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2012 Transforming Drug Development Brochure 
Final Brochure 

produced by

AptivSolutions 

 

Berry Consultants 

 

TessellaNEW 

 

7:30 Registration and Continental Breakfast 

8:30 Chair's Introduction to Morning Session

Roger LewisRoger Lewis, M.D., Ph.D., Professor of Emergency Medicine, Harbor-UCLA Medical Center; Senior Medical Scientist, Berry Consultants, LLC





What is Currently Wrong in Drug Development? 

8:45 Understanding and Building on the Limitations of Traditional Drug Development

Kenneth GetzKenneth Getz, Senior Research Fellow, Director of Sponsored Programs, Tufts CSDD Chairman, CISCRP




  • Delineating challenges in traditional R&D productivity and efficiency
  • Identifying opportunities to improve and transform R&D
  • Envisioning future strategies and practices

What is the Adaptive Design Proposition?  

9:30 The Potential of Adaptive Designs

Don BerryDon Berry, Ph.D., Professor of Biostatistics, University of Texas MD Anderson Cancer Center; Founder and Senior Statistical Scientist, Berry Consultants, LLC




  • Why adapt? How to adapt? Examples
  • What role for Bayes?
  • Asking—and answering—many questions in one trial, including who benefits from what therapy?

10:00 The Design of Complex Adaptive Trials

Scott BerryScott Berry, Ph.D., President & Senior Statistical Scientist, Berry Consultants, LLC





  • The process of creating an adaptive trial
  • The role of simulations in the design
  • Understanding the value and efficiencies of adaptations

10:30 Coffee Break

10:50 The Benefits of Modelling and Simulating Clinical Trials

Tom ParkeTom Parke, Head, Clinical Trial Solutions, Tessella





  • Integration with PK/PD and early clinical
  • Refinement of the design with the clinical team
  • Quantitative decision making about drug development strategy

11:20 Execution of Complex Adaptive Trials

Vlad DragalinVlad Dragalin, Ph.D., Senior Vice President, Innovation Center, Aptiv Solutions





  • Linking design to execution
  • Maintaining trial integrity
  • The central role of integrated technology

11:50 PANEL DISCUSSION: The Adaptive Proposition

Moderated by Roger Lewis, M.D., Ph.D., Professor of Emergency Medicine, Harbor-UCLA Medical Center; Senior Medical Scientist, Berry Consultants, LLC

12:30 Networking Luncheon

1:30 Chair's Introduction to Afternoon Session

Andy GrieveProfessor Andy Grieve, Senior Vice President,Clinical Trial Methodology, Aptiv Solutions





Implementing the Solution and Barriers to Wider Adoption 

1:45 Implementation of Trial Optimization

Brenda GaydosBrenda L. Gaydos, Ph.D., Research Fellow & Head, Clinical Trial Optimization, Eli Lilly





  • Trial design optimization
  • Improving estimates of risk and use in decision making
  • Scalable approach to leverage trial simulation

2:30 Implementation of Adaptive Trials and the Barriers

Mike Krams, M.D., Vice President & Head, Neurology Franchise, Johnson & Johnson

3:15 Refreshment Break

 

Implementing the Change Strategy 

3:35 Implementing the Change Strategy

Steve Arlington, Ph.D., Global Advisory Leader, Pharmaceuticals and Life Sciences, PwC

  • Creating the momentum for change
  • Communicating with stakeholders
  • Creating a framework for success

The Long Term Vision 

4:15 The Future Vision For Product Development

Scott GottliebScott Gottlieb, Research Fellow, American Enterprise Institute





  • What does reshaping the industry through wider adoption of innovative adaptive designs actually mean
  • What will product development look like in 5 years time
  • How do we deliver an action plan for success

5:00 PANEL DISCUSSION: The Need, Opportunities and Challenges

Moderated by Professor Andy Grieve, Senior Vice President, Clinical Trial Methodology, Aptiv Solutions

5:45 Cocktail Reception
 

chairpersons

Professor Andy Grieve,
Senior Vice President, Clinical Trial Methodology, Aptiv Solutions

Roger Lewis, MD, Ph.D.,
Professor of Emergency Medicine Harbor-UCLA Medical Center Senior Medical Scientist, Berry Consultants, LLC

speakers

Kenneth Getz,
Senior Research Fellow, Director of Sponsored Programs, Tufts CSDD Chairman, CISCRP

Don Berry, Ph.D.,
Professor of Biostatistics, University of Texas MD Anderson Cancer Center; Founder and Senior Statistical Scientist, Berry Consultants, LLC

Scott Berry, Ph.D.,
President & Senior Statistical Scientist, Berry Consultants, LLC

Tom Parke,
Head, Clinical Trial Solutions, Tessella

Vlad Dragalin, Ph.D.,
Senior Vice President, Innovation Center, Aptiv Solutions

Brenda L. Gaydos, Ph.D.,
Research Fellow & Head, Clinical Trial Optimization, Eli Lilly

Mike Krams, M.D.,
Vice President & Head, Neurology Franchise, Johnson & Johnson

Steve Arlington, Ph.D.,
Global Advisory Leader, Pharmaceuticals and Life Sciences, PwC

Scott Gottlieb,
Research Fellow, American Enterprise Institute