Biomarker Data Interpretation and Challenges of Biological Variation

With the emphasis on biomarkers to improve drug development, the question arises as how to interpret the data.
The traditional clinical laboratory methodology for interpreting data involves the identification of the expected values (the normal range), and from this range, defining the probability of disease or no disease (sensitivity and specificity). The challenge in drug development is in monitoring the patient over time while identifying if important changes have occurred in the biomarker values that indicate inappropriate toxicity or demonstrate appropriate efficacy.

The use of the reference interval as a means of identifying toxicity or efficacy will be challenged and an alternative approach embracing biological variation will be proposed.

Biomarker Data Interpretation and Challenges of Biological Variation was presented by Gordon F Kapke Ph.D., Sr. Director Biomarker Services, with Covance Central Laboratory Services and aired on 2009-01-28. For more details or to download this event, please visit our site at www.fxconferences.com

Biologic vs. Non-biologic: Current FDA Thinking on IVDs

In the United States, in vitro diagnostic products are classified and reviewed under two separate FDA Centers, depending on whether the product is intended to be used to diagnose a condition, predict if a particular treatment will be effective or monitor the effect of a treatment, or if it is intended to be used in the testing of transfusable blood or cellular products.

In this audio conference we highlight the differences in the two product review processes between the Centers and provide insight into their expectations regarding information required in submissions and following product approval. Recent Guidance Documents issued by FDA are discussed.

Biologic vs. Non-biologic: Current FDA Thinking on IVDs was presented by Ann Quinlan-Smith & Pamela J. Vaughan, President & Senior Principal Consultant, with Alquest, Inc. and aired on 2008-02-28. For more details or to download this event, please visit our site at www.fxconferences.com

Best Practices for Implementing ISO14971:2007

Learn how to put an effective risk management plan in place and fulfill the requirements of ISO14971

In the medical device development process, it has become a regulatory necessity to implement an effective risk management plan to fulfill the requirements of ISO14971. Manufacturers, however, still struggle to comply with ISO14971 and find a meaningful way to introduce risk management to the overall operating framework.

In this audio conference, Mr. Weber discusses the elements of risk management, the current interpretations of regulatory requirements, as well as advice on implementation of a compliant risk management process. ISO 14971:2007 helps companies input risk management strategies, it can help many types of businesses from software-based to broadband provision-related enterprises working with devices. Additionally, the presentation provides practical tips to comply with ISO14971, implement risk management, and minimize the administrative burdens imposed to handle the additional process.

Best Practices for Implementing ISO14971:2007 was presented by Markus Weber, Principal Consultant, with System Safety Inc. and aired on 2008-02-21. For more details or to download this event, please visit our site at www.fxconferences.com

Best Practices for Creating & Translating Global Content

Today, life sciences companies are experiencing tremendous pressure from regulatory bodies to conform to mounting numbers of industry standards. At the same time, they must always look to improve cost and time efficiencies and maintain the highest levels of quality and safety. All of these pressures present a daunting challenge for companies who then need to translate and localize critical information into multiple languages around the world. They can no longer rely on paper-based, manual business processes that are time consuming and error prone. Fortunately, new technologies are revolutionizing the functionality of translation management systems, improving a company's ability to manage and translate information into multiple languages through a set of seamless business processes and best practices.

In this presentation, we discuss globalization best practices to help your organization scale your global reach, growing your business and your bottom line.

Best Practices for Creating & Translating Global Content was presented by Steve Billings & Bill Rabkin, Idiom Technologies and aired on 2007-11-29. For more details or to download this event, please visit our site at www.fxconferences.com

Asian Clinical Trials: What to Know Before You Go

Thinking of conducting clinical trials in Asia?

Certainly more and more pharmaceutical companies are, and with good reason. The predominantly secondary healthcare environment, treatment-naïve patients and large population can mean less time to recruit and faster clinical development. Data quality is high, there are fewer competing studies, and the presence of large hospitals means more patients per site and dramatically reduced trial costs. But jumping on the Asian bandwagon without the proper forethought and knowledge could turn your trial into a tribulation.

Asian Clinical Trials: What to Know Before You Go was presented by Anthony Bishop, Quintiles East Asia and aired on 2004-07-27. For more details or to download this event, please visit our site at www.fxconferences.com

An Introduction to Translation Memory Technology

You've heard of translation memory, but what exactly is it? What can and can't it do for you and your company? And what's the difference between translation memory and machine translation?

This audio conference gives an overview of some of the translation memory systems on the market today, and introduce attendees to their main features -- like statistics, recycling of previous translations, and improved consistency through the use of TMs and terminology databases. The speaker also presents case studies highlighting the use and benefits of TM technology.

An Introduction to Translation Memory Technology was presented by Angelika Zerfass, Translation Tools Consultant and is previously recorded. To download this event, please visit our site at www.fxconferences.com

Adaptive Clinical Trials: How Advanced Adaptive Methods Can Improve Your Next Study

Adaptive methods are increasingly used for statistical issues in research, but this limited use overlooks the most powerful and sustained advantages: application of the same adaptive principles to how a study is run. This approach focuses on continuous measurement and refinement of key study metrics that include rapid enrollment, reduced waste, lowering monitoring costs, and quick study conclusion and database lock. Compared to traditional approaches, adaptive methods typically enable 20% faster enrollment, 20-80% lower study query rates, 20-60% lower monitoring costs, and 50% faster database locks.

This audio conference discusses the tools and processes essential to this approach, along with design and planning issues and net financial impact on Net Present Value and Internal Rate of Return.

Adaptive Clinical Trials: How Advanced Adaptive Methods Can Improve Your Next Study was presented by Michael Rosenberg, M.D., Ph. D., CEO, with Health Decisions and aired on 2009-02-18. To download this event, please visit our site at www.fxconferences.com

A Guide to Efficient Translation Management

Managing translation projects efficiently is all about choosing the right tool for the job. Translators use translation memory tools. Localizers use localization tools. What specialized tools exist for managing translation projects? When is automation and workflow management the answer?

This presentation, Angelika Zerfass provides an overview of the latest tools and technology available to the translation project manager, from small helpers to full-fledged workflow management tools. Learn how and when these tools can help them work faster and more efficiently, cutting costs and improving translation quality.

A Guide to Efficient Translation Management is previously recorded, and is available for download at www.fxconferences.com

21 Steps to Easier Globalization through Better Writing

Going global? Many of the problems encountered during the localization process can be traced back to the earliest stages of developing product documentation. The good news is most of these problems can be avoided by following a few basic rules.

John Smart has spent over two decades helping companies market to 218 countries. In this presentation, he will describe the 21 most common problems encountered in writing for a global audience, identifying each type of error, describing the problem and showing how to make corrections. The presentation uses real-life examples to highlight potential cultural problems, including inappropriate number and color references, and the confusing use of dates and numbers. Attendees will be able to put the conference material to immediate use in improving their technical literature.

21 Steps to Easier Globalization through Better Writing is previously recorded and is available to download at www.fxconferences.com

Regulatory Framework to Support Biomarker Development: EU & the USA

The European and US regulatory authorities recognize the potential of biomarkers to support the clinical and nonclinical development of medicinal products. Guidelines to clarify regulatory expectations have been published and both EMEA and FDA have developed procedures for companies to obtain input and advice on biomarker development. Importantly, those same regulatory authorities have both also formalized qualification procedures that result in an opinion on the acceptability/suitability of a biomarker.

This audio conference provides an overview of the EU and US biomarker qualification procedures. The speaker explains the steps involved, the data package required, and provides insight into why going through these procedures can add significant value with regards to investment opportunities, partnering and licensing deals.

Regulatory Framework to Support Biomarker Development: EU & the USA is being presented by Dr. Patricia Hurley, Head of Project Management and Biomarkers Division, with ERA Consulting (UK) Ltd. and airs on Thursday, January 21, 2010. For more details or to register, please visit our site at www.fxconferences.com

EU Medical Device eLabeling, Compliance & Software Requirements

Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. Currently, most Instructions for Use are provided in paper format, which can be very lengthy. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. This is especially the case with IVDs, since these are usually used by healthcare professionals in a clinical environment, with relatively common access to computers and Internet facilities.

However, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.

EU Medical Device eLabeling, Compliance & Software Requirements is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Wednesday, January 13, 2010. For more details or to register, please visit our site at www.fxconferences.com

Post-Marketing Issues for Medical Device Companies

Mismanaged product recalls can prove to be a drain on a business’ resources and reputation, both of which can erode a company’s bottom line for years to come. Timely, effective product recalls, on the other hand, can strengthen an organization’s brand image well into the future. Inefficient medical device reporting also presents a clear and present danger. It can damage your company’s reputation and even threaten your ability to operate. So how should an organization alter the way it does business to guarantee that if post-market problems arise, it is equipped to quickly meet and resolve these issues?

This audio conference, conducted by Caryn M. Silverman, partner at Sedgwick, Detert, Moran and Arnold LLP, provides practical, step-by-step information that will help guide you through these challenging post-marketing processes. She defines and discusses medical device reporting, recall classifications and strategies -- as well as where and when exceptions to the rule apply -- Dear Doctor letters and post-marketing surveillance. This event airs on Wednesday, January 20, 2010, for more details please visit our site at www.fxconferences.com

ANDA vs. 505(b)(2): When and Why?

The cost of development and the uncertainty of regulatory review make the development of new drugs, and even new forms of older drugs, a risky proposition. Generic drugs can utilize the ANDA pathway or, with some allowed changes, the 505(j)(C) regulatory route. This simplifies the development process and greatly shortens the time to market for products that fit the definition. But what if your product cannot fit the generic definition for approval through an abbreviated pathway? In this situation, many companies employ a 505(b)(2) strategy.

This presentation is designed to help regulatory executives understand some of the nuances of these two regulatory pathways. Our speakers clarify the processes involved in the ANDA and the 505(b)(2), and examine the advantages and disadvantages of both.

ANDA vs. 505(b)(2): When and Why? is being presented by Joel Falk & Dr. Nick Fleischer, Executive Vice President & Vice President, with The Weinberg Group and airs on Thursday, January 14, 2010. For more details or to register, please visit our site at www.fxconferences.com

Proof-of-Concept Clinical Trials: How to Maximize the Chances of Your Drug Demonstrating Benefit

Regardless of the pharmaceutical development company, therapeutic area or regulatory pathway taken to get a drug onto the market, at some point there is a need to validate the business and scientific/regulatory case in a “proof-of-concept” clinical trial. If the development program supporting a proof-of-concept trial is done well, then it is up to the drug to demonstrate an acceptable risk-benefit profile.

In this audio conference, our speaker examines the framework necessary to maximize the chance of a successful proof-of-concept trial for a new chemical entity (the hardest case). The session also includes a discussion and case histories of the supporting nonclinical safety program, pharmacokinetic and pharmacodynamic evaluations, maximum tolerated dose issues, study design and endpoints in the context of a regulated industry.

Proof-of-Concept Clinical Trials: How to Maximize the Chances of Your Drug Demonstrating Benefit is being presented by Dr. Scott Oglesby, Director, Scientific Consulting, with Beckloff Associates, a Cardinal Health Company and airs on Tuesday, January 19, 2010. For more details or to register, please visit our site at www.fxconferences.com

Best Practices: Recording and Translating Audio for eLearning

Voiceover dramatically increases the impact of training programs, and has become ubiquitous in eLearning. While new technologies have lowered audio production and distribution costs in recent years, it remains an expensive component and must therefore be done right the first time. This can be critical when dealing with large amounts of audio files or multiple languages.

In this presentation, the speaker gives practical advice to streamline the different steps of audio production, both in English and in foreign languages: script preparation, voice selection, audio recording, post-production, file naming, linguistic quality assurance and more. Attendees on the media production side, as well as the localization side, learn valuable tricks to help them achieve higher quality, faster turnaround times and lower costs.

Best Practices: Recording and Translating Audio for eLearning is being presented by Xavier Marchand, Chief Operating Officer, with JBI Studios and airs on Tuesday, January 12, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

An Integrated Approach to Managing Supply Chain Risk

Supply chain integrity has never been a bigger or more complex challenge for today's global businesses. Increased pressure for improved financial performance, combined with the need to optimize assets and resources, has resulted in a growing reliance on outsourcing and offshoring, often to developing countries. However, with the benefit of reduced costs comes the increased and more complex threat of supply chain interruption. Efficient supply chains are by definition lean, stretched and fragile, resulting in an ever-present threat of breakdown. While most organizations prepare themselves for the more obvious areas of weakness, breakdown can come from unanticipated causes and all too often, traditional insurance products fail to provide any, or sufficient, financial help.

Many companies fail to appraise the full extent of supply chain vulnerabilities, and as a result, are not totally confident that risks are managed within acceptable financial targets. In this session our experts explain how an integrated model for the identification, treatment and acceptance of risk can address these concerns.

An Integrated Approach to Managing Supply Chain Risk is being presented by James Bird & Andrew Tait, Partner, Jardine Lloyd Thompson & Principal, Core Risks Ltd. and airs on Wednesday, January 27, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

Overcoming Cultural Barriers to Global Marketing

Jean Monnet, the founder of the European Community, once declared, "If I were again facing the challenge to integrate Europe, I would probably start with culture." Culture is the context in which things happen. Whether you develop, market, sell or purchase products for a global audience or interact with people from around the world -- even if they work in the next cubicle -- you must address the issues of culture to be effective.

How and why do the needs of people from one country differ from those in a different country? How do you assess this? In this presentation we examine definitions of culture and consider how cultural differences are expressed. We will then explore the use of tools called cultural models, review the variables that define these models of culture, and weigh their usefulness. We also discuss how to develop a customized model of culture for your particular context.

Overcoming Cultural Barriers to Global Marketing was presented by Nancy Hoft, of Nancy Hoft Consulting and is previously recorded. To learn more or download this event, please visit our site at www.fxconferences.com

Contracts: Aligning Sponsor & CRO Interests

A primary objective for the outsourcing and procurement divisions of pharmaceutical and biotech companies is to select the best CRO to undertake their project and deliver it to success. A primary objective for the CRO is to deliver the project to success and earn repeat business with the Sponsor. Both parties' core objective is the same: to deliver the study to success. However, for both organizations it is essential that the business objectives are aligned and therefore, when entering into a Sponsor-CRO contractual arrangement, there are various elements of risk to be considered by both parties.

This presentation, the last in a three-part series on best practices for outsourcing, focuses on the components of managing both legal and financial risk through effective contracting.

Contracts: Aligning Sponsor & CRO Interests was presented by Lynn Polgar, Associate Director, US Contract Management Group, with Covance and is previously recorded. For more details or to download this event, please visit our site at www.fxconferences.com

Leveraging Clinical Development Opportunities in India

India presents a compelling environment for global clinical trials because of its access to investigators, large patient populations with diseases of the industrialized and developing world, a cost-effective, English-speaking graduate workforce, and progressive regulatory environment. These benefits are now well recognized by the global pharmaceutical industry. Moreover, because of India's pristine FDA audits, continued streamlining of regulatory approvals and demonstrated intent to uphold international intellectual property standards, the country has become even more attractive as an important locale for clinical development.

As a result, multinational pharmaceutical companies are striving to build clinical development capabilities within their local operating companies in India, and the country's nascent CRO industry is enjoying an annual growth of about 40%. This, however, poses resourcing constraints and unresolved ethical issues about the robustness of patient consent. Hence, it is becoming increasingly important for sponsors to select investigators, sites and resources that will be able to deliver data of the quality and integrity that they seek.

This presentation draws on recent experiences and case studies related to the benefits and challenges of conducting clinical trials as well as data management in India.

Leveraging Clinical Development Opportunities in India was presented by Dr. Nermeen Varawalla, Vice President, Investigator Relations, with PRA International and aired on 2007-05-30. For more details or to download this event, please visit our site at www.fxconferences.com

Managing Long-Term Registries: Strategies for Successful Management of Long-Term Clinical Programs

Management of registries and other longitudinal studies creates unique challenges for sponsors, CROs, and other vendors. Programs of many years’ duration are faced with management and operational challenges. Management challenges include staff turnover at the sponsor as well as CROs and vendors. Proactive management of these staff changes that ensure successful ongoing team interactions is essential to program survival. Maintenance of project document history and documentation is another management challenge for long term programs. Ensuring that project decisions and documentation are well specified and accessible to all relevant stakeholders ensures common understanding and expectations across all stakeholder groups and assists project teams in addressing questions about decisions made by predecessor teams or team members.

Operational challenges for managing long term programs include changes in the marketplace and standards of care. Changes in these over time can significantly impact sponsor needs for data. Additionally data collection tools and strategies can also change significantly over time. Use of sequential adaptive methodology to anticipate potential changes at the program planning stage can facilitate changes as these are required over time.

Finally, challenges can be posed by turnover of site staff site, and long term involvement and enthusiasm of sites can be difficult to maintain. Strategies for successful engagement of sites for the study’s duration, and retraining of site staff over time require upfront planning and ongoing re-examination. Representatives from stakeholder groups including CROs, Other Vendors/Sponsors/Sites will discuss lessons learned from the management of long term programs including strategies that have contributed to successful management as well as pitfalls to avoid in managing future programs.

Managing Long-Term Registries: Strategies for Successful Management of Long-Term Clinical Programs was presented by Eunice Franklin-Becker, Project Manager, Registries and Observational Studies, with Covance Periapproval Services and aired on 2009-02-25. For more details, or to download this conference please visit our site at www.fxconferences.com

The ABCs of FDA: Regulatory, Fraud and Abuse Issues

More and more companies are venturing into medical devices, drugs or biologics in an effort to diversify or to promote new biotechnologies. At the same time, the United States government is taking a more active role in regulating the manufacturers, providers and payers in the healthcare industry. The collision of these two trends – increased interest in marketing healthcare products along with increased government involvement in regulation and enforcement – require companies to attain FDA regulatory compliance and prevent fraud and abuse violations in order to be successful in this industry and avoid multi-million dollar fines and penalties.

In this audio conference, the speaker addresses the basic things that people and companies need to know about dealing with the FDA and succeeding in the life sciences industry.

The ABCs of FDA: Regulatory, Fraud and Abuse Issues was presented by Bethany Gilbert, with Hodgson Russ LLP and aired on 2008-05-15. For more details, or to download this event please visit our site at www.fxconferences.com

Setting Up and Managing a European Distribution Network

Lining up European distribution can be a daunting challenge. The European market is the largest consumer and industrial market in the world. The European Union (EU) has added 12 countries since May 2004, bringing the total population of the 27 EU countries to almost 500 million. The European medical technology market has 30% of the world market. With an aging population, this market has huge growth potential and is the recipient of almost half of all US medical technology exports.

To be successful in Europe, you need to set up distributors in each local market. After you determine which countries have the highest market potential, it is vital to conduct a thorough screening & selection process to find the best possible distribution partners in those countries. In addition to setting up distributors, you may also need to consider a European support structure to accommodate long term growth, including European warehousing, reverse logistics, and potentially European product support.

This presentation focuses on the opportunities and challenges of doing business in Europe, with practical advice for handling key distribution and product support issues.

Setting Up and Managing a European Distribution Network was presented by Michael van der Woude, Partner, with EDM Services and aired on 2008-10-21. For more details or to download this event, please visit our site at www.fxconferences.com