Finding and Assessing Global Drug Development Partners

It takes, on average, somewhere around 15 years and a billion dollars to take a drug development project “from bench to bedside.” One factor contributing greatly to that protracted timeline is the significant difficulty in finding and then collaborating with qualified partners. The problem is exacerbated when development is taking place on a global scale. Asking colleagues and consultants might net you a recommendation for the largest CROs, but if you need a good regulatory consultant familiar with Chinese Investigator Document Review, for example, you could be out of luck. And even when a pharma company does identify a service provider, the interaction isn't straightforward: there is no simple way of searching for and comparing services, profiles and reputation.

There are myriad websites designed to help consumers find hotels and local businesses, and they have made these transactions much more transparent. However, the life sciences industry has lagged behind: companies still mainly generate leads on development partners largely by word of mouth and by attending industry trade shows and conferences. In this audio conference, our speaker explores new ways to connect, evaluate and engage drug development partners around the world.

Finding and Assessing Global Drug Development Partners is being presented by Jae Chung, Founder & CEO, of goBalto and airs on Tuesday, February 9, 2010. For more details or to register, please visit our site at www.fxconferences.com

Clinical Trials: Why is India Irresistible?

In recent years, India has proven itself as a solid-performing region for conducting clinical trials. As it has evolved and emerged, it has caught the attention of global pharmaceutical and biotech companies. The reason for the growth in this region is simple: India, with a population of over 1.15 billion people, has one of the largest patient populations in the world. In addition to its large patient population, India has nearly 700,000 specialty hospital beds, 290-plus medical colleges, and skilled English-speaking medical professionals.

In this session we examine the factors that have made India one of the hottest places in the world to conduct clinical trials. Attendees come away with proven strategies to overcome challenges and maximize the “India advantage.”

Clinical Trials: Why is India Irresistible? is being presented by Dr. Pramod Kabra, Director of Clinical Operations, with PRA International and airs on Thursday, January 28, 2010. For more details or to register, please visit our site at www.fxconferences.com

Design and Regulatory Considerations in Anti-Infective Drug Development

The current regulatory environment in anti-infective drug development is changing due to updates in submission requirements as well as the potential for risk mitigation strategies post-launch. Conversely, the need to develop drugs with acceptable risk/benefit profiles for emerging and re-emerging infectious diseases is certainly present considering the rising concerns of disease due to drug-resistant pathogens, biothreat agents and novel influenza strains.

In this conference our speakers review some of the basic principles surrounding anti-infective drug development in the framework of regulatory submissions. They also provide an update on some of the most important changes in recent years related to specific anti-infective indications.

Design and Regulatory Considerations in Anti-Infective Drug Development is being presented by Dr. John Powers, George Washington University School of Medicine & Dr. Carl Kraus, PRA International and airs on Wednesday, December 16, 2009. For more details or to register, please visit our site at www.fxconferences.com

Studies in Special Patient Populations: More than Just a Regulatory Requirement

In global drug development, supportive trials -- such as those in special patient populations -- are required to complement the regulatory submission package. Studies in hepatically or renally impaired patient populations are therefore often performed in parallel to Phase III trials in order to have them completed when the NDA is filed. However, in aging populations with reduced organ function, these studies can provide valuable information on interpretation of clinical data generated in Phases II and III.

In this audio conference, the speaker discusses the strategic and organizational aspects of these trials, while providing a deeper understanding of their value in special patient populations.

Studies in Special Patient Populations: More than Just a Regulatory Requirement is being presented by Dr. Christian Reh, Vice President, Clinical Affairs, Early Development Services, with PRA International and airs on Thursday, October 29, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Conducting Drug Trials in Asia Pacific

With constant pressure to reduce the cost of drug development and to find eligible subjects for clinical trials, developing areas of the world are of increasing interest to trial sponsors. But how does the quality of data compare with traditional sites? And what about the rate of recruitment? Do these alternative sites really offer a substantial benefit in terms of time and cost savings?

This presentation, the second in a series featuring speakers from Covance addressing alternative site selection, focuses on the opportunities and the reality of performing clinical trials in the Asia Pacific market.

Conducting Drug Trials in Asia Pacific was presented by Dr. Helen Ormandy, Director, Centres of Excellence, with Covance Asia Pacific and aired on 2006-05-04. For more details or to download this conference, please visit our site at www.fxconferences.com

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Building Bridges: A Practical Guide to Leading Global Pharma and Biotech Teams

Today, whether the task is to develop a new drug, launch a product or work on a strategic project, much of our work is done through global teams. These teams are usually cross-functional, cross-geographic, cross-cultural and span multiple time zones. They may also cross company lines through strategic alliances. They face the challenges of having to work "virtually", with a balance of high tech and high touch.

Based on Lynda's experience working with over 1,000 global teams in over 25 countries, She will provide the participants with "best practice" learnings and tools relevant to developing and leading world class global teams.

Building Bridges: A Practical Guide to Leading Global Pharma and Biotech Teams is presented by Lynda McDermott, President, of EquiPro International and airs Wednesday, November 19, 2008. For more details or to register please visit our site www.fxconferences.com

Changing Your Approach for Success in Post-Market Research

There is a growing industry awareness of post-marketing research, thanks to the many pressures surrounding this phase of drug development. The demands of new regulatory guidelines, decreased pipelines, challenges to extend life cycle management, and increases in drug and healthcare costs, have propelled pharmaceutical and biotech personnel into the world of post-marketing research. These changes have, in turn, made it necessary to understand the differences between pre-marketing and post-marketing environments.

In this audio conference, the speaker provides a fresh perspective and useful tools to help attendees strategically plan and execute post-marketing research.

Changing Your Approach for Success in Post-Market Research is presented by Maria Harrison, Vice President, Late Phase Development, of PRA International and airs Thursday, Oct. 16, 2008. For more information or to registration, please visit our site www.fxconferences.com

Alternative Site Selection: China

This will be the second of two Covance audio conferences dealing with alternative site selection, and will focus on opportunities for the conduct of clinical research in China. This presentation will provide an overview of the current clinical research environment in China and explore reasons why China should be considered as part of global drug development strategies.

Alternative Site Selection: China is presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, of Covance. For more details please visit our site www.fxconferences.com