Recent Perspectives on Trial Design - Minimizing Patients for Oncology Trials

is being presented by Dr. John Constant, Vice President Scientific Affairs, with PRA International and airs on Wednesday, May 26th, 2010. For more details or to register, please visit our site at www.fxconferences.com

Oncology trials have long been at the forefront of novel design thinking, due in part to the extreme needs and historically toxic or complex therapies for cancer. With the regulatory Critical Path Initiatives and the general urgent need for more efficient clinical development adaptive and other patient – efficient designs are continuing to receive increasing attention and FDA has recently published their long-awaited Guidance on adaptive designs. This session will overview recent developments in oncology design thinking and issues related to adaptive, single arm and Phase I/II designs as used in practice in oncology trials.

Oncology Trials in 2009: Challenges & Innovative Approaches

One of the greatest risks for oncology trials today is the delay in clinical development timelines. The main reason for the timeline delay is patient recruitment. Due to the increase in the number of ongoing clinical trials in recent years, and subsequently decreased enrollment in the developed countries, innovative approaches are necessary to mitigate the risk of delay.

To meet clinical development timelines, proactive planning and comprehensive data analysis are necessary to mitigate the risk. Detailed planning and appropriate site and country selection are the most critical factors in meeting target patient accrual goals. This audio conference provides practical guidelines and innovative ideas which are useful when conducting oncology trials in the current environment.

Oncology Trials in 2009: Challenges & Innovative Approaches is being presented by Dr. Ute Berger, Vice President & Head of Medical Affairs - Europe, Africa & Asia-Pacific, with PRA International and airs on Tuesday, July 28, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Adaptive/Novel Designs in Oncology: Overview & Issues

Oncology trials have long been at the forefront of novel design thinking, due in part to the extreme needs and historically toxic or complex therapies for cancer. With FDA's Critical Path Initiative and the general urgent need for more efficient clinical development adaptive designs, these trials are receiving increased attention. There is a call to modernize drug development and utilize bioinformation to evaluate safety and effectiveness.

Adaptive designs have become popular tools in oncology research, helping to achieve more effective and affordable trials. This conference gives an overview of adaptive design thinking and issues, and explores their place in oncology trial design.

Adaptive/Novel Designs in Oncology: Overview & Issues is being presented by Dr. John Constant, Vice President Scientific Affairs, Statistical Consulting, Oncology/Hematology, with PRA International and airs on Tuesday, May 19, 2009. For more details please visit our site at www.fxconferences.com

Meeting the Challenges of Global Oncology Trials

Successful global oncology trials require careful planning, starting with looking at the strategic elements that span people, process and technology. Challenges in clinical research in oncology today include multiple new agents for multiple new targets combined with an increase in the number of patients needed to demonstrate that a therapy provides a significant benefit for patients. There is also a need to minimize the time it takes to go from basic science discoveries into clinical studies. The risk posed by delays in study start-up and patient recruitment can be mitigated by proactively planning for the study.

Planning needs to reflect the traditional and nontraditional considerations of feasibility and study design and incorporate trends and best practices. Patient recruitment is a key strategic consideration, along with epidemiological and genetic factors. Facilities, expertise and other resources along with technology play a key role in global trial planning.

Area-specific regulatory requirements vary in terms of standards of care, and differences among healthcare systems influence trial planning, as do local and cultural considerations.

This presentation focuses on the central challenges in global oncology trials today and make recommendations about how they might be addressed to mitigate risks in terms of timelines and costs.

Meeting the Challenges of Global Oncology Trials was presented by Dr. Ute Berger, Senior Director of Therapeutic Expertise Oncology & Hematology, with PRA International and is available for download at www.fxconferences.com

Effective Licensing in the Wake of MedImmune v. Genentech

The licensing of life science technologies, especially oncology-related technologies, is becoming an essential part of doing business. With MedImmune v. Genentech, the United States Supreme Court transformed the relationship between patent licensors and licensees. Historically, licensees were prevented from challenging patents on invalidity grounds. Now, a licensee may challenge a patent's validity while paying royalties to the licensor.

Although framed as a procedural question of standing to bring suit, the application of this Supreme Court case has the potential to shift the decision making of licensors and licensees and to significantly change the volume and cost of patent licensing activities. In this audio conference Dr. Samardija explores the Supreme Court decision and the various decisions that have followed, and provides attendees with 10 drafting tips to decrease the risks associated with a licensee challenging the validity of a patent.

Effective Licensing in the Wake of MedImmune v. Genentech is being presented by Michael R. Samardzija, PhD, with Bracewell & Giuliani and airs on Thursday, January 29, 2009. For more details, or to register for this conference please visit our web site at www.fxconferences.com

Meeting the Challenges of Global Oncology Trials

Successful global oncology trials require careful planning, starting with looking at the strategic elements that span people, process and technology. Challenges in clinical research in oncology today include multiple new agents for multiple new targets combined with an increase in the number of patients needed to demonstrate that a therapy provides a significant benefit for patients. There is also a need to minimize the time it takes to go from basic science discoveries into clinical studies. The risk posed by delays in study start-up and patient recruitment can be mitigated by proactively planning for the study.

Planning needs to reflect the traditional and nontraditional considerations of feasibility and study design and incorporate trends and best practices. Patient recruitment is a key strategic consideration, along with epidemiological and genetic factors. Facilities, expertise and other resources along with technology play a key role in global trial planning.

Area-specific regulatory requirements vary in terms of standards of care, and differences among healthcare systems influence trial planning, as do local and cultural considerations.

This presentation will focus on the central challenges in global oncology trials today and make recommendations about how they might be addressed to mitigate risks in terms of timelines and costs.

This event is presented by Ute Berger of PRA International. To learn more, please visit www.fxconferences.com.