce the students of biotechnology to obtain an overview of the pharmaceutical industry. The concept of clinical trials is discussed in brief.
Visit : www.acriindia.com
ACRI is a leading pharmacovigilance training Institute in Bangalore.
ACRI creates a value add for every degree. Our PG course is diploma in clinical research and PG diploma in pharmavigilance are approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
This document summarizes the history and scientific processes of Pharmanex, a company that develops nutritional supplements. It describes how Pharmanex was founded by former pharmaceutical executives to bring scientific standards to the supplement industry. Pharmanex employs over 125 scientists and conducts extensive research to select, source, standardize and test botanical ingredients in its products. Clinical studies have shown that Pharmanex's signature product, LifePak, is effective at significantly increasing antioxidant levels in the body.
This document provides an overview of evidence-based medicine (EBM). It defines EBM as integrating the best research evidence with clinical expertise and patient values. The history and obstacles of EBM are discussed. The document outlines how to practice EBM using the 5 A's framework: Ask, Acquire, Appraise, Apply, and Assess. A case example is provided to demonstrate how to formulate a focused clinical question using the PICO format.
Do Antidepressants Cause Birth Defects?lawsuitlegal
Are SSRI antidepressant medications causing congenital birth defects? See the latest research for and against a causal link.
A recent FDA advisory warned consumers that reports of adverse condition risks for PPHN (persistent pulmonary hypertension of the newborn) and heart and lung conditions in newborn babies was based on a single study which subsequent research has made inconclusive. Still, birth defect attorneys across the nation are investigating injury claims from families across the nation whose babies were exposed to SSRI medications in utero and suffered complications.
SSRI birth defect allegations include a number of congenital problems ranging from heart defects, cranial malformations, spina bifida and other conditions, just to name a few. The following attempts to lay out the research, both for and against and provides our opinion on the matter as well as what can be done if your baby was diagnosed with a congenital defect.
If you have a potential SSRI lawsuit and would like more information about your legal options, visit our website and share what happened to speak with a leading birth defect attorney about your rights and legal options today.
Challenges In Pharmacovigilance Dr Vishwas, by Dr. Vishwas Sovani MD ,VP P...Until ROI
The document discusses several challenges related to pharmacovigilance when the same drug is marketed by different sponsors, such as generic manufacturers. It notes issues around aggregate safety reporting, signal detection, and obtaining safety data from other companies. The document also proposes "Safety in a Capsule" as a software solution that could help address these challenges by providing a unified platform for adverse event reporting, signal detection, and analytics across multiple drug manufacturers.
Earlier when you required a custom feature in your Salesforce installation to support your business process, the only available options were to create a brand new app and integrate it in your Salesforce or to use existing features in a creative way to achieve the same objective. However Salesforce evolved and we now have got Salesforce Visual Flow, also known as Salesforce Visual Workflow or simply Salesforce Flow.
Visual flow can be summed up as an app inside the Salesforce app. Analogically, what methods are to object oriented programming, visual flow is to Salesforce. To be more precise, a Flow is a wizard or a set of screens in sequential order which can be used to complete a business process. This business process can be anything like filling out a form, or working on a script, or even filling out a survey. The Flow has the ability to fetch, edit, and create all Salesforce information in an appealing, quick and smart manner.
Difference between Salesforce.com Flow and Workflow
Salesforce Flow or Visual Workflow is often confused with a feature named Workflow in Salesforce and that’s forgivable! They may be similar in certain fashion such as assisting in automating a business process, but in essence they both are different. Here is how:
- Visual Workflow is more of a front-end based tool. It is mainly used when you have to display or collect information through screens making it more visible to the users. Workflow on the other hand execute pre-defined rules behind the scenes. They are used to process information rather than collecting it.
- While Workflows are mainly triggered by events, Visual Workflows are triggered by user actions. However in Visual Workflows, you can also Autolaunch Flows i.e. start a Flow without user interaction. Since they are triggered without user interactions you cannot include steps, choices, screens or dynamic choices in your Autolaunch Flow.
- Flows can fetch, delete, update or even create records on multiple objects but Workflows are defined to affect only a single specified object. The exception to this is the case of Workflows having to update fields on specified object’s related master records.
How to create and trigger Flow?
Flows can be used to execute a business logic, interact with Salesforce Databases, call defined Apex classes and guide user through screens. There are three main aspects of a Flow creation process:
- Designing
- Management
- Flow Runtime
You can create Flows and open Cloud Flow Designer by going through the following steps
Name-> Setup-> App Setup-> Create-> Workflow & Approvals-> Flows-> New Flow.
Once you have defined your Flow you can easily add it to any Visualforce page or you can add your Flow’s URL link to your Salesforce installation’s homepage.
You can create your Flow triggers by going through the same above process and instead of clicking Flow, click Flow Trigger.
The law of diminishing marginal utility states that as consumption of a good increases, the marginal utility from each additional unit decreases. Marginal utility refers to the additional satisfaction gained from consuming one more unit of a good. An example is provided of a thirsty man drinking glasses of water, where the utility declines with each additional glass. A table shows total utility and marginal utility decreasing as consumption increases from 1 to 6 glasses. The marginal utility curve slopes downward to illustrate this pattern of diminishing returns to scale. There are assumptions and exceptions to the law, and it has practical implications such as diversification of production and progressive taxation.
The document provides an overview of a seminar presentation on ordinal utility analysis and indifference curve approach. It includes 13 sections covering topics like the introduction to utility analysis, cardinal vs ordinal utility approaches, assumptions of ordinal utility analysis, meaning and properties of indifference curves, marginal rate of substitution, and principles of diminishing marginal rate of substitution. The presentation aims to explain key concepts of ordinal utility theory using indifference curve analysis.
This document discusses adverse drug reactions, including definitions, classifications, monitoring, documentation, and reporting. It defines an adverse drug reaction as an unintended response to a drug that occurs at normal doses. Adverse events are classified as serious if they result in death, hospitalization, disability, or required intervention. Adverse reactions are categorized as Type A or Type B. Monitoring involves identifying reactions, assessing causality using methods like the Naranjo algorithm, documenting in forms, and reporting serious reactions to authorities.
The document discusses Journey Builder for Apps, a Salesforce Marketing Cloud product. It provides an overview of the webinar on Journey Builder, including information about the presenters and a safe harbor statement. It then discusses how Journey Builder allows companies to bring the customer journey to life across different channels like email, mobile, and apps to engage customers and improve retention. A live demo of Journey Builder's capabilities is included on the webinar.
The document discusses trends in the mobile enterprise market in 2015. It finds that the number of mobile enterprise application companies has grown 20% in the last year to 313 companies. While this growth rate is modest, it is similar to the early days of software as a service. Industry-focused mobile apps now make up about a third of companies. Early mergers and acquisitions have centered on productivity apps. The number of mobile enterprise enabler companies has also grown, now totaling 220 companies focused on problems like user engagement and development efficiency. Funding of both mobile apps and enablers is accelerating, with several categories like productivity, payments, and analytics receiving significant investments.
The document discusses cardinal and ordinal utility analysis, the law of diminishing marginal utility, consumer surplus, and the Engel curve. It explains that cardinal utility can be measured while ordinal utility focuses on preference ranking. The law of diminishing marginal utility states that the satisfaction from additional units of a good declines as consumption increases. Consumer surplus is the difference between the most one would pay and the actual price paid, representing surplus satisfaction. The Engel curve shows how spending patterns change with different income levels.
You’ve heard the word “Salesforce” being thrown around by small and big enterprises, but you have no idea if your business needs it? If you’re running a business that’s growing just the way you want it to, you will probably need Salesforce CRM sooner than later. But first things first—learn what Salesforce CRM is, how it works and how you should use it to support your day to day operations.
Read the blog in detail
http://suyati.com/how-salesforce-crm-works-and-uses/
For any information on our Salesforce capabilities, email services@suyati.com.
http://suyati.com/
This document provides an introduction to Six Sigma, including an overview of what it is, why it's used, key concepts like defects per million opportunities (DPMO) at different sigma levels, and the DMAIC methodology involving define, measure, analyze, improve, and control phases. It also outlines some common Six Sigma tools and roles like Green Belts, Black Belts, Master Black Belts, Champions, and executive leadership. The goal of Six Sigma is to improve quality, reduce defects and variation in processes, and increase customer satisfaction.
(MBL305) You Have Data from the Devices, Now What?: Getting the Value of the IoTAmazon Web Services
We are collecting tons of sensor data from billions of devices. How do you get the value from your IoT data sources? In this session, we will explore different strategies for collecting and ingesting data, understanding its frequency, and leveraging the potential of the cloud to analyze and predict trends and behavior to get most out of your deployed devices.
Six sigma is a statistical approach to process improvement that aims to reduce defects. It was developed by Motorola in the 1970s to improve quality. The six sigma method includes phases such as Define, Measure, Analyze, Improve, and Control to identify and remove defects in processes. It uses statistical tools and follows a DMAIC or DMADV model. While six sigma aims to improve processes and reduce defects, some critics argue it is more focused on appraisal than prevention and does not always yield quality improvements.
The document provides an overview of Six Sigma, including:
1) It defines Six Sigma as a methodology for continuous improvement and creating high quality products and processes using statistical tools.
2) It discusses the origins and growth of Six Sigma at Motorola and GE in the 1980s-1990s.
3) It describes the DMAIC methodology used for process improvement projects and the roles of Master Black Belts, Black Belts, and Green Belts in a Six Sigma organization.
A Planner's Playbook - Everything I learned about planning at Miami Ad School...Sytse Kooistra
After being in advertising for 4 years, I needed some new guidance and inspiration as a strategist. And that is exactly what I found: I spent the summer of 2013 with 17 other (soon to be) planners from all over the world attending the Account Planning Bootcamp at Miami Ad School New York.
Thanks to the 38 industry heroes and instructors that shared their knowledge and coached us in those 3 months, I learned more than I ever could imagine about planning.
'A Planner's Playbook' is my attempt to summarize all that wisdom in 30 short nuggets (or plays, to stick with the metaphor of a playbook) and share it with you. I left out all the difficult frameworks and models and kept in simple by just stating, in my opinion (and in that of my instructors), what a planner should be and do.
Enjoy reading.
This module is intended to introduce the students of biotechnology to obtain an overview of the pharmaceutical industry. The concept of clinical trials is discussed in brief.
Visit : www.acriindia.com
ACRI is a leading pharmacovigilance training Institute in Bangalore.
ACRI creates a value add for every degree. Our PG course is diploma in clinical research and PG diploma in pharmavigilance are approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
This document summarizes the history and scientific processes of Pharmanex, a company that develops nutritional supplements. It describes how Pharmanex was founded by former pharmaceutical executives to bring scientific standards to the supplement industry. Pharmanex employs over 125 scientists and conducts extensive research to select, source, standardize and test botanical ingredients in its products. Clinical studies have shown that Pharmanex's signature product, LifePak, is effective at significantly increasing antioxidant levels in the body.
This document provides an overview of evidence-based medicine (EBM). It defines EBM as integrating the best research evidence with clinical expertise and patient values. The history and obstacles of EBM are discussed. The document outlines how to practice EBM using the 5 A's framework: Ask, Acquire, Appraise, Apply, and Assess. A case example is provided to demonstrate how to formulate a focused clinical question using the PICO format.
Do Antidepressants Cause Birth Defects?lawsuitlegal
Are SSRI antidepressant medications causing congenital birth defects? See the latest research for and against a causal link.
A recent FDA advisory warned consumers that reports of adverse condition risks for PPHN (persistent pulmonary hypertension of the newborn) and heart and lung conditions in newborn babies was based on a single study which subsequent research has made inconclusive. Still, birth defect attorneys across the nation are investigating injury claims from families across the nation whose babies were exposed to SSRI medications in utero and suffered complications.
SSRI birth defect allegations include a number of congenital problems ranging from heart defects, cranial malformations, spina bifida and other conditions, just to name a few. The following attempts to lay out the research, both for and against and provides our opinion on the matter as well as what can be done if your baby was diagnosed with a congenital defect.
If you have a potential SSRI lawsuit and would like more information about your legal options, visit our website and share what happened to speak with a leading birth defect attorney about your rights and legal options today.
This document provides an introduction to pharmacovigilance. It defines pharmacovigilance as the science relating to detecting, assessing, understanding, and preventing adverse drug reactions. The document outlines the need for pharmacovigilance due to limitations of clinical trials, medication errors, and adverse drug reactions being a leading cause of death. It describes Egypt's pharmacovigilance center and important terms like adverse drug reactions, adverse events, and serious reports. Healthcare professionals, patients, and marketing authorization holders should report valid adverse events containing identifiable information to the pharmacovigilance center.
Qui Tam: Off Label Drug Marketing [Data Snapshot]lawsuitlegal
When does the promotion of a pharmaceutical become illegal?
Learn what is considered off-label use for popular drugs and when it becomes unlawful in this data snapshot.
We share the most common types of off-label uses, where it happens most often, and what exceptions provide 'safe haven' protection.
Most doctors and hospitals are prescribing doctors as they should be, with the patients in mind.
However, off-label prescriptions are important when considered in relation to the False Claims Act. The issue of insurance reimbursement takes center stage when drugs are being used unlawfully and these healthcare organizations are receiving insurance payments for improper use.
So take a moment to review the data with us on Off-Label Marketing relating to qui tam actions, today.
Adverse Event Monitoring
• Identify relationships between drugs, diseases and devices and their associated events
• Use new filter options to search, visualize and export drug, device and disease-specific details
• Learn how new query language possibilities enable identification of specific drug- or device-related adverse events
Drug Types: Biosimilars, generics and more. December 2017 Webinar 12122017Fight Colorectal Cancer
This document provides information about an upcoming webinar on drug types including biosimilars and generics. It outlines details like the speaker, how to ask questions during the webinar, and instructions for accessing the webinar archive and following along on Twitter. It also provides brief bios of the speaker and gives technical instructions for participating in the webinar platform. Finally, it lists some resources and includes a standard disclaimer.
Lecture given to Unit 8 (INDS 208) -- Pathobiology Treatment and Prevention of Disease -- in the undergraduate medical curriculum at McGill University on September 10, 2012.
The document describes the process of pre-clinical trials for testing new drugs. It involves:
1) Identifying a drug target through basic research and applying that knowledge through applied research.
2) Developing a bioassay, usually using animal or cell models, to test the drug's safety and effectiveness.
3) Establishing the effective and toxic doses of the drug through screening in the bioassay system.
4) Filing for approval as an Investigational New Drug with the FDA if results show promise, allowing tests in human clinical trials. The goal of pre-clinical trials is to determine if a new drug or medical device is safe and effective before testing in humans using the scientific method.
The pre-clinical trial process involves testing new drugs on animal and cell bioassays before human testing to determine if they are safe and effective. It begins with basic research to identify a drug target related to a disease. Researchers then develop a bioassay and screen drug candidates to find ones that act on the target as intended without toxicity. Effective and toxic doses are established, and approval is sought from the FDA to begin clinical trials on humans by filing an Investigational New Drug application. The goal of pre-clinical trials is to apply findings from basic research on biochemical pathways and identify promising drug candidates ready for initial human testing.
The document describes the process of pre-clinical trials for testing new drugs. It involves:
1) Identifying a drug target based on basic research findings. Researchers determine targets associated with disease processes.
2) Developing a bioassay system like cell cultures or animal models to test the drug's safety and effectiveness.
3) Screening candidate drug compounds in the bioassay to determine if they interact safely and effectively with the target.
4) Establishing the effective and toxic dosage levels of any promising compounds before filing for approval to begin human clinical trials. The goal is to use the scientific method to evaluate drugs in living systems before testing in humans.
The document discusses searching the pharmacology literature. It outlines the five phases of the drug life cycle: drug discovery, pre-clinical research, clinical trials, review, and ongoing analysis. It provides examples of databases to search within each phase, such as PubMed, Embase, and ClinicalTrials.gov. Advanced search techniques are covered, including using subject headings, Boolean operators, and filters. It also reviews citation management software like RefWorks.
This document provides guidance on evaluating product recalls. It discusses factors to consider such as hazard evaluation, population segmentation, seriousness of hazards, and consequences. Examples of recall scenarios are presented and questions are provided to facilitate discussion. Attendees are encouraged to discuss real cases and how they would be handled. The goal is to enhance understanding of recall strategies and decision making.
Pathway studio reaxys medicinal chemistry schizophrenia presentation 063015Ann-Marie Roche
Drug discovery expert, Jim Rinker, will discuss the process for exploring drug targets for schizophrenia using the tools in Elsevier's R&D portfolio. This approach features a specific workflow between Reaxys Medicinal Chemistry and Pathway Studio. Beginning with mapping known schizophrenia drugs to regulators, Mr. Rinker will walk through the keys steps in finding the proper drug used to improve cognitive function. This step-by-step method of research and data extraction will demonstrate how using these platforms can help identify side effects, build a consensus model, properly profile drugs and effectively map cognition.
Medication Error a pharmacist perspective 2-23-01Charles Sharkey
Medication errors are a serious and preventable issue that cause many deaths each year. Root causes are complex systems with multiple layers and disciplines involved in the medication use cycle. Common types of errors include look-alike or sound-alike drug names, confusing abbreviations, incorrect dosages, and improper packaging or labeling. Strategies to prevent errors include identifying high alert medications, improving order entry processes, and redesigning systems with safety as a priority.
How predictive models help Medicinal Chemists design better drugs_webinarAnn-Marie Roche
All scientific disciplines, including medicinal chemistry, are experiencing a revolution in unprecedented rates of data being generated and the subsequent analysis and exploitation of this data is increasingly fundamental to innovation. Using data to design better compounds is a challenge for Medicinal and Computational chemists.
The design of small-molecule drug candidates, encompassing characteristics such as potency, selectivity and ADMET (absorption, distribution, metabolism, excretion and toxicity) is a key factor in the success of clinical trials and computer-aided drug discovery/design methods have played a major role in the development of therapeutically important small molecules for over three decades. These methods are broadly classified as either structure-based or ligand-based.
In this webinar our expert Dr. Olivier Barberan will discuss ligand-based methods and he will cover the following:
How to use only ligand information to predict activity depending on its similarity/dissimilarity to previously known active ligands.
- Discuss ligand-based pharmacophores, molecular descriptors, and quantitative structure-activity relationships and important tools such as target/ligand databases necessary for successful implementation of various computer-aided drug discovery/design methods in a drug discovery campaign.
Webinar: New RMC - Your lead_optimization Solution June082017Ann-Marie Roche
The document discusses Reaxys Medicinal Chemistry and how it supports hit-to-lead and lead optimization processes. It provides high quality data on topics like efficacy, ADMET properties, and animal models to help computational and medicinal chemists. The pX concept normalizes bioactivity measurements like IC50, Ki, and % inhibition into a single comparable metric, making it possible to compare compound affinity regardless of the metric reported. This allows researchers to more easily search for and analyze active compounds.
Oil&Gas Thought Leader Webinar - New Plays for Old Ideas - Dr.Gabor TariAnn-Marie Roche
In our April 2017 webinar, three industry experts shared their research and demonstrated the importance of focusing on fundamental geologic and geophysical research approaches that integrate variety of data, information and concepts from disparate sources and related disciplines.
This back-to-fundamentals research can both inspire and accelerate exploration teams’ thinking about petroleum systems and lead to a path to success.
Dr Gabor Tari is currently the Group Chief Geologist at OMV. He has over 20 years’ experience working in upstream oil & gas and has worked for Amoco, BP, and Vanco, before joining OMV in 2007. Gabor has worked on exploration projects in basins around the globe, including Romania, Angola, North Africa, and the Middle East. He has authored over 50 scientific publications, presented papers at dozens of conferences, and most recently co-authored the book Permo-Triassic Salt Provinces of Europe, North Africa and the Atlantic Margins, with Dr Joan Flinch (Repsol) and Juan Soto, Professor of Geodynamics in the Granada University and in the Instituto Andaluz de Ciencias de la Tierra, Spain, which is currently available from Elsevier for pre-order online.
Gabor discussed and shared some examples of how new plays can be built on a solid foundation of petroleum system development and research, and how new ideas can be garnered from building on published research of oil & gas companies, academia, service providers and consultants.
Oil&Gas Thought-Leader Webinar - New Plays for Old Ideas - Dr. Rob ForknerAnn-Marie Roche
In our April 2017 webinar, three industry experts shared their research and demonstrated the importance of focusing on fundamental geologic and geophysical research approaches that integrate variety of data, information and concepts from disparate sources and related disciplines. This back-to-fundamentals research can both inspire and accelerate exploration teams’ thinking about petroleum systems and lead to a path to success.
Dr Rob Forkner is a carbonate geologist at Statoil, working in the carbonate plays and reservoirs research group in Austin, Texas, focusing on carbonate play prediction in Atlantic margin systems. Prior to Statoil, Rob worked at Maersk and Shell in onshore and offshore in well planning, geosteering, high-resolution sequence stratigraphy and facies prediction, carbonate sedimentology in unconventional assets, evaporite classification and prediction, rock typing, and more recently, carbonate system suppression and recovery during Oceanic Anoxic Events.
Oil&Gas Thought-Leader Webinar - New Plays for Old Ideas - Dr. Sander HoubenAnn-Marie Roche
Dr. Sander Houben presented on combining paleoceanographic and exploration tools to study Early Jurassic anoxic events. He discussed how carbon isotopes can be used as a stratigraphic tool to analyze perturbations to the carbon cycle during these events. Palynological analysis of indicators of photic zone anoxia and chemocline migration provided insight into changes in water column ecology. A case study of the Toarcian OAE and Posidonia Shale Formation showed how isotopic analyses revealed a major increase in export of hydrogen-rich organic matter due to intensified primary productivity by diazotrophs under low oxygen conditions. Paleoceanographic observations combined with an exploration geology perspective provided understanding of the formation of
Embase for pharmacovigilance: Search and validation March 22 2017Ann-Marie Roche
Scientific literature plays a critical role in Pharmacovigilance and Drug Safety workflows. Monitoring literature for mentions of adverse drug reactions (ADRs) is mandated by regulatory bodies, and marketing authorization holders (MAHs) that do not properly report ADRs can be subject to heavy fines. With an increasing volume of unstructured content to cover, along with rising labor costs, MAHs are looking for ways to make their literature monitoring more effective and efficient.
Abstract and indexing (A&I) databases play an important role in Literature Monitoring – due to the vast amount of scientific literature published daily – in order for MAH’s to locate specific articles or conference presentations that may be relevant for their products (for both benefit/risk analysis and ADR detection). Rather than reading all the literature, MAH’s create search strategies that identify the relevant records in A&I databases and execute the searches regularly. GVP module VI mandates that searches are done at least weekly, but many companies maintain a daily monitoring and review cycle.
In this webinar, Senior Product Development Manager Embase, Dr. Ivan Krstic discussed best practices for saving time, staying current, validating search strategies and mitigating risk in the face of these increasingly complex processes in literature monitoring
Literature Management for Pharmacovigilance: Outsource or in-house solution? ...Ann-Marie Roche
Pharmaceutical companies are required to screen scientific literature on a regular basis and this comes with many challenges, such as handling large amounts of data, building search strings and integrating EMA MLM results. Out-sourcing literature screening to service providers reduces the workload for the PV-team, but how does it impact the literature management process overall? Maybe it results in decreased oversight and additional activities like audits and reconciliation? And what about building the search strategy?
During this webinar our PV expert, Dr. Joyce De Langen spoke about the following:
• The importance of literature management in Pharmacovigilance and the challenges.
• An evaluation of the benefits and risks of outsourcing literature management versus alternative solutions.
About the speaker:
Joyce de Langen, Ph.D has more than 10 years of experience in the domain of pharmacovigilance and drug safety. Through her work in the pharmaceutical industry, academia and regulatory authorities, Joyce has developed a broad perspective and knowledge in pharmacovigilance and drug safety.
Finding the right medical device information in embase 11 2016Ann-Marie Roche
The document discusses guidelines for systematic reviews of biomedical literature in Clinical Evaluation Reports (CERs) for medical devices, highlighting how Embase addresses the requirements through its comprehensive indexing of devices, manufacturers, and adverse effects, as well as features for building sensitive searches. It also provides examples of searches in Embase to find information on device clinical performance, comparisons, and safety for a case study on an everolimus eluting coronary stent.
The document discusses medical device adverse event reporting requirements, including definitions of reportable events and timelines for submitting reports to regulatory agencies. It provides an overview of the classification system for medical devices and regulations around reporting malfunctions, deaths and serious injuries caused by devices. Reporting requirements and challenges involving software as a medical device are also reviewed.
The All-New 2016 Engineering Academic Challenge - developed by students for students
The Engineering Academic Challenge (formerly as the Knovel Academic Challenge) is an immersive, 5-week interactive problem-set competition, featuring weekly thematic engineering challenges built around five transdisciplinary themes inspired by the National Academy of Engineering Grand Challenges.
Literature monitoring for pv what are we doing at galderma elsevier webinarAnn-Marie Roche
The document discusses literature monitoring for pharmacovigilance. It describes weekly monitoring of individual case safety reports and periodic monitoring through development safety update reports and periodic benefit-risk evaluation reports. Key databases for literature searches are Medline and Embase. While Embase has more extensive drug coverage, searches on Medline via PubMed are more reliable due to the potential for loss of MeSH subheadings when mapping to Emtree and the risk of false negatives and positives when searching Embase alone. Literature searches support signal detection and periodic evaluation of a product's safety profile.
This document discusses how drug analytics based on manually extracted semantic relationships in Embase can be useful for drug development, repurposing, and safety. It describes how relationships between drugs, diseases, and adverse reactions that are manually indexed can provide valuable information for drug repurposing, development, and safety. Specific examples are provided to show how the semantic relationships can guide drug repositioning strategies, investigate new combination drugs, identify drug-drug interactions, collect drug comparison data, and help improve risk management.
This document discusses Lean Six Sigma and resources available through Knovel to support Lean Six Sigma implementation. It provides an overview of the Lean Six Sigma implementation process including strategic leadership and vision, deployment planning, and execution and results. It describes Knovel's Lean Six Sigma resources such as handbooks, case studies, templates, and guides covering tools like DMAIC, DOE, SPC etc. that can help with the different belts and project phases from Define to Control. Other resources discussed include those for Design for Six Sigma and practical applications/case studies.
Reaxys provides a unified information portal that integrates data from multiple chemistry sources through a single interface. It links chemistry data, structures, citations, and full-text articles. Reaxys also integrates in-house data from sources like electronic lab notebooks through its API and can be used for activities like compound screening, literature searching, and patent analysis to support drug discovery.
Phil Lorenzi discusses pathway analysis approaches and their uses in biomedical research and drug development. He compares strategies for analyzing the autophagy and apoptosis pathways, finding that integrating multiple methods provides the most comprehensive understanding. Lorenzi also provides examples of how pathway analysis could have predicted problems with COX-2 inhibitors and helped explain past failures of AKT inhibitors. He concludes that pathway analysis is consistent with approvals of EGFR, MEK, RANKL and PARP inhibitors and may support development of GLS inhibitors.
Searching literature databases for post authorisation safety studies (pass)Ann-Marie Roche
This document discusses using literature databases like Embase to conduct post-authorization safety studies (PASS) through systematic literature reviews and meta-analyses. It provides an example PASS on the drug brentuximab vedotin that identified adverse events like peripheral neuropathy and infections. The document reviews how to structure a literature search using the PICO framework and Embase's in-depth indexing of concepts, relationships, and causality to comprehensively identify safety outcomes reported for a drug.
Julie glanville embase sunrise seminar may 2016Ann-Marie Roche
Simple text mining tools can help Embase users in several ways:
- Frequency analysis of terms in records can identify useful search terms and concepts to explore. Tools like EndNote and Voyant allow viewing frequencies of words in titles, abstracts, and subject headings.
- Phrase analysis identifies common word combinations or concepts in the text, beyond single words. Voyant and TERMINE are useful for this.
- Word collocation analysis shows which words frequently occur near each other, suggesting relationships between ideas. The Voyant collocates tool supports this.
- Cluster and network visualizations identify major themes or concepts within a set of records. VOSviewer creates visual maps of related terms.
Exploring records
Ian crowlesmith embase retrospective mla 2016Ann-Marie Roche
Embase began in 1946 as Excerpta Medica, founded to provide medical abstracts. It was acquired by Elsevier in 1971 and became available online in 1978. Key developments included introducing a controlled vocabulary called Emtree in 1987 and adding item types and check tags for evidence-based medicine in 1990. Currently, Embase indexes articles in great depth using natural language and extensively covers drugs and devices. The taxonomy Emtree is regularly updated to reflect new terms.
The document provides an update on new features and enhancements to Embase.com. Key points include:
- The addition of a new PICO search page that allows users to build clinical searches by splitting questions into Patient, Intervention, Comparison, and Outcome elements.
- Other enhancements include improved search tips, the ability to add synonyms and view all abstracts, as well as analytics capabilities for drug safety and repurposing based on triple indexing of content.
- Future plans include improvements to content, taxonomy, and indexing as well as a revamp of the search platform interface and functionality.
This document discusses upcoming changes to process safety management (PSM) regulations and standards. It notes several major industrial accidents in recent decades that prompted reforms. New PSM requirements in California will likely be adopted more widely and require more prescriptive tasks, reporting, and accountability. To ensure future PSM success, the document recommends: making no distinction between internal/external compliance; expanding the definition of mechanical integrity; understanding "double jeopardy"; not replacing investigations with management of change; knowing what the operations team is doing; and clarifying teamwork expectations regarding stop work authorizations.
Finding a drug safety solution for you - Embase and PharmaPendium - Webinar 25 Oct 2012inar. 25 oct2012
1. Welcome to our drug safety webinar!
Featuring the Embase and
PharmaPendium combined drug
safety solution
Your host: Ann-Marie Roche Your presenter: Pooja Jain
3. Need to know
• Your control panel:
– Questions for asking the presenter a
question or making a comment.
– Option for full screen view
• Questions during the webinar
and time for Q&A at the end.
4. Finding A Drug Safety Solution:
Finding A Drug Safety Solution:
Embase + PharmaPendium
Embase + PharmaPendium
Presented By: Pooja Jain, M.Sc., MBA
Date: Oct 25 2012
5. ••Embase is an online information
Embase is an online information PharmaPendium is the only online
PharmaPendium is the only online
source of biomedical literature that
source of biomedical literature that resource to allow drug development
resource to allow drug development
serves pharmacovigilance reporting
serves pharmacovigilance reporting teams to efficiently extract:
teams to efficiently extract:
needs by broadly tracking adverse
needs by broadly tracking adverse
events from comprehensive high-
events from comprehensive high- ••Best-in-class drug development
Best-in-class drug development
quality sources.
quality sources. information
information
••Embase records are deeply indexed
Embase records are deeply indexed ••Allavailable FDA approvals since 1938
All available FDA approvals since 1938
using our Emtree thesaurus to make
using our Emtree thesaurus to make ++EMA since 1995 ++more
EMA since 1995 more
searching faster, more accurate and
searching faster, more accurate and
more specific. Emtree lists more than
more specific. Emtree lists more than ••More than 1.5 million pages of drug
More than 1.5 million pages of drug
60,000 preferred terms and over
60,000 preferred terms and over reviews
reviews
260,000 synonyms, including generic
260,000 synonyms, including generic
and trade names of drugs.
and trade names of drugs. ••More than 4,000 drugs covered
More than 4,000 drugs covered
••Compared to MEDLINE, Embase has
Compared to MEDLINE, Embase has ••Comparative exposure data
Comparative exposure data
over 2,000 more journals in addition to
over 2,000 more journals in addition to
conference reports. In total Embase
conference reports. In total Embase ••Regulatory precedents
Regulatory precedents
indexes over 7,000 journals.
indexes over 7,000 journals.
6. Acarbose example
“Acarbose” search in Embase
Filter by “adverse event”
Filter by “liver toxicity”
Identification of relevant articles
Identify any warning
Reports of post- Adverse events
signs that there may Adverse event not
marketing adverse reported to affect
be drug induced reported in labeling
events patient compliance
liver toxicity
Can we find
Did we actually find
evidence of these Could we have
Was there any evidence of this in
adverse events at known about these
evidence of this the approval
the preclinical and adverse events
before the drug was package? How do
clinical stages before the label
approved? we mitigate risk
before drug was updated?
moving forward?
approval?
14. Acarbose example
“Acarbose” search in Embase
Filter by “adverse event”
Filter by “liver toxicity”
Identification of relevant articles
Identify any warning
signs that there may
be drug induced
liver toxicity
Was there any
evidence of this
before the drug was
approved?
15.
16.
17.
18.
19.
20.
21. Summary
• Link critical post marketing findings to the drug and validate
its relevance in the context of the studies that were
performed as part of the drug approval process
• Look at post marketing findings and understand how they
could be relevant across different drugs and drug classes
• Get directly to the study that was done and now find ways in
which study designs could be optimized to reduce the chance
of seeing those same events take place with a drug that you
are currently developing
22. Acarbose example
“Acarbose” search in Embase
Filter by “adverse event”
Filter by “liver toxicity”
Identification of relevant articles
Identify any warning
Reports of post-
signs that there may
marketing adverse
be drug induced
events
liver toxicity
Can we find
evidence of these
Was there any
adverse events at
evidence of this
the preclinical and
before the drug was
clinical stages
approved?
before drug
approval?
40. Summary
• Found postmarketing adverse event reporting in the Japanese
demographic
• Found drugs within the antidiabetic drug class which
demonstrated similar adverse events in the Japanese
demographic and were then able to do comparative adverse
event analysis on those drugs
• Found extracted drug safety data in both preclinical and
clinical studies across different drug classes
41. Acarbose example
“Acarbose” search in Embase
Filter by “adverse event”
Filter by “liver toxicity”
Identification of relevant articles
Identify any warning
Reports of post-
signs that there may Adverse event not
marketing adverse
be drug induced reported in labeling
events
liver toxicity
Can we find
evidence of these Could we have
Was there any
adverse events at known about these
evidence of this
the preclinical and adverse events
before the drug was
clinical stages before the label
approved?
before drug was updated?
approval?
51. Summary
• Found postmarketing adverse event reporting in the Japanese
demographic
• Found drugs within the antidiabetic drug class which
demonstrated similar adverse events in the Japanese
demographic and were then able to do comparative adverse
event analysis on those drugs
• Found extracted drug safety data in both preclinical and
clinical studies across different drug classes
• Found adverse events not yet reported on the label
52. Acarbose example
“Acarbose” search in Embase
Filter by “adverse event”
Filter by “liver toxicity”
Identification of relevant articles
Identify any warning
Reports of post- Adverse events
signs that there may Adverse event not
marketing adverse reported to affect
be drug induced reported in labeling
events patient compliance
liver toxicity
Can we find
Did we actually find
evidence of these Could we have
Was there any evidence of this in
adverse events at known about these
evidence of this the approval
the preclinical and adverse events
before the drug was package? How do
clinical stages before the label
approved? we mitigate risk
before drug was updated?
moving forward?
approval?
55. Summary
• Found evidence that patient compliance was an issue with
acarbose due to its adverse events
• These concerns were clearly expressed in the approval
package and should have been further considered before
launching the drug on the market
• Now if you are facing similar adverse events in your clinical
trials, what information can you find that can help you
mediate that risk of patients withdrawing from your drug?
56. Acarbose example
“Acarbose” search in Embase
Filter by “adverse event”
Filter by “liver toxicity”
Identification of relevant articles
Identify any warning
Reports of post- Adverse events
signs that there may Adverse event not
marketing adverse reported to affect
be drug induced reported in labeling
events patient compliance
liver toxicity
Can we find
Did we actually find
evidence of these Could we have
Was there any evidence of this in
adverse events at known about these
evidence of this the approval
the preclinical and adverse events
before the drug was package? How do
clinical stages before the label
approved? we mitigate risk
before drug was updated?
moving forward?
approval?
57.
58.
59. However a combinatorial drug
therapy of acarbose and
metformin is not approved yet
by the FDA or EMEA. Was this
ever tested before?
64. Summary
• Found evidence of acarbose plus metformin combination
therapy in recent clinical studies
• However the same combination has been considered by the
FDA before
• Gained insight into the risk factors of combining therapies
where both drugs have similar adverse events
• Found a possible way of mitigating that risk of patient
withdrawal if that type of combination therapy were to be
explored again
65. Acarbose example
“Acarbose” search in Embase
Filter by “adverse event”
Filter by “liver toxicity”
Identification of relevant articles
Identify any warning
Reports of post- Adverse events
signs that there may Adverse event not
marketing adverse reported to affect
be drug induced reported in labeling
events patient compliance
liver toxicity
Can we find
Did we actually find
evidence of these Could we have
Was there any evidence of this in
adverse events at known about these
evidence of this the approval
the preclinical and adverse events
before the drug was package? How do
clinical stages before the label
approved? we mitigate risk
before drug was updated?
moving forward?
approval?
66.
67. • The Q&A will be sent to you by email.
• For more information and questions please
contact bdtraining@elsevier.com
• Check out upcoming and previous Embase and
PharmPendium webinars at
http://www.embase.com/info/embase-webinars
and
http://www.pharmapendium.com/info/pharmape
ndium-webinars.
Please fill out the survey
Please fill out the survey
that appears on your
that appears on your
screen after leaving the
screen after leaving the
webinar.
webinar.
Editor's Notes
Embase is developed and maintained by Elsevier and to briefly put it into context, Elsevier is serving 3 main areas of interest to you, Biology, Chemistry and Medicine. [first click] Embase is one of the products serving your needs in these areas, we also have Reaxys, our Chemistry workflow tool and I will be presenting a webinar on Reaxys tomorrow, Pharmapendium, giving searchable access to all FDA and EMA approval documentation and our new target finding and validation tool, Target Insights. [second click] Sciverse ScienceDirect provides full text access to over 10 million journal articles and is continuously looking for new and novel ways to enable further understanding of the scientific literature through applications and new article formats. Sciverse Scopus is our all science database, illumin8 enables product and partnering decisions for R&D and innovation professionals working at the front-end of innovation and Sciverse is a lens on the worlds research activity. And so to todays Embase session…
We will be placing the webinar slides and recording online so you can listen to it again, in your own time. During the session you may send us your questions by using the chat or Ask a Question function on the webinar control panel. We will answer as many of your questions as possible throughout the webinar and all questions will be included in a complete Q&A and sent to all attendees by email, as well as a link to the recording. If you wish to have a full screen view, please click on the red arrow. Your control panel will be hidden. Click again on the red arrow to see your control panel again.
In order to show the depth and breadth of information, we will choose a drug that was approved in 1995 just so we can show you how examples of much information you can access when having both PP and Embase as there is a lot of rich data that we can extract out.
Before I proceed, I will just mention that here [CLICK] I am showing some smaller screenshots, but then I will show a full screen view so you can see what the results look like a bit better. The purpose of the smaller screenshots is to help you visualize how to initially navigate Embase. So here you will see what Embase looks like when you go on the home page. Now due to time limits, I am not going to go into all of the functionalities of Embase. You will be prompted to fill out a short survey at the end of this webinar. By filling out your information, we will have the opportunity to contact you about the products that you indicate you are interested in learning more about and then we can really show you a more in-depth product demo. With that said you will still be able to follow along as I have made sure you can get a good grasp of how the products can help you answer some key questions you have pertaining to drug safety. Therefore we are going to largely focus on the specific functionalities and features that pertain to the examples that we will demonstrate. So again, here you see the home page of Embase. Now to find information related to Acarbose specifically, we can click on the tab named “drug” to get more relevant searches. [CLICK] We can actually choose from a number of drug subheadings that can lead us to information that is more relevant to an end user. For the example that we will show today, we will first do a search with just the drug name, acarbose, alone and then we will later on show you the results we get when we choose “adverse drug reaction” as a subheading since our examples are focused on drug safety. Just by doing this one initial search, we will demonstrate the depth and breadth of information that you can access using Embase and PP together as a comprehensive source for drug safety information.
[CLICK] Here we have a screenshot of a search that was performed with just acarbose alone. We can see we get almost 5000 results. Now just to show you how much information you would have missed if you relied on PubMed alone, [CLICK] if you do a simple acarbose search in PubMed, you get less than one third of the results. This is largely due to the fact that PubMed does not do full-text searching. So a lot of the data that you can find in the body of the article, you will miss out on. Hence if the words that you are searching for are not in the title, abstract, keyword list, you lose a lot. And this is a huge risk to take if you are working in drug safety.
In order to show the depth and breadth of information, we will choose a drug that was approved in 2004 just so we can show you how much information you can access when having both PP and Embase as there is a lot of rich data that we can extract out.
As we go through the examples, we will be pointing out some articles that you would have missed if you used PubMed exclusively.
So let’s look at a larger full screen view of just the acarbose search. You will see your search query displayed here [CLICK] . Your results showed here [CLICK]. And additional filter options shown here [CLICK]. Here the filters are drugs, disease, study type, journal title, publication type, and publication year. I will talk about these filters a bit more on the next slide. Now since your search results are so large, one thing we can do, which we mentioned earlier, is to filter based on adverse drug reactions from the drug tab we showed earlier. So on the next slide you will see how we can narrow down the search results even further by filtering records on “adverse drug reaction”.
Now we have gone from almost 5000 records to almost 1000 articles. On the left hand side, I have an expanded view of one of the filters, Disease. Here you will see the top 25 terms listed with the highest frequency from my search query. To narrow down the results even further, we can look at liver toxicity since liver toxicity is one of the main reasons why drugs can fail either in the clinic or have serious issues post-approval.
Now we have narrowed the results to just 194 results. We have a highly relevant set of records now and we can go in and see what kind of insights we can find. And all of this literally just took a few minutes, so it saves end users a lot of time. We will be referring to this result set very often during the presentation since we will be pulling a lot of interesting articles from this search query. [CLICK]. By looking at our results, one article that may pop out is the one that mentions elevated transaminase levels in the title. [CLICK] If we look at the abstract, we can see that acarbose is no where to be found in the abstract. Hence this article would have definitely been missed in PubMed. But if you click on the index terms tab, [CLICK] you can see the list of terms which are present in the full text, and acarbose is indeed listed here. Hence you can see that it is a relevant article.
So we are now at this point where we are going to now look into PharmaPendium and see what information we can find.
So now, we can switch over to PharmaPendium. This is the home page.
So let’s start off with a search that will search records containing the word “transaminase” and we can restrict that search to just “labels” to see what drugs actually had data related to transaminase on the labels themselves.
Here we can see that we actually get over 1500 results. You can now actually compare information from different drugs to see what kinds of elevated transaminase levels were found. This kind of comparative drug view is only visible in PharmaPendium. And this is a huge value driver for end users. To be able to compare data amongst drugs which are targeting the same indication or which belong to the same class is really huge. To narrow the results further, we can click on the “show filter tab”.
We can then select drugs and drug classes and go under the antidiabetic drug class to then find acarbose and see if there is any mention of transaminase in its labels. [CLICK] Indeed we see that there are 4 results found with acarbose. So we just need to select this and click “apply filter”.
So here we can see the 4 results. Now if you look at the lines closely, it looks like it is the same result mentioned 4 times. In fact, [CLICK], the results pertain to different labels which can be really useful because you may want to know how has the data changed since the drug was approved. To give you an example of how easy it is from here to go into PharmaPendium and find the data, simply click on the link which is at the top of each result, so for example we would click right right where the top red box is in the result list…
And then here we would land on the page from where the data was extracted from. And here you can get to the information you are looking for without having to waste a lot of time searching for information. In PharmaPendium, none of the content is altered at all, it is the original content so you can be rest assured that you are getting all of the correct information. Keepign everything in its original form was actually a requirement from the FDA.
(Read off slide) Now I will leave you with one more observation.
In order to show the depth and breadth of information, we will choose a drug that was approved in 1995 just so we can show you how examples of much information you can access when having both PP and Embase as there is a lot of rich data that we can extract out.
Now let’s go back again to this result page where we had searched acarbose and then filtered by adverse drug reaction and liver toxicity. If we scroll down the results….
We will come to this result, #13, called “Hepatotoxicity and hepatic metabolism of available drugs: current problems and possible solutions in preclinical stages” which looks like a really interesting article since it talks about drugs linked to having fatal hepatotoxicity. Now from the abstract and title alone, it is not completely clear if this article is directly relevant to acarbose. However…
If we click on the index terms, we can see acarbose is mentioned in the drug index terms hence it is an article that can be of relevance to the particular end user. Remember our scenario again, that we are interested in finding post-marketing information on adverse events related to liver toxicity for acarbose. This article would not have been picked up by PubMed, hence critical information would have been lost during our pharmacovigilance monitoring. Now we don’t have a subscription to this article
Here is another example of an article called “Prediction of severe adverse drug reactions using pharmacogenetic biomarkers” which also looks really interesting. This too would have been missed by PubMed, and here since we have access to the article, I can show you what kind of information you could have gotten.
By looking a little more closely at the abstract, we can see that this article actually focuses on the Japanese demographic, which is information that is often times hard to get.
This table was found in the article which lists drugs that reported cases of hepatotoxicity in 2008. [CLICK] Acarbose is linked to several of these cases. In addition, you can see that there is mention of numerous other drugs. Which one of these drugs are approved for the treatment of diabetes in the United States and Europe?
You can go into PharmaPendium and look up the list of [CLICK] antidiabetic drugs and then cross-reference that list to the one in the title. This list is too long… but going through the list we can actually identify additional drugs.
In fact we see 2 more drugs identified. So where do you go from here? Well you can actually go back into PharmaPendium and now do a comparative adverse event search and see which drug has a better safety profile and then from there try to figure out why.
So if we go into PharmaPendium, and it is very easy, all we have to is click on the safety data search tab as indicated by the yellow arrow and we will get to this safety data search form. We just need to click on the “add drugs and drug classes” link to add the drugs that we want to compare.
On the left hand side, [CLICK] this “browse drug” tab will appear from which we can actually find the drugs we want to pick out. Simply click the add button and they will be added to the list [CLICK] displayed here. Then click on “search now”.
And you will see [CLICK] over 1700 lines of extracted adverse event and toxicity data available for you to compare the safety profiles of each drug and even export so that you can do some more advanced analysis with your team. But till then, you can actually narrow down your search results even further by clicking on [CLICK] “show filter” and facilitate your comparative analysis.
In this case we can actually choose [CLICK] to see which adverse event we would like to do a comparative search on. We can choose “hepatic and hepatobiliary disorders.
Within minutes you can find extracted comparative adverse event data like what you can see here. Not only can you get comparative data between drugs but also across species, which is really valuable when you are trying to see how to best design your clinical trial and preclinical studies to avoid seeing adverse events such as these. And by gaining visibility into the dosing used for studies that showed these adverse events, you can then use this information to design better studies which can save an incredible amount of time and money.
Now if we go back to the “show filters” tab, where we had selected the hepatic and hepatobiliary disorders, you can also look up information on transaminases under [CLICK] liver function analysis. Also very critical extracted information that you gain with just a few clicks. And it is a great way to supplement the insights that you would get from Embase in order to get the comprehensive drug safety picture of pre and post marketing events.
And last time we had restricted the transaminase search to just the FDA labels. But here when we search the whle document you can see how valuable it is to be able to see at what doses you start to observe elevated aminotransferase events.
You can also look at preclinical studies…
And now see what were the preclinical studies that observed this event and understand what were the warning signs that these observations were going to translate to the clinic.
(Read off slide) Now I will leave you with one more observation.
In order to show the depth and breadth of information, we will choose a drug that was approved in 1995 just so we can show you how examples of much information you can access when having both PP and Embase as there is a lot of rich data that we can extract out.
Now let’s picture a scenario where you are a scientist in the year 2010. You are monitoring post-marketing adverse events for acarbose because you are developing a drug in the same drug class and you want to know if there has been any major adverse events since the last approved label, which in this case, would be in 2008.This is where Embase can help give you access to studies which have published additional clinical trials related to this topic.
We looked at another article from our 194 article subset which actually [click] mentions how treatment with acarbose actually resulted in cases of potentially fatal hepatotoxicity. Now this was not mentioned at all in the 2008 label.
If we now go in PP and look at the drug acarbose, where you can have links to the approval packages, pharmacokinetic data and adverse and toxicity events, and we look under post marketing [CLICK] events….
You can see all of the adverse event reporting. Once again by clicking [CLICK] on the show filter tab…
You can actually look for hepatic failures and get a more comprehensive view of all of the reports which have been made for hepatic failures.
When you select for hepatic failures you will see [CLICK] we get 17 reports. By clicking on those 17 reports….
We can actually get a view of what were the concomitant drugs, secondary suspect drugs, and interacting drugs which could have also been identified as playing a role in the adverse events listed. Again, this can provide really key insights for pharmacovigilance monitoring. As you can see, many of the adverse events led to death. One can then go back in Embase and further search for these events and get more clarity as to why these events took place.
So when looking at the 2008 label, you can see that nothing is mentioned about any fatal adverse events being reported…despite what we have seen.
But in the 2011 label, [CLICK] it does mention fatal outcomes, however it took 3 years to show up on the label. Hence you don’t want to wait 3 years before you find out that this drug has fatal adverse events assoicated with it, especially if you are developing a drug which belongs to the same drug class or has the same target.
(Read off slide) Now I will leave you with one more observation.
In order to show the depth and breadth of information, we will choose a drug that was approved in 1995 just so we can show you how examples of much information you can access when having both PP and Embase as there is a lot of rich data that we can extract out.
# 32 prediabetes: to treat or not to treat
In fact if you look in PP, you can see studies which were done. When we do a “discontinuation” search in the acarbose drug approval package, we can retrieve information on what are some potential reasons for discontinuation of the drug. [CLICK] And we can see that the reason why patients discontinued the drug was largely due to gastrointestinal events.
(Read off slide) This is actually what we are going to answer next with our final embase plus pharmapendium example.
So we can actually show you an example of how to answer that last question by actually giving another example for the last use case related to patient compliance.
So let’s go back and see the 194 results again in Embase and let’s [CLICK] open up the drug filter. Here we can immediately see that after acarbose, metformin is the next frequent drug mentioned. It might be interesting to see if this is a hint of some kind of combination drug therapy.
So [CLICK] we can go under the Advanced search tab and type acarbose and metformin [CLICK] in the search bar..
We will come across this interesting 2010 article where they do mention studies [CLICK] of both acarbose and metformin studies and how the combination of both is superior than just the monotherapy with metformin alone. From here, by looking at PharmaPendium we actually know that the combination of acarbose and meformin is nt actually approved yet by the FDA or EMEA. We can then ask, was this ever tested before the approval of acarbose? And in fact the answer is yes and you can find that information very easily in PharmaPendium.
Now here I had actually came across the information on acarbose and metformin accidentally by typing in “dosing concerns” in the FDA approval package search bar [CLICK]. However you can easily type in metformin and come to the same pages as well. Now I would like to point your attention to a few things on this slide. First [CLICK] you can see that it clearly states that though acarose was approved in 1995 for treatment of type 2 diabetes as noth a monotherapy and in combination with study with acarbose sulfonylureas, the combination with metformin was not approved. [CLICK] Here you can also see that this was a study was felt to be inadequate because the combination of both acarbose and metformin potentiated the gastrointestinal events which could lead to low patient compliance. Hence if you were to carry out drug combination studies, you may want to carefully carry out your dose response studies in order to minimize the gastrointestinal adverse events.
Here you also see a clinical study in the states.
As we scroll down you can see the same concern that was found in the Canadian study, that the combination of both may lead to an acceptably high rate of gastrointestinal complaints. [CLICK] So how can we optimize studies moving forward. Is there any hint that we can find in the approval package that can provide us some guidance?
Well if we scroll further down into the package, we can see some interesting information that is provided. One solution is to preselect patients who are already on the metformin therapy AND who are tolerant to the gastrointestinal effects and then put those patients on the acarbose plus metformin therapy to see what happens. And this is an example of some of the really good pieces of information that are in these approval packages.
(Read off slide) Now I will leave you with one more observation.
Overall, as you can see with this one drug example how useful and critical it is to have Embase and PP together in order to get that comprehensive view of drug safety from preclinical and clinical studies, to post-marketing reports. I really encourage you to let us know if you would like to be contacted to receive further information on these products to see how we can best serve your needs.