is being presented by Kay Bross, Program Director, Member and Vendor Relations, with SAFE-BioPharma Association and airs on Wednesday, July 28th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Many large pharmaceutical companies are transitioning to the SAFE-BioPharma digital identity and digital signature standard. The standard was developed by a consortium of biopharmaceutical and related companies with participation from the US FDA and the European Medicines Agency, and is used to verify and manage digital identities involved in electronic transactions and to apply digital signatures to electronic documents.
These sponsors are now asking CROs to obtain the necessary SAFE-BioPharma credentials to complete a fully electronic communication/transaction sharing circle. The payoff is faster exchanges and more readily accessible records, with accelerated turnaround for trial contract execution. Also, R&D eLab Notebook entries are secured into the future, and can be used as court evidence.
But how exactly do these digital identities and signatures differ from other electronic signatures, and what are the legal implications of using one over the other? In this audio conference, attendees get all the answers from Kay Bross of SAFE-BioPharma Association, the non-profit group that created and manages the SAFE-BioPharma® digital identity and digital signature standard.
Wednesday, June 30, 2010
Monday, June 28, 2010
Strategic Immunogenicity Planning for Successful Biosimilar Development
is being presented by Ana T. Menendez, Senior Director, Biotechnology, Catalent Pharma Solutions and airs on Tuesday, August 10th, 2010. For more details or to register please visit our site at www.fxconferences.com
The FDA has recently provided a pathway to biosimilar development, which is expected to increase annual biosimilar revenues from $0.06 billion in 2008 to $1.95 billion by 2014 (Visiongain Report Biosimilars and Follow-on Biologics 2009-2024, 2009).
Biopharmaceuticals demonstrate therapeutic success because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. Immunogenicity programs need to establish immunogenic similarity between innovator and biosimilar. Quick identification, characterization and interpretation of antibody response is crucial to interpret changes in the potency and safety of the drug.
The first part of this audio conference reviews intrinsic and external factors that can significantly impact immunogenicity risk management. The next two sections explain key documents (regulatory & industry), methods and timeline expectations to assure compliance. The last section discusses relevant case studies that highlight the impact of immunogenicity on the success of clinical trials.
The FDA has recently provided a pathway to biosimilar development, which is expected to increase annual biosimilar revenues from $0.06 billion in 2008 to $1.95 billion by 2014 (Visiongain Report Biosimilars and Follow-on Biologics 2009-2024, 2009).
Biopharmaceuticals demonstrate therapeutic success because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. Immunogenicity programs need to establish immunogenic similarity between innovator and biosimilar. Quick identification, characterization and interpretation of antibody response is crucial to interpret changes in the potency and safety of the drug.
The first part of this audio conference reviews intrinsic and external factors that can significantly impact immunogenicity risk management. The next two sections explain key documents (regulatory & industry), methods and timeline expectations to assure compliance. The last section discusses relevant case studies that highlight the impact of immunogenicity on the success of clinical trials.
Thursday, June 24, 2010
The Future of Clinical Trial Site and Patient Recruitment Is Here
is being presented by Kent Tholke, Senior Vice President, Scientific and Medical Affairs, with PRA International and airs on Thursday, July 22nd, 2010. For more details or to register, please visit our site at www.fxconferences.com
The key to successful site and patient recruitment is having the ability to mine electronic health records as well as pharmacy, claims, laboratory and historical CRO recruitment data using proprietary search algorithms. Current research indicates that more than 25% of clinical trial sites are unproductive. Relying on a data-driven decision making process will lead to far fewer non-productive clinical trial sites, shorter development timelines, greater patient recruitment and ultimately lower drug development costs.
With more clinical trials being conducted — and with the majority of them operating under delayed timelines — patient access has become the critical piece to solving what has become a very inefficient and costly puzzle known as drug development. While the process of drug development over the last few decades has been heavily driven by scientific methodology, the process by which clinical trials are conducted has consistently lacked the same rigor. Achieving successful patient access and meeting clinical trial timelines will require CROs to use more accurate processes for site selection and targeted patient enrollment.
Although having access to relevant data is important to enhancing site selection and patient recruitment, sponsors and CROs must also mine this data with algorithms that have been established to match planned patient populations and inclusion/exclusion criteria. When sponsors and CROs apply detailed search algorithms across multiple patient data platforms, they are able to find and target sites with the appropriate patient populations and confirm that the planned trial design matches customary care practices. This confirmation is the first step to both determining a trial’s feasibility and mining patient data. In addition, sponsor companies can use data-mining algorithms to determine if medical professionals are treating the target patient population as expected and to locate the patients by physician practice.
This audio conference explores the power of mining EHR/EMR, lab, pharmacy, claims and historical CRO recruitment data. It will also review how using data-driven decision making to validate trial designs and patient and site selection is a key to successful drug development.
The key to successful site and patient recruitment is having the ability to mine electronic health records as well as pharmacy, claims, laboratory and historical CRO recruitment data using proprietary search algorithms. Current research indicates that more than 25% of clinical trial sites are unproductive. Relying on a data-driven decision making process will lead to far fewer non-productive clinical trial sites, shorter development timelines, greater patient recruitment and ultimately lower drug development costs.
With more clinical trials being conducted — and with the majority of them operating under delayed timelines — patient access has become the critical piece to solving what has become a very inefficient and costly puzzle known as drug development. While the process of drug development over the last few decades has been heavily driven by scientific methodology, the process by which clinical trials are conducted has consistently lacked the same rigor. Achieving successful patient access and meeting clinical trial timelines will require CROs to use more accurate processes for site selection and targeted patient enrollment.
Although having access to relevant data is important to enhancing site selection and patient recruitment, sponsors and CROs must also mine this data with algorithms that have been established to match planned patient populations and inclusion/exclusion criteria. When sponsors and CROs apply detailed search algorithms across multiple patient data platforms, they are able to find and target sites with the appropriate patient populations and confirm that the planned trial design matches customary care practices. This confirmation is the first step to both determining a trial’s feasibility and mining patient data. In addition, sponsor companies can use data-mining algorithms to determine if medical professionals are treating the target patient population as expected and to locate the patients by physician practice.
This audio conference explores the power of mining EHR/EMR, lab, pharmacy, claims and historical CRO recruitment data. It will also review how using data-driven decision making to validate trial designs and patient and site selection is a key to successful drug development.
Monday, June 21, 2010
The FDA’s New Emphasis on Supplier Controls – What Device Manufacturers Need to Know
is being presented by Vinny Sastri, President, of Winovia LLC and airs on Thursday, July 29th, 2010. For more details or to register, please visit our site at www.fxconferences.com
The FDA will be putting a lot more emphasis on purchasing controls and supplier selection and audit requirements for medical device manufacturers. In December of 2008 the Global Harmonization Task Force issued a guidance document on “the Controls of Products and Services Obtained from Suppliers” detailing the requirements and expectations manufacturers must meet to exert more control over their suppliers.
This audio conference presentation reviews those expectations and the details of the new guidance document, and also discusses how these new requirements affect medical device manufacturers. Our speaker also looks at how design and development, risk management and process controls are intricately linked to purchasing controls.
The FDA will be putting a lot more emphasis on purchasing controls and supplier selection and audit requirements for medical device manufacturers. In December of 2008 the Global Harmonization Task Force issued a guidance document on “the Controls of Products and Services Obtained from Suppliers” detailing the requirements and expectations manufacturers must meet to exert more control over their suppliers.
This audio conference presentation reviews those expectations and the details of the new guidance document, and also discusses how these new requirements affect medical device manufacturers. Our speaker also looks at how design and development, risk management and process controls are intricately linked to purchasing controls.
Thursday, June 17, 2010
Logistical Considerations for Clinical Trials in India
is being presented by Anthony Leone & Stevie Hills, International Customer Service Manager & International Customer Service Supervisor, with World Courier, Inc. and airs on Tuesday, July 27th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
India is one of the primary emerging markets for the pharmaceutical and biotechnology industries. Clinical trial expenditure in India for 2010 is expected to reach one billion dollars. This projection greatly exceeds 2009 spend. While India offers many compelling reasons to attract focus in the emerging market arena it also presents logistical challenges.
This presentation focuses on how you can ensure regulatory compliance and supply chain integrity at any stage of the clinical study pipeline when conducting studies in India. Our speakers reveal what advance planning and effective partnerships with logistical providers can mean to the success of your projects. The presentation draws on real-life anecdotes to provide transportation advice and reinforce the necessity of doing your homework in order to successfully conduct clinical studies in India.
India is one of the primary emerging markets for the pharmaceutical and biotechnology industries. Clinical trial expenditure in India for 2010 is expected to reach one billion dollars. This projection greatly exceeds 2009 spend. While India offers many compelling reasons to attract focus in the emerging market arena it also presents logistical challenges.
This presentation focuses on how you can ensure regulatory compliance and supply chain integrity at any stage of the clinical study pipeline when conducting studies in India. Our speakers reveal what advance planning and effective partnerships with logistical providers can mean to the success of your projects. The presentation draws on real-life anecdotes to provide transportation advice and reinforce the necessity of doing your homework in order to successfully conduct clinical studies in India.
Wednesday, June 16, 2010
Cloud Computing for the FDA-Regulated Company
is being presented by John English, Principal, John T. English Regulatory Consulting and airs on Thursday, July 15th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Your inbox and the media are both full of offerings and commentary on cloud computing. What exactly is it? Why are IT and finance people so bullish on it? Are there regulatory implications to embracing this strategy?
This presentation looks at the technical aspects of the 'cloud' paradigm in terms appropriate for the non-IT professional. The speaker uses this information, along with current examples from industry, to explain the fiscal and technical advantages that are driving many companies to explore and/or adopt this approach. The presentation also reviews and analyzes some basic issues an FDA-regulated company must understand and take into account before jumping on the cloud computing bandwagon.
Your inbox and the media are both full of offerings and commentary on cloud computing. What exactly is it? Why are IT and finance people so bullish on it? Are there regulatory implications to embracing this strategy?
This presentation looks at the technical aspects of the 'cloud' paradigm in terms appropriate for the non-IT professional. The speaker uses this information, along with current examples from industry, to explain the fiscal and technical advantages that are driving many companies to explore and/or adopt this approach. The presentation also reviews and analyzes some basic issues an FDA-regulated company must understand and take into account before jumping on the cloud computing bandwagon.
Tuesday, June 15, 2010
Using Practical Statistics to Interpret Stability Results
is being presented by Steven Walfish, President, of Statistical Outsourcing Services and airs on Wednesday, July 21st, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
The ICH Q1 is not prescriptive on which statistics are most appropriate for reporting stability data. More importantly, using the incorrect statistics can lead to incorrect conclusions.
In this audio conference, our speaker reviews the statistical concepts used in stability analysis, using an overview of the ICH Q1 guidance as the framework for discussion. The presentation looks at linear models as the statistical tool used for stability analysis, but also covers methods for dealing with data that does fit the linear model. Typically, regression analysis is used to assess stability, and in this audio conference the speaker highlights the assumptions and risks of regression. Finally, the presentation draws on real-life examples to discuss the covariance model for determining poolability of the lots.
The ICH Q1 is not prescriptive on which statistics are most appropriate for reporting stability data. More importantly, using the incorrect statistics can lead to incorrect conclusions.
In this audio conference, our speaker reviews the statistical concepts used in stability analysis, using an overview of the ICH Q1 guidance as the framework for discussion. The presentation looks at linear models as the statistical tool used for stability analysis, but also covers methods for dealing with data that does fit the linear model. Typically, regression analysis is used to assess stability, and in this audio conference the speaker highlights the assumptions and risks of regression. Finally, the presentation draws on real-life examples to discuss the covariance model for determining poolability of the lots.
Friday, June 11, 2010
Managing Your Online Reputation
is being presented by Marcela Jenney, Marketing and Branding Strategist, with Latitudes and airs on Thursday, July 8th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Google has evolved from a brand name into a verb. Google provides its users with the most relevant and useful information, including facts about you, your expertise, your business, and personal life. When potential employers, clients, and leads are interested in you or your business, they use Google to check you out. In a 2009 study on online reputation commissioned by Microsoft, which includes data not just from the U.S. but also from the U.K., Germany, and France, 79% of U.S. hiring managers and job recruiters surveyed said they reviewed online information about job applicants. Most of those surveyed said that what they found online influenced their selection criteria.
As a professional, you are being “watched” online. Therefore, you must protect that online presence that is influencing the decision-making process of your stakeholders. In this presentation you will learn tips, techniques and methods you can use to manage your online reputation, like diagnosing your online presence, monitoring your name, and utilizing tools for identity management.
Google has evolved from a brand name into a verb. Google provides its users with the most relevant and useful information, including facts about you, your expertise, your business, and personal life. When potential employers, clients, and leads are interested in you or your business, they use Google to check you out. In a 2009 study on online reputation commissioned by Microsoft, which includes data not just from the U.S. but also from the U.K., Germany, and France, 79% of U.S. hiring managers and job recruiters surveyed said they reviewed online information about job applicants. Most of those surveyed said that what they found online influenced their selection criteria.
As a professional, you are being “watched” online. Therefore, you must protect that online presence that is influencing the decision-making process of your stakeholders. In this presentation you will learn tips, techniques and methods you can use to manage your online reputation, like diagnosing your online presence, monitoring your name, and utilizing tools for identity management.
Wednesday, June 9, 2010
Localization Tools for eLearning: Articulate, Flash and Captivate
is being presented by Xavier Marchand, COO, of JBI Studios and airs on Wednesday, July 7th, 2010. For more details or to register please visit our site at www.fxconferences.com
Corporate training departments can choose between a variety of tools to develop internal elearning courses, each with their pros and cons in terms of cost, versatility and learning curve. For those training a global workforce, the "localization-friendliness" of the tool can have have serious cost implications and become an important factor in the selection process. Separately, once the tool is chosen, being able to make full use of its features and capabilities can help smooth and speed up the localization process.
In this presentation our speaker, Xavier Marchand of JBI Studios, discusses three of the most popular elearning tools – Articulate, Captivate, and Flash – examining the relative strengths and weaknesses of each from a localization perspective.
Corporate training departments can choose between a variety of tools to develop internal elearning courses, each with their pros and cons in terms of cost, versatility and learning curve. For those training a global workforce, the "localization-friendliness" of the tool can have have serious cost implications and become an important factor in the selection process. Separately, once the tool is chosen, being able to make full use of its features and capabilities can help smooth and speed up the localization process.
In this presentation our speaker, Xavier Marchand of JBI Studios, discusses three of the most popular elearning tools – Articulate, Captivate, and Flash – examining the relative strengths and weaknesses of each from a localization perspective.
Tuesday, June 8, 2010
EU Regulatory and CMC/Quality Requirements for Advanced Therapy Medicinal Products
is being presented by Dr. Elliot Lawrence, Associate Director of Regulatory Affairs , with ERA Consulting (UK) Ltd. and airs on Tuesday, July 13th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Advanced therapy medicinal products (ATMPs) are medicinal products for human use based on gene therapy, somatic cell therapy or tissue engineering. They potentially offer new treatments for diseases and injuries of the human body. The European regulatory framework regarding ATMPs has recently changed to help facilitate free movement of ATMPs within the EU and patient access to these products, and also to foster the competitiveness of European pharmaceutical companies in the field.
This audio conference details the relevant EU regulations, regulatory procedures, and guidelines applicable to ATMPs since the changes in legislation. The speaker also discusses how the changes in the regulatory framework impact the development of an ATMP in terms of the CMC/quality requirements.
Advanced therapy medicinal products (ATMPs) are medicinal products for human use based on gene therapy, somatic cell therapy or tissue engineering. They potentially offer new treatments for diseases and injuries of the human body. The European regulatory framework regarding ATMPs has recently changed to help facilitate free movement of ATMPs within the EU and patient access to these products, and also to foster the competitiveness of European pharmaceutical companies in the field.
This audio conference details the relevant EU regulations, regulatory procedures, and guidelines applicable to ATMPs since the changes in legislation. The speaker also discusses how the changes in the regulatory framework impact the development of an ATMP in terms of the CMC/quality requirements.
Monday, June 7, 2010
Beyond Using SharePoint to Manage Regulatory Documents
is being presented by John Postle & Kent Fernald, Vice President, Life Sciences & Development Manager / CTO, with Court Square Group and airs on Thursday, July 8th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Pharmaceutical and biotech companies have been facing increasing demands to improve their organizational effectiveness through information sharing and collaboration. At the same time, there is an important need for a controlled document management system that is compliant with FDA regulations. In this conference, our speakers not only look at the steps that have been successful for designing, configuring, and implementing Microsoft SharePoint within the confines of a regulated environment, but also review organizational collaboration features (wikis and blogs) and document workflows that organizations are using.
Speakers John Postle and Kent Fernald explain how to achieve ongoing compliance through the use of SharePoint as a validated application in a qualified environment. They also present real-life examples of several regulatory compliant business applications that have been developed using the SharePoint platform.
Pharmaceutical and biotech companies have been facing increasing demands to improve their organizational effectiveness through information sharing and collaboration. At the same time, there is an important need for a controlled document management system that is compliant with FDA regulations. In this conference, our speakers not only look at the steps that have been successful for designing, configuring, and implementing Microsoft SharePoint within the confines of a regulated environment, but also review organizational collaboration features (wikis and blogs) and document workflows that organizations are using.
Speakers John Postle and Kent Fernald explain how to achieve ongoing compliance through the use of SharePoint as a validated application in a qualified environment. They also present real-life examples of several regulatory compliant business applications that have been developed using the SharePoint platform.
Thursday, June 3, 2010
Introduction to Software Localization
is being presented by Sandra La Brasca, Solutions Development Director, with ForeignExchange Translations and airs on Tuesday, July 6th, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com
Forethought and planning is beneficial with any translation or localization project. With software localization, it becomes paramount. This presentation focuses on the importance of proper preparation before launching any software localization project. The speaker provides concrete examples of the issues that can arise in the absence of adequate planning – issues related to terminology, tools to be used and technical considerations such as proper software internationalization. Additionally, the presentation outlines the steps involved in localization from translation through final testing, and discusses the ROI of proper preparation, showing the costs incurred for internationalization versus fixing internationalization bugs later in the development process.
Forethought and planning is beneficial with any translation or localization project. With software localization, it becomes paramount. This presentation focuses on the importance of proper preparation before launching any software localization project. The speaker provides concrete examples of the issues that can arise in the absence of adequate planning – issues related to terminology, tools to be used and technical considerations such as proper software internationalization. Additionally, the presentation outlines the steps involved in localization from translation through final testing, and discusses the ROI of proper preparation, showing the costs incurred for internationalization versus fixing internationalization bugs later in the development process.
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