Agenda – Investigator-Initiated Trials (IIT) Forum

  • Day One
  • Day Two

Day One

 TUESDAY, NOVEMBER 19

8:45 – 9:00

CHAIRPERSON’S OPENING REMARKS
Kjersten Teeter, Associate Director and Head, Global Medical Affairs, ISS Program Management, SANOFI

9:00 – 9:45

INVESTIGATOR-INITIATED TRIAL START-UP AND MANAGEMENT BEST PRACTICES
Jasna Tholens, Clinical Program Leader, Director, IIS North America, JANSSEN

9:45 – 10:30

BENCHMARK BEST PRACTICES FOR NEGOTIATING CONTRACTS TO IMPROVE STUDY START-UP
Matthew Rogers, Senior Global Agreements Specialist, MERCK

10:30 – 11:00

NETWORKING BREAK

11:00 – 11:45

EVALUATE FAIR MARKET VALUE (FMV) STANDARDS AND UTILIZATION
Kirk Taylor, Senior Vice President, Medical Affairs Strategy and Operations, VERASTEM ONCOLOGY

11:45 – 12:30

NAVIGATE THE CHALLENGES WHEN BUDGETING AND CONTRACTING FOR GLOBAL IIT
Talia Biran, Executive Director, Medical Affairs, Oncology, LEXICON PHARMACEUTICALS, INC

12:30 – 1:30

NETWORKING LUNCH

1:30 – 2:15

OVERCOME PUBLICATION CHALLENGES FOR EFFICIENT COLLABORATIONS
Cynthia Barbitsch, Director/Team Leader of Clinical and Research Collaborations (CRC), PFIZER

2:15 – 3:00

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

3:00 – 3:30

NETWORKING BREAK

3:30 – 4:15

EFFECTIVELY DEMONSTRATE THE VALUE OF INVESTIGATOR-INITIATED TRIALS TO INTERNAL LEADERSHIP
Dennis Decktor, Director, Medical Affairs, REGENERON

4:15 – 5:00

KEY MANAGEMENT MODELS FOR IIT TEAM LEADERSHIP
Gurveen Saberwal, Senior Project Manager, IITs, Global Medical Affairs Oncology, SERVIER


Day Two

 WEDNESDAY, NOVEMBER 20

8:45 – 9:00

CHAIRPERSON’S RECAP OF DAY ONE
Kjersten Teeter, Associate Director and Head, Global Medical Affairs, ISS Program Management, SANOFI

9:00 – 9:45

BEST PRACTICES TO ENSURE QUALITY AND COMPLIANCE THROUGH THE IIT LIFE CYCLE
Anouk Lindley, Associate Director, Global Medical Affairs Operations, INCYTE

9:45 – 10:30

TECHNOLOGIES AND INITIATIVES FOR MONITORING AND TRACKING INVESTIGATOR-INITIATED TRIALS
Karen Klahn, MBA, Associate Director, Global Medical Affairs, TAKEDA PHARMACEUTICALS

10:30 – 11:00

NETWORKING BREAK

11:00 – 11:45

UNDERSTAND PRINCIPLE INVESTIGATOR NEEDS AND TIMELINES TO ESTABLISH LONGITUDINAL ROAD MAPS FOR CLINICAL TRIALS
Harvey Arbit, Ph.D., MBA, Professor, UNIVERSITY OF MINNESOTA COLLEGE OF PHARMACY

11:45 – 12:30

ENSURE COMPLIANT AND EFFICIENT INVESTIGATOR-INITIATED STUDIES BY LEVERAGING TECHNOLOGY
If you are interested in leading this session, contact Michael Williams at [email protected]

12:30 – 1:30

NETWORKING LUNCH

1:30 – 2:15

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

2:15 – 3:00

GAIN AN UNDERSTANDING OF FDA REGULATIONS WHEN PREPARING IITS
Dana Gardner, Director, Oncology MISP/SE Scientific Leadership and Research Manager Team Leader, Oncology, MERCK