Agenda – Investigator-Initiated Trials (IIT) Forum

  • Day One
  • Day Two

Day One

 TUESDAY, NOVEMBER 19

9:00 – 9:15

INTRODUCTION FROM CHAIRPERSON
Jennifer Gaskin, Director, Head of Global Medical and Scientific Affairs, KARYOPHARM THERAPEUTICS INC

9:15 – 10:00

ENHANCE YOUR OPERATIONAL IITs THROUGH A DIVERSE BENCHMARKING AND PROCESSES EXPERIENCE
Kimberly Cheshire-Kinney, Global Operations Head, IIS and Collaborative Studies-MAO, Global Clinical Development Operations, JANSSEN
Robert Jones, Global Program Lead, Collaborative Studies, Medical Affairs Operations, JANSSEN

10:00 – 10:45

BENCHMARK BEST PRACTICES FOR MAINTAINING AND ESTABLISHING START-UP RELATIONSHIPS
Christy Gilchrist, Ph.D., CRA, Director, Cancer Research Institute, SAINT VINCENT HOSPITAL

10:45 – 11:15

NETWORKING BREAK

11:15 – 11:45

DEVELOPING A PILLAR OF INVESTIGATOR-INITIATED TRIALS TARGETING PATIENT-CENTERED OUTCOMES RESEARCH (PCOR)
Manisha Verma, M.D., MPH, Director, Research Department of Digestive Diseases and Transplantation, Einstein Healthcare Network, Assistant Professor of Medicine, Sidney Kimmel Medical College

11:45 – 12:30

EVALUATE FAIR MARKET VALUE (FMV) STANDARDS AND UTILIZATION
Anton Ehrhardt, Ph.D., Former Vice President, Global Medical Affairs, MITRA BIOTECH; Former President, IISRA

12:30 – 1:30

LUNCH BREAK

1:30 – 2:15

CHALLENGES AND SOLUTIONS OF INVESTIGATOR-INITIATED STUDIES IN A SMALL BIOTECH COMPANY
Talia Biran, Vice President, Clinical Development and Medical Affairs, ONCOLYS USA, INC

2:15 – 3:15

PANEL: ASSESS THE LEVELS OF COLLABORATION AND INVOLVEMENT WITHIN THE CONTINUUM OF INVESTIGATOR SPONSORED RESEARCH
Talia Biran, Vice President, Clinical Development and Medical Affairs, ONCOLYS USA, INC
Archie Stone, Ph.D., Vice President, Medical Affairs, ALCRESTA THERAPEUTICS
Sudeesh Tantry, Vice President, Global Medical Affairs, GLENMARK THERAPEUTICS

3:15 – 3:45

NETWORKING BREAK

3:45 – 4:30

UNDERSTAND INVESTIGATOR NEEDS AND TIMELINES TO ESTABLISH A SUCCESSFUL AND COMPLIANT TRIAL BY UNDERSTANDING INVESTIGATOR GOALS
Harvey Arbit, Pharm.D., MBA, Professor, UNIVERSITY OF MINNESOTA COLLEGE OF PHARMACY


Day Two

 WEDNESDAY, NOVEMBER 20

9:00 – 9:15

INTRODUCTION FROM CHAIRPERSON
Kimberly Cheshire-Kinney, Global Operations Head, IIS and Collaborative Studies-MAO, Global Clinical Development Operations, JANSSEN R&D

9:15 – 10:00

LEARN HOW TO DRAFT A WINNING IIT FUNDING PROPOSAL
Jennifer Gaskin, Director, Head of Global Medical and Scientific Affairs, KARYOPHARM THERAPEUTICS INC.
Tricia Gunter, B.A., CCRP, Senior Clinical Project Manager, Global Medical Research and Global Medical and Scientific Affairs Operations, KARYOPHARM THERAPEUTICS INC.

10:00 – 10:45

EVALUATE FAIR MARKET VALUE (FMV) STANDARDS AND UTILIZATION
Kirk Taylor, Senior Vice Present, Regional Medical Affairs, North America, EMD SERONO

10:45 – 11:15

NETWORKING BREAK

11:15 – 12:00

PROCESSES FOR MAINTAINING THE IIT QUALITY AND ENSURING RESULTS
Peter Shaw, MBBS, DRCOG, Chief Medical Officer, BIOVENTUS

12:00 – 12:45

AVANT-GARDE APPROACHES TO GETTING THE MOST OUT OF INVESTIGATOR-INITIATED TRIALS
Allecia A. Harley, MPH, CRA, Former Associate Vice President, Office of Research Affairs, RUSH UNIVERSITY

12:45 – 1:45

LUNCH BREAK

1:45 – 2:30

ENSURING COMPLIANCE FOR YOUR IIT PROGRAM: AN INDUSTRY PERSPECTIVE
Dana Gardner, Director, Scientific Affairs, MERCK

2:30 – 3:15

USING TECHNOLOGY TO ENHANCE AND ADVANCE INVESTIGATOR-INITIATED TRIALS
Jeremy Keeton, ONC Investigator-Initiated Trials Project Manager, Eli Lilly and Company