| Trial Design| MONDAY, FEBRUARY 25th:PRE-CONFERENCE SYMPOSIUMS | | | 1: Optimizing Trial Design |
| | 10:50 | Opening Remarks from the Symposium Chair Larry A. Blankstein, PhD, Senior Director, Clinical Research, GENZYME |
| | 11:00 | Justifying your Dose when Dose Ranging Isn't Possible
| | • | Differentiation of efficacy effects in individual cohorts is frequently impractical | | • | The use of advanced design techniques coupled with modeling can more accurately predict the dose than conventional methods | | • | Examples of such techniques are presented |
Robert Schmouder, Head of Translational Medicine, NOVARTIS |
| | 11:40 | Biomarkers and the Transition to Personalized Medicine | | • | The use of biomarkers may significantly contribute to more efficient drug development through characterization of disease in the individual patient,
early detection of subclinical toxicity, and indicators of drug activity | | • | Key activity/safety biomarkers used in drug development will be transitioned into Individualized medicine applications | | • | Examples of success and of issues will be presented using bone biomarkers |
Lawrence Oliver, PhD, Scientific Director, Mayo Clinical Trial Services,
Department of Laboratory Medicine and Pathology, MAYO CLINIC |
| | 12:20 | Luncheon for Coference Attendees |
| | 1:40 | Clinical Trials in Oncology: New Challenges and Perspectives Clinical development in oncology will become increasingly more difficult in terms of endpoints, sample size, statistics... We review some of the key issues related to clinical
trials in oncology and discuss some of the solutions proposed to overcome these points. Jean Pierre Bizzare, Vice President Clinical Oncology, SANOFI-AVENTIS |
| | 2:20 | Seamless Trial Design and Adaptive Clinical Trials Everyone benefits when we maximize the use of interim analysis to increase the efficiency and safety of medical product development. Many design aspects of clinical trials are amenable to adaptation. This presentation explores these concepts and illustrate how we may seamlessly progress from one trial phase to another. David B. Snead, PhD, Associate Director, Biostatistics, CENTOCOR R&D, INC |
| | 3;00 | Afternoon Networking & Refreshments Break |
| | 3:30 | Breaking the Recruitment Paradigm: Recruit Only Pre-Qualified Candidates See the impact of harnessing the largest database of its kind with unique algorithms, scoring methods, and weighting models. | | • | Forecasting optimal inclusion/exclusion criteria | | • | Saving months in clinical trial timelines & preventing millions in lost revenue from study delays | | • | Benefiting from "real-time" recruitment and trial status | | • | Directing pre-qualified patients (based on protocol) to high-scoring investigators | | • | Realizing higher retention rates, less MD effort |
Paul Smith, Chief Operating Officer, PROVISIO, INC |
| 4:00
| Aligning Drug Supply Expectations: Governance to Develop & Administer Policy and Manage Supply Challenges
Developing policies for drug supply in a global company while managing
drug supply challenges and assessing impact on operations and the
portfolio at large is challenging. The use of escalation and governance
bodies to globally administer policy and manage limited supply
chain resources is discussed. Examples of successes are provided
(e.g. reduction in time for label approval, development portfolio prioritization). Kunal Jaiswal, Associate Director, Clinical Supply Chain,
SCHERING PLOUGH CORPORATION
|
|