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
Laura Vessey, Director, Early Clinical Development, MERCK

9:15AM – 10:00AM

Discuss the Vital Aspect Protocol Has in Order to Advance Drug Development During Early Stage Development
Rosemarie Pincus, Senior Protocol Writer, 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

11:15AM – 12:00PM

Develop a Successful Relationship Between Sponsor and CRO That Satisfies the Interest of All Parties Involved
Laura Vessey, Director, Early Clinical Development, MERCK

12:45PM – 1:45PM

Luncheon

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.


Day Two

 Friday, October 12

8:00AM – 9:00AM

Continental Breakfast

9:00AM – 9:15AM

Chairperson's Recap of Day One
Laura Vessey, Director, Early Clinical Development, MERCK

10:45AM – 11:15AM

Networking Break

11:15AM – 12:15PM

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

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

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

2:45PM – 3:30PM

CASE STUDY: Evaluate the Continued Development of the Risk Management System to Stay in Compliance During Early Stage Development
Joe Kunakorn, M.S., Associate Director, Headquarters Clinical Quality Management, Oncology, Quality and Continuous Improvement, MERCK

3:30PM – 3:45PM

Chairperson’s Closing Remarks
Laura Vessey, Director, Early Clinical Development, MERCK