Institute for International Research

Online Documentation Now Available!

Dear Colleague,

It is a particularly interesting and important time in the Phase I industry. Many methods have been created to determine the efficacy of a drug before it reaches the human trials stages; microdosing, biomarkers, pk/pd modeling and biosimulation. These instruments have been utilized now for years; however the rate of attrition and money spent on new compounds by the industry has increased dramatically, with no substantial new products to show for it. The FDA's Critical Path Initiative outlines the value of using these methods in pre-clinical studies. However, budgetary constrictions and lack of manpower don't necessarily allow the exploration of these processes or tell you if they have been effective. Recent industry news regarding patient safety has been of particular concern. What's the solution?

The 7th Annual conference is designed to help those in charge of Phase I Trials explore solutions to make earlier go/no go decisions, reduce attrition and ensure patient safety.

Sessions are designed to obtain the latest information about:M

• Patient safety in clinical trials
• Thorough QT/QTc Studies
• Biomarkers
• Microdosing
• Computer simulation
• Translational medicine
• The Critical Path Initiative
• Innovative trial design
• Overseas Phase I trials
• Optimization in Trial Design

Day One begins with the goals and progress of the Critical Path Initiative. The program continues with the latest developments in translational medicine and biomarkers. The afternoon is dedicated to presenting sessions on information about designing effective, innovative trials, using computer simulation in earlystage clinical research and comparing the nuances of regulatory framework in the United States, Canada and the European Union.

Day Two kicks off with analyzing the value of microdosing in Phase I trials. The conference continues with a keynote address by Hamilton Jordan, former White House Chief of Staff and four-time cancer survivor, who provides the industry with a look at clinical trials from a patient's perspective. The morning concludes with presentations by Francis P. Crawley on learning from the TGN1412 London Phase I study, exploring trials overseas and the future of partnerships abroad. The afternoon kicks off with a look at using IRBs to promote timely, compliant reviews. It continues with a presentation about using exploratory INDs to help you use less resources. Following is an extensive case study outlining clinical trial optimization and it's applicability to early-stage studies. The conference concludes with a look at personalized medicine and it's effect on the future of Phase I Trials.

Pre-Conference Workshops

• Overcoming Challenges Currently Affecting Patient Recruitment
• Examining the Use of QT Studies in Phase I Trials

Don't miss this opportunity to learn from a truly distinguished faculty on benchmarking best practices for go/no go decision making, efficiencies in development and most importantly ensuring patient safety. The conference includes networking functions designed to help you exchange information with other thought leaders in the industry. Send your team and benefit from IIR's special group discount – three or more individuals and you'll receive a 15% discount off the registration fee. We look forward to seeing you October 11-13 at Red Rock Resort in Las Vegas.

Sincerely,