Agenda – Adaptive Clinical Trials Symposium

  • Day One
  • Day Two

Day One

 Thursday, March 22

9:00AM – 9:15AM

Chairperson’s Opening Remarks
Chitra Edwin, RAC Senior Vice President of Regulatory Affairs and Compliance, SPOTLIGHT INNOVATION

9:15AM – 10:00AM

The Platform Trial — An Efficient Approach to Clinical Development of Novel Compounds
Vlad Dragalin, Ph.D., Vice President, Scientific Fellow and Head of Quantitative Sciences Consultancy Group, JANSSEN R&D, USA

10:00AM – 10:45AM

Adaptive Trial Design: Delivering the Unicorn of Clinical Trials in the UK
Divya Chadha Manek, Head of Business Development, National Institute for Health Research (NIHR), Clinical Research Network (CRN)

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

Moving Forward: Advancements in Data Collection for Neurological Diseases
Alex Sverdlov, Director, Statistical Scientist, NOVARTIS

12:00PM – 12:45PM

Accelerated Approval at Interim Analysis and a Long-Term Endpoint for Full Approval at Final Analysis With Sample Size Adaptation Based on the Long-Term Endpoint
Mingxiu Hu, Senior Vice President, Head of Data Science and R&D Systems, NEKTAR THERAPEUTICS

12:45PM – 1:45PM

Luncheon

1:45PM – 2:30PM

In-Depth Look at the Bayesian Method for Adaptive Clinical Trial Design for the Treatment of Alzheimer's Disease
Chad Swanson, Ph.D., Director, Clinical Neuroscience, EISAI

2:30PM – 3:15PM

Accelerating Adaptive Clinical Trials Via Virtual Collaboration
Lance Hill, CEO, Within3

3:15PM – 3:45PM

Networking Break

4:30PM – 5:15PM

Implications of Personalized Medicine on Adaptive Clinical Trial Design
Chitra Edwin, RAC Senior Vice President of Regulatory Affairs and Compliance, SPOTLIGHT INNOVATION


Day Two

 Friday, March 23

8:00AM – 8:45AM

Continental Breakfast

8:45AM – 9:00AM

Chairperson’s Recap of Day One
Chitra Edwin, RAC Senior Vice President of Regulatory Affairs and Compliance, SPOTLIGHT INNOVATION

9:00AM – 9:45AM

Discover How Adaptive Design Influences Operational Analytics
Balazs Flink, Head of Clinical Trial Analytics, Business Insights and Analytics, BRISTOL-MYERS SQUIBB

9:45AM – 10:30AM

Multi-Arm Adaptive Design Incorporating Efficacy and Safety
Mark Chang, Ph.D., Senior Vice President, Strategic Statistical Consulting, Veristat

10:30AM – 11:15AM

Utilize Dose Escalation in Bayesian Design to Determine the Efficacy and Toxicity of a Drug
Inna Perevozskaya, Senior Director and U.S. Team Lead Statistical Innovation Group, GLAXOSMITHKLINE
Yuehui Wu, Director Statistics, GLAXOSMITHKLINE

11:15AM – 11:45AM

Networking Break

11:45AM – 12:30PM

Case Study: TRV130 Phase 2 Adaptive Dose-Finding Trial in Bunionectomy
Jim Bolognese, Senior Director Strategic Consulting, Cytel Inc

1:15PM – 2:15PM

Luncheon

2:15PM – 3:00PM

Recruit Patients With Inclusion/Exclusion Criteria That Are Less Strict Than Usual to Allow for Adaptive Design
Ramses Sadek, Ph.D., Professor of Biostatistics, Department of Population Health Sciences; Director of Biostatistics Core, Georgia Cancer Center, Augusta, University

3:00PM – 4:15PM

Improve Patient Enrollment Outcomes Through Real-Time Corrections During the Recruitment Process
Amer Alghabban, Managing Director, GXP COMPLIANCE and TRAINING PARTNERS LIMITED

4:15PM – 4:30PM

Chairperson’s Closing Remarks
Chitra Edwin, RAC Senior Vice President of Regulatory Affairs and Compliance, SPOTLIGHT INNOVATION