Agenda

Day 1: Thursday, May 5, 2022


8:00 - 8:30      Registration and Continental Breakfast

8:30 - 9:00      Welcome & Introduction
Program Co-Chairs:
Lisa Benson, President, Pediatric Clinical Research Consulting, LLC
Amanda Galster, MPH, CCRP, Research Director, University of Arizona Health Sciences 
Grace Wentzel, CHRC, CCRP, Director, Clinical Research Services, Abigail Wexner Research Institute, Nationwide Children’s Hospital

9:00 - 10:00    Challenges and Opportunities for Pediatric Drug and Device Development
Jonathan M. Davis, MD, Chief of Newborn Medicine, Tufts University School of Medicine
Why has pediatric drug and device development been so limited compared to adults? Dr. Davis will discuss what legislative and regulatory efforts exist to facilitate drug/device development. In addition, he will discuss what novel international collaborations also exist to facilitate drug/device development.

10:00 - 10:15    Break

10:15 - 11:15      How to Think About Regulatory Distinctions in the Pediatric Critical Care Environment
David Staley, MA, Associate Director, Institutional Research Center of Excellence, Advarra Consulting 
Mr. Staley will analyze ways of thinking through regulatory distinctions in pediatric research carried out in NICUs and PICUs. From there, attendees will identify some unique challenges when conducting research in the pediatric critical care environment and explore suggested methods for addressing these challenges. Finally, attendees will consider a case study to apply the ideas and methods presented during this session.

11:15 - 12:15    Real World Data Focus on Neonatology
Collin Hovinga, PharmD, MS, FCCP, Senior Vice President, Institute for Advanced Clinical Trials for Children (I-ACT)
Dr. Hovinga will discuss the potential role of real world data (RWD) in neonatology studies from different stakeholder perspectives. He will also describe the establishment of a neonatal RWD warehouse and outline ways stakeholders might contribute and access neonatal RWD.

12:15 - 1:00     Lunch (Provided)

1:00 - 1:45      Ethical Considerations when Enrolling Families in Clinical Research Studies in a Critical Care Setting
Amanda Galster, MPH, CCRP, Research Director, University of Arizona Health Sciences  

Ms. Galster will review the ethical principles and therapeutic misconceptions in the context of pediatric clinical research, with special considerations in the PICU and NICU. 

1:45 - 2:45      Round Table Discussion – Ethical Considerations Scenarios
Program Faculty  
This round table discussion will provide an opportunity to further discuss the previously presented topic and allow an interactive exchange from all attendees.

2:45 - 3:00     Break

3:00 - 4:00     Practicalities of Conducting Research in a Critical Care Setting
Vidya Iyer, MBBS, CPI, Director Clinical Research, OBGYN/Pediatrics; Manager, Tufts CTSI’s Clinical and Translational Research Center and Research Assistant Professor, Tufts University School of Medicine
Dr. Iyer will discuss general challenges of conducting clinical research in pediatrics with examples of specific studies in the NICU and PICU setting moving on to discuss possible, practical ways to conduct studies in these settings.

4:00 - 4:45      NICU Staff Engagement  
Kim Jennings, BA, CCRP, Director, Clinical Site Network System Operations, Institute for Advanced Clinical Trials for Children (I-ACT)
Ms. Jennings will discuss best practices used to engage the NICU staff in conducting and managing clinical trials. It will also include lessons learned from my experiences managing and conducting clinical trials in a NICU. It will also include information on how to best educate the staff on the protocol.

4:45 - 5:00      Wrap Up and Questions


Day 2: Friday, May 6, 2022


8:00 - 8:30     Continental Breakfast

8:30 - 9:15      Budgeting for Pediatric Clinical Research
Lisa Benson, President, Pediatric Clinical Research Consulting, LLC
Ms. Benson will discuss special considerations for developing pediatric research study budgets including a review of "hidden costs". She will present best practices for contract negotiations and payment collection.

9:15 - 10:00    Monitoring, Auditing and Compliance for Pediatric Clinical Trials
Lisa Benson, President, Pediatric Clinical Research Consulting, LLC
Ms. Benson will consider monitoring and auditing issues specific to pediatric research. Ms. Benson will highlight FDA inspections and financial compliance. The concept of minimizing risk through good clinical practice will also be explored.

10:00 - 10:15    Break

10:15 - 11:15    Sponsor Perspective on Conducting Pediatric Clinical Trials
Edress Darsey, PharmD, FPPAG, Pediatric Clinical Director, Pediatric Center of Excellence, Pfizer Inc.  

Dr. Darsey will discuss what makes pediatric and neonatal clinical trials different and challenging from a clinical view. She will also explain why drug development studies are performed in the pediatric population and how far drug development has come in the past 10-20 years. 

11:15 - 12:15    Redefining the Clinical Research Workforce Two Years Post the Start of a Pandemic
Grace Wentzel, CHRC, CCRP, Director, Clinical Research Services, Abigail Wexner Research Institute, Nationwide Children’s Hospital

Ms. Wentzel will discuss the current state of the workforce including the Great Resignation, specific challenges experienced in clinical research, changing terms of engagement of the workforce and possible steps clinical research sites, CRO’s and sponsors can take to recruit and retain talent in this complex environment.

12:15 - 1:00     Lunch (Provided)

1:00 - 2:00      Shifting from Mortality to Morbidity Research in the Pediatric Intensive Care Unit
Mallory Perry, PhD, RN, Clinical Research Associate; NIH/NIGMS Postdoctoral Fellow, Children’s Hospital of Philadelphia Research Institute
Children are surviving critical illness, yet rates of new morbidity are steadily increasing. Dr. Perry will discuss the importance of survivorship research in pediatric critical care, the risk factors for new morbidity after discharge from the Pediatric Intensive Care Unit and challenges in conducting such research. Dr. Perry will use exemplars from her current research she is conducting in critically ill sepsis survivors.

2:00 - 2:45      Round Table Discussion - Overcoming Challenges in Clinical Research in a Critical Care Setting
Program Faculty 
This second round table discussion will provide an opportunity for attendees to discuss the challenges they have personally faced working in a critical care setting and how to overcome those challenges.

2:45 - 3:00      Break

3:00 - 4:00     Working with Distressed Families
Vidya Iyer, MBBS, CPI, Director Clinical Research, OBGYN/Pediatrics; Manager, Tufts CTSI’s Clinical and Translational Research Center and Research Assistant Professor, Tufts University School of Medicine
Dr. Iyer will recap challenges in conducting trials in pediatric critical care settings from the previous talks with possible ways to mitigate these challenges including leveraging the clinical care team in engaging with distressed families.

4:00 - 4:30      Wrap Up and Questions