5th Annual Phase I Studies

Venue: Park Hyatt Washington

Location: Washington DC, United States

Event Date/Time: Jan 26, 2004 End Date/Time: Jan 29, 2004
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Examining Regulatory Updates and Case Studies on New Approaches to Optimize Phase I Trials

New Regulation/Guidance for Phase I

Regulation and guidance recently introduced in the US, Europe and Canada has greatly impacted Phase I trials: the FDA safe starting dose for adult healthy volunteers; FDA/ICH E14 QTc; the European Clinical Trial Directive; and changes in the IND requirements for the conduct of trials in healthy volunteers for Phase I imposed by Health Canada.

Earlier Go/No Go Decisions

Ongoing experimentation in Phase I trials is creating new approaches that generate more informative data sets. These Phase I data sets enable earlier go/no go decisions and a smoother transition to Phase II. Such methodologies however now need to be conducted in accordance with the new regulation and guidances.

In light of these recent developments, the objective of IIR’s 5th Annual Phase I Clinical Trials event is two-fold:

Firstly, on Conference Day One (Regulation/Guidance Updates) we examine the full impact of the new regulation and guidance. The European Forum for Good Clinical Practice gives updates on the European Clinical Trial Directive; Philip Sager, MD, FACC, FAHA, FACP, Director, Cardiovascular Research, Schering-Plough Research Institute and ICH E14 Expert Working Group Member discusses the current approach to performing the Thorough Clinical QT and its impact on Phase I trials; and Health Canada addresses its clinical trial regulation and inspection program. A case study follows on conducting a Phase I trial under the regulation in Canada.

Secondly, on Conference Day Two (Practical Implementation), we present industry case studies with new data illustrating different approaches to optimize Phase I trials. Among the issues examined is a case study on accurately modeling dose selection and escalation; a Human Genome Sciences case study on interspecies Pharmacokinetic scaling of albumin fusion proteins: application to the First-in-Human clinical trial of Albuferon™; Merck gives an update on the latest developments in biomarkers, providing you with practical points for implementation; and an assessment of the applicability of the oncology approach to Phase I to other therapeutic areas is also given.

Post-Conference Seminar: January 29, 2004
Optimizing Phase I Oncology Trials

At the request of previous attendees and professionals in clinical pharmacology who kindly gave their input for the content of this event, we are proud to present a new one-day post conference seminar that focuses on optimizing Phase I oncology trials. Through case study presentations, the objective of this seminar is to understand best practices approaches to optimize Phase I oncology trials.

Seminar Highlights Include:

Applying NCI Concepts in Oncology Biomarkers to Industry Sponsored Phase I Trials for Improved Quality and Speed

Learn from Pfizer Case Studies on PK/PD Driven Phase I Development in Oncology: Achieving Early Proof-of-Concept with a Single Dose Trial in Cancer Patients Used as Volunteers

Gain from the Daiichi Experience in the Optimal Use of Pre-Clinical and Phase I Information to Improve and Accelerate Go/No Go Decision-Making in Cancer Therapy

Pre-Conference Half-Day Workshops:
January 26, 2004

We are also happy to start the event with two new half-day workshops:

Optimizing Phase I Studies with Biologics to Facilitate Earlier Go/No Go Decisions
Cardiovascular Safety Assessment in Phase I Clinical Trials