Agenda – 6th Clinical Trials Phase I & Phase IIA Summit

  • Main Conference Day One
  • Main Conference Day Two

Main Conference Day One


9:00AM – 9:15AM

Co-Chairpersons' Opening Remarks
Jim Nissel, Senior Director, Clinical Pharmacology, Celgene
Laura Vessey, Director of Early Development, Clinical Oncology, Johnson & Johnson

9:15AM – 10:00AM

Proactive Vs. Reactive — Identify Strategies to Mitigate Risk in Your Clinical Development
Wesley Day, Vice President and Head Clinical Development, Mitsubishi Tanabe

10:00AM – 10:45AM

Concordance of Respiratory and CNS Safety Pharmacology Findings: Translation to the Clinic
Bruce Morimoto, Vice President, Drug Development Operations, Alkahest

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

Implementing an Outsourced Model for Your Early Phase Clinical Operations
Jim Nissel, Senior Director, Clinical Pharmacology, Celgene
Susan Lubin, Associate Director of Operations, Bristol Myers Squibb

12:00PM – 12:45PM

Comprehensive Early Clinical Development Plans — Creating a Road Map to Success
Paul Rothenberg, Executive Director, Strategic Product Development, COVANCE

12:45PM – 1:45PM


1:45PM – 2:30PM

Bioinformatic Considerations for Early Stage Biomarker Implementation and Analysis
Danielle Greenawalt, Director, Head Early Stage Translational Bioinformatics, Bristol-Myers Squibb

2:30PM – 3:15PM

Streamlining Your Study Documents With Consistency and Clarity by Writing Quality Protocols
Jim Sabogal, Head of Healthcare and Life Sciences, T-Systems North America

3:15PM – 3:45PM

Networking Break

3:45PM – 4:30PM

Roadblocks With Minority Enrollment Onto Clinical Trials
Martin Gutierrez, Director, Phase I Program, Hackensack Meridian Health
Chelsea McCabe, Phase I Oncology, Hackensack Meridian Health

4:30PM – 5:15PM

Streamline Your Study Documents With Consistency and Clarity by Writing Quality Protocols
Rosemarie Pincus, Principal Medical Writing Scientist, Johnson & Johnson

5:15PM – 5:15PM

Day One Concludes

Main Conference Day Two


8:00AM – 9:00AM

Continental Breakfast

10:00AM – 10:45AM

From Addition to Integration — Innovative Approaches to Integrating Japan Into Global Clinical Development
Nozomu Miyawak, Senior Manager of Global Clinical Development, Souseikai

10:45AM – 11:15AM

Networking Break

11:15AM – 12:15PM

Examine the Challenge of Identifying and Recruiting Special Populations
William B. Smith, President, New Orleans Center for Clinical Research

12:15PM – 1:15PM


1:15PM – 2:00PM

How QT Studies in Phase I Can Save Time, Cost, and Complications
Pranab Mitra, Associate Principal Scientist, Merck

2:00PM – 2:45PM

Effective New Patient Recruitment: What Method Should You Be Employing?
Angela Genge, Executive Director, Clinical Research Unit, The Montreal Neurological Institute