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16 October 2007, Tuesday 

12:00 pm Luncheon Workshop
(Sponsorship Available. For more information, contact Arnie Wolfson at 781-972-5431 or awolfson@healthtech.com)

SESSION I: 
LAYING THE GROUND WORK FOR EARLY DECISION MAKING

1:45 Welcome to Toronto

1:50 Co-Chairperson’s Opening Remarks
Jerald S. Schindler, Dr. P.H., Vice President, Biostatistics and Research Decision Sciences, Late Stage Clinical Development Statistics, Merck Research Laboratories
2:00 Setting the Stage for Adaptive Design Trials
Judith A. Quinlan, Ph.D., Director Statistics, Biopharmaceuticals, GlaxoSmithKline
Adaptive designs are more than just a buzz word. In this presentation the audience will be introduced to the concept of adaptive designs. The definition of an adaptive design will be provided, along with answers to important questions about why we need to adapt, and have greater flexibility in clinical trials. There will be an overview of where in clinical development adaptive designs can be used and be of benefit, with particular reference to their utilization within the learn and confirm paradigm. However, the advantages of adaptive designs to drug development don’t stop there, and an introduction to how adaptive designs can be of benefit as a portfolio management tool will also be introduced. 
2:30 How Wyeth is Transforming R&D: The Learn and Confirm Model of Clinical Development
Michelle J. Ballard, Ph.D., P.M.P, Director, R&D Implementation Office, Wyeth Research
In 2006, Wyeth began to implement a major transformation of its R&D organization by putting in place “The Learn and Confirm Model” of Clinical Development, which shifts the paradigm from the traditional clinical phases I, II, III, to a more flexible and responsive approach to development. Specifically, this presentation will review:
  • Wyeth’s development team structure, which strategically focuses on disease specific portfolios of assets 
  • Our enhanced capabilities enabled by: 1) integration of development strategies and “Learning” across assets, and 2) application of innovative approaches such as modeling and simulation, translational medicine, and adaptive trial designs 
  • The novel breakthrough changes that have been implemented to enhance operational efficiency and support innovation throughout Learn and Confirm, and our approach to managing the magnitude of change.
3:00 The Use of Bayesian Methods in Go/No-Go Decision Making
Graeme E. Archer, Ph.D., Statistics Director, Psychiatry Centre of Excellence in Drug Discovery, GlaxoSmithKline
Bayesian techniques are becoming quite commonplace in drug development, and the use of adaptive designs is becoming more widespread. However, the great utility of Bayesian thinking lies in allowing more natural portfolio progression decisions, based on the data available at any point in time (because of the Likelihood Principle). I will show some relatively simple techniques, which help cross-disciplinary Project Teams set sensible (not p-value driven) hurdles for Go/No-Go decision making for an asset, both at an interim decision-point and at a study endpoint, based on multiple studies or multiple endpoints within studies. The talk will be illustrated with real examples.

3:30 Exhibit Viewing, Networking and Refreshment Break

4:00 Evaluating Adaptive Dose-Ranging Studies: Conclusions and Recommendations from the PhRMA Working Group
Jose Pinheiro, Ph.D., Director, Biostatistics, Novartis
Poor dose selection resulting from incorrect or incomplete knowledge of dose response relationship is one of the root causes of high attrition rates currently observed in Phase III trials. Adaptive dose-ranging studies form an innovative class of designs aimed at striking the desired balance between needed dose response information and increased costs and timelines. In these designs, the number of doses and/or proportion of patients allocated to doses are allowed to change as safety and efficacy information is accrued and analyzed. As part of its Pharmaceutical Innovation Steering Committee initiative, PhRMA has formed a working group (WG) to evaluate and propose recommendations on the use of adaptive dose-ranging designs in clinical development. This WG has evaluated different adaptive and non-adaptive dose-ranging methodologies, under a variety of practical trial scenarios, through a comprehensive simulation study. This talk will discuss the conclusions and recommendations from the WG.
4:30 Adaptive Clinical Trials – Making Them Happen
Tom Parke, BSc, Head of Adaptive Clinical Trial Solutions
There is increasing interest in using adaptive clinical trials to improve the efficiency and effectiveness of drug development, but currently there is a lot more interest than actual action. One of the significant barriers to the use of these trials is the perceived difficulty in implementing them. Tessella has however had the good fortune to be involved in some highly innovative adaptive clinical trials. This talk will draw on our experience, describing some of the strategies and techniques that we can see emerging from the trials we have run and those we are currently involved with. 
5:00 Adaptive Dose-finding Designs for Oncology Single and Dual Agent Combinations Using Accumulated Data from all Patients
Sumithra J. Mandrekar, Ph.D., Biostatistician, Division of Biostatistics, Mayo Clinic
Historically, designs for chemotherapeutic dose seeking trials have been geared towards finding the maximum tolerated dose, with safety as the primary outcome. Agents with specific biologic targets with unknown dose efficacy curves and limited toxicity profile require novel designs. We present designs for identifying an optimal dose or combination region utilizing both toxicity and efficacy data. A continual reassessment method with straightforward dose selection criteria using accumulated data from all patients treated thus far is employed based on the flexible continuation-ratio model. A generalization of the single agent model allowing for separate toxicity and efficacy curves for each agent to generate a dose outcome surface for the two agent combination is used. Our simulation studies demonstrated that the proposed designs have favorable operating characteristics under a variety of scenarios.

5:30 Panel Discussion with Speakers

6:00 Adjourn

6:30 Net Working Reception 
(Sponsorship Available. For more information, contact Arnie Wolfson at 781-972-5431 or awolfson@healthtech.com

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