Event Calendar

Investigator-Initiated Research

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2019 Agenda


Saturday, September 28, 1:40-2:25                                       

Investigator Initiated Trials - The Tale of Two Roles in One

Unlike industry sponsored trials focused on regulatory approval of new medications, investigator initiated trials (IITs) are developed and executed under the direction of 3rd party investigators who are physician researchers, often within an academic institution. Biopharmaceutical companies are using them as a creative and cost-effective way to innovate and further improve patient safety. Yet, these trials do come with some risks, potentially for the investigator and institutions. What is the guidance available and what are ways to ensure subject protection, data integrity, and ethical quality research? 225
Presenter: Cynthia Clark, PhD, MSN, CRNP, CCRC, Director of Research Operations Dermatology, Perelman Center for Advanced Medicine, 
Hospital of the University of Pennsylvania

Unlike industry sponsored trials focused on regulatory approval of new medications, investigator initiated trials (IITs) are developed and executed under the direction of 3rd party investigators who are physician researchers, often within an academic institution. Biopharmaceutical companies are using them as a creative and cost-effective way to innovate and further improve patient safety. Yet, these trials do come with some risks, potentially for the investigator and institutions. What is the guidance available and what are ways to ensure subject protection, data integrity, and ethical quality research? 225

Presenter: Cynthia Clark, PhD, MSN, CRNP, CCRC, Director of Research Operations Dermatology, Perelman Center for Advanced Medicine, Hospital of the University of Pennsylvania

Track: Investigator-Initiated Research


Saturday, September 28, 2:30-3:15                                     

Understanding Monitoring and Auditing in the Context of Investigator-Initiated Research

This presentation will provide an overview and define the activities of monitoring and auditing in clinical research. Beyond that, Ms. Gaskin will provide a guideline for how to structure these activities in investigator-initiated research with limited infrastructure and resources. 227

Presenter: Jennifer Gaskin, BA, CCRP, CMQ-OE, Director, Karyopharm

Track: Investigator-Initiated Research


Saturday, September 28, 3:45-4:30                                   

Investigational Product Management: Understand Your Responsibilities as a Sponsor/Investigator to Ensure Compliance

This presentation will review the responsibilities of the sponsor-investigator related to investigational product management, when performing investigator-initiated research. It will include a discussion of the regulations, resources and best practices to manage investigational product through the life-cycle of a clinical trial. 229

Presenter: Kathleen O’Malley, RN, BSN, CCRP, Associate Director of Education and Training, Jefferson Clinical Research Institute, Thomas Jefferson University

Track: Investigator-Initiated Research


Saturday, September 28, 4:35-5:20                                  

Meeting with Regulatory Authorities

Early, proactive, and productive communication with regulatory agencies can benefit many areas of investigator-initiated research. Many times, sponsor-investigators may have questions about IND or IDE related investigations that require a more detailed review or discussion than the information found in procedural guidance. Ms. Talley will review what types of mechanisms are available to request a meeting with specific centers or offices at the FDA and the purposes of each, how this relates to different types of IITs or investigator-driven technology development, and the benefit of doing so. The following meeting and communication types will be discussed: administrative, product-related (CDER, CBER, CDRH), safety/product inquiries. 231

Presenter: Christina Talley, MS, RAC, CCRP, CCRC, Director, Regulatory Affairs & Translational Management, Houston Methodist Research Institute

Track: Investigator-Initiated Research