Early Phase Research Site Strategy Summit

On-Demand Content | Virtual Event

AGENDA – ALL TIMES ARE IN EASTERN TIME

Hear from a Principal Investigator on how to bond a team to partner for your patients. Dr. Graff will explore how to lead phase I teams successfully in collaboration.
  • Identify broad stakeholders to expand access and awareness of clinical research team
  • Strategies for PI leadership of clinical research teams
  • Partnering to eliminate barriers to early phase research
Stephanie L. Graff, MD, FACP, Director of Breast Oncology, Lifespan Cancer Institute, Assistant Professor of Medicine, BROWN UNIVERSITY
A discussion on Phase 1 studies and setting up regulatory structures and pharmacy setups to accommodate the needs of investigational pharmacies in such Phase 1 study facilities. At the end of this discussion the audience should be able to:
  • Understand the key pharmacy stakeholders
  • Identify agencies that may play a role in setting up a Phase I IDS pharmacy
  • Evaluate key legal and regulatory expectations associated with managing a Phase I pharmacy.
Darshan Kulkarni, Pharm.D, MS, Esq, Regulatory & Compliance Attorney, THE KULKARNI LAW FIRM
Victoria Flores, MBA, ACRP-CP, Medicare Coverage Specialist Clinical Research, BAYLOR SCOTT & WHITE HEALTH
This session is designed to address the evolution of Phase I clinical trials for cancer treatment and explore how to optimize recruitment within the current landscape. Barriers to recruitment will be discussed, as well as strategies for successful recruitment.
  • Identify the current landscape of Phase I cancer treatment trials.
  • Recognize barriers and opportunities for recruitment into Phase I cancer treatment trials.
  • Optimize emerging strategies for recruitment into Phase I cancer treatment trials.
Teresa Knoop, MSN, RN, AOCN
Kelly Willenberg, CEOKELLY WILLENBERG & ASSOCIATES  
Successful collaboration with physician customers is an art. Define your goals and stretch your capabilities. Discuss challenges and how to meet those to create a positive environment.
  • Define physician scientists and understand attributes to improve success.
  • List necessary Resources for developing research projects and/or programs.
  • Discuss barriers to collaboration with physician scientists.
Jan Kueber, MBA, BSN, OCN, Nurse Manager, Translational OncologyPRISMA HEALTH
  • Identify the unique regulatory and operational challenges of monitoring IITs
  • Learn the key components of monitoring IITs including monitoring plans & schedules, remote risk-based monitoring, and alignment with data capture
  • Discuss strategies to address operational challenges of monitoring IITs and share lessons learned
Wendy Portier, Independent Contractor, KELLY WILLENBERG & ASSOCIATES
Cindy Dunn, Independent Contractor, KELLY WILLENBERG & ASSOCIATES
  • Analyze need for a Coverage Analysis in early phase trials
  • Evaluating who should perform a review of therapeutic intent and the CA
  • Explore operations at a phase I unit and a large academic medical center
Jennifer Kellen, Senior Director, Investigator Grants, EXELIXIS
Dawn N. L. Pittinger, MBA, CHRC, CRCP, Research Billing Compliance Manager at MOFFITT CANCER CENTER IN TAMPA, FL
First in Human (FIH) and Phase 1 trials are very complex! This session will help your site to understand the requirements of the trial and evaluate the time involved, not only at the patient visit level but at the site level. Explore the entire course of a trial and never leave money on the table!

Objectives:
  • Analyze the study by reviewing the Protocol, Lab & Pharmacy Manual, ICF, Pharma Budget Template, etc.
  • Translate the logistics of the trial from what is on paper (schedule of events) to what will occur in a clinical setting
  • Evaluate the billing by enhancing your knowledge of the study with good processes that allow you to bill correctly and collect on invoicing.
Angela Ebel, Vice President of Research, MARY CROWLEY CANCER RESEARCH