agenda
Expert speakers | Thought-provoking topics | Collaborative discussion
Our speakers will dive deep into a variety of collaborative themes across this year's topic: Advancing Pediatric Cancer Drug Development through Pharmacokinetics, Modeling, and Improved Clinical Trial Designs
October 18, 2023
10:00 am Welcome from our Co-Chairs
Led by Brenda Weigel, MD, Director of the Division of Pediatric Hematology/Oncology at University of Minnesota; Jeffrey Skolnik, MD, Senior Vice President of Clinical Development at Inovio Pharmaceuticals
Key Concepts - Chaired by Yuki Otani, MD, PhD, Pediatric Pulmonologist and Advisor, Global PK/PD and Pharmacometrics at Eli Lilly and Company
10:15 am Basic Concepts and Terminology of Pharmacokinetics
Speaker: Izna Ali, PharmD, PhD, Senior Clinical Pharmacokineticist at Abbvie
10:45 am How Pharmacokinetics can Enhance the Design of Your Clinical Trial
Speaker: Ryan Jarret, PhD, Advisor, Global PK/PD & Pharmacometrics at Eli Lilly and Company
11:15 am Dose-Response Relationship: Step from Animals to Humans Flawed?
Speaker: Jingqi Gong, Ph.D., Associate Director of Quantitative Systems Pharmacology at GSK
11:45 – 12:30 pm Break for lunch
Clinical Session - Chaired by Jennifer Foster MD, MPH, Assoc. Prof. of Pediatrics-Oncology at Baylor College of Medicine
12:30 pm What are critical elements and practical expectations for the FDA?
Speaker: Amy Barone, MD, Cross-Disciplinary Team Leader, Division of Oncology, Office of New Drugs, U.S. Food and Drug Administration
1:30 pm Case Study: How to Bring Dabrafenib + Trametinib to the Clinic for Using Data?
Speaker: Dr. Jordan Hansford, Program Leader, Paediatric Neuro-Oncology Research at South Australian Health and Medical Research Institute (SAHMRI)
2:30 pm Trial Design: Operationalize a Trial in the Pediatric Population
Speaker: Julie Maher, Senior Director of Rare Disease, Advanced Therapeutics, and Pediatrics Team at Fortrea
3:30 pm Panel Discussion
4:00 – 4:30 pm Wrap-Up with Co-Chairs, Brenda Weigel, MD and Jeffrey Skolnik, MD
October 19, 2023
10:00 am Opening remarks from our Co-Chairs
Led by Brenda Weigel, MD, Director of the Division of Pediatric Hematology/Oncology at University of Minnesota; Jeffrey Skolnik, MD, Senior Vice President of Clinical Development at Inovio Pharmaceuticals
Current State - Chaired by Elizabeth Fox, MD, Senior Vice President of Clinical Trials Research at St. Jude Children’s Research Hospital
10:15 am Keynote: Data with a Focus on Pharmacokinetics and Clinical Trials
Speaker: Frank M. Balis, MD, Director of Cancer Clinical Research at Children's Hospital of Philadelphia Research Institute
11:00 am Are Adults Just Big Kids? Optimizing Pediatric Drug Exposure Based on Adult Experience
Speaker: Michael Craig Cox, PharmD, MHSc, BCOP, Senior Vice President, Head of Early Development at Circle Pharma
11:30 am Breakout Sessions – Seriously, How Can We Solve Barriers?
Group 1 led by: Kristine Crews, PharmD, BCPS, Clinical Pharmacogenomics Residency Director at St. Jude Children's Research Hospital
Group 2 led by: Rachel Kudgus, PhD, Director of Clinical Pharmacology at Allucent
12 - 12:30 pm Break for lunch
Future State - Chaired by Clinton Stewart, PharmD, Member, Pharmacy and Pharmaceutical Sciences at St. Jude Children's Research Hospital
12:30 pm Advanced Modeling Techniques Enhance Drug Development for Childhood Cancer
Speaker: Don Mager, Professor and Chair of the Dept of Pharmaceutical Sciences, School of Pharmaceutical Sciences at University of Buffalo
1:30 pm Artificial Intelligence and Machine Learning: The New Frontier of Drug Development and Cancer Research
Speaker: Qi Liu, PhD, Associate Director for Innovation & Partnership at Office of Clinical Pharmacology, U.S. Food and Drug Administration
2:30 pm Revitalizing Cancer Trials Post-Pandemic – Time for Reform
Speaker: James Spicer, professor of experimental cancer medicine at King's College London and a consultant in medical oncology
3:30 pm Panel Discussion
4:00 – 4:30 pm Closing Notes with Co-Chairs, Brenda Weigel, MD and Jeffrey Skolnik, MD

Critical stakeholder collaboration
CureSearch PEDS serves as a synergistic platform for driving critical stakeholder collaborations to accelerate the pace of pediatric drug development. This annual symposium brings together leaders from all areas of the global pediatric cancer ecosystem to drive the collaborations necessary to accelerate and drive real, measurable change in children’s cancer research. Experts in the field convene to provide real-world examples and solutions relating to clinical trial design, optimization and conduct.
Symposium Co-Chairs

Jeffrey Skolnik, MD
Vice President, Clinical Development
Inovio Pharmaceuticals Inc.

Brenda Weigel, MD
Director of the Division of Pediatric Hematology and Oncology
University of Minnesota's Masonic Cancer Center
Working Group Members
Brenda Weigel, MD (Chair), University of Minnesota
Jeffrey Skolnik, PhD (Chair), Inovio Pharmaceuticals
Lou Stancato, PhD, Eli Lilly and Company
Beth Fox, MD, St. Jude Children’s Research Hospital
Clinton Stewart, PharmD, St. Jude Children's Research Hospital
Jeff Barrett, PhD, Aridhia
Peter Adamson, MD, Sanofi
Daniel Morgenstern, MD, Hospital for Sick Children
Diana Merino, PhD, AstraZeneca
sponsors




wHAT ARE PEOPLE SAYING ABOUT PEDS?
"There are lots of moving parts to PIPs/PSPs but with the right knowledge and support, that can be done in a way that supports drug development in pediatric oncology."
“The pediatric oncology community (academia, industry, regulatory, advocacy) is made up of a very special set of dedicated experts working diligently to improve pediatric drug development.”
“There are many people working very hard to figure out how to advance drugs for children. On the other hand, companies aren't really geared up for the process yet.”
“This was truly a one-of-a-kind effort that's invaluable to our community!”
“Collaboration/partnership/Communication. It's not anything revelatory, but the sessions reinforced the importance of these concepts across all of Peds Oncology development. The better and more efficient that industry, regulators and academia can be at working together, the faster that new and better drugs will become available for pediatric cancer patients.”
“I really wanted to thank the organizers for allowing for enough time for substantive discussions. The Q&A sessions were brilliant.”