Agenda – 5th Clinical Trials Phase I & Phase IIA Summit

  • Day One
  • Day Two

Day One

 Thursday, October 11

9:00AM – 9:15AM

Chairperson’s Opening Remarks
Jaclyn Patterson, Senior Director, Early Development, Clinical Trial Management, REGENERON

9:15AM – 10:00AM

Write Quality Protocols to Focus on Streamlining, Clarity and Consistency Within the Study Documents
Rosemarie Pincus, Principal Medical Writing Scientist, Oncology Division, JOHNSON AND JOHNSON

10:00AM – 10:45AM

Identify, Prepare for, and Recruit Special Populations
Presented by High Point Clinical Trials Center

10:45AM – 11:15AM

Networking Break

12:45PM – 1:45PM

Luncheon

1:45PM – 2:30PM

Bayesian Adaptive Design for the Treatment of Alzheimer’s Disease: Application to Early Stage Development
Chad Swanson, Senior Director, Clinical Neuroscience, EISAI

3:15PM – 3:45PM

Networking Break

3:45PM – 4:30PM

Dealing With Uncertainty in First-in-Human and Early Clinical Trials
Howard Uderman, M.D., Senior Medical Director Clinical Development and Outcomes Research, Novo Nordisk Inc.

4:30PM – 5:15PM

PANEL: Evaluate Different Methods to Improve Safety and Efficacy While Diminishing Risk
Sudeesh K. Tantry, Ph.D., Vice President, Clinical Development, GLENMARK PHARMACEUTICALS
Pranab Mitra, Associate Principal Scientist, Merck


Day Two

 Friday, October 12

8:00AM – 9:00AM

Continental Breakfast

9:00AM – 9:15AM

Chairperson's Recap of Day One
Jaclyn Patterson, Senior Director, Early Development, Clinical Trial Management, REGENERON

9:15AM – 10:00AM

Develop a Successful Relationship Between Sponsor and CRO That Satisfies the Interest of All Parties Involved
Jaclyn Patterson, Senior Director, Early Development, Clinical Trial Management, REGENERON

10:00AM – 10:45AM

Identify Recruitment Challenges With Special Populations
William B. Smith, M.D., FACC, President, NEW ORLEANS CENTER FOR CLINICAL RESEARCH

10:45AM – 11:15AM

Networking Break

11:15AM – 12:15PM

Establish Data Architecture Using Innovative Cloud Services
Brian Smith, VP, Operations, ERT

12:15PM – 1:15PM

Luncheon

1:15PM – 2:00PM

Investigate the Biomarker Disparities and Applications in Early Stage Clinical Development
Ramon Mohanlal, Chief Medical Officer, BEYONDSPRING PHARMACEUTICALS

2:00PM – 2:45PM

CASE STUDY: Consider an Uncommon Method to Further Advance the Implementation of Standards During Design and Analysis
Farhan Hameed, Director, Clinical Informatics Lead, Digital Medicine and Pfizer Innovation Research (PfIRe) Lab, Early Clinical Development, World Wide Research & Development, PFIZER

2:45PM – 3:30PM

Chairperson’s Closing Remarks
Jaclyn Patterson, Senior Director, Early Development, Clinical Trial Management, REGENERON