Hear from the leading experts at the industry's premier event as they share their experiences and discuss the methodology, logistics, and tools necessary to achieve maximum benefits when implementing adaptive clinical trials.
| NEW ADDITION TO THE PROGRAM | Featured Presentation
Adapting FDA Trial Design to Guide the More Effective Use of Medicines
Scott Gottlieb, M.D., Resident Fellow, American Enterprise Insitute - Former Deputy Commissioner, Medical & Scientific Affairs, FDA | |
 |
| | Special Offer for "Virtual", Start-up and Emerging Companies
As part of IBC's ongoing effort to support the initiatives of small and emerging companies, a limited number of reduced rate passes will be made available to "virtual", start-up and emerging companies to attend this conference. For eligibility criteria and to apply for one of these passes, please contact Tracy Beaudoin at tbeaudoin@ibcusa.com. | |
|
| | Keynote Presentations Adaptive Trials: Unlocking the Opportunity and the Competitive Advantage
Jerald S. Schindler, Dr. P.H., Vice President, Biostatistics and Research, Decision Sciences, Late Stage Clinical Development Statistics, Merck Research Laboratories Experience with Adaptive Dose-ranging Studies in "Learn"
Michael Krams, M.D., Assistant Vice President, Clinical Development, Adaptive Trials, Wyeth Research | |
|
| | "If we are successful in better adapting scientifically rigorous information that helps predict response into the clinical trials themselves, the results will be clinical development programs that tell doctors a lot more about which patients are likely to benefit from a new medicine. It will enable the day when we are able to reliably deliver the right drug in the right dose to the right patient." -Scott Gottlieb, M.D., Resident Fellow, American Enterprise Insitute - Former Deputy Commissioner, Medical & Scientific Affairs, FDA | |
|
Adaptive Designs are no longer just a concept, rather the future of clinical trials. Pharmaceutical companies are increasingly conducting adaptive trials allowing them to make early strategic decisions that are resulting in lowered costs, reduced risk, and improved efficiencies.
IBC's 4th International Adaptive Designs for Clinical Trials conference is the leading forum to provide you with the solid knowledge of the methodology, recent advancements and strategic guidance on how, when, and why to implement an adaptive design.
By attending this conference you will:
- Benefit from real-world case studies presented by AstraZeneca, GlaxoSmithKline, Cytel Inc., and others on how adaptive clinical trials are being implemented, the logistics behind the planning, and the results.
- Hear from industry leaders on recent advancements and regulatory positions—how and when to involve the FDA.
- Gain a solid understanding of commonly used adaptive methods, the Bayesian decision approach, and practical issues and recommendations.
- Discuss the key guidelines for implementing an IT infrastructure and outline a strategy for staged implementation.
- Listen to presentations from members of the PhRMA Adaptive Design Working Group on experiences, disease areas, strategies and types of adaptations most commonly used.
- Learn how and when to use Phase II/III seamless designs.
- Determine the impact of dose-selection strategies on the probability of success in Phase III.
